linjc16/ctgov huggingface dataset:
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects

Official Title
-----------------
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: DA-2803
* Drug: DA-2803-R
* Drug: Placebo of DA-2803
* Drug: Placebo of DA-2803-R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male and female subjects of ages in the range over 19 The subjects HBsAg positive for at least 6 months or has history of Chronic Hepatitis B The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000 IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent Exclusion Criteria: The subjects who have been infected with HCV, HDV, HIV The subjects who have Hemochromatosis, Wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Drug: DA-2803<br>* All participants are administered one tablet per day for 48 weeks<br>Drug: Placebo of DA-2803-R<br>* All participants are administered one tablet per day for 48 weeks<br>|
| Experimental: Reference group<br> | Drug: DA-2803-R<br>* All participants are administered one tablet per day for 48 weeks<br>Drug: Placebo of DA-2803<br>* All participants are administered one tablet per day for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA(log10 IU/mL) change | HBV DNA(log10 IU/mL) change compared to baseline | 48 weeks |
Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study is a national multicenter real-world investigation aimed at evaluating the real-world effectiveness and safety of Iruplinalkib in the treatment of ALK-positive NSCLC in China. The study aims to enroll ALK-positive NSCLC patients who have undergone treatment with Iruplinalkib prior to enrollment. Demographic information, medical history, Iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related data will be collected for all enrolled patients. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. The primary sources of data for this study will mainly consist of patients' routine medical records or healthcare documentation.

Official Title
-----------------
Real-World Study of Iruplinalkib in the Treatment of ALK-Positive Non-Small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer (NSCLC)

Intervention / Treatment
-----------------
* Drug: Iruplinalkib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients willingly contribute their clinical data for this study Patients with ALK-positive non-small cell lung cancer Age ≥ 18 years Patients who have undergone treatment with Iruplinalkib. Exclusion Criteria: Known pregnant or lactating females Patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.

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: Iruplinalkib|Iruplinalkib is administered orally with approximately fixed dosing times each day. The recommended dosage is once daily, on an empty stomach or with food, at 60 mg per dose for the first 1 to 7 days. If tolerated, the dosage is increased to 180 mg per dose starting from the 8th day.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) |  | 36 months |
Flexible Reaching Control in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
Current research and theories have highlighted that the parameters linked to movement planning, e.g. the decision to select a movement goal, and adaptation, e.g. the ability to update control dependent on a novel dynamical context, are update quickly and within an ongoing movement in the general population. In parallel, it has been suggested that the evaluation of movement costs is a function of the basal ganglia, and it is impaired in Parkinson disease (PD). Here the investigators want to test whether these mechanisms also alter the ability of patients to update control during an ongoing action. A positive result would confirm that movement-related costs and dynamical representations depend on the integrity of the basal ganglia, in contrast a negative result would indicate that the deficit in PD is more specifically related to movement initiation, which would invite one to reconsider the cause of bradykinesia in this population.

Official Title
-----------------
Behavioural Study of Reaching Control in Healthy Volunteers and Volunteers With Parkinson Disease in Dynamical Context

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

Intervention / Treatment
-----------------
* Other: Reaching movements
* Other: Disease Assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to perform the task (assessed during the experiment) Exclusion Criteria: Inability to perform the task (motor) or to understand the task requirements (cognitive)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| PD<br>Patients with Parkinson disease | Other: Reaching movements<br>* Participants will be instructed to perform reaching movements by moving the handle of a robotic arm mounted with a virtual reality display.<br>Other: Disease Assessment<br>* Disease stage assessed by trained professionals<br>|
| Control<br>Healthy volunteers | Other: Reaching movements<br>* Participants will be instructed to perform reaching movements by moving the handle of a robotic arm mounted with a virtual reality display.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematics | Position of the handle as a function of time. Units are millimetres | Measured during the entire experiment (an average of 4.5 years) | 
| Surface Electromyogram | Surface recordings of muscles activities from the main muscles involved in movement production. Units are volts | Measured during the entire experiment (an average of 4.5 years) | 
| Applied forces | Forces applied by participants on the robotic handle. Units are Newtons | Measured during the entire experiment (an average of 4.5 years) |
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

