linjc16/ctgov huggingface dataset:
Investigation of Genetic Marker Associated With Obesity in Koreans

Study Overview
=================
Brief Summary
-----------------
A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the obese patients and the normal control will be performed to find genetic marker for obesity

Official Title
-----------------
Investigation of Genetic Marker Associated With Obesity in Koreans, A Single-nucleotide Polymorphism(SNP) Analysis for Korean Obese

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25 30kg/m2 Exclusion Criteria: All were nonsmokers and had no evidence of cancer, liver, renal, hematological disease or other metabolic disorders other than obesity

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| controls<br>control group with a BMI of less thatn 25kg/m2 | |
| obese group<br>Obese patients with BMI 25-30 kg/m2 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotyping for the SNP associated with BMI |  | one year |
Hydroxyurea in Primary Progressive Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The pathogenesis of MS remain elusive, however some studies have linked the disease with infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or immunomodulating action alone may be less suitable for primary progressive MS.This study will evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has recently been used in combination with antiretroviral drugs in HIV and has been shown to limit immune activation and suppress viral load by both antiviral and cytostatic activities. Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV. For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral action , confirming the role of EBV in the pathogenesis of MS.

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Hydroxyurea
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sign written informed consent 18 to 60 years of age inclusive diagnosis of PP-MS according to McDonald criteria EDSS score at screening of 2-7 inclusive Exclusion Criteria: hypersensitivity to hydroxyurea patients who were treated with immunosuppressive drugs or steroid three month before respiratory or urinary infections history or presence of malignancy pregnancy or lactation low compliance to the therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Hydroxyurea<br> | Drug: Hydroxyurea<br>* 500 mg/die per os for two years<br>|
| Placebo Comparator: Placebo<br> | Other: placebo<br>* 500 mg/die per os for two years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the evaluation of safety and tolerability of hydroxyurea |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis |  | two yeras |
Characterizing Follicles From Auto-transplanted Ovarian Tissue

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to characterize the hormonal conditions in egg follicles in women who, prior to fertility treatment, have had autotransplanted frozen ovarian tissue for the purpose of fertility preservation.

Official Title
-----------------
Characterizing Follicles From Auto-transplanted Ovarian Tissue

Conditions
-----------------
Infertility, Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18 years or older Has had frozen and later autotransplanted ovarian tissue for fertility preservation purposes Included in fertility treatment with eff retrieval at the Fertility Clinic Regional Hospital Skive Is willing and able to give informed consent Exclusion Criteria: - Patients undergoing fertility treatment but have not received autotransplanted ovarian tissue for fertility preservation purposes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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 |
| --- | --- | --- |
| Characterize hormone production in follicles from autotransplanted ovarian tissue | Women undergoing fertility treatment | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.

Conditions
-----------------
Cystoid Macular Edema,, Retinal Thickening

Intervention / Treatment
-----------------
* Drug: 2. Xibrom (Bromfenac)
* Drug: 1. Pred Forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age scheduled to undergo cataract surgery Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams) Expected visual outcome of 20/25 or better. Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: · Known contraindication to any study medication or any of their components Uncontrolled systemic disease Required use of ocular medications other than the study medications during the study Abnormal pre-operative OCTs Diabetic patients with a history of macular edema or diabetic retinopathy AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease Only one eye of each patient can be enrolled

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: 1. Pred Forte<br>* Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks. Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.<br>|
| Other: 2<br> | Drug: 2. Xibrom (Bromfenac)<br>* Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cystoid Macular Edema |  | 11 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Thickening |  | 11 months |
Generation of a Surgical Field in the Left Lateral Decubitus Position

Study Overview
=================
Brief Summary
-----------------
The generation of a good surgical field at the mid-lower mediastinum during thoracoscopic esophagectomy in the left lateral decubitus position is often complicated. The investigators developed a simple and useful technique for surgical field generation.

Official Title
-----------------
Generation of a Surgical Field at the Mid-lower Mediastinum for Thoracoscopic Esophagectomy in the Left Lateral Decubitus Position

Conditions
-----------------
Esophageal Cancer, Thoracic Diseases

Intervention / Treatment
-----------------
* Other: Thoracoscopic esophagectomy in left decubitus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent thoracoscopic esophageal resection from April 2015 to December 2019 in our hospital. Exclusion Criteria: patients who underwent open thoracotomy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Thoracoscopic esophagectomy in left decubitus|Making surgical field at thoracoscopic esophagectomy in left decubitus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of thoracoscopic esophagectomy | The rate of completion of thoracic esophagectomy with our method for the generation of surgical field in mid-lower mediastinum. | During surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left decubitus position, Mid-lower mediastinum, Thoracoscopic esophagectomy
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.

