linjc16/ctgov huggingface dataset:
Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas.

Study Overview
=================
Brief Summary
-----------------
In our multicenter retrospective study, preoperative CA 19.9 levels predicts the presence of lymph node metastasis at final histology in patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma .

Detailed Description
-----------------
A retrospective analysis have been conducted on more than 2.000 patients underwent pancreatoduodenectomy for pancreatic ductal adenocarcinoma radiologically resectable at the preoperative staging. Preoperatory levels of CA 19.9 were measured in order to identify a relation with nodal involvement at the pathological staging.

Official Title
-----------------
Preoperative CA 19.9 Level Predicts Lymph Node Metastasis in Resectable Adenocarcinoma of the Head of the Pancreas: a Further Plea for Biological Resectability Criteria.

Conditions
-----------------
Pancreas Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergone pancreatoduodenectomy No preoperative radiological suspicion of lymph node metastases. Exclusion Criteria: - Age < 18

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Quantitative data - Preoperatory levels of CA 19.9 (U/ml) | Define relation of quantitative data (CA 19.9 (U/ml)) with nodal positivity at the final pathological report | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ca 19.9, Pancreatic adenocarcinoma, Pancreatoduodenectomy
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).

Official Title
-----------------
A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: BMS-986435
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability Key Exclusion Criteria: Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant Note: Other protocol-defined inclusion/exclusion criteria apply

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
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986435<br> | Drug: BMS-986435<br>* Specified dose on specified days<br>* Other names: MYK-224;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events (TEAEs) |  | Up to approximately 15 weeks | 
| Incidence of serious adverse events (SAEs) |  | Up to approximately 15 weeks | 
| Incidence of AEs leading to treatment discontinuation |  | Up to approximately 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of plasma concentrations of MYK-224 |  | Up to approximately 15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMS-986435, MYK-224, Pharmacokinetics, Pharmacodynamics, Safety, HFpEF
Perioperative Smartwatch Monitoring to Predict Complications

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center, observational study designed to to quantify complications following major visceral surgery major visceral surgery (such as pancreatic resection or colorectal colorectal surgery), and to identify digital biomarkers (collected pre, and post-operatively by a connected watch) enabling early early identification of patients with post-operative complications. Patients will be invited to wear a watch during the perioperative period, and will receive questionnaires about their their health status.

Official Title
-----------------
Perioperative Smartwatch Monitoring as a Tool to Predict Post-operative Complications in Patients Undergoing Major Abdominal Surgery. A Single Center Prospective Observational Study.

Conditions
-----------------
Post-Op Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients will be recruited prospectively for a total of 50 patients. Inclusion criteria are : Patients scheduled for elective major visceral surgery (pancreatic resection or colorectal surgery) under general anesthesia 18 years of age or older Exclusion criteria will be : - Patient refusal and/or inability to understand and sign 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 |
| --- | --- | --- |
| Comprehensive Complication Index | The primary endpoint was the overall postoperative morbidity following major visceral surgery (such as pancreatic resection or colorectal surgery) as defined by the CCI (Comprehensive Complication Index), which calculates a patient's overall morbidity following surgery based on the Clavien-Dindo classification of complications. The Comprehensive Complication Index (CCI) reflects the severity of this overall burden of complications for the patient on a scale ranging from 0 (no complications) to 100 (death). | J30 post-op |
Formative Usability Assessment of Wireless Thermal Anisotropy Devices

Study Overview
=================
Brief Summary
-----------------
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.

Official Title
-----------------
Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts

Conditions
-----------------
Hydrocephalus

Intervention / Treatment
-----------------
* Device: Thermal Anisotropy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) Subject or caregiver can clearly communicate and document information in English Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision Subject is at least 5 years old but not more than 80 years old Exclusion Criteria: Presence of an interfering open wound in the device application region Subject-reported history of adverse skin reactions to adhesives

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Usability Assessment Cohort<br>No interventions administered. Device usability assessment only. | Device: Thermal Anisotropy<br>* Usability assessment observation.<br>* Other names: FlowSense;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory device usability feedback | Identification of usability risks [unscored] | 2 hours |
In Depth Observational Clinical Trial Of Retinitis Pigmentosa Patients

Study Overview
=================
Brief Summary
-----------------
Typically, clinical research participation favors a specific demographic group, and little research exists on how trial attributes affect participation. As such, this study seeks to analyze data from different demographic groups and check for recurring trends that could provide valuable insights for future retinitis pigmentosa patients.

