linjc16/ctgov huggingface dataset:
A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study

Study Overview
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Brief Summary
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This is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Environmental exposure and daily within and out-of-school activities will be evaluated in a random subgroup.

Detailed Description
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Myopia is the most common refractive error and a major reason for reducing uncorrected visual acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted in a significant increase in myopia due to the changed lifestyle of schoolchildren dramatically. However, it is unclear which kind of risk factors should be the first to bear the brunt before and during COVID-19. And which factors should be emphasized and confronted as the optimum strategy for myopia prevention and control? This cohort study aims to determine the risk factors, prevalence, and incidence of myopia, and SE changes among schoolchildren before and during COVID-19, hence identifying the factors that impact the onset and progression of myopia. This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged 6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China will be analyzed. Over a 3-year follow-up period, students will receive detailed eye examinations annually and complete questionnaires about eye-use environment, eye-use habits, lifestyle, and family and subjective factors. In a 5% random sample size of this cohort study, outdoor activity, light intensity, eye use habits, and eye use environment data will be obtained using objective measuring devices. Myopia was defined as spherical equivalent refractive (SER) of ≤ -0.5D.

Official Title
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A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study

Conditions
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Myopia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All 6-18 years students Exclusion Criteria: No eye diseases such as cataracts, glaucoma, keratoconus, etc. No psychiatric disorders Astigmatism ≤ -6.00D

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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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 |
| --- | --- | --- |
| Prevalence of myopia | Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye | One day measurement | 
| Prevalence of high myopia | High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye | One day measurement |
AMH and Functional Hypothalamic Amenorrhea

Study Overview
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Brief Summary
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The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Furthermore, after the resumption of the spontaneous menstrual cycle, we will reanalyze AMH levels, which we hypothesize to find higher. If our hypotheses are confirmed correct, we could support the thesis that AMH is not a good index of ovarian reserve in patients with functional hypothalamic amenorrhea.

Official Title
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AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea

Conditions
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Amenorrhea Secondary

Intervention / Treatment
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* Diagnostic Test: venous sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 15-34 years. Diagnosis of functional hypothalamic amenorrhea (for at least 2 years). Signature of informed consent. Exclusion Criteria: Polycystic ovary syndrome Taking oral contraceptives in the previous three months Other clinically relevant endocrinopathies positive MAP-test (Medroxyprogesterone acetate test) Estroprogestin replacement therapy Autoimmune disorders Failure to sign informed consent

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 34 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with functional hypothalamic amenorrhea<br>Women aged 15-34 years Diagnosis of functional hypothalamic amenorrhea (for at least 2 years) No interventions to be administered | Diagnostic Test: venous sampling<br>* venous sampling<br>|
| Healthy controls<br>Women aged 15-34 years Normal menstrual cycles No interventions to be administered | Diagnostic Test: venous sampling<br>* venous sampling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMH assay | Check serological AMH levels in patients with FHA