linjc16/ctgov huggingface dataset:
A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Multiple myeloma patients with normal ability of communication and understanding will be enrolled. DT, GAD-7, PHQ-15 and PSQI scales are designed to assess the mental health status of the patients. Demographic and disease data of patients will be collected as well. The main aim is to explore the factors affecting the mental health of myeloma patients.

Official Title
-----------------
A Multicenter Cross-sectional Study on Mental Health of Patients With Multiple Myeloma

Conditions
-----------------
Psychological Distress, Insomnia, Somatic Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic multiple myeloma were diagnosed according to the criteria of Chinese multiple myeloma diagnosis and treatment guidelines (revised in 2022). Age ≥18 years, with junior high school education or above. Patients have normal ability of communication and understanding. Informed consent has been signed. Exclusion Criteria: Who has kinship with other enrolled patients. Life expectancy of< 6 months.

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 |
| --- | --- | --- |
| morbidity of psychological distress in patients with multiple myeloma. | The total score of DT scale ≥4 points is defined as obviously psychological distress. | Baseline (the time when the patient is enrolled to the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity of anxiety in patients with multiple myeloma. | GAD-7 scale is applied to assess the anxiety of the patient | Baseline (the time when the patient is enrolled to the study) | 
| morbidity of insomnia in patients with multiple myeloma. | PSQI scale is applied to assess the insomnia of the patient | Baseline (the time when the patient is enrolled to the study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple myeloma, mental health
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.

Detailed Description
-----------------
Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition of failure: (a) radiological evidence of metastatic disease or b) initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of biochemical failure were used: 1) rising PSA with a final value >1.0 ng/mL and 2) rise above PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival, and positive prostate biopsy at 36 months.

Official Title
-----------------
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer

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

Intervention / Treatment
-----------------
* Procedure: Cryoablation and External Beam Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically localized prostate cancer PSA < 20ng/ml Negative bone scan Exclusion Criteria: Previous TURP Previous hormone therapy
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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cryoablation and External Beam Radiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No evidence of disease progression (NEDP) at 36 months |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate biopsy status |  | 36 months post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryoablation, Radiation, Prostate Cancer
Sublingual Microcirculation of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope

Study Overview
=================
Brief Summary
-----------------
This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39 (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males and 15 females). The sublingual microcirculation will be examined with the incident dark field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims to compare the differences of microcirculation among the three groups and between genders.

Official Title
-----------------
Population Research of Sublingual Microcirculation Data of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers aged from 20 to 79 years old BMI ranged from 18.5 to 27 kg/m2 Exclusion Criteria: Systolic blood pressure > 140 mm Hg, diastolic blood pressure > 95 mm Hg, or systolic blood pressure < 90 mm Hg at enrollment Body temperature > 37.5 ℃ or < 35.5 ℃ at enrollment had been diagnose with any one of the following diseases hypertension diabetes mellitus peripheral arterial occlusive disease coronary arterial disease liver cirrhosis chronic kidney disease stroke anemia asthma chronic bronchitis any metabolic diseases any hematologic disease uncured cancer chronic uncontrolled infection other disease may limit daily activities non-native speakers

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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 |
| --- | --- |
| Group 20-39<br>Patients aged from 20 to 39 years old. 30 males and 30 females. | |
| Group 40-59<br>Patients aged from 40 to 59 years old. 30 males and 30 females. | |
| Group 60-79<br>Patients aged from 60 to 79 years old. 15 males and 15 females. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total small vessel density of sublingual small vessels measured by Cytocam | Total small vessel density will be measured by Cytocam | Once at enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfused small vessel density of sublingual small vessels measured by Cytocam | Perfused small vessel density will be measured by Cytocam | Once at enrollment |
Metformin in Pregnancy in Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant PCOS women under metformin treatment. 47 non diabetic Polycystic Ovary Syndrome (PCOS) women became pregnant during metformin treatment and continued taking the drug during gestation. An oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-40 yr, metformin treatment for at least 3 months before entering the pregnancy, gestational age between 5 and 12 wk Exclusion Criteria: diabetes mellitus significant liver or renal impairment neoplasms and other endocrine diseases the use of drugs other than metformin able to interfere with glucose and insulin metabolism.

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

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

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: metformin<br> | Drug: Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of gestational diabetes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of spontaneous abortion |  |  | 
| number of hypertensive disorders |  |  | 
| number of live births |  |  | 
| number of newborns with macrosomia |  |  | 
| incidence of delivery by caesarian section |  |  |
Alberta Hip Improvement Project

Study Overview
=================
Brief Summary
-----------------
A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.

