linjc16/ctgov huggingface dataset:
Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir

Study Overview
=================
Brief Summary
-----------------
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir

Official Title
-----------------
A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects

Conditions
-----------------
Healthy Volunteer Study

Intervention / Treatment
-----------------
* Drug: Cohort 1 BEM + Ruzasvir
* Drug: Cohort 2 Ruzasvir + BEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug. Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2. Willing to comply with the study requirements and to provide written informed consent. Exclusion Criteria: Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2. Abuse of alcohol or drugs. Use of other investigational drugs within 28 days of dosing. Concomitant use of prescription medications, or systemic over-the-counter medications. Other clinically significant medical conditions or laboratory abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEM vs BEM + Ruzasvir n=16<br> | Drug: Cohort 1 BEM + Ruzasvir<br>* Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions<br>* Other names: AT-527;|
| Experimental: Ruzasvir vs Ruzasvir + BEM n=16<br> | Drug: Cohort 2 Ruzasvir + BEM<br>* Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions<br>* Other names: AT-527;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of BEM | Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC) | Days 6, 12, 18 | 
| Pharmacokinetics (PK) of Ruzasvir | Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC) | Days 6, 12, 18 |
Study of CM310 in Subjects With Seasonal Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.

Detailed Description
-----------------
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Official Title
-----------------
A Multicenter, Single Arm Phase II Clinical Study Evaluating the Efficacy of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Biological: CM310


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-65. Understand the study and sign the Informed Consent Form voluntarily. Take effective contraception measures throughout the study period. Exclusion Criteria: Used other investigational drugs. Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310. Plan to participate in other studies during this clinical trial. With malignant or benign tumors of the nasal cavity. Other reasons the researcher believes that the subject is not suitable to participate in this study.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM310<br>CM310, Subcutaneous injection | Biological: CM310<br>* CM310 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS) | The total score of nasal symptoms (TNSS) is the sum of four symptom scores: runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3 points. | Up to week 12 |
A Long-term Follow-up Study of Participants Who Received an Allogeneic CAR T-Cell Product

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to collect information on the long-term safety of study participants who received Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in a Precision BioSciences, Inc. (PBI) Clinical Study. The main questions it aims to answer are: -What were the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)? Participants will visit a study center 3 times during the first year, and once per year after that for a physical exam and other assessments to check for CEI.

Detailed Description
-----------------
This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in a PBI clinical study involving PBCAR product dosing. This study protocol does not include administration of a PBCAR product; however, subjects may receive investigational products other than a PBCAR product through participation in other clinical studies during the period of this observational study.

Official Title
-----------------
Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in a Precision BioSciences, Inc., Clinical Study

Conditions
-----------------
Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receipt of at least 1 dose of PBCAR product in a PBI clinical study. A signed informed consent form (ICF). Willingness and ability to adhere to the study schedule and all other protocol requirements. Exclusion Criteria: No unique exclusion criteria apply to this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Frequency of Clinically Significant Clinical Events of Interest (CEI) |  | Up to 15 years | 
| Severity of Clinically Significant CEI |  | Up to 15 years | 
| Duration of Clinically Significant CEI |  | Up to 15 years | 
| Outcome of Clinically Significant CEI |  | Up to 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Disease Response |  | Up to 15 years | 
| Overall Survival Rate |  | Up to 15 years | 
| Occurrence of Secondary Malignancy |  | Up to 15 years | 
| PBCAR Persistence |  | Up to 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PBCAR, Allogeneic chimeric antigen receptor (CAR) T cell products
A Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Colorectal Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method

Study Overview
=================
Brief Summary
-----------------
The study is a real-world observational clinical study. Patients diagnosed as colorectal cancer through histopathology were screened and enrolled. Before anti-tumor treatment, colonoscopy biopsy tissue specimens, surgical specimens, and malignant pleural effusion or ascites specimens, etc. are collected. The investigators will perform a drug sensitivity testing based on a novel drug susceptibility testing method to test the commonly used anti-tumor treatment regimens. Patients were given conventional anti-tumor treatment according to the medical judgment of the doctors. Finally, the investigator will evaluate the consistency of clinical efficacy in colorectal cancer treatment and drug susceptibility outcomes.

