linjc16/ctgov huggingface dataset:
A Study to Evaluate the Efficacy and Safety of CREZET Tablet

Study Overview
=================
Brief Summary
-----------------
This observation study is to evaluate blood lipid-lowering effects and liver/renal safety, changes in HbA1c and FPG in patients with dyslipidemia who administered CREZET tablets for 24 weeks.

Detailed Description
-----------------
A subject who is diagnosed with dyslipidemia and scheduled to administer CREZET tablets, will be enrolled in this study based on the doctor's medical decision. The CREZET Tablet will be administered for 24 weeks, and the data including demographic information, body measurement, vital signs and etc will be collected during the study period. The data collection point is as follows. Visit 1 (baseline, day 0) Visit 2 (at 12 weeks) Visit 3 (at 24 weeks)

Official Title
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A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of CREZET Tablet in Patients With Dyslipidemia

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Ezetimibe/Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: an adult male and female over 19 years of age A patient with dyslipidemia who is scheduled to administer Crezet tablets according to the medical judgment of the investigator based on permission A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied Exclusion Criteria: A person who is prohibited from administering according to the permission of the Crezet definition Patients who overreact to the principal or component of the Crezet definition Patients with active liver disease or patients with persistent high symptoms of serum aminotransferase levels a patient with a muscle disease a patient administered in combination with a cyclosporine-med Patients with severe renal failure (Creatinine Clearance (CLcr) < 30 mL/min) Women and lactating women who may be pregnant or pregnant Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption A person who has a history of taking Crezet tablets within three months of the date of registration A person who is deemed inappropriate to participate in this observational study based on the judgment of investigator.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ezetimibe/Rosuvastatin|Patient treated with Crezet Tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of change | The Rate of change in LDL-C | at 24 weeks from baseline |
Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. The main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer. The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.

Official Title
-----------------
Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Raman spectrum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who plan to undergo bronchoscopic biopsy or EBUS-TBNA Visible intratracheal lesions under bronchoscope Non-visible lesions suspected of lung cancer Exclusion Criteria: The patient could not tolerate further examination aimed at clarifying the cause of the disease or refused to accept further examination aimed at clarifying the cause of the disease due to poor general condition, serious organ dysfunction, etc The patient has no definite diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raman spectrum analysis<br>The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis. | Diagnostic Test: Raman spectrum<br>* The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer. | The diagnosis would be confirmed according to the pathological results. | 7 days after the biopsy |
Insulin Like Growth Factor-1 Against Oxidative Stress in Vitiligo

Study Overview
=================
Brief Summary
-----------------
Insulin like growth factor has a protective role on melanocytes against the oxidative stress. The aim is to investigate this effect in vitiligo patients.

Official Title
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Assessing the Protective Role of Insulin Like Growth Factor 1 Against Oxidative Stress in Vitiligo Patients

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Diagnostic Test: skin biopsy examined by ELISA technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-segmental vitiligo Exclusion Criteria: Pregnant or lactating females Smokers Patients with any endocrinal disease known to affect GH or IGF-1 as Diabetes (by measuring HbA1c) and Thyroid disturbance (by measuring TSH) Patients with liver disease (by measuring AST, ALT and GGT) Obese patients (by measuring BMI) Patients with history of ischemic heart disease (known medical history of angina or myocardial infarction or history of recurrent chest pain, left shoulder pain, shortness of breath or fatigue on the ordinary effort or less than the ordinary effort ) Patients with history of Peripheral arterial disease (Known medical history of peripheral arterial thrombosis or history of recurrent claudications) Patients with history of cerebero-vascular disease (known medical history of transient ischemic attacks or stroke) Patients who received systemic treatment for vitiligo during the previous six months or topical treatment during the previous two months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: skin biopsy examined by ELISA technique|skin biopsy examined by ELISA technique|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate for IGF-1 and IMA levels in vitiligo | To measure the level of IGF-1 and the level of IMA in perilesional and distant skin of vitiligo patients and compare these levels with normal controls to investigate the relationship between IGF-1, as a protective from oxidative stress and IMA, as a marker of oxidative stress in vitiligo. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure IMA in vitiligo and correlate it with psychological status of patients | To measure the serum level of IMA as a marker of oxidative stress in vitiligo patients versus normal controls 2- To correlate the findings with the VIS-22 score | One year |
Appraising Clinical Trial Experiences of Patients With Insomnia

Study Overview
=================
Brief Summary
-----------------
Medical research participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future insomnia patients during clinical study.

Official Title
-----------------
An Observational Study Investigating the Experience of Patients Undergoing Active Insomnia Clinical Trials

Conditions
-----------------
Insomnia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. Participant has a diagnosis of insomnia. Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Exclusion Criteria: Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results. Pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Rate of patients who decide to enroll in an insomnia clinical research. |  | 3 months | 
| Number of insomnia patients who remain in clinical study until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia
COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics

Study Overview
=================
Brief Summary
-----------------
In some clinical forms of COVID-19, an uncontrolled hyper-inflammatory reaction known as a cytokine storm appears abruptly, around day 7, and is associated with rapid respiratory deterioration, requiring hospitalization in an intensive care unit (ICU). At present, although risk factors for this severe form have been described, there are no validated criteria for determining which individual patients will develop this aggravation. The study of respiratory sounds (amplitude, frequency, ...) has made it possible in other respiratory pathologies (e.g., chronic obstructive pulmonary disease) to predict exacerbations several days in advance. Having a predictive respiratory pattern for worsening in COVID-19 would make it possible to anticipate the need for intensive care hospital beds, by means of a tool easily available on a mobile phone.

