linjc16/ctgov huggingface dataset:
CARE: Cancer Risk Perception and Women of Color

Study Overview
=================
Brief Summary
-----------------
This study examines patient understanding of current and lifetime risk for breast cancer in women of color from diverse racial and ethnic backgrounds.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Examine the association between BC risk factors and BC risk perceptions among younger Black and Hispanic women and explore differences in associations by race and ethnicity (Black Hispanic, Black, Hispanic). II. Explore how younger Black and Hispanic women conceptualize and formulate their risk for BC and to explore the relationship between risk perceptions and risk-reduction strategies. OUTLINE: This is an observational study. Patients complete a survey and may participate in an interview on study.

Official Title
-----------------
CARE: Cancer Risk Perception and Women of Color

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Other: Non-Interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identify as female Between the ages of 25 and 50 No medical history of breast cancer Reside in Arizona or Florida Exclusion Criteria: Unable to understand or comprehend English or Spanish

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health Services Research<br>Patients complete a survey and may participate in an interview on study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of risk | Measured using a 0-100% response (percent lifetime risk) and a 5-point verbal scale ranging from 'very low' to 'very high' (ordinal lifetime risk). Participants will also be asked to assess their risk compared to women their age with the response options of 'much lower', 'about the same', and 'much higher' (comparative risk likelihood). | Baseline (at enrollment) |
Butorphanol in Pain Following Ablation for Hepatic Tumor

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation was to evaluate the influence of Butorphanol on postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor. Employing a rigorously designed multicentral, randomized, and placebo-controlled format, patients subjected to microwave ablation were assigned randomly to either Butorphanol (experimental group) or normal saline (control group). Primary outcomes encompassed intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the 6-hour mark (VAS) and comprehensive pain assessment outcomes.

Official Title
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Effectiveness of Butorphanol in Alleviating Postoperative Visceral Pain Following Microwave Ablation for Hepatic Tumor: A Multicentral, Randomized, Placebo-Controlled Trial

Conditions
-----------------
Visceral Pain, Microwave Ablation, Hepatic Tumor

Intervention / Treatment
-----------------
* Drug: Butorphanol
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients performing Microwave Ablation sign the informed consent Exclusion Criteria: Patients with a body mass index > 30 kg/m2 a history of depression opioid dependence poorly controlled hypertension (systolic blood pressure > 180 mmHg) myocardial infarction severe liver disease significant abdominal pain before surgery patients with sensory system or language dysfunctions who could not cooperate to complete the scale pregnant women.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butorphanol<br> | Drug: Butorphanol<br>* The pharmacological attributes of Butorphanol, characterized by its mild impact on cardiopulmonary dynamics and demonstrated efficacy in attenuating mechanical traction-induced discomfort, culminate in an ameliorative effect on postoperative nausea and vomiting rates. Importantly, it substantively attenuates visceral postoperative pain. However, sedation can also cause dizziness, drowsiness, and other adverse reactions during recovery<br>|
| Placebo Comparator: normal saline<br> | Drug: normal saline<br>* normal saline contain 0.9% NaCl sodium.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral Pain | VAS score of visceral pain | during the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral Pain | VAS score of visceral pain | 6-hour after surgery |
Knowledge Beliefs and Expectations of Chronic Musculoskeletal Patients About Their Physiotherapy Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the knowledge, beliefs and expectations of patients with chronic musculoskeletal pain about their physiotherapy program and the relationship that they built with physiotherapists.

Detailed Description
-----------------
The main questions of this study are: Have patients with chronic pain educated in pain? To what extent physiotherapists use appropriate communication skills and show empathy? What expectations do the patients have of their rehabilitation program?

Official Title
-----------------
Knowledge Beliefs and Expectations of Chronic Musculoskeletal Patients About Their Physiotherapy Program

Conditions
-----------------
Chronic Musculoskeletal Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic musculoskeletal pain more than 3 months and intensity more than 3/10 VAS. Greek speaking patients patients who are following or followed a physiotherapy treatment for their pain Exclusion Criteria: None

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics | Questions will include participants' demographic characteristics (e.g. gender, age, education, employment status) | Baseline | 
| Knowledge about their pain | Fourteen questions about history of pain (e.g. intense, duration, area, other symptoms, radiation, previous history, diagnosis) | Baseline | 
| Pain (Neuroscience) Education | Patients will be asked whether they have received any education or explanation about their conditions from a healthcare professional (e.g. What have they learned about their pain? What do they know about pain neuroscience education? Whether it was explained to them and how understanding pain helped them?) | Baseline | 
| Patient's Experience about healthcare professional's communication skills | Seventeen questions on a five point Likert scale (1=never, 2= rarely, 3=sometimes, 4=often, 5=always). Questions adapted by the Calgary-Cambridge observation guide that delineates and structures the skills which aid doctor-patient communication. | Baseline | 
| Patient's Expectations | Four questions regarding patients' expectations for chronic pain management | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic musculoskeletal pain, pain education, patient expectations, communication skills, physiotherapy
Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to establish a cancer registry to facilitate research and assist in the identification of additional risk factors for hepatocellular carcinoma. The main objectives are: provide a mechanism to store the information about subjects with hepatocellular carcinoma use of tissue samples for translational/further research purposes

