linjc16/ctgov huggingface dataset:
Radiotherapy Alternates Human Epidermal Growth Factor 2 (Her2) Expression in Human Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Based on fundamental study （in Vitro and in Vivo, Pro. Jianjian Li）， Her2 expression would be changed from negative to positive by cancer irradiation with liner-accelerator at dose 6GY or up. The propose of this study is to reveal the irradiation result on Her2 expression in human breast cancer.

Official Title
-----------------
Study on Human Epidermal Growth Factor 2 (Her2) Expression Changes in Human Breast Cancer After Radiotherapy

Conditions
-----------------
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological confirmed advanced breast cancer cancer sample can be obtained by fine needle biopsy IHC and FISH confirmed Her2 negative radiotherapy indication for local residual cancer Exclusion Criteria: no radiotherapy indication patient refuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| Her2 changes during radiotherapy | biopsy is obtained by fine needle biopsy，Her2 is checked by Immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH). | every week up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast, Cancer, Human Epidermal Growth Factor 2 (Her2), irradiation
Tibolone Endometrium Study (Study 32972)(P06470)

Study Overview
=================
Brief Summary
-----------------
Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.

Official Title
-----------------
A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women

Conditions
-----------------
Postmenopausal Women

Intervention / Treatment
-----------------
* Drug: tibolone
* Drug: Tibolone 2.5 mg
* Drug: CE/MPA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive). Exclusion Criteria: Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'. Double layer endometrial thickness > 6 mm as assessed by transvaginal ultrasonography (TVUS). Any previous or current unopposed estrogen administration or tamoxifen citrate. Any unexplained vaginal bleeding following the menopause. Women with abnormal Pap smear test results (PAP IIb and higher) Previous use of raloxifene hydrochloride for longer than one month.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibolone 1.25 mg<br> | Drug: tibolone<br>* oral 1.25 mg tablet, once daily, for 2 years<br>|
| Experimental: Tibolone 2.5 mg<br> | Drug: Tibolone 2.5 mg<br>* oral 2.5 mg tablet, once daily, for 2 years<br>* Other names: Livial;|
| Active Comparator: CE/MPA<br> | Drug: CE/MPA<br>* oral, 0.625 mg tablet conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate tablet placed together in a single capsule, once daily, for 2 years<br>* Other names: Provera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial biopsy and histological examination |  | At 1 year and 2 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log. |  | TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording |
Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL. The study is not placebo-controlled or randomized.

Official Title
-----------------
An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: PROCHYMAL (remestemcel-L)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently active moderate-to-severe Crohn's disease exhausted standard-of-care options age 18 to 70 inclusive body weight between 30 and 150 kg adequate renal function not at risk for tuberculosis (TB) activation or re-activation Exclusion Criteria: biologic therapy for Crohn's within last 8 weeks confirmed adverse reactions during prior PROCHYMAL study participation alcohol or substance abuse, current or within past 6 months active HIV or hepatitis B or C infection surgery or trauma with 6 weeks allergy to bovine or porcine products elevated serum liver enzymes elevated serum bilirubin active malignancy within 5 years (other than some resected skin cancers) bacteremia or other serious bacterial or fungal infection within 3 months colonic dysplasia unstable arrhythmia or serious heart condition

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PROCHYMAL (remestemcel-L)|intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Influence of Fortified Pomegranate Juice (Punica Granatum) on Seasonal Influenza and Swine Flu Patients

Study Overview
=================
Brief Summary
-----------------
It has been shown in laboratory studies that pomegranate juice contains anti-viral action against influenza. The researchers wish to investigate the effect of pomegranate juice on patients suffering from influenza A (seasonal or swine flu).

Official Title
-----------------
The Influence of Fortified Pomegranate Juice (Punica Granatum) on Seasonal Influenza and Swine Flu Patients - A Prospective Randomized Trial

Conditions
-----------------
Influenza A, Swine Flu

Intervention / Treatment
-----------------
* Dietary Supplement: Pomegranate juice
* Dietary Supplement: Placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals confirmed and suffering from Influenza A Exclusion Criteria: Individuals suffering from influenza included in the high risk group

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Pomegranate juice<br> | Dietary Supplement: Pomegranate juice<br>* Twice daily ingestion of pomegranate juice over 4-5 days<br>|
| Placebo Comparator: Placebo drink<br> | Dietary Supplement: Placebo drink<br>* Twice daily ingestion of placebo drink over 4-5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early relief of influenza symptoms |  | Within one week |
Effectiveness of Rosuvastatin at Preventing the Progression of Atherosclerosis in HIV Positive Patients

Study Overview
=================
Brief Summary
-----------------
Rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. The goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with HIV. We expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.

Detailed Description
-----------------
HIV+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. B-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. We hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.

Official Title
-----------------
Randomized, Multicentre, Double- Blind, Placebo Controlled Trial of Rosuvastatin 10 mg for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Ultrasound in HIV-positive Patients Treated With Antiretrovirals

Conditions
-----------------
Atherosclerosis, HIV Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive, at least one cardiovascular disease risk factor Exclusion Criteria: Diabetes Previous vascular disease Muscular disease Current use of other lipid lowering therapy

Ages Eligible for Study
-----------------
Minimum Age: 35 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: 1<br>10 mg/day rosuvastatin for 96 weeks | Drug: Rosuvastatin<br>* 10 mg/day rosuvastatin<br>* Other names: Crestor;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo, 10 mg a day for 96 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average total thickness (a composite of carotid intima media thickness and total plaque area) |  | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid Intima Media Thickness, Total Plaque Area, Lipids |  | 96 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins, Intima Media Thickness, Plaque Area
The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2 7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36 months after the surgery.

