linjc16/ctgov huggingface dataset:
Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures.

Study Overview
=================
Brief Summary
-----------------
Multicentric Italian registry aimed to evaluated the role and results of plastic and metal stents in the treatment of malignant distal biliary strictures

Official Title
-----------------
Metal and Plastic Biliary Stents to Drain Malignant Distal Biliary Strictures. Registry of the Italian Society of Digestive Endoscopy.

Conditions
-----------------
Biliary Stricture, Stent Stenosis

Intervention / Treatment
-----------------
* Device: Biliary stents insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant distal biliary stricture Need for Palliative and pre-operative biliary drainage Age > 18 Signature of the informed consent Exclusion Criteria: Previous endoscopic/radiological biliary drainage Stricture close to the main hepatic confluence(< 2 cm) Duodenal stenosis Post- surgical altered anatomy Benign disease

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: Biliary stents insertion|Endoscopic placement of plastic and metal biliary stents|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the potency of biliary stents (plastic and metal) | Time to occurrence of jaundice/cholangitis | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biliary stricture, Plastic stent, Self Expandable Metal stent
Pharmacokinetics and Safety/Tolerability of CKD-379

Study Overview
=================
Brief Summary
-----------------
A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

Detailed Description
-----------------
A randomized, open-label, single dose, 2-period, 2-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Official Title
-----------------
A Randomized, Open-label, Single Dose, 2-period, 2-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects

Conditions
-----------------
Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: CKD-379
* Drug: D759+D745+D150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 19 aged and 50 aged in healthy adult 50.0kg≤Body weight≤90.0kg and 18.0kg/m2≤body mass index(BMI)≤27.0kg/m2 Exclusion Criteria: Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis etc.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis Have a gastrointestinal disease(Crohn's disease, ulcer etc.) history that can effect drug absorption or surgery Those who are pregnant or breastfeeding Those who are deemed inappropriate to participate in clinical trial by investigators

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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: Sequence 1<br>Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379) | Drug: CKD-379<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|
| Experimental: Sequence 2<br>Period 1: Test drug(CKD-379) Period 2: Reference drug(D759+D745+D150) | Drug: CKD-379<br>* 1 tablet administration under fed condition<br>Drug: D759+D745+D150<br>* 3 tablet coadministration under fed condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration of the drug | 0 48hours | 
| AUClast | Area under the concentration-time curve from the time of dosing to the last measurable concentration | 0 48hours |
Serum Biomarkers in Parkinson's Disease at Different Stages

Study Overview
=================
Brief Summary
-----------------
Determine clinical characteristics of parkinsonian patients in various stages of disease; Measure peripheral neurodegeneration, synaptic, and inflammation biomarkers in a population of parkinsonian patients at various stages of disease. Measure vesicular neurodegeneration, synaptic and inflammation biomarkers

Official Title
-----------------
Serum Biomarkers in Parkinson's Disease at Different Stages

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Procedure: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with idiopathic PD according to Movement Disorders Society (MDS) criteria; Age: 18-80 years; Signature of informed consent to participate in this study Exclusion criteria. Women pregnant Inflammatory or autoimmune diseases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biomarkers<br> | Procedure: blood sample<br>* blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine clinical characteristics of parkinsonian patients in various stages of disease | Determine clinical characteristics of parkinsonian patients in various stages of disease by means of MDS-UPDRS score changes. | 3 years | 
| Determine clinical characteristics of parkinsonian patients in various stages of disease | Determine clinical characteristics of parkinsonian patients in various stages of disease by means of NMS score changes. | 3 years | 
| Determine biooogical characteristics of parkinsonian patients in various stages of disease | dosage of serum IL-1b, IL6, IL-5, IL-4, IL17, TNFa, IFNg, IL10, total-alpha-synuclein, NfL, BDNF (ng/ml for all) | 3 years |
Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors

Study Overview
=================
Brief Summary
-----------------
This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.

Detailed Description
-----------------
Objectives: This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors. Materials and Methods: Twenty liver failure patients and twenty healthy donors are selected. Blood samples obtained from all patients prior to transplant will analyzed. HDL subfraction analysis will done by continuous disc polyacrylamide gel electrophoresis. Plasma levels of apolipoprotein A-1 (ApoA-I), cholesteryl ester transfer protein (CETP), and lecithin-cholesterol acyltransferase (LCAT) will determined by enzyme-linked immunosorbent assay.

Official Title
-----------------
Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors

Conditions
-----------------
Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver failure patients Exclusion Criteria: patients not giving consent Participants who had oncological and hematological diseases, coronary failure, kidney failure, malnutrition, diabetes, traumatic brain injury, or cadaveric LT and who were using psychoactive medicines or having a respiratory system or CNS diseases were excluded from the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Patients with liver failure | |
| Group 2<br>Healthy donors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL Subfractions | Evaluation of HDL Subfractions in groups | Blood will collected from all patients before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-associated enzymes | ApoA1, CETP and LCAT levels in groups | Blood will collected from all patients before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Failure, HDL Subfractions, ApoA1, CETP, LCAT
Exploring Clinical Study Experiences of People With Depression

Study Overview
=================
Brief Summary
-----------------
The study seeks to delve into the firsthand experiences of patients diagnosed with depression who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future depression patients and play an active role in advancing medical research.

Official Title
-----------------
Inside Depression Clinical Trials: Patient Experiences Shared While Undergoing Clinical Trials

Conditions
-----------------
Depression

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

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 patients who decide to participate in a depression clinical trial |  | 3 months | 
| Rate of patients who remain in depression clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression
Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Study Overview
=================
Brief Summary
-----------------
A prospective study will be conducted to assess the outcomes of patients who underwent concurrent robotic-assisted mastectomy and robotic-assisted free DIEP flap harvest for breast reconstruction between March 2020 and June 25, 2023. Demographic data, including age, body mass index (BMI), and medical history, were collected, along with surgical time and perioperative parameters. The incidence of acute and chronic complications was documented.

Official Title
-----------------
Oncoplastic Entirely Robot-Assisted Approach (OPERA) - Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction

Conditions
-----------------
Breast Cancer, Breast Reconstruction

Intervention / Treatment
-----------------
* Procedure: Oncoplastic Entirely Robot-Assisted Approach (OPERA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients with unilateral breast cancer received robotic-assisted mastectomy and robotic assisted free DIEP flap harvest for breast reconstruction. | Procedure: Oncoplastic Entirely Robot-Assisted Approach (OPERA)<br>* Robotic-assisted surgery in both mastectomy and free DIEP flap harvest, so-called Oncoplastic Entirely Robot-Assisted Approach (OPERA).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-open | Whether the patient return to the operation room to check the blood flow or re-do the anastomosis. | Post-operative 14 days | 
| Acute complication (< 30 days) |  | Post-operative 30 days | 
| Chronic complication (> 30 days) |  | One year after surgery |
Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
Exploring the efficacy and pregnancy outcomes of conservative treatment for atypical endometrial hyperplasia and endometrial cancer. Study the factors related to predicting treatment efficacy.

Official Title
-----------------
Clinical Study of Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer

Conditions
-----------------
Atypical Endometrial Hyperplasia and Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) age ≤ 45 years old, strong desire to preserve reproductive function, and no factors of reproductive dysfunction evaluated before treatment; (2) The pathological type is atypical endometrial hyperplasia or endometrial cancer; (3) Imaging examination confirmed that the tumor was localized to the endometrium; (4) There are follow-up conditions available.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| complete remission<br> | |
| non-complete remission<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate |  | 6months |
HER2 Expression of CTC to Predict Response in HER2-low Advanced Breast Cancer Patients Treated With ADC

Study Overview
=================
Brief Summary
-----------------
To evaluate the predictive and prognostic value of HER2 expression of circulating tumor cells in HER2-low advanced breast cancer patients treated with ADC

Official Title
-----------------
An Exploratory Clinical Study of HER2 Expression of Circulating Tumor Cells : Predictive and Prognostic Value in HER2-low Advanced Breast Cancer Patients Treated With ADC

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

Intervention / Treatment
-----------------
* Biological: HER2 expression of circulating tumor cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has pathologically documented breast cancer that: Is unresectable or metastatic Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) Has progressed on, and would no longer benefit from, endocrine therapy Has been treated at least 1 prior line of chemotherapy in the metastatic setting Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions Receives anti-HER2 ADC treatment Life expectancy > 3 months Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before selection ECOG ≤2 Exclusion Criteria: Has breast cancer ever assessed with high-HER2 expression Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HER2 expression of circulating tumor cells|Detect HER2 expression of circulating tumor cells dynamically during ADC-based treatment in HER2-low ABC|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival(PFS) | PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR was defined as the proportion of patients with a complete response or a partial response. | 2years | 
| Overall survival(OS) | OS was defined as the time from the start of treatment to death from any cause | 5 years |
Temporomandibular Joint in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
the investigators study aimed to evaluate temporomandibular joint involvement in rheumatoid arthritis patients and healthy individuals 142 participants were recruited in two groups: 72 patients with Rheumatoid Arthritis (RA), and 70 healthy controls. All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies. TMD diagnosis was determined according to the standardized and validated diagnostic criteria for TMD (DC/TMD): myalgia, arthralgia, articular disc, displacement, degenerative joint disease, and headache attributed to TMD. Bruxism, a probable sleep and/or awake bruxism diagnosis was determined based on self-report and several clinical findings.

Official Title
-----------------
Temporomandibular Joint in Patients With Rheumatoid Arthritis

Conditions
-----------------
Temporomandibular Joint Disorders, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Diagnostic Test: seropositivity of rheumatoid factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria included: age > 18 years old individuals who had a minimum of 12 natural teeth. Exclusion criteria included: trauma or surgery on the jaw facial nerve paralysis tooth implant scleroderma cerebrovascular accident schizophrenia steroid injection within the last six months.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 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 |
| --- | --- |
| RA group<br> | Diagnostic Test: seropositivity of rheumatoid factor<br>* All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies<br>* Other names: anticitrullinated protein antibodies;|
| Control group<br> | Diagnostic Test: seropositivity of rheumatoid factor<br>* All participants were tested for seropositivity of rheumatoid factor and anticitrullinated protein antibodies<br>* Other names: anticitrullinated protein antibodies;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with prevalence of TMD | patients were interviewed, filled out the questionnaire, and examined | 2 years | 
| Number of patients with TMD-pain diagnoses | patients were interviewed, filled out the questionnaire, and examined | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, Temporomandibular joints, Bruxism