Detailed Description
-----------------
The Establishment of a Tissue Registry for Hepatocellular Carcinoma biopsy specimens for genetic and histologic research (TIR-HCC) is a project aimed at addressing the high incidence rates of primary liver cancer in Armenia. This initiative seeks to establish a cancer registry to support research efforts and identify additional risk factors associated with hepatocellular carcinoma (HCC). The study will involve patients of Armenian descent who exhibit clinical, biochemical, and imaging evidence of hepatocellular carcinoma. Data collection will include tissue and blood samples, which will undergo histologic and genetic analyses. Additionally, relevant clinical history, laboratory results, imaging findings, and gut microbiota profiles will be collected. To ensure a comprehensive dataset, samples will be collected from eight institutions in Armenia. The project aims to accumulate data from a total of 500 patients, providing a substantial pool for research and analysis. By establishing the TIR-HCC registry, researchers hope to contribute to the understanding of hepatocellular carcinoma and potentially identify new risk factors associated with the disease. The collected data will aid in advancing knowledge of HCC and guide future strategies for prevention, early detection, and treatment.

Official Title
-----------------
Establishment of a Tissue Registry for Hepatocellular Carcinoma Specimens for Genetic and Histologic Research

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy-confirmed diagnosis of HCC Armenian descent Having given their signed Informed consent Exclusion Criteria: Failure to obtain informed consent
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 |
| --- | --- | --- |
| Creation of a registry | The primary outcome of this study is to provide a mechanism to store the information about subjects with hepatocellular carcinoma. The outcome will be measured by the number of patients involved in the registry, measured by absolute numbers. The target number is 500 patients. | 5 year |
Lyric4 Outcomes Evaluation

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical investigation is to obtain feedback on Lyric4 device updates within a cohort of experienced adult Lyric hearing instrument users. The main question it aims to answer is: • Do device updates cause a change in Lyric patient experience? Participants will be asked to complete questionnaires about their past experience with Lyric, as well as their experience with Lyric during the study period. They will also be asked to undergo aided audiometric testing with Lyric devices.

Official Title
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Evaluation of Daily- and Extended-wear Hearing Instruments

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Lyric4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experience with Lyric hearing instruments Willingness to travel to the study site and complete study procedures Adults, age 18 or older Fluency with English (written/spoken) Exclusion Criteria: No Lyric hearing instrument experience Ear health issues preventing Lyric fitting or requiring medical clearance prior to fitting Difficulty reading when corrected for vision loss

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: Experienced Lyric Users<br>This cohort of participants is required to have Lyric hearing instrument experience, and they will be asked to wear Lyric for the duration of the study period and report on their experience. | Device: Lyric4<br>* Lyric4 Hearing instrument use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aided Audiometric Testing |  | From enrollment to the end of the study period, approximately one month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hearing loss
Prediction of Axillary Lymph Node Metastasis Status in Breast Cancer Based on PET/CT Radiomics

Study Overview
=================
Brief Summary
-----------------
Patients with suspected breast cancer undergoing PET/CT at our hospital. The PET/CT center's chief physician and senior attending physician reviewed the films together and disagreement, if any, was resolved by consensus. The lesion was visually identified. A 3D region of interest(ROI) of the lesion was automatically outlined using the 40% threshold method, and PET metabolic parameters were measured . Breast lesions with radionuclide concentrations greater than those in normal breast tissue are considered to be breast cancer lesions, while lymph nodes with radionuclide concentrations greater than those in muscle tissue are considered to be metastatic lymph nodes. Image segmentation: Image segmentation was performed using ITK-SNAP software (4) (version 3.6.0, http://www.itksnap.org/), Brush Style: circular, Brush Size: 10, Brush Options: 3D. The entire tumor volume was outlined on the PET image as ROI for segmentation. An open source Python package (PyRadiomics version 3.0.1(5)) was used to extract the radiomics features from the ROI. Univariate and multivariate binary logistic regressions were used to construct model for predicting lymph node metastasis in breast cancer.