Detailed Description
-----------------
This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry

Official Title
-----------------
A Provincial Initiative to Examine the Efficacy, Cost-effectiveness and Long-term Safety of Alternative Hip Bearing Surfaces Versus Conventional Therapy for Degenerative Joint Disease of the Hip

Conditions
-----------------
Arthroplasty, Replacement, Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documentation of DJD of hip patient at least 18 years patient able to provide written consent Male under 65 years, female under 56 years Orthopedic surgeon has received appropriate training to implant an alternative device Exclusion Criteria: renal failure (MOM only) child bearing potential (MOM only) inappropriate femoral anatomy, including evidence of osteoporosis inflammatory arthritis (MOM) Unwilling to consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard<br>Standard hip replacement subjects (polyethylene) | |
| Alternative Bearing<br>Subjects with ceramic on ceramic total hip replacement or metal on metal hip resurfacing. | |

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
-----------------
Prospective, Conventional therapy, Registry, Metal-on-metal, Ceramic-on-ceramic, Hip Arthroplasty
Compassionate Use of the Becker Expander/Breast Implant

Study Overview
=================
Brief Summary
-----------------
To provide access of the Becker Expander/Breast implant to women who do not meet inclusion/exclusion criteria of the Becker Continued Access Study Patients' physician will contact Mentor to request use of the device and each request will be reviewed by Mentor, an IRB, and the FDA on a case-by-case basis

Official Title
-----------------
Compassionate Use of the Becker Expander/Breast Implant

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

Intervention / Treatment
-----------------
* Device: Becker 50 Expander/Breast implant
* Device: Becker 25 Expander/Breast implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who require a Becker Expander/Breast implant who do not meet inclusion/exclusion criteria of the Becker Continued Access Study

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Becker 50 Expander/Breast implant|The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant. The Becker 50 Expander/Breast Implant has a 50% gel volume and a 50% saline volume, so a 400cc implant would nominally have 200cc of saline and 200cc of silicone. The Becker 50 Expander/Breast Implant is available in sizes from 300 to 700cc.|
|Device: Becker 25 Expander/Breast implant|The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant. The Becker 25 Expander/Breast Implant has a silicone gel volume of approximately 25% and saline volume of approximately 75%. The Becker Expander/Breast Implant is available in sizes 150 - 800cc.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis

Study Overview
=================
Brief Summary
-----------------
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis

Conditions
-----------------
Acute Bronchitis

Intervention / Treatment
-----------------
* Drug: DW1601
* Drug: DW16011
* Drug: DW16012


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both gender, 19 years ≤ age ≤ 80 years Bronchitis Severity Score* ≥ 5point at Visit 2 (Randomized Visit) Acute bronchitis within 48hr based on Visit 2 (Randomized Visit) Those who can comply with the requirements of clinical trials Written consent voluntarily to participate in this clinical trial Exclusion Criteria: Patients who investigators determines to severe respiratory disease that would interfere with study assessment Patients with systemic infections requiring systemic antibiotic therapy patient with hemostatic disorder

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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: TEST<br>tid PO, DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml | Drug: DW1601<br>* Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)<br>|
| Active Comparator: Reference 1<br>tid PO, Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml | Drug: DW16011<br>* Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)<br>|
| Active Comparator: Reference 2<br>tid PO, Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml | Drug: DW16012<br>* Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchitis Severity Score(BSS) |  | Day 4 |
The Establishment of Multiple Point Prediction Model About Tacrolimus Metabolic Differences Based on Genetic Network After Liver Transplantation and the Application of Multicenter

Study Overview
=================
Brief Summary
-----------------
Combined with the clinical data of FK506 and the database of GO and Kyoto Encyclopedia of Genes and Genomes（KEGG）, the investigators aim to carry out the bioinformatic analysis and build a muti-locus genetic model, then muti-center assess the predictive accuracy of FK506 metabolic differences.

Conditions
-----------------
Cirrhosis, Liver

Intervention / Treatment
-----------------
* Drug: Tacrolimus（FK506）


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of end-tage liver diseases 18 years old or above Han nationality Therapeutic regimen：TAC Exclusion Criteria: Less than 18 years old Other races Therapeutic regimen：cyclosporine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Tacrolimus/dose1<br>Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days | Drug: Tacrolimus（FK506）<br> <br> |
| Active Comparator: Tacrolimus/dose2<br>Tacrolimus 5mg tablet and dosage based on Co once/twice a day for 7 days | Drug: Tacrolimus（FK506）<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of Tacrolimus |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Transplantation, Individualized Therapy, Polymorphism
Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients

Study Overview
=================
Brief Summary
-----------------
Interferon gamma releasing assay(IGRA) is useful to diagnose latent tuberculosis. However,IGRA responses could show within-subject variability. We wanted to determine long-term IGRA variability in health-care workers who continuously expose to tuberculosis patients.

Detailed Description
-----------------
IGRA will be performed monthly in health-care workers with continuous exposure to tuberculosis patients for 1 year.

Official Title
-----------------
Monthly Follow up of Interferon Gamma Releasing Assay Among Health-care Workers Treating TB Patients

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Other: Blood samplings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care workers who are continuously exposed to TB patients Age > 20 years Exclusion Criteria: Pregnant Active TB Use of immunosuppressants

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Health care workers<br> | Other: Blood samplings<br>* About 3.5ml of blood will be drawn from the participants monthly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of interferon-gamma releasing assay |  | monthly for 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IGRA, variability, Long-term variability of IGRA