Official Title
-----------------
A Real-world Observational Clinical Study Aims to Assess the Consistency of Clinical Efficacy in Colorectal Cancer Treatment and Drug Susceptibility Outcomes Using a Novel Drug Susceptibility Testing Method

Conditions
-----------------
Colorectal Cancer, Organoids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged ≥ 18 and ≤80; Patients with colorectal cancer diagnosed by histopathology; Patients who need neoadjuvant treatment; adjuvant therapy after radical surgery or palliative treatment; Fresh tumor tissue specimens or malignant pleural effusion or ascites can be obtained; Patients who sign the informed consent form, and are able to comply with the study period treatment process. Exclusion Criteria: Inability to follow the research protocol; Inability to obtain relevant fresh specimens by biopsy/surgery/puncture; Concomitant contraindications to chemotherapy; pregnant or lactating women; Patients deemed inappropriate by investigators.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | An Indicator of efficacy of postoperative adjuvant therapy | From date of surgery until the date of first documented recurrence，up to 3 years | 
| Sensitivity | Cases in which drug susceptibility results are sensitive to the antineoplastic regimen as apercentage of the cases that are effective in clinical evaluation | Through study completion, an average of 1 year | 
| Specificity | Cases in which drug susceptibility results are resistance to the antineoplastic regimen as apercentage of the cases that are ineffective in clinical evaluation | Through study completion, an average of 1 year |
Accuracy of Robotically Assisted Cranial Biopsies

Study Overview
=================
Brief Summary
-----------------
This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial. The goal is to determine whether the robotic procedure to be examined can achieve a clinically acceptable value of at least 90% in terms of diagnostic yield.

Detailed Description
-----------------
The goals of the project are to determine the accuracy of Cirq® Robotic Alignment Module Cranial navigated biopsy procedures, Automatic Image Registration accuracy within the workflow, and compatibility of Cirq® Robotic Alignment Module Cranial in the clinical workflow. Patients will undergo cranial biopsies according to standard of care using released products within their intended use with the exception that the accuracy of the biopsy needle will be measured using a specific intraoperative workflow.

Official Title
-----------------
Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration

Conditions
-----------------
Intracranial Neoplasm

Intervention / Treatment
-----------------
* Device: Cirq® Robotic Alignment Module Cranial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff Ability to consent to the procedure Exclusion Criteria: Pregnancy Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent

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 |
| --- | --- |
| Biopsy Patient<br>Patient with a confirmed intracranial neoplasm scheduled for a biopsy with Cirq® Robotic Alignment Module Cranial and registration via Auto-Registration Software Universal Automatic Image Registration Cranial and Loop-X® Mobile Imaging Robot. | Device: Cirq® Robotic Alignment Module Cranial<br>* Robotic navigation for cranial biopsy procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Determine the percentage of diagnostically significant biopsies determined histologically | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target point and entry point error | Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location | 24 months | 
| Time for procedure | Determine the time needed for the intraoperative biopsy procedure | 24 months |
ML Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture

Study Overview
=================
Brief Summary
-----------------
This study aimed to address the issue of peritoneal metastasis (PM) following the rupture of hepatocellular carcinoma (HCC) and its adverse impact on patient prognosis. Clinical data from 522 patients with ruptured HCC who underwent surgery at seven different medical centers were collected and analyzed. Machine learning models were employed for analysis and prediction.

Official Title
-----------------
Machine Learning Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture

Conditions
-----------------
Peritoneal Metastasis

Intervention / Treatment
-----------------
* Other: Peritoneal Metastasis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:(1) HCC confirmed by pathologists (2) two preoperative imaging findings suggestive of tumor rupture (3) R0 resection (4) first tumor detection - Exclusion Criteria:(1) previous antitumor therapy (2) combination of other types of tumors (3) incomplete clinical data -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Training cohort<br>All cases were randomly grouped according to 7:3, with 70% defined as the training group | Other: Peritoneal Metastasis<br>* Patients experiencing postoperative peritoneal metastasis<br>|
| Validation cohort<br>All cases were randomly grouped according to 7:3, with 30% defined as the validation group | Other: Peritoneal Metastasis<br>* Patients experiencing postoperative peritoneal metastasis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Overall survival (OS) was defined as the time from the date of surgery to death | 2018-2023 |
Late Respiratory Consequences of SARS-CoV-2 Pneumonia

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about the respiratory system in post-COVID syndrome. The main question aims to answer: how the post-COVID syndrome alters the lung function Participants will be asked to perform lung function tests. Researchers will compare post-COVID group to matched control healthy individuals.

