linjc16/ctgov huggingface dataset:
Ripretinib in Chinese Patients With Advanced GIST: a Real World Study

Study Overview
=================
Brief Summary
-----------------
to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world

Detailed Description
-----------------
Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.

Official Title
-----------------
A Large Scale, Multicenter, Real-World Study on Patients With Advanced GIST Receiving Ripretinib

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: Ripretinib Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -≥18 years old Histologically confirmed gastrointestinal stromal tumor (GIST) At least one measurable lesion (mRECIST v1.1) Received or receiving ripretinib treatment Exclusion Criteria: Patients who received <1 cycle of ripretinib treatment Medical records are incomplete

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

| Intervention/Treatment |
| --- |
|Drug: Ripretinib Oral Tablet|Oral kinase inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | To assess the efficacy (progression-free survival [PFS] | approximately 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCR | To assess disease control rate (DCR) | approximately 6 months | 
| OS | to assess median overall survival (mOS) | approximately 12 months |
Quality of Nursing Care During The Covid-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
Enabling school-age children to evaluate the care they receive provides feedback on the quality of care by determining children's satisfaction with care, and gives important feedback on the quantity and quality of care. Evaluation of nursing care, emotions and behaviors from the perspective of children during the Covid-19 pandemic process will guide the improvement of the quality of care. As a result of the literature review on this subject, no research has been found, and it is thought that this research will contribute to the field. This research was conducted to evaluate nursing care and emotions from the perspective of hospitalized children during the Covid-19 pandemic process.

Official Title
-----------------
Quality of Nursing Care During The Covid-19 Pandemic From The Perspective Of Hospitalized Children: A Cross-Sectional Study

Conditions
-----------------
COVID-19 Pandemic, Children, Only, Hospitalism, Nurse's Role, Feelings

Intervention / Treatment
-----------------
* Other: descriptive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study included volunteer children who were hospitalized for at least 3 days in the - -- -pediatric clinic, whose native language was Turkish, between the ages of 8-13, who did not have any visual, auditory or mental problems, and whose parents gave consent for the study. Exclusion Criteria: who fall outside the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 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 |
| --- | --- |
| study group<br>8-13 age group (N=128). | Other: descriptive<br>* This research was conducted to evaluate nursing care from the perspective of hospitalized children during the Covid-19 pandemic process and to determine their feelings during this process.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Scale Evaluation Quality of Care From Children's Point of View | The Scale Evaluation Quality of Care From Children's Point of View is a 5-point Likert-type scale (never = 1, rarely agree = 2, sometimes agree= 3, often agree = 4, always agree=5) involving 15 items, which was developed by Yilmaz and Ak (2018). The minimum score that can be obtained from the scale is 15 and the maximum score is 75. | 4 month |
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

Detailed Description
-----------------
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Official Title
-----------------
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers Under Fasting Conditions

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: DWJ1543
* Drug: DWC202216


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 year old Healthy adult volunteers Exclusion Criteria: Eye disorders including cataracts Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: DWJ1543<br> | Drug: DWJ1543<br>* DWJ1543<br>|
| Experimental: Intervention: DWC202216<br> | Drug: DWC202216<br>* DWC202216<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543 |  | At pre-dose (0 hour), and post-dose 1 to 120 hour. | 
| Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543 |  | At pre-dose (0 hour), and post-dose 1 to 120 hour. |
Adaptation of the Uniform Data Set for Telematic Administration

Study Overview
=================
Brief Summary
-----------------
The present project is an evolution of the previous RIN 2019 study aimed at validating and standardizing the Uniform Data Set (UDS) for dementia, a battery of tests exploring various cognitive domains (memory, language, praxis, executive functions) and involving partial tablet-based computerization for data collection. In the present study, a UDS-based instrument that can be used in remote examiner-assisted telematic administration will be validated. This will be followed by standardization of the same on a sample of healthy subjects.