Official Title
-----------------
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Conditions
-----------------
Haemophilia B

Intervention / Treatment
-----------------
* Drug: Nonacog beta pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries Exclusion Criteria: - Not applicable as this is a study collecting third-party data from registries
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haemophilia B<br>Patients with haemophilia B treated with nonacog beta pegol who report adverse events to the PedNet and EUHASS, and possibly other national or international registries. | Drug: Nonacog beta pegol<br>* Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B | Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events) | From start of data collection (week 0) to end of data collection (after 9 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B | Number of events (de novo FIX inhibitors more than or equal to 0.6 Bethesda units); anaphylaxis and other allergic reactions; thromboembolic events) | From start of data collection (week 0) to end of data collection (after 9 years) |
TIPE2 Associated With Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
TIPE2, a negative regulator of innate and adaptive immunity that maintains immune homeostasis. The investigators want to know whether TIPE2 is a risk factor for graft loss and gives rise to the immune dysfunction in renal transplant patients.

Official Title
-----------------
Department of Renal Transplantation, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China

Conditions
-----------------
Renal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: long-term surival(>5year),AR and CR kidney transplant patients and healty Volunteers as control Exclusion Criteria: without hepatitis , tumor and infections

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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
-----------------
we have complieted party research
Dysphagia Awareness In Medical and Nursing Students

Study Overview
=================
Brief Summary
-----------------
A survey consisting of questions about swallowing and dysphagia was provided to universities' medicine and nursing students. The answers of students were analyzed

Detailed Description
-----------------
The undergraduate training of health care professionals may provide the necessary theoretical and practical approach to future nurses and physicians. This study was planned to investigate students' dysphagia knowledge level and awareness in the medicine and nursing faculties. A survey consisting of questions about swallowing and dysphagia was provided to universities' medicine and nursing students. The answers of students were analyzed

Official Title
-----------------
Awareness of Dysphagia in Medical and Nursing Students

Conditions
-----------------
Dysphagia, Awareness, Students

Intervention / Treatment
-----------------
* Other: no intervention group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The fourth, fifth, and sixth-grade students in the faculty of medicine The second, third, and fourth-grade students in the nursing faculty Exclusion Criteria: The first, second and third-grade students in the faculty of medicine The first grade students in the nursing faculty

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention group|The awareness of medical and nursing students were evaluated. there is no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A survey | A survey that consists of questions related to dysphagia awareness | Participants completed the survey at once. 20 minutes required to complete the survey | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dysphagia, awareness, medical students, nursing students
Child-Physician Recommendation on Parental Adherence to Colorectal Cancer Screening

Study Overview
=================
Brief Summary
-----------------
Physician recommendation has been shown to be one of the most significant predictors for colorectal cancer (CRC) screening. This study aims to identify the amount of parents of internal medicine residents at NYU who are eligible for CRC screening but have not received it. Investigators will perform an intervention and quantify the amount of parents eligible for CRC screening after the intervention. This study will entail sending 2 brief surveys (one before the intervention and one after) which determine if the parents of the residents are eligible for CRC screening. The intervention will be asking the residents with eligible parents to have a discussion with their parents about CRC screening options and to address their concerns. Investigators will provide a one page document the residents can give their parents as a reference as part of the intervention.

Official Title
-----------------
Child-Physician Recommendation on Parental Adherence to Colorectal Cancer Screening

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Internal medicine residents at NYU - PGY1, PGY2, and PGY3 during 2017-2018 academic year

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRC screening Survey<br>Residents with parents eligible for CRC screening will be asked to provide their e-mail address, solely for the use of distributing the follow up survey so it can be linked to 2 brief (3-5 min) surveys | Other: Survey<br>* Survey with 4-7 questions about each parents' demographics and CRC screening history. Depending on answers, provided a CRC screening document and asked to discuss screening with parents, followed by a brief survey in 4 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CRC screening rate of eligible parents of internal medicine residents at NYU from before to after the intervention |  | Baseline to 6 Months |
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in Premenopausal Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.

Detailed Description
-----------------
The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer. This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting. The survey will enroll approximately 300 patients. - Leuprorelin This multi-center survey will be conducted in Japan.

Official Title
-----------------
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in Premenopausal Breast Cancer

Conditions
-----------------
Premenopausal Breast Cancer

Intervention / Treatment
-----------------
* Drug: Leuprorelin acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Participants with premenopausal breast cancer will be included. Exclusion Criteria: Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues Pregnant or potentially pregnant participants and breastfeeding participants
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leuprorelin acetate<br>Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care. | Drug: Leuprorelin acetate<br>* Leuplin PRO for Injection Kit 22.5 mg<br>* Other names: Leuplin PRO for Injection Kit 22.5 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Events |  | Up to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Up to Week 24 |