Official Title
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COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics

Conditions
-----------------
Sars-CoV-2 Infection, COVID-19

Intervention / Treatment
-----------------
* Device: COVOICE application use - initial
* Device: COVOICE application use - follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French speaking Affiliated to a social security system Owning a mobile phone capable of accessing the COVOICE application Exclusion Criteria: Incapable adults People deprived of their liberty People under administrative or judicial supervision Patients intubated or hospitalized in intensive care unit

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID<br> | Device: COVOICE application use - follow-up<br>* Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days<br>|
| Other respiratory diseases<br> | Device: COVOICE application use - follow-up<br>* Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days<br>|
| Healthy<br> | Device: COVOICE application use - initial<br>* Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening |  | Through study completion (36 months) | 
| Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening |  | Through study completion (36 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voice
Study of Music Therapy in Pain Rehabilitation Programs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure changes in mood, symptom burden, pain level, and stress scores in patients before and after a 20-minute music therapy intervention.

Official Title
-----------------
How Efficient is Music Therapy as a Distraction Technique in the Pain Rehabilitation Program Patients

Conditions
-----------------
Music Therapy

Intervention / Treatment
-----------------
* Behavioral: Music Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Patients that are enrolled in the Pain Rehabilitation Center, Mayo Florida Exclusion Criteria: - ≤ 18 years of age.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy in Pain Rehabilitation<br>Subjects undergoing care at the Mayo Clinic Florida Pain Rehabilitation Center (PRC) to address pain will receive a 20-minute music therapy intervention | Behavioral: Music Therapy<br>* 20-minute music-therapy-informed interventions (musical bingo, songwriting, lyric scramble) guided by a music therapist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mood | We will use the NCCN distress thermometer before and after the creative work intervention to assess distress. For those patients who indicate high feelings of depression, their mood would be dealt with in accordance with clinic practice. The Distress Thermometer measures distress on a 0 to 10 scale. To report your distress, circle the number that matches your level of distress in the past week. The Problem List includes problems from 5 areas of life: practical, family, emotional, spiritual/religious, and physical problems. The higher the score the more distress experienced in that domain. | Baseline, after music intervention approximately 20 minutes | 
| Change in pain level | A 0-10 Likert Pain scale will be used. 0 = No Pain, 10 = Worst Pain Imaginable | Baseline, after music intervention approximately 20 minutes |
Nutritional Risk Factors and Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
This observational study aims to learn about the relationship between the nutritional status of patients with colorectal cancer and clinical outcome after colorectal surgery. The main question[s] it aims to answer are: which anthropometric, laboratory and specific parameters best define that patient is at nutritional risk will patients that are at nutritional risk stay longer in the hospital after surgery than those who are not at nutritional risk Patients will be preoperatively examined anthropometrically, radiologically and laboratoryally. Postoperatively, the course of their treatment will be monitored, as well as the monitoring of postoperative complications. A group of patients with and without malnutrition will be compared.

Official Title
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Nutritional Risk Factors in Patients With Colorectal Cancer

Conditions
-----------------
Colorectal Cancer, Nutrition Related Cancer

Intervention / Treatment
-----------------
* Procedure: Colorectal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer First operation of this type Exclusion Criteria: Urgent surgery Peritoneal carcinomatosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group with colorectal cancer and malnutrition<br> | Procedure: Colorectal surgery<br>* Right hemicolectomy, left colectomy, total colectomy, anterior resection<br>|
| Group with colorectal cancer without malnutrition<br> | Procedure: Colorectal surgery<br>* Right hemicolectomy, left colectomy, total colectomy, anterior resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay |  | 30 days |
Development and Management of Registry in Patients With Gynecologic Cancer in Korea

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to identify and analyze the characteristics, treatment trends, prognostic factors and survival prognosis of Korean gynecologic cancer patients. Ultimately, the final goal is to contribute to the development of safe surgical methods and treatment for gynecologic cancer to improve survival rates.

Detailed Description
-----------------
Cervical cancer, endometrial cancer, and ovarian cancer represent gynecologic cancers. There are many open issues that need to be addressed, specifically the surgical method, disease recurrence and survival outcome in the so called real world setting. The aim of this observational study is to collect both retrospective and prospective medical information of gynecologic cancer patients.

Official Title
-----------------
Development and Management of Registry in Patients With Gynecologic Cancer in Korea

Conditions
-----------------
Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Intervention / Treatment
-----------------
* Other: Patient registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients 18 years or older Written informed consent (prospective cohort) Confirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer Exclusion Criteria: Unconfirmed diagnosis of cervical cancer, endometrial cancer or ovarian cancer

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cervical cancer<br>No interventions | Other: Patient registry<br>* Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures<br>|
| Endometrial cancer<br>No interventions | Other: Patient registry<br>* Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures<br>|
| Ovarian cancer, Fallopian tube cancer, Peritoneal cancer<br>No interventions | Other: Patient registry<br>* Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Analyzed for all patients as time from diagnosis to death as a result of any cause, stratified according to baseline characteristics, surgical methods, and treatment | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Analyzed for all patients, as time from diagnosis to progression of disease or death as a result of any cause, stratified according to baseline characteristics, surgical methods, and treatment | 5 years |