Official Title
-----------------
Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration

Conditions
-----------------
Dementia, Mild, Dementia of Alzheimer Type

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female and male subject between 50 and 90 years no negative score on the Questionario anamnestico tarature internist pathology in pharmacological compensation signing of informed consent Exclusion Criteria: neurological pathologies decompensated methabolic pathology use of Benzodiazepine and psychoactive drugs

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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 |
| --- | --- |
| Experimental: Normal subjects<br> | Diagnostic Test: IUDS<br>* a battery of neuropsycological test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance index | Measure the concordance index in the administration of individual battery tests between in-person and computer-based administration | from baseline through study completion, an average of 1 year and a half | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regression lines | Describe for each individual test the regression lines and correction factors for the interfering demographic variables (age schooling and sex) | from baseline through study completion, an average of 1 year and a half |
Establishment and Application of an Artificial Intelligence Algorithm for Automatic Identification of Intraoperative Bleeding During Laparoscopic Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
Surgeons will label surgical videos of laparoscopic pancreaticoduodenectomy with bleeding information from multicenter. The labeled surgical video will be used as training material to train the algorithmic model so as to build an artificial intelligence algorithm that can automatically identify intraoperative bleeding in this surgery. Then, we will test the performance capability of the algorithm.

Official Title
-----------------
Establishment and Application of an Artificial Intelligence Algorithm for Automatic Identification of Intraoperative Bleeding During Laparoscopic Pancreaticoduodenectomy

Conditions
-----------------
Laparoscopic Pancreaticoduodenectomy

Intervention / Treatment
-----------------
* Other: laparoscopic pancreaticoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. surgical videos that recorded complete laparoscopic pancreaticoduodenectomy including resection and reconstruction phases. Exclusion Criteria: 1.surgical videos that recorded laparoscopic pancreaticoduodenectomy combined with resection and reconstruction of mesentericoportal vein.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LPD cohort<br>surgical videos of laparoscopic pancreaticoduodenectomy with label to build and test the algorithms. | Other: laparoscopic pancreaticoduodenectomy<br>* we recorded the surgical videos of laparoscopic pancreaticoduodenectomy, and labeled the information in the video to build and test the algorithms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance of artifical intelligence algorithm | test the performance of the algorithm , including accuracy | through study completion, an average of 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic pancreaticoduodenectomy, surgical videos, artificial intelligence
Italian Registry Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
ITARECIPE is a multicenter national registry designed to study the diagnosis and evolution of Chronic Pancreatitis

Detailed Description
-----------------
Chronic pancreatitis (PC) is a relatively rare disease (45/100,000 population) in Italy, with heterogeneous aetiology, clinical history and treatment. Patients need to be treated by different specialists, but almost always the gastroenterologist is central in diagnosis and treatment. The study will be the first National Registry, prospective and will collect data on the history of the disease and its outcomes. Data will be collected through an electronic data collection form (e-CRF) that the Sponsor (AISP) will make available to the Participating Centres. Patients enrolled will be both new diagnoses or follow-up visits of patients with a diagnosis already made no more than 1 year before the signing of informed consent for the study in question: only data on the diagnosis and follow-up visits prior to the signing of the informed consent will be collected retrospectively (no more than one year). Data from patients visited in the Centres included in the study will be collected prospectively. In addition to the first visits, data will also be collected on follow-up visits that are scheduled according to the clinical need of each patient, which differ according to the stage of the disease

Official Title
-----------------
Registro Italiano Pancreatite Cronica

Conditions
-----------------
Chronic Pancreatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 12 years; Diagnosis definite or probable according to the M-ANNHEIM criteria; First evidence of diagnosis within 12 months of enrolment. Exclusion Criteria: Age < 12 years; History of known disease with certainty for > 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Disease Progression | The collection of data on disease progression in terms of the need for medical, endoscopic or surgical therapy, the risk of pancreatic exo-endocrine failure and the risk of developing pancreatic and extrapancreatic complications and death. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pancreatitis, surveillance chronic pancreatitis, chronic pancreatitis diagnosis, chronic pancreatitis therapy
Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study

Study Overview
=================
Brief Summary
-----------------
This is a retrospective clinical study aimed at observing and evaluating the effectiveness and safety of checkpoint inhibitors in the treatment of patients with solid tumors in actual clinical applications. To explore predictors of efficacy patients with unresectable solid tumors receiving checkpoint inhibitors and develop and further validate predictive models.

Detailed Description
-----------------
The clinical data of patients with unresectable solid tumors were collected retrospectively, who received two or more cycles of checkpoint inhibitor therapy. The progression-free survival (PFS), overall survival (OS) and related adverse reactions of the patients were followed up. To screen prognostic factors, develop predictive models and visualize them as nomograms.

Official Title
-----------------
Checkpoint Inhibitors in Patients With Solid Tumors: a Retrospective Real-world Study

Conditions
-----------------
Immunotherapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old and gender is not limited. Patients with unresectable solid tumors confirmed by pathology or histology. Patients received checkpoint inhibitor therapy for 2 cycles or more. Exclusion Criteria: Have a history of immunodeficiency, or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation. Pre-existing thyroid dysfunction that cannot be maintained within the normal range even with medical treatment. Pregnant or breastfeeding women. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders. The investigator judges that other conditions are not suitable for inclusion in the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS） | PFS is defined as the time from initiation of checkpoint inhibitors until disease progression or death, whichever comes first. | Up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as the time from initiation of checkpoint inhibitors to death or last follow-up. | Up to 24 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, Checkpoint inhibitor, Solid tumor, Predictor
Role of C-Reactive Protein /Albumin Ratio in Evaluation of Disease Activity in Patients With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.

Detailed Description
-----------------
Inflammatory bowel disease (IBD) is defined as a life long chronic inflammatory disease affecting the gastrointestinal tract resulting from the interaction of environmental and genetic elements, has been a global healthcare problem with a steadily increasing incide IBD is mainly composed of two different bowel-relapsing disorders, including Crohn's disease (CD) and ulcerative colitis (UC). Early detection of the disease activity of IBD is of great significance for the treatment of this disease, which can effectively prevent complications and therefore improve prognosis as well as quality of life. In current clinical practice, commonly used noninvasive biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), are considered to be important for both early diagnosis and accurate monitoring of the disease activity in IBD patients. The C-reactive protein/albumin ratio (CAR) is indicative of the balance between inflammation and nutritional status, making it an excellent marker for assessing disease activity in patients The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity inde (CDAI).

Official Title
-----------------
Role of C-Reactive Protein /Albumin Ratio in Evaluation of Disease Activity in Patients With Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: CRP/Albumin ratio in IBD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with IBD which included Crohn disease and Ulcertive colitis patients above age 18 years old. Exclusion Criteria: concurrent infections, liver cirrhosis, hematological diseases, heart failure, malignancies, autoimmune diseases, or congenital or acquired immunodeficiencies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: CRP/Albumin ratio in IBD|Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP/Albumin ratio in IBD | Role of C-Reactive Protein /Albumin Ratio in evaluation of Disease Activity in Patients with Inflammatory Bowel Disease. | Baseline |
A Study of the Clinical Application of [18F]RCCB6 PET Imaging in the Diagnosis of CD70-expressing Multiple Tumors

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to establish and optimize the [18F]RCCB6 imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer and lymphoma was evaluated.

Official Title
-----------------
A Study of the Clinical Application of [18F]RCCB6 PET Imaging in the Diagnosis of CD70-expressing Multiple Tumors

Conditions
-----------------
Kidney Cancer, Lymphomas, Positron Emission Tomography

Intervention / Treatment
-----------------
* Radiation: [18F]RCCB6 PET Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between 18 and 65 years of age and of either sex. Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver. Willingness and ability to cooperate with all programs of this study. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from the study: Severe hepatic and renal insufficiency; Targeted therapy prior to radiotherapy or PET/CT scan. 5T4 expression in existing lesions was assessed by immunohistochemistry using antibody clones. Renal function: serum creatinine less than or equal to the upper limit of the normal range; Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range. History of serious surgery in the last month. Those who have participated in other clinical trials during the same period.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with renal cancer<br>Intravenous injection of 3.7 MBq [0.05 MCi]/kg of [18F]RCCB6 in a single dose. | Radiation: [18F]RCCB6 PET Imaging<br>* Intravenous injection of 3.7 MBq [0.05 MCi]/kg of [18F]RCCB6 in a single dose.<br>|
| Experimental: patients with lymphoma<br>Intravenous injection of 3.7 MBq [0.05 MCi]/kg of [18F]RCCB6 in a single dose. | Radiation: [18F]RCCB6 PET Imaging<br>* Intravenous injection of 3.7 MBq [0.05 MCi]/kg of [18F]RCCB6 in a single dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete PET imaging | Evaluating the sensitivity and specificity of using [18F]RCCB6 to diagnose renal and hepatocellular carcinoma | 90mins from time of injection |