linjc16/ctgov huggingface dataset:
A Study of Contrast-Enhanced Mammography (CEM) Scans in People With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.

Official Title
-----------------
Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer

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

Intervention / Treatment
-----------------
* Diagnostic Test: Contrast-Enhanced Mammography
* Diagnostic Test: Breast MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any women >18 years of age at time of informed consent Diagnosed with breast cancer and schedule for NAT Exclusion Criteria: History of kidney disease, creatinine level >1.3 or eGFR <45. Known allergic reaction to gadolinium or iodinated contrast media. Contraindication to contrast-enhanced breast MRI. Lesion not included in the field of view of either pre- or post-NAT MRI or CEM Presence of pacemakers or automated implantable cardioverter defibrilator Pregnant women

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Breast Cancer<br>Participants will have a diagnosis of breast cancer | Diagnostic Test: Contrast-Enhanced Mammography<br>* Participants will have pre- and post-treatment CEM of the affected breast<br>* Other names: CEM;Diagnostic Test: Breast MRI<br>* Pre- and post-NAT breast MRI will be performed for all participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition | compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT. | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, Memorial Sloan Kettering Cancer Center, 23-224
NPO Before Sedation

Study Overview
=================
Brief Summary
-----------------
Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited. Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).

Official Title
-----------------
Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.

Conditions
-----------------
Pediatric ALL

Intervention / Treatment
-----------------
* Other: 4 hours of fasting time
* Other: 1 hour of fasting time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children scheduled for elective echocardiography Aged under 3 years old Exclusion Criteria: Comorbidity other than hear disease or chromosomal disease Patients with delayed gastric emptying Patients with structural abnormalities of the stomach or esophagus Difficult airway management Parents refuse to participate in the study Unable to achieve sedation Neonatal

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 3 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4H group<br>fasting more than 4 hours before sedation | Other: 4 hours of fasting time<br>* Oral intake is not allowed for 4 hours before sedation including water<br>|
| Experimental: 1H group<br>oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation | Other: 1 hour of fasting time<br>* Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric astral cross-sectional area | Gastric astral cross-sectional area measured with gastric ultrasound | 10 minutes before sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated gastric volume | Calculated gastric volume using the formula | 10 minutes before sedation | 
| Perlas grade | Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration | 10 minutes before sedation | 
| Quality of sdeation | 0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling | 10 minutes after sedation |
Helicobacter Pylori Screening at Sohag University

Study Overview
=================
Brief Summary
-----------------
Screen of Helicobacter pylori in hyperemesis gravidarum in early pregnancy to detect the impact of the severity of the disease on pregnant women

Official Title
-----------------
Helicobacter Pylori Screening in Hyperemesis Gravidarum in Early Pregnancy

Conditions
-----------------
In Early Pregnancy

Intervention / Treatment
-----------------
* Diagnostic Test: Stool antigen test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant woman <16wk Exclusion Criteria: pregnant woman >16wks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Stool antigen test|Antigen test in the stool analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive | Positive for Helicobacter pylori | 2 days |
Comparison of Dental Pain Response in Children

Study Overview
=================
Brief Summary
-----------------
Study involves the observation of the child's behavior during a dental treatment procedure. This allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure.

Official Title
-----------------
Comparison of Behavioral , Physiological and Self-reported Pain Responses in Children With Dental Pain

Conditions
-----------------
Dental Anxiety

Intervention / Treatment
-----------------
* Behavioral: experimental


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range: Children aged between 6-12 years old (or any other specific age range) will be included in the study. Dental pain: Participants who have been diagnosed with dental pain by their dentist will be included. Consent: Informed consent must be obtained from the child and their parents or guardians before the study. Exclusion Criteria: Participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression. Participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: behaviour<br> | Behavioral: experimental<br>* During the procedure, the chairside assistant can capture video recordings of the child's behavior and facial expressions. These videos can be later reviewed by a trained observer who can evaluate the child's pain experience<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Analysis of pain after the treatment pain will be measured by using Visual Analogue Scale(VAS) which is an 10-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured | immediately after completion of the treatment within 60 seconds |
Heart Failure With Improved Ejection Fraction and Deep Learning

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to design a deep learning-based trained model to assist in HFimpEF diagnosis.

Official Title
-----------------
Deep Learning-Based Prediction Model of Heart Failure With Improved Ejection Fraction

Conditions
-----------------
Heart Failure, Diagnosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years. The diagnostic criteria of HF follows the 2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure, having symptoms of dyspnea, fatigue or decreased activity tolerance, having signs of fluid retention (such as pulmonary congestion and peripheral edema), having echocardiogram abnormalities in cardiac structure and/or function, showing elevated natriuretic peptide levels (BNP>35 ng/L or/and N-terminal pro-BNP >125 ng/L). Have reviewing echocardiography after discharge. Exclusion Criteria: Patients with hypertrophic, restrictive, or invasive cardiomyopathy and congenital or rheumatic heart disease. Patients with heart transplantation during follow-up.

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 |
| --- | --- |
| HFrEF group<br>Heart failure patients with LVEF persistently ≤40%. | |
| HFimpEF group<br>Heart failure patients with previous LVEF ≤40% and a follow-up LVEF of more than 40%. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of left ventricular ejection fraction | left ventricular ejection fraction value in millimeters | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of clinical predictor of EF improvement | weight in kilograms, height in meters(weight and height will be combined to report BMI in kg/m^2) | 3 months | 
| the independent clinical predictor of HFimpEF | prealbumin in mg/L | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Left ventricular ejection fraction, Heart failure with improved ejection fraction, Deep learning
Self-Care Behaviors Scale in Endometriosis

Study Overview
=================
Brief Summary
-----------------
In this study, it was aimed to develop a reliable and valid scale to measure the self-care behaviors of women with endometriosis.