Official Title
-----------------
Retinitis Pigmentosa Clinical Study: Examining the Clinical Trial Journey of Retinitis Pigmentosa Patients

Conditions
-----------------
Retinitis Pigmentosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is 18+ years old Confirmed diagnosis of retinitis pigmentosa Signed Written Informed Consent Exclusion Criteria: Inability to perform regular electronic reporting Participant is actively receiving study therapy in another trial Women of childbearing potential without a negative pregnancy test; or women who are lactating.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of patient decides to enroll in clinical trial |  | 3 months | 
| Rate of patients who remain in clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinitis pigmentosa
Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)

Study Overview
=================
Brief Summary
-----------------
The primary study objective is to collect biospecimen samples (e.g., blood) from participants diagnosed with Chronic Granulomatous Disease (CGD). The biospecimens will be used to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.

Official Title
-----------------
Whole Blood Biospecimen Collection for Subjects With Chronic Granulomatous Disease (CGD)

Conditions
-----------------
Chronic Granulomatous Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Specimen Donation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is willing and able to provide written informed consent The participant is willing and able to provide appropriate photo identification Participants aged 18 to 85 Participants have been diagnosed with Chronic Granulomatous Disease (CGD) Subjects who have a confirmed p47phox CGD mutation or Subjects who have a confirmed X-linked CGD mutation Exclusion Criteria: Participants who are pregnant or are nursing Participants with a known history of HIV, hepatitis, or other infectious diseases Participants who have taken an investigational product in the last 30 days Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| CGD with p47phox phenotype<br> | Diagnostic Test: Specimen Donation<br>* blood donation<br>|
| X-Linked CGD<br> | Diagnostic Test: Specimen Donation<br>* blood donation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants have been diagnosed with Chronic Granulomatous Disease (CGD) | Participants have been diagnosed with Chronic Granulomatous Disease (CGD) | 1 Year |
A Study of Immunotherapy Treatment in People With Sarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information from participants' medical records to improve our knowledge about immunotherapy use and how effective it is as a treatment for people with sarcoma. Immunotherapy drugs boost the immune system's ability to fight cancer by blocking proteins that act as a brake on the immune system. Blocking these proteins is like releasing the brakes, so that the immune system can target cancer cells and destroy them. This action is sometimes described as immune checkpoint blockade.

Official Title
-----------------
An Observational Study of Sarcoma Patients Treated With Immune Checkpoint Blockade-based Therapy at Memorial Sloan Kettering Cancer Center

Conditions
-----------------
Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have a histologic diagnosis of sarcoma confirmed by an MSK pathologist. Any prospectively identified patient being treated or to be treated with an immune checkpoint inhibitor, such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-LAG3 inhibitor, either as monotherapy or in combination with additional systemic therapy o Novel immune checkpoints inhibitors that are developed after submission of this protocol will also be included) Please Note: there is no age requirement. Patients of all ages are eligible to enroll Exclusion Criteria: Patient unwilling to consent to collection of historical and longitudinal clinicopathologic data in the patient medical record from baseline (the period prior to ICB initiation), during, and after ICB treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with sarcoma<br>This is an observational prospective cohort study of patients with sarcoma treated with immune checkpoint blockade (ICB; anti-PD-1, PD-L1, and/or CTLA-4) based therapy at Memorial Sloan Kettering Cancer Center (MSK) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect real-world observational clinical, radiographic, and molecular features | of sarcoma patients treated with ICB, as documented in medical records, to improve knowledge about immunotherapy use and efficacy in sarcoma. Descriptive statistics will be used to summarize the overall study population and their clinicopathologic characteristics using median, interquartile range and range, frequency and/or percentages. | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
23-254, Immunotherapy, Immune Blockade-Based Therapy
Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of tradipitant in the treatment of motion sickness.