Official Title
-----------------
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene Ciloleucel

Conditions
-----------------
Follicular Lymphoma, Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Axicabtagene Ciloleucel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential) Deemed medically fit and stable to receive the product per the investigator's evaluation Repeat leukapheresis is not feasible per the investigator's assessment Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release In the investigator's opinion, there is no satisfactory alternative therapy available to the individual Exclusion Criteria: History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel Uncontrolled active infection or inflammation per physician assessment Primary central nervous system lymphoma

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 |
| --- |
|Drug: Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase I Clinical Study of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry of HRS-9815 for PET/CT imaging in adult patients with prostate cancer.

Official Title
-----------------
Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Radiation Dosimetry of HRS-9815 for PET/CT Imaging in Patients With Prostate Cancer.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: HRS-9815 injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing; Male, age ≥18 years; ECOG score 0 - 1; Histologically confirmed adenocarcinoma of the prostate; Exclusion Criteria: Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study. Active syphilis infection. Known allergy, hypersensitivity, or contraindication to the trial product or any component of its formulation.。 Active in other clinical studies or less than 4 weeks after the last dose in the previous clinical study at the time of the first dose.

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

Sexes Eligible for Study
-----------------
Male

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: HRS-9815 injection<br> | Drug: HRS-9815 injection<br>* HRS-9815 injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AEs and SAEs, |  | up to 30 days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | up to 1 days follow-up | 
| time to maximum plasma concentration (Tmax) |  | up to 1 days follow-up | 
| biological half-life (t1/2) |  | up to 1 days follow-up | 
| cumulative urinary excretion rate based on radioactivity; |  | up to 1 days follow-up | 
| Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs; |  | up to 1 days follow-up | 
| Mean standardized uptake value (SUVmean) |  | up to 1 days follow-up | 
| Maximum standardized uptake value (SUVmax), |  | up to 1 days follow-up | 
| Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up] |  | up to 1 days follow-up |
Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions

Study Overview
=================
Brief Summary
-----------------
Advancements in imaging capacities and the development of a precise puncture-guiding transducer have made transthoracic ultrasonography a useful diagnostic tool for evaluating peripheral subpleural lung tumours. Different human tissues have varying levels of elasticity because of the properties of the extracellular matrix. Pleural two-dimensional (2D) shear-wave elastography (SWE) can be used to differentiate between malignant pleural effusion and benign pleural disease. Transthoracic 2D-SWE uses acoustic radiation force and assesses the velocity of tissue displacement propagation in multiple focal zones. The shear waves are monitored in 2D by creating a near-cylindrical shear-wave cone, enabling measurement of the shear-wave speed or Young's modulus (E) on a colour quantitative elastogram. Based on the hypothesis that transthoracic 2D-SWE could add accurate tissue stiffness information to B-mode grayscale ultrasound images and help in differentiating lung malignancy from benign lung lesions.

Official Title
-----------------
Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Radiographic evidence of pulmonary lesions Exclusion Criteria: Patients less than 18 years. Patients refusing to participate in the study. Inability to hold breath for at least 5 s.

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 |
| --- |
|Diagnostic Test: Ultrasound elastography|Using an ultrasound scanner (Aloka Echo Camera SSD-3500; Aloka Prosound, Yokohama, Japan) for chest ultrasound examinations. If patients has multiple subpleural lung lesions, the largest and most approachable lesion to perform 2 Dimensions- shear wave elastography (2D-SWE) will be chosen.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the predictive value of transthoracic 2 Dimension- Shear Wave Elastography (2D-SWE) in the diagnosis of peripheral lung lesions. | Peripheral lung lesions evaluated using 2 Dimension- Shear Wave Elastography to differentiate between benign and malignant lung lesions comparing the results to definitive diagnostic method either microbiological results and pathological specimens obtained by biobsy if indicated. | 1 MONTH | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound elastography, lung lesions
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Detailed Description
-----------------
Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344 and NCT05779397).

Official Title
-----------------
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Conditions
-----------------
Fever

Intervention / Treatment
-----------------
* Device: Masimo INVSENSOR00063


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant age ≥ 1 year Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference. English-or Spanish-speaking patient or parent/Legal Guardian Exclusion Criteria: Participants deemed not suitable for the study at the discretion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masimo INVSENSOR00063<br>All subjects are enrolled into this arm and will have temperature measurements obtained. | Device: Masimo INVSENSOR00063<br>* Masimo INVSENSOR00063 will be used to measure temperature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 | Masimo INVSENSOR00063 temperature measurements will be compared to reference temperature measurements. Accuracy of Masimo INVSENSOR00063 will be measured using clinical bias, limits of agreement and repeatability. | About 15-30 minutes |
Free and Cued Selective Reminding Test (16-words) Turkish Adaptation Study

Study Overview
=================
Brief Summary
-----------------
An Adaptation Study of Free and Cued Selective Reminding Test in Turkish

Detailed Description
-----------------
As very commonly used for objectifying Alzheimer Disease memory deficits, an adaptive selection of word choices are done for the use of free and cued selective reminding test (FCSRT) procedure in Turkish population. In this study the validity and reliability of the test to measure memory deficits in persons with memory complaints will be discussed.

Official Title
-----------------
Free and Cued Selective Reminding Test (16-words) Turkish Adaptation Study

Conditions
-----------------
Dementia, Memory Impairment

Intervention / Treatment
-----------------
* Behavioral: SIHT-16


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having memory complaints demanding clinical consultation for the memory complaint Exclusion Criteria: vascular pathology extrapyramidal findings psychiatric illness epilepsy cognition affecting drug use
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Turkish Adaptation Study of Free and Cued Selective Reminding Test (SIHT-16)<br>Outcomes of Turkish adaptation of Free and cued selective reminding test (SIHT-16) is compared with memory and non-memory test in three alternative lists: a,b, and c parallel lists. The participants are assessed in neurological diagnosis routine. | Behavioral: SIHT-16<br>* a pencil-paper assessment tool.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of translation | Variances of answers given to each form will be compared to each other to know if they are similar or different. | once | 
| Factor Analyses | Factor Analyses must be conducted to redefine the weight of each item on measuring memory deficits to be sure that turkish words version is similar to original factor weights. | once | 
| Validity of the ability of the measure to objectify the memory deficit in dementia | Test measures must be sensitive enough to objectify a memory deficits even in early stages of dementia. The scores of memory test in early and late stages of dementia will be compared to see if they are different. It's expected to be different. | once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adaptation, Alzheimer Disease, Memory Complaint, Memory, Dementia, Free and Cued Selective Reminding Test, Validity
Abg in Blunt Chest Trauma

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the value of ABG measurments in patients with blunt chest trauma and its role in prognosis of different outcomes and the results would aid the emergency physicians to speed up the management and reduce the cost of diagnosis

Official Title
-----------------
Arterial Blood Gas as an Early Screening Tool for Predicting Lung Injury in Blunt Chest Trauma

Conditions
-----------------
Blunt Injury of Thorax

Intervention / Treatment
-----------------
* Other: ABG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - all patient with polytrauma or blunt trauma to chest and thoraco-abdominal area from both genders are included in the study Exclusion Criteria: shocked patients whom were intubated ,patients that had pulmonary disease or heart diseases ,penetrating chest injury ,pregnant female ,patients who do not want to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ABG|ABG|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood gas as an early screening tool for predicting lung injury in blunt chest trauma | evaluate the diagnostic accuracy of ABG as a screening tool for identifying and early diagnosis lung injury in adult in blunt chest trauma | 5 minutes after arrival to emergency |