Official Title
-----------------
Changes in the Respiratory System in Post-COVID Syndrome

Conditions
-----------------
Long COVID, Respiratory Function Tests

Intervention / Treatment
-----------------
* Diagnostic Test: Lung function test
* Biological: COVID infection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 infections in the post-COVID group. - Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-COVID<br>Patients with COVID-19 infections. | Diagnostic Test: Lung function test<br>* Spirometry to assess lung volumes, forced oscillations to measure respiratory mechanics, whole body plethysmography to assess static lung volumes and airway resistance, lung diffusion capacity measurements.<br>Biological: COVID infection<br>* Verified COVID-19 infection.<br>|
| Control<br>Patients without earlier diagnosis of COVID-19. | Diagnostic Test: Lung function test<br>* Spirometry to assess lung volumes, forced oscillations to measure respiratory mechanics, whole body plethysmography to assess static lung volumes and airway resistance, lung diffusion capacity measurements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory mechanics | Mechanical properties of the airways and respiratory tissues | 6-12 months after COVID-19 infections | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | Forced expiratory lung volumes | 6-12 months after COVID-19 infections | 
| Lung diffusion capacity | DLCO | 6-12 months after COVID-19 infections | 
| Plethysmography | Measurement of functional residual capacity and airway resistance by using a whole body plethysmograph. | 6-12 months after COVID-19 infections |
Discovering Factors in Cervical Cancer Patients' Clinical Trial Experiences

Study Overview
=================
Brief Summary
-----------------
The percentages of participants in clinical studies haven't always been perfectly representative of a particular group. This research examines the variables that affect a patient's choice to enroll in, discontinue participation in, or resume participation in a clinical trial for cervical cancer. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future cervical cancer studies.

Official Title
-----------------
A Look at the Patterns in Medical Research Participation Among Patients With Cervical Cancer

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old Ability to understand and the willingness to sign a written informed consent document. Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Exclusion Criteria: Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

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

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

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 |
| --- | --- | --- |
| Rate of patients who decide to enroll in a cervical cancer clinical study. |  | 3 months | 
| Number of cervical cancer study participants who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Cancer
A Study of Pressure Waveform Analysis in Coronary Artery-II

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to test the feasibility of intracoronary adenosine administration during coronary flow reserve(CFR) and index of microcirculatory resistance(IMR) assessment in a population with angina. The main questions it aims to answer are: Repeatability of CFR and IMR assessment while hyperemia with intracoronary adenosine was administered. Evaluate the correlation of the intrinsic signal of coronary waveform versus physiologic ischemia, while defined by fractional flow reserve(FFR) and CFR respectively. The predictive value of FFR, CFR, and IMR on major adverse cardiovascular outcomes in 3 years Participants will undergo FFR, CFR, and IMR assessments in the catheterization laboratory of the National Taiwan University Hospital Hsin-Chu Branch, then clinical events follow up for 3 years.

Official Title
-----------------
A Study of Pressure Waveform Analysis in Coronary Artery-II

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Procedure: CFR and IMR group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with angina Exclusion Criteria: Severe valvular heart disease History of asthma Heart rate less than 50 beats per minute systolic blood pressure less than 90 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| CFR and IMR group<br> | Procedure: CFR and IMR group<br>* Participants will undergo repeat intracoronary adenosine administration during CFR and IMR measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability of CFR and IMR value | To compare the difference of individual value, while repeat the measurement within 1 minutes | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular outcomes | Including death, myocardial infarction, stroke and heart failure | 3 year |