Official Title
-----------------
A Study on the Construction of a Comprehensive Predictive Model for Axillary Lymph Node Metastasis in Breast Cancer

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Other: Radiomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) 18F-FDG PET/CT for breast occupancy; 2) adult female patients with pathologically confirmed breast cancer (age ≥18 years); 3) no history of surgery, radiotherapy, or chemotherapy before 18F-FDG PET/CT; and 4) interval between 18F-FDG PET/CT and puncture/surgery ≤2 weeks. Exclusion Criteria: 1) multifocal, bilateral, or occult breast cancer; 2) incomplete clinical or pathological data; 3) poor PET/CT image quality, when metabolic tumor volume(MTV) cannot be automatically segmented; and 4) concomitant malignant tumors.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axillary lymph node metastasis<br> | Other: Radiomics<br>* PET Radiomics<br>|
| No axillary lymph node metastasis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiomics score | Higher radiomics scores indicate better model prediction performance | 1 day During the inspection |
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients

Study Overview
=================
Brief Summary
-----------------
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).

Official Title
-----------------
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients

Conditions
-----------------
Vital Sign Evaluation

Intervention / Treatment
-----------------
* Device: Informed Vital Core App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 22 -85 years of age Subjects willing to sign the Informed Consent Form and comply with the protocol Exclusion Criteria Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject Condition that does not allow the subject to remain still for 60 seconds at a time Subjects with cardiac arrhythmia Any known medical condition which may result in an inaccurate measurement using the reference device Subjects with the inability to complete an ECG.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Informed Vital Core App|All subjects assigned to a single arm, pulse rate measurement will be collected, calculated, and displayed on the web based application. A conventional ECG device will also be used to collect and display the heart rate at the same time. If additional consent is obtained subjects may provide blood pressure and SpO2 measurements for the web based application.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Rate non-inferiority | The primary endpoint is a non-inferiority comparison to an FDA approved reference device to establish that PR measured with the IVC App are accurate. | Baseline only, single visit |
Prediction of Early Recovery of Liver Function After LDLT in Children: An Ambispective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The investigators included children with living donor liver transplantation (LDLT) from January 1, 2018 to July 31, 2022 as a retrospective cohort, and the group from August 1, 2022 to June 30, 2023 as a prospective cohort. The investigators collected the demographic and clinicopathological data of donors and recipients, and determined the risk factors of early postoperative delayed recovery of hepatic function (DRHF) by univariate and multivariate Logical regression analyses.

Official Title
-----------------
Prediction of Early Recovery of Liver Function After Living Donor Liver Transplantation in Children: An Ambispective Cohort Study

Conditions
-----------------
Liver and Biliary Tract Disorders in Duration of Pregnancy, Other End-stage Liver Diseases in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with the indication of LDLT [cholestatic liver disease (such as BA), metabolic liver disease (such as Wilson's disease and Ornithine transcarbamylase deficiency), acute liver failure (such as drug induced), neoplastic disease (such as hepatoblastoma), vascular disease (such as cavernous transformation of portal vein and congenital absence of portal vein), re-transplantation and others]; the relatives of the children voluntarily donated part of the liver which met the requirements of LDLT. Exclusion Criteria: recipients with contraindications of LDLT (such as coagulation dysfunction, acute infection, cardiopulmonary failure); failure to complete LDLT due to various reasons (such as death during or within 3 days after operation); recipients or donors with incomplete necessary data.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum 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 |
| --- | --- |
| living donor liver transplantation in children<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DRHF | Investigators collected liver function data of children after LDLT. Delayed recovery of hepatic function (DRHF) is characterized by the increase of PT-INR combined with hyperbilirubinemia on or after postoperative day 5. | 30 days after LDLT in children |
Evaluation of Artificial Intelligence Models for Diagnosis of Anterior Open Bite Malocclusion

Study Overview
=================
Brief Summary
-----------------
Building artificial intelligence models for diagnosis of anterior open bite malocclusion

Detailed Description
-----------------
The study aims at creating artificial intelligence models, with the input being the pre-treatment photographs and radiographs of open bite patients that are routinely taken for diagnosis and treatment planning. The output of the AI model will be the type and phenotype of anterior open bite. The photographs and radiographs with highest quality will be arranged in certain standardized templates to facilitate the machine learning process.

Official Title
-----------------
Evaluation of Artificial Intelligence Models for Diagnosis of Anterior Open Bite Malocclusion

Conditions
-----------------
Artificial Intelligence, Open Bite

Intervention / Treatment
-----------------
* Diagnostic Test: artificial intelligence model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anterior open bite Exclusion Criteria: craniofacial syndromes, previous orthodontic treatment, poor quality records

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: artificial intelligence model|artificial intelligence model of anterior open bite diagnosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficiency of artificial intelligence (AI) model in diagnosis of anterior open bite | The percentage of agreement between the AI model result and the actual diagnosis | 8 months |