Detailed Description
-----------------
In this study, it was aimed to develop a reliable and valid scale to measure the self-care behaviors of women with endometriosis.This research is of methodological type.Data will be collected by using Participant Description Questionnaire and Self-Care Behaviors Scale in Endometriosis.

Official Title
-----------------
Development of the Self-Care Behaviors Scale in Endometriosis

Conditions
-----------------
Endometriosis, Self Care, Behavior, Nursing Role

Intervention / Treatment
-----------------
* Other: Scale development


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reproductive age, Diagnosed with endometriosis, Having no medical or gynecological problems other than endometriosis, Able to read and write, Not pregnant, No barriers to communication, Not diagnosed with a psychiatric illness, Volunteer to participate in the study, Women who can speak and understand Turkish will be included. Exclusion Criteria: • Women who incomplete in the data collection forms incompletely will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Scale development|Scale development|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care Behaviors Scale in Endometriosis | This scale will be developed to measure the self-care behaviors of women with endometriosis.After the reliability and validity analyzes of the scale, the sub-dimensions of the scale, the number of items and the total score will be determined. | 9 months |
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

Study Overview
=================
Brief Summary
-----------------
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.

Official Title
-----------------
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

Conditions
-----------------
Inguinal Hernia Repair

Intervention / Treatment
-----------------
* Device: Robotic-assisted inguinal hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged > 18 years Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed. Able to provide Informed Consent according to local regulation Exclusion Criteria: Morbidly obese patients (BMI > 40) Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery Bleeding diathesis Pregnancy Patients with pacemakers or internal defibrillators Any planned concomitant procedures Patient deprived of liberty by administrative or judicial decision or under legal guardianship Participation in another interventional clinical trial

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Robotic-assisted inguinal hernia repair|Primary transperitoneal unilateral or bilateral inguinal hernia repair with the Dexter robotic system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events |  | perioperatively up to 30 days | 
| Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach |  | intraoperative |
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones

Study Overview
=================
Brief Summary
-----------------
To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

Detailed Description
-----------------
Detection of gallbladder gallstone using Dual Energy CT compare to gallblader ultrasound (gold standard). All patients who undergo dual-energy CT scans will undergo abdominal ultrasound for gallstones. Performance of CT to conventionnal KeV will be compare to low Kev monoenergetic reconstruction, and Effective Z. Expected duration of inclusion 3-6 months. No follow-up.

Official Title
-----------------
Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones

Conditions
-----------------
Gallstone

Intervention / Treatment
-----------------
* Other: gallbladder ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient referred to the radiology department for an abdominal CT for abdominal pain, suspicion of cholangitis, cholecystitis, migration of stones, acute pancreatitis, suspicion of perforated ulcer in the emergency setting. Non-objection of the subject to participate in the study Affiliation to a French social security scheme or beneficiary of such a scheme. Exclusion Criteria: Cholecystectomy Legal incapacity or limited legal capacity, legal safeguard Pregnant women Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator Subject being in the exclusion period of another study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: gallblader ultrasound<br> | Other: gallbladder ultrasound<br>* gallbladder ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gallstone detection using Dual Energy CT | Number - size of gallstones | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gallstone detection using reconstruction to conventionnal KeV. | Number - size of gallstones | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal and pelvic scan, abdominal Ultrasound
Studying Patient Experiences in Osteoporosis Clinical Trials

Study Overview
=================
Brief Summary
-----------------
Clinical trials for osteoporosis are designed to assess the safety and effectiveness of novel osteoporosis treatments. These trials play a crucial role in establishing whether these new treatments outperform existing options and provide substantial evidence to support their adoption within the wider population. The primary aim of this particular study is to investigate the experiences of individuals diagnosed with osteoporosis who participate in a distinct clinical trial involving a medical intervention. The focus will be on closely monitoring the rates of trial completion and withdrawal among these participants.

Official Title
-----------------
Uncovering Osteoporosis Clinical Trials: Firsthand Patient Insights Into Clinical Trial Experiences

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with osteoporosis Patient has self-identified as planning to enroll in an observational clinical trial Patient is a minimum of 18 years or older Exclusion Criteria: Pregnant or nursing patients Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form

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 |
| --- | --- | --- |
| Number of patients who decide to join in an osteoporosis clinical trial |  | 3 months | 
| Rate of patients who remain in osteoporosis clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis
Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)

Official Title
-----------------
A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)

Conditions
-----------------
cGVHD

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years inclusive at the time of signing the ICF Allogeneic SCT 90 to 180 days prior to enrollment Able to comprehend and willing to provide informed consent Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel Exclusion Criteria: There are no exclusion criteria for this study

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 |
| --- | --- |
| At risk for GVHD<br>Equal or Greater than 18 years old post alloSCT | Other: Non-Interventional<br>* This is an observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Burden of cGVHD diagnosis and severity |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe personal and healthcare resources associated with the management of cGVHD |  | 36 months | 
| To describe changes in the proteomic, cytologic and molecular profile in blood, serum and saliva cGVHD |  | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic graft versus host disease, cGVHD, MA-GVHD-401, THRIVE, GVHD, chronic GVHD, allogenic stem cell transplant (alloSCT)