Official Title
-----------------
The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring

Conditions
-----------------
Non-small-cell Lung Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 years old Patients with histologically documented (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer. Patients will undergo surgery. Patients with preoperative CTCs ≥8.5 Units / 3 ml Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients with histologically documented not (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer. After the operation review, patients' result of CTC, CT and tumor markers is incomplete at the same point. The blood sample isn't collected in predetermined time. The blood samples appear hemolysis. The blood sample isn't enough.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence. |  | 3 years | 
| Liconography using conventional CT examination results. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small-cell lung carcinoma, Circulating tumor cells
Study of the Nutritional, Metabolic, and Body Composition Profile in Children and Adolescents With Epidermolysis Bullosa

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Characterize the nutritional and metabolic profile of children and adolescents with epidermolysis bullosa. II. Determine patterns of body composition in these patients. III. Determine the energy requirements of these patients by measuring resting energy expenditure. IV. Assess protein nutrition by measuring lean body mass.

Detailed Description
-----------------
PROTOCOL OUTLINE: Data collected from a 5-day food diary are analyzed for protein, nutrient, and calorie intake. Nutritional, metabolic, and body composition are evaluated by indirect calorimetry, total body electrical conductivity, total body potassium, and lean body mass.

Conditions
-----------------
Epidermolysis Bullosa

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Epidermolysis bullosa Patient age: 2 months to 18 years

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease
Modified Functional Magnetic Stimulation Treatment for Constipation Improvement

Study Overview
=================
Brief Summary
-----------------
To prove the modify functional magnetic stimulation could improve constipation.

Detailed Description
-----------------
Permission： Any agent without effecting gastrointestinal motility or defecation is allowed. Inhibition： From test day to the next day(48 hours),it's not allowed to take any medication treatment which might affect digestive system or excretory system.

Official Title
-----------------
Modified Functional Magnetic Stimulation Treatment for Constipation Improvement

Conditions
-----------------
Constipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who age between 20 60 years old and have suffered from chronic constipation for more than 6 months will be enrolled in this study. Exclusion Criteria: Patients with implantation chip of brain Patients with implantation of pacemaker Patients with heart transplantation Patients are embedded electronic and Life support products. People who have be implanted metal、electronic devices、artificial joints or fixator. Patients with hemiplegia Patients with peripheral neuritis Patients with Prostate abnormalities Patients with Pregnancy Patients with Fever Patients with Injure Patients with Heart disease Patients with Consciousness disturbance Patients with Organic constipation Patients with Kidney stone Patients with Ureteric calculus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental Group<br> | |
| Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To improve bowel movement by the modify functional magnetic stimulation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constipation, Stimulation Treatment
Uterine Artery Blood Flow in Pregnant Women With PCOS Treated With Metformin

Study Overview
=================
Brief Summary
-----------------
FlowMet study is a sub-study of the PregMet study (registered in 2005). The aim of the FlowMet study is to register the possible effect of metformin on the blood flow of the uterine artery in pregnant PCOS women. The participants will be examined with ultrasound Doppler in gestational week 10-13: before and 3h after the first tablet intake of metformin/placebo and 10-14 days after inclusion in the trial blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.

Official Title
-----------------
Uterine Artery Blood Flow in Pregnant Women With Polycystic Ovary Syndrome(PCOS)Treated With Metformin - a Substudy to The PregMet Study

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Same as in the PregMet study. As this study is a sub-study/extended study of the PregMet study, ONLY those included in the PregMet study (NCT00159536) can participate. Exclusion Criteria: Same as in the PregMet study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Metformin 1000mg x 2 daily. Orally. From Weifa | Drug: Metformin<br>* 1000 mg x 2 daily. Orally. First tablet taken after the first Doppler examination and 3 hours before the next Doppler examination.<br>* Other names: metformin 500mg tablets from Weifa;|
| Placebo Comparator: 2<br>Placebo 2 tablets x 2 daily. Orally From Weifa | Drug: Placebo<br>* Placebo 2 tablets x 2 daily. Orally from Weifa<br>* Other names: Placebo tablets from Weifa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulsatility index of the uterine artery | 3 hrs before and after drug intake, 2 weeks after inclusion, and during medication | up to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow in the umbilical artery and fetal cerebral artery |  | 24 weeks gestational | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, pregnancy, metformin, blood flow, Pulsatility index
Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy

Study Overview
=================
Brief Summary
-----------------
This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative variables and short-term outcome of RALM and TLM patients.

Detailed Description
-----------------
All patients with symptomatic uterine myomas who underwent traditional laparoscopic myomectomy or robotic laparoscopic myomectomy were enrolled.

Conditions
-----------------
Uterine Myoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases with uterine myoma

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| uterine myoma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of postoperation abdominal drainage |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time |  | 1 day | 
| blood loss |  | 1 day |