linjc16/ctgov huggingface dataset:
Clinical Trial of YuWell YE900 Electronic Sphygmomanometer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the accuracy of the YuWell YE900 medical electronic blood pressure monitor for blood pressure measurements in adults and children according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

Official Title
-----------------
Validation of the YuWell YE900 Medical Electronic Blood Pressure Monitor in Adults and Children According to the AAMI/ESH/ISO 81060-2:2018 Standard

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Diagnostic Test: YuWell YE900 Electronic Sphygmomanometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 Years and older (Child, Adult, Older Adult); Subjects voluntarily participate in the clinical trial and sign the informed consent. Exclusion Criteria: Disturbance of consciousness; Patients requiring hemodialysis; Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases; Pregnant and lactating women; Patients with cardiac arrhythmias; Other conditions that the investigator considers ineligible for clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 3 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: YuWell YE900 and mercury sphygmomanometer<br>Blood Pressure Measurement with the YuWell YE900 Electronic Sphygmomanometer (YuWell YE900) and with Desk Mercury Sphygmomanometer. | Diagnostic Test: YuWell YE900 Electronic Sphygmomanometer<br>* Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.<br>* Other names: Blood Pressure Measurement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure measurement data | Systolic Pressure and Diastolic Pressure | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AAMI/ESH/ISO 81060-2: 2018 standard, blood pressure measurement, blood pressure monitor, validation study, YuWell YE900
Rituxmab Versus IL-6 in Treating ILD

Study Overview
=================
Brief Summary
-----------------
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test

Detailed Description
-----------------
All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive shortness of breath is the most frequently presentation going to ER pulmonary unit first. It should be considered in case of persistent dry cough or dyspnea, which should be looked for in any patient with SSc. an etiological assessment must be conducted in order not to mistakenly attribute ILD to the SSc.

Official Title
-----------------
Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients

Conditions
-----------------
Interstitial Lung Disease, Scleroderma

Intervention / Treatment
-----------------
* Drug: Rituximab
* Drug: IL6 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active ILD scleroderma Exclusion Criteria: abnormal liver enzymes renal impairment neutropenia <1000 cells/mm3 thrombocytopenia < 50,000 cells/mm3

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituxmab<br>1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year | Drug: Rituximab<br>* IV infusion 1000 mg<br>* Other names: Rituxan;|
| Experimental: IL-6 inhibitor<br>6 mg/kg IV infusion every month not exceed 600 mg for 1 year | Drug: IL6 inhibitor<br>* 6 mg/kg I V infusion monthly<br>* Other names: Actemra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forced vital capacity | pulmonary function test | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| computed tomography chest | imaging | 1 year | 
| modified rodnan skin score | skin score | 6 months |
Exercise-induced Collective Rhabdomyolysis

Study Overview
=================
Brief Summary
-----------------
Rhabdomyolysis, which is a characteristic occurrence in associated with muscle cell necrosis, develops due to various causes.The investigators herein report a rare case of collective rhabdomyolysis after high intensity resistance training, including 35 teenagers（participants），in which markedly elevated levels of serum creatine kinase (CK) and serum myoglobin were observed. This high intensity resistance trainings is a part of Military Training(MT)，which all the middle school students must finish before admission。

Official Title
-----------------
Exercise-induced Collective Rhabdomyolysis

Conditions
-----------------
Rhabdomyolysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of rhabdomyolysis; Caused by military training; Informed consent； Must be able to cooperate with blood test. Exclusion Criteria: Caused by drugs and other reasons; No hospitalization event
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 |
| --- | --- | --- |
| serum creatine kinase； | Change in serum creatine kinase at 3 months | 3 months | 
| serum myoglobin | At the time of discharge | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhabdomyolysis, Military Training
Sonographic Assessment for Prediction of Labor Induction Success

Study Overview
=================
Brief Summary
-----------------
The study is conducted to assess several sonographic parameters for prediction of labor induction success. These parameters include cervical length, fetal head circumference, and fetal head to cervix angle.

Detailed Description
-----------------
Pregnant women at term over 37 weeks' gestation visiting the obstetric emergency room for various obstetric indications will be assessed. Women with obstetric or medical indication for induction will receive an explanation regarding the study protocol and will sign an informed consent. After recruitment and during the evaluation in the obstetric emergency room, patients will undergo transvaginal sonography during which, cervical length, fetal head circumference and fetal head to cervix angle will be measured. Relevant demographic and obstetric information will be collected from a computerized database.

Official Title
-----------------
Sonographic Assessment of Fetal Head Circumference, Cervical Length and Fetal Head to Cervix Angle for Prediction of Labor Induction Success

Conditions
-----------------
Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
-----------------
* Diagnostic Test: Transvaginal sonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy. Term pregnancy. Exclusion Criteria: Multiple gestation. Fetal anomalies and malformations. Preterm pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transvaginal sonography|Transvaginal sonography for measurement of cervical length, fetal head circumference and fetal head to cervix angle .|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in induction of labor | Vaginal delivery rate after labor induction | From admission to the obstetric emergency room up to 24 hours postpartum |
A Pharmacokinetic Study of TRK-100STP in Japanese Patients With Renal Impairment

Study Overview
=================
Brief Summary
-----------------
The PK and safety profiles to be examined following a single oral administration of TRK-100STP (120 μg) under fasting conditions to patients with renal impairment and to subjects with normal renal function.

Official Title
-----------------
A Pharmacokinetic Study of TRK-100STP -A Single Oral Administration Study in Japanese Patients With Renal Impairment as Compared to Subjects With Normal Renal Function

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: beraprost sodium(BPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The eGFR 1 day before study drug administration are stipulated as follows. Subjects with normal renal function : ≥90 Patients with mild renal impairment : ≥60 to <90 Patients with moderate renal impairment : ≥30 to <60 Patients with severe renal impairment : ≥15 to <30 Exclusion Criteria: Patients on dialysis Patients who have a history of undergoing renal transplantation Patients with diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subjects with normal renal function<br> | Drug: beraprost sodium(BPS)<br> <br> |
| Experimental: patients with mild renal impairment<br> | Drug: beraprost sodium(BPS)<br> <br> |
| Experimental: patients with moderate renal impairment<br> | Drug: beraprost sodium(BPS)<br> <br> |
| Experimental: patients with severe renal impairment<br> | Drug: beraprost sodium(BPS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of pharmacokinetic parameters of TRK-100STP such as maximum observed concentration (Cmax,pg/mL), area under the plasma concentration-time curve (AUC,pg·hr/mL), time at maximum concentration (Tmax,hr) and mean residence time (MRT,hr) |  | Up to 48hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRK-100STP, PK, beraprost sodium, Japanese males and females, Subjects with mild/moderate/severe patients, renal impairment
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes

Study Overview
=================
Brief Summary
-----------------
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis

Official Title
-----------------
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes

Conditions
-----------------
Cartilage Injuries in the Human Knee

Intervention / Treatment
-----------------
* Procedure: Human allogenic chondrocytes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Important cartilage injury in the knee Exclusion Criteria: Important axis deviation Inflammatory joint disorder Severe obesity

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: 1<br>Implantation of fresh human allogenic chondrocytes | Procedure: Human allogenic chondrocytes<br>* Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of the cartilage injuries |  | After 2 years |
Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients With NSCLC

Study Overview
=================
Brief Summary
-----------------
Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment. The purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.

Official Title
-----------------
Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients With Non Small Cell Lung Cancer Mass Tissue Imaging HyperIONTM

Conditions
-----------------
Advanced Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Advanced NSCLC with PD-L1 TPS of 50% or greater Administration of first line pembrolizumab between January 2017 & December 2019 Exclusion Criteria: Auto-immune disease Prior exposure to immunotherapy First dose pembrolizumab administered after December 2019
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 |
| --- | --- | --- |
| Identifying predictive biomarkers of anti-PD-1 response | Identifying predictive biomarkers of anti-PD-1 response by highlighting discriminant cell profiles between responder and non-responder patients | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pembrolizumab, biomarkers, multiplex imaging
A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

Study Overview
=================
Brief Summary
-----------------
This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.

Detailed Description
-----------------
Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo. In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4 groups L-756423 and IDV are blinded to the investigator and patient. All groups receive open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized Pilot Study to Compare the Safety and Activity of L-756423/Indinavir, 1600/800 Mg Qd or 800/400 Mg Bid Versus Indinavir, 800 Mg q8h, All in Combination With Stavudine and Lamivudine

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: L-756423
* Drug: Indinavir sulfate
* Drug: Lamivudine
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this trial if you: Have HIV infection. Have levels of CD4 cells of 100 cells/mm3 or greater. Have a viral load of 10,000 copies/ml or greater. Are 18 years of age or older. Exclusion Criteria You may not be eligible for this trial if you: Have ever taken anti-HIV drugs.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: L-756423|nan|
|Drug: Indinavir sulfate|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|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
-----------------
Drug Therapy, Combination, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Evaluation of Implants Placed in the Regular Dentist's Practice

Study Overview
=================
Brief Summary
-----------------
This study is an evaluation of the implants placed in a regular dentist's practice regarding: gingiva condition stability of implant prothetic quality questionnaires for the patients

Official Title
-----------------
Retrospective Evaluation of Implants Placed in the Regular Dentist's Practice. A Study to Evaluate Implant Success, Prosthetic Complications, Opinion of the Patient, and Quality of Care

Conditions
-----------------
Dental Implant

Intervention / Treatment
-----------------
* Procedure: Clinical examination (implant stability, gingiva condition, etc.)
* Procedure: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with implants placed in a regular dentist's practice

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placed implants<br> | Procedure: Clinical examination (implant stability, gingiva condition, etc.)<br>* Clinical examination (implant stability, gingiva condition, etc.) to follow<br>Procedure: Questionnaires<br>* Questionnaires are used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingiva condition |  | t0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implant