linjc16/ctgov huggingface dataset:
A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.

Official Title
-----------------
A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: TQB3456


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent Exclusion Criteria: Patients with non-small-cell lung cancer who have received osimertinib or other raw materials or preparations for EGFRT790M mutant drugs Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: TQB3456<br>p.o. qd | Drug: TQB3456<br>* Observe the safety and pk when the subjects take TQB3456 p.o. qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-Limiting Toxicities（DLT） | an adverse event cccurring after initiation of TQ-B3456 that met any following criteria： >=Grade 3 of non-hematology toxicity Grade 4 hematology toxicity | Baseline up to 28 days |
IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study

Study Overview
=================
Brief Summary
-----------------
Our objective is to evaluate the inter and intra observer reproducibility of the measure of elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of mucles of patients with and without hamstring injury. 76 patients will be evaluated cross sectionally twice by two ultrasonographists.

Detailed Description
-----------------
Muscle trauma mainly results from sporting activities and accounts for 10 to 55% of sports injuries. Information on ARFI muscle trauma management is scarce. The present study sought to assess the initial ARFI characteristics of muscle in sports people with and without injury. Our objective here is to evaluate the inter and intra observer reproducibility of the measure of elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of muscles of patients with and without hamstring injury. 76 patients will be evaluated cross sectionally twice by two ultrasonographists(and then we will evaluate the evolution after 3 months for patient with injury according to the ARFI results).

Official Title
-----------------
IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study

Conditions
-----------------
Muscle Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients justifying an ultrasound evaluation for suspicion of muscle injury Exclusion Criteria: Inflammatory muscle disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Elasticity | ultrasound | Inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle
Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia. The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty. Design: Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Design Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Conditions
-----------------
Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Naftopidil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients aged 4 years or more diagnosed with BPH Exclusion Criteria: subjects with uncontrolled blood pressure subjects with hepatic or renal dysfunction subjects with prostate cancer Had treatments for BPH using other alpha receptor antagonists within 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naftopidil dose 2<br>PO administration | Drug: Naftopidil<br> <br> |
| Placebo Comparator: Placebo<br>PO administration | |
| Experimental: Naftopidil dose 1<br>PO administration | Drug: Naftopidil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy(IPSS score change) |  | From 0 week(baseline) to 12 week(end of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ) |  | From 0 week(baseline) to 12 week(end of the treatment) |
Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Study Overview
=================
Brief Summary
-----------------
The syndrome of distractibility is a behavioral disorder induced by a lesion or a dysfunction of the frontal lobe. This sign is frequent in patients with progressive supranuclear palsy (PSP), a neurodegenerative disorder with severe neuronal loss in the prefrontal cortex and cholinergic systems, in particular in the Meynert basalis nucleus. This could participate in the occurrence of the distractibility in these patients. The aim of this study is to evaluate the effect of the donepezil, an anticholinesterase, on the distractibility in PSP patients, by using oculomotor and neuropsychological assessments.

Official Title
-----------------
Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Conditions
-----------------
Supranuclear Palsy, Progressive

Intervention / Treatment
-----------------
* Drug: donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with PSP Age > 30 years old Disease duration < 5 years Mini mental state (MMS) > 24 Antisaccades %: 40-80% Exclusion Criteria: Other parkinsonian syndromes MMS < 24

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: donepezil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Progressive supranuclear palsy, Frontal lobe, Oculomotor testing, Neuropsychological scores, Motor disability (UPDRS), Distractibility
Distance Healing in Wound Healing

Study Overview
=================
Brief Summary
-----------------
This trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery.

Official Title
-----------------
Placebo Effects in Distance Healing of Wounds

Conditions
-----------------
Breast Reconstruction Surgery

Intervention / Treatment
-----------------
* Behavioral: Distance healing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing major plastic surgery (> 2 hours in length) Health status is excellent with no systemic disease, no limitation on activity, no danger of death or disease of one body system, well-controlled underlying disease Exclusion Criteria: Remove history of breast or other cancers History of radiation therapy to the abdomen or any radiation within the past three months Non-English speaking Unable or unwilling to fill out questionnaires Current smoker Morbid obesity Circulatory inadequacies (i.e., diabetes, hypovolemia) Nutritional deficits as evidenced by neutropenia (WBC <2500/ml) or hypoalbuminemia (albumin <3.3mmg/dl) / chart review

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distant Healing<br>This group received distant healing but was blinded to the condition. | Behavioral: Distance healing<br> <br> |
| Placebo Comparator: Non-blinded Distant Healing<br>This group received the distant healing intervention and was called every day they were receiving to be told they were receiving it, therefore enhancing expectancy. | Behavioral: Distance healing<br> <br> |
| No Intervention: Blinded Control<br>This group was blinded to the intervention condition and did not receive any distant healing. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collagen deposition in a surrogate wound |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POMS normalized mood scores | Compared from baseline to end of distant healing period | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast reconstruction surgery, prayer, distance healing, wound healing
Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Neutropenia, defined by an absolute count of polymorphonuclear neutrophils less than <1500/mm3, exposes patients to infectious complications that can lead to sepsis or septic shock. The mortality risk is higher risk. The recommendations published in 2016 were formulated to homogenize the clinical practices to improve the survival.

Detailed Description
-----------------
We evaluate the adequacy antibiotics prescriptions in febrile neutropenia with suspected infection and evaluate factors influencing adequacy therapy and mortality consequence.

Official Title
-----------------
Antibiotics Management of Septic Neutropenic Patients in the Intensive Care Unit : New Recommendations do They Change Our Clinical Practice ?

Conditions
-----------------
Neutropenia, Febrile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sepsis or septic shock at admission or during the stay Exclusion Criteria: Minor Pregnancy Opposition
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adequate antibiotic prescription | Proportion of adequate antibiotic prescription | Through study completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality of all causes | Mortality of all causes | ICU, hospital and 28-day mortality |
Dynamic and Static Autoregulation After Brain Injury

Study Overview
=================
Brief Summary
-----------------
The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status.

Official Title
-----------------
Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury

Conditions
-----------------
Acute Brain Injuries, TBI (Traumatic Brain Injury), Intracranial Hemorrhages

Intervention / Treatment
-----------------
* Other: There are no interventions in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic brain injury Intracranial hemorrhage Exclusion Criteria: Measurement of TCD were impossible Injury of the legs (if the both tigh cuffs for dynamic autoregulation could not be fixed)

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 |
| --- | --- |
| Brain injury<br>Patients after traumatic brain injury or spontaneous intracranial bleeding | Other: There are no interventions in this study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disturbed cerebrovascular autoregulation after brain injury |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dynamic cerebrovascular autoregulation, static cerebrovascular autoregulation, acute brain injury, transcranial Doppler ultrasound, critical care
Surgical Correction of Astigmatism

Study Overview
=================
Brief Summary
-----------------
Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years. During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism. In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.

Official Title
-----------------
Comparative Study of Surgical Laser Correction of Astigmatism

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Procedure: ReLEx
* Procedure: LASIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopic astigmatism between -2.0 and -5.0 diopters Maximal difference in spherical equivalent refraction of 2 D between eyes No ocular or systemic disease Not pregnant or breastfeeding Minimum BSCVA of 0.8 (decimal) Normal corneal topography Sufficient corneal thickness to allow the treatment Exclusion Criteria: Subjects not fulfilling the above criteria

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReLEx<br>One eye is treated with ReLEx the other with LASIK | Procedure: ReLEx<br> <br> * Other names: Device: Carl Zeiss Meditec Visumax Femtosecond Laser;|
| Active Comparator: LASIK<br>One eye is treated with ReLEx the other with LASIK | Procedure: LASIK<br> <br> * Other names: Device: Carl Zeiss Meditec MEL-80 excimer laser;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refraction |  | 1 year |
Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.

Official Title
-----------------
An Open-label, Crossover Study to Assess the Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Immediate- and Modified-release Formulations in Healthy Adult Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: XW10172


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male of female participants who are 18 to 55 years of age, inclusive. Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study. Exclusion Criteria: Evidence or history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, psychiatric, neurological, immunological, or endocrine disorders, poor vision, or allergic disease including drug allergies, including immediate type hypersensitivity. A history of childhood asthma that has resolved is acceptable. Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XW10172<br> | Drug: XW10172<br>* Various formulations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 12 hours | 
| Trough concentration (Cmin) |  | 12 hours | 
| Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration (AUC0-tlast) |  | 12 hours | 
| AUC from time 0 extrapolated to infinity (AUC0-inf) |  | 12 hours | 
| AUC over the dosing interval (AUCtau) |  | 12 hours | 
| Apparent terminal half-life (t1/2) |  | 12 hours | 
| Cmax and AUC ratios of metabolite to XW10172 |  | 12 hours | 
| Apparent oral clearance (CL/F) |  | 12 hours | 
| Time to reach Cmax (Tmax) |  | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, severity, and causality of AEs |  | Up to 14 Days |