Official Title
-----------------
Motion Serifos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness During Travel

Conditions
-----------------
Motion Sickness

Intervention / Treatment
-----------------
* Drug: Tradipitant
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of motion sickness Age 18-75 Exclusion Criteria: Nausea-inducing disorder other than motion sickness BMI>40 History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tradipitant<br>Oral Capsule | Drug: Tradipitant<br>* Oral Capsule<br>|
| Placebo Comparator: Placebo<br>Oral Capsule | Drug: Placebo<br>* Oral Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of vomiting measured by Vomiting Assessment (VA) | Prevention of vomiting measured by Vomiting Assessment (VA) score | 1 day |
A Prospective Longitudinal Mixed Study on the Change Track of Sleep Quality in Critically Ill Children

Study Overview
=================
Brief Summary
-----------------
This research adopts the uniform parallel hybrid research design; The quantitative data and qualitative data were collected at the same time, and then the quantitative and qualitative data were analyzed respectively. Finally, the two data sets were combined. Comprehensive interpretation of the study issues through complementarity and mutual validation of quantitative and qualitative data.

Detailed Description
-----------------
With the progress and development of medical technology, the mortality rate of critically ill children continues to decline. To improve the long-term prognosis of children has become a new goal of modern medicine. Sleep disorders in critically ill children are caused by disease factors, the complex environment of ICU, and various treatment factors, which have seriously affected the patient's rehabilitation and long-term quality of life. Attention should be paid to the sleep disorders in critically ill children. At present, the research on sleep disorders in critically ill patients in China is mostly focused on adults, and the critically ill children are rarely involved, and there is no research related to sleep disorders and recovery tracks of critically ill children. This prospective longitudinal mixed study aims to describe the change trajectory of sleep disorder and recovery in critically ill children and provide suggestions for subsequent clinical workers to formulate reasonable intervention measures.

Official Title
-----------------
Sleep Quality of Critically Ill Children Change Trajectory and Prediction Factors: A Prospective Longitudinal Mixed Study

Conditions
-----------------
Critical Illness, Child, Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ① Age 3-12 years; Children who are conscious during ICU, children with Glasgow score of 15 Exclusion Criteria: (1) did not meet the discharge standards, and asked to be discharged; Children with sleep disorder before admission to PICU, that is, those with baseline CSHQ score > 41; The child had a history of mental illness and cognitive impairment. Children with brain injury, coma, disturbance of consciousness, epilepsy and status epilepticus, obstructive sleep apnea hypopnea syndrome; ⑤ Children with hearing and hearing impairment ⑥ICU stay > 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 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 |
| --- | --- | --- |
| Mean Total Night Sleep Minutes | Mean Total Night Sleep Minutes | 2023.12.31 | 
| Deep sleep time | Deep sleep time | 2023.12.31 | 
| Children sleep habit questionnaire score | Children sleep habit questionnaire score | 2023.12.31 |
ChatGPT v.s. Human in Writing a Preoperative Visit Sheet

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the performance of large language models i.e. ChatGPT, in making preoperative visit sheets using clinical records. The main questions it aims to answer are: Can large language models read clinical records and make preoperative visit sheets same as physicians? Can physicians distinguish preoperative visit sheets made by physicians and models? Participants' records will be generated using ChatGPT-4, and read by both ChatGPT-4 and physicians to make 2 separate preoperative visit sheets, and form 2 groups, GPT group and physician group respectively. A group of professionals will compare result of above mentioned 2 groups to see if ChatGPT can afford to write preoperative visit sheets.

Official Title
-----------------
Using Natural Language Processing Models for Writing Preoperative Visit Sheets: a Preliminary Study Comparing ChatGPT and Clinicians

Conditions
-----------------
Preoperative Care

Intervention / Treatment
-----------------
* Other: ChatGPT-4
* Other: Clinician


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any as records are generated using ChatGPT-4. Exclusion Criteria: Any as records are generated using ChatGPT-4.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experiment<br> | Other: ChatGPT-4<br>* Subjects' clinical records will be read by ChatGPT-4 to write preoperative visit sheets.<br>|
| Control<br> | Other: Clinician<br>* Subjects' clinical records will be read by clinicians to write preoperative visit sheets.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Familiarity to human writing | Based on professionals' subjective evaluation, familiarity is a binary result indicating weather professionals think the preoperative visit sheet was written by physicians or ChatGPT, where 0 indicates not written by human and 1 indicates written by human. | Each record will be screened for 6 minutes at most and results will be given in 8 minutes after receiving a record. | 
| Satisfaction for clinical use | A grading score of 1-10 indicating weather the professionals think the preoperative visit sheet is suitable in clinical use. | Each record will be screened for 6 minutes at most and results will be given in 8 minutes after receiving a record. |