linjc16/ctgov huggingface dataset:
Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy

Study Overview
=================
Brief Summary
-----------------
Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.

Detailed Description
-----------------
This is a phase II, multi-center study. Sixty-seven patients are planned to be enrolled. All patients will receive Icotinib 125 mg BID administered for 8 weeks. Patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.

Official Title
-----------------
Sun Yat-sen University Cancer Center

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

Intervention / Treatment
-----------------
* Drug: Icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older ECOG 0 or 1 Primary or metastatic tumor onfirmed as triple negative Measurable disease per RECIST version 1.1 normal organ function, including bone marrow function, renal function, liver function, and cardiac function Two or more prior chemotherapy signed and dated an informed consent form Life expectancy of at least 12 weeks Exclusion Criteria: Pregnant or breast feeding ECOG score ≧2 Uncontrolled medical problems Hepatic, renal, or bone marrow dysfunction as detailed above Concurrent malignancy or history of other malignancy within the last five years except as noted above Patients were unable or unwilling to comply with program requirements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: Icotinib<br>Icotinib 125 mg BID | Drug: Icotinib<br>* Icotinib 125 mg BID<br>* Other names: Conmana;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | the time from randomization to the date of disease progression or death from any causes | 36 months |
A Pharmacogenomic Study of Candesartan in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of genetic variations on the response to candesartan in patients with heart failure who are already treated with an ACE inhibitor.

Official Title
-----------------
Effect of ACE Inhibitor Plus High Dose Candesartan on BNP and Inflammation in Patients With LV Dysfunction: Impact of Renin-angiotensin-aldosterone System Genetic Polymorphisms

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Candesartan up to 32 mg daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Principal Inclusion Criteria: Male or female > or = 18 years old. Symptomatic CHF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization. LVEF < or = 40% Treatment with an optimal and stable dose of ACE inhibitor for at least 4 weeks prior to enrolment in the study. Principal Exclusion Criteria: Treatment with an ARB within 8 weeks prior to randomization. Known hypersensitivity to ARBs or ACE inhibitors. Creatinine clearance < 30 ml/min or serum creatinine > 221 Current serum potassium > or = 5.0 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia. Known bilateral renal artery stenosis. Current symptomatic hypotension and/or systolic B.P. < 90 mmHg. Decompensated heart failure described as hospitalization or I.V. administration of medication in emergency room or heart failure clinic within 4 weeks Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization. Connective tissue disease or chronic inflammatory condition Acute inflammatory process such as an infection or gout attack in the last 2 weeks. Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Candesartan up to 32 mg daily|Candesartan 4 to 32 mg daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BNP and NT-proBNP |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 16 weeks | 
| CRP |  | 16 weeks | 
| Renin |  | 16 weeks | 
| Aldosterone |  | 16 weeks | 
| Insulin resistance/ glucose |  | 16 weeks | 
| NYHA functional class |  | 16 weeks | 
| Tolerability |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candesartan, Heart failure, Gene polymorphism, ACE inhibitors, BNP, Pharmacogenomics
Effects of Victoza® Versus Lyxumia® on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

Study Overview
=================
Brief Summary
-----------------
The present study will compare lixisenatide and liraglutide in a population of subjects with T2DM not optimally controlled on OADs and / or insulin, which is the target population for these medications.

Official Title
-----------------
Effects of Victoza® (Liraglutide) Versus Lyxumia® (Lixisenatide) on Gastroesophageal Reflux, Gastric Emptying and Gastric Acid Secretion

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Liraglutide
* Drug: Lixisenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male or female aged 18-65 years (both inclusive) T2DM diagnosis Exclusion Criteria: Contraindications (including known or suspected hypersensitivity) to GLP-1 mimetics Use of GLP-1 mimetics or DPP-IV inhibitors Clinically relevant dysglycaemia as indicated by HbA1C ≥ 10%

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>The highest injected once daily dose will be 1.8 mg s.c. for liraglutide. | Drug: Liraglutide<br> <br> |
| Experimental: Lixisenatide<br>The highest injected once daily dose will be 20µg s.c. for lixisenatide. | Drug: Lixisenatide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (week -1) in the number of reflux episodes |  | 24 hours after 10 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (week -1) in the time of pH < 4.0 in the lower third of the oesophagus |  | After 10 weeks of treatment |
Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.

Official Title
-----------------
Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

Conditions
-----------------
Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information. Exclusion Criteria: Off-label use of Daklinza and Sunvepra Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information

Ages Eligible for Study
-----------------
Minimum Age: 19 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 expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities |  | 6 months to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence proportion of AEs leading to discontinuation of study therapy |  | 6 months to 5 years | 
| Incidence rate of AEs leading to discontinuation of study therapy |  | 6 months to 5 years | 
| Timing of laboratory abnormalities by toxicity grade |  | 6 months to 5 years | 
| Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected |  | 4 Weeks to 24 Weeks | 
| The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL) |  | 24 Weeks to 36 Weeks |
Areas of Brain Responsible for Understanding American Sign Language

Study Overview
=================
Brief Summary
-----------------
The human brain is made up of two halves called hemispheres. Each half of the brain is responsible for processing different kinds of information. Previous neuroimaging studies have shown that both the right and left hemispheres are involved when processing information given in American Sign Language (ASL). However, the study also showed that when processing spoken language, the left hemisphere was mostly involved. Researchers would like to find out more about how the brain processes American Sign Language (ASL). This study is designed to determine if the right hemisphere is necessary for normal understanding of ASL.

Detailed Description
-----------------
The purpose of this protocol is to determine if the right hemisphere activation associated with perception of American Sign Language (ASL) in deaf subjects and in normal hearing individuals raised by deaf parents (who learned ASL before written English) is necessary for appropriate understanding of ASL.

Official Title
-----------------
Hemispheric Lateralization of Language Receptive Function in the Deaf and in Hearing Individuals Who Learned ASL as First Language

Conditions
-----------------
Brain Mapping, Deafness, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Subject age between 18 and 65 years. Adult hearing offsprings of deaf parents. Congenitally deaf individuals. Intact hearing volunteers. No subjects with personal or family history of seizures or other neurological or demyelinating disorders. No pregnant women tested after urine pregnancy test. No subjects with severe coronary disease. No subjects with metal in the cranium except mouth. No subjects with intracardiac lines and implanted medication pumps. No subjects with increased intracranial pressure as evaluated by clinical means. No subjects with cardiac pacemakers. No subjects with an intake of neuroleptics.
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Deafness, Hemisphere Dominance, Language, Plasticity, Speech, rTMS
Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

Study Overview
=================
Brief Summary
-----------------
This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.

Detailed Description
-----------------
The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.

Official Title
-----------------
Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation

Conditions
-----------------
Abortion, First Trimester

Intervention / Treatment
-----------------
* Drug: mifepristone-misoprostol treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestation up to 63 days General good health Willingness to provide contact information for follow-up Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination Exclusion Criteria: Ectopic pregnancy Intrauterine device (IUD) in place

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

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

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 |
| --- | --- |
| Other: mifepristone-misoprostol treatment<br>200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone | Drug: mifepristone-misoprostol treatment<br>* 200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.<br>* Other names: medical abortion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mifepristone, Misoprostol, Buccal administration
Pathogenic Microorganisms in Adult Severe Pneumonia Patients

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province

Detailed Description
-----------------
The pathogenic microorganisms of adult patients with severe pneumonia is detected in this study. Clinical treatment does not involve , so it meets the ethical requirements. The clinical data, laboratory test results and imaging data of adult severe pneumonia patients in different hospitals in different cities are recorded. The pathogenic microorganism is detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical treatment.

Official Title
-----------------
A Multicenter Clinical Study on the Detection of Pathogenic Microorganisms in Adult Severe Pneumonia Patients in Liaoning Province

Conditions
-----------------
Pathogenic Microorganism of Serious Pneumonia

Intervention / Treatment
-----------------
* Other: pathogenic microorganism


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the standard of severe pneumonia： Main standards： Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy. Secondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 < 60mmHg; azotemia (BUN ≥ 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC < 4 × 109 / L); thrombocytopenia (< 10 × 109 / L); hypothermia (T < 36 ℃). Exclusion Criteria: refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples

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 |
| --- |
|Other: pathogenic microorganism|Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province | Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing | 2020.7-2023.12 |
Demonstration of a New Device to Measure the Force of Delivering a Baby

Study Overview
=================
Brief Summary
-----------------
This study is an observational study to prove that a new device, which measures the force of delivering a baby, (US patent 6,684,165) functions as described in the patent. This is the first time this has been used with patients.

Detailed Description
-----------------
Currently, there is no way to measure how hard a doctor or midwife pulls when a baby is delivered. This device is a platform with special sensors. The doctor or midwife stands/sits on the platform while delivering the baby, and using a simple physical principle: for every action, there is an equal an opposite reaction. Prior to building the prototype and starting the study, the system and concept has been patented (US patent 6,684,165). In reality, this is not really a medical device since it does not touch the patient and does not have any effect on the delivery itself. It is merely a new type of external observation of the delivery of a baby that happens to produce useful information (the force that is exerted when the baby is delivered).

Official Title
-----------------
Demonstration of a New Device to Measure the Force of Delivering a Baby

Conditions
-----------------
Full Term Singleton Pregnancy

Intervention / Treatment
-----------------
* Device: Peisner device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy at term Singleton gestation Vertex presentation Exclusion Criteria: Non-reassuring fetal heart rate tracing

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Peisner device|The doctor/midwife stands on the device while the baby is delivered. The device measures how much force is exerted on the baby.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force Exerted on a Fetus as the Delivery Occurs | The amount of force exerted on the fetus was measured in ounces. It was calculated based on measurements from the force transducers in the platform. The obstetrician stands or sits on the platform as the infant is delivered. | Assessment was done after the delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labor and delivery, Vaginal delivery
The Effect of Transcutaneous Electric Nerve Stimulation on Primary Dysmenorrhea-a Randomized Control Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.

Detailed Description
-----------------
Over 50% of American women suffered from dysmenorrhea and 10% of them will take sick leave for 1-2 days. Previous randomized control studies have demonstrated the pain relief effect of using high frequency TENS in dysmenorrheal pain. However, no investigation has been conducted to investigate the effect of high frequency TENS in female population in our country. The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.

Official Title
-----------------
The Effect of Transcutaneous Electric Nerve Stimulation on Primary Dysmenorrhea-a Randomized Control Study

Conditions
-----------------
Primary Dysmenorrhea,

Intervention / Treatment
-----------------
* Device: Transcutaneous Electric Nerve Stimulation (TENS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary Dysmenorrhea Exclusion Criteria: subjects with organic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcutaneous Electric Nerve Stimulation (TENS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all measure the pain threshold, |  |  | 
| self-rating questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Dysmenorrhea,, Transcutaneous Electric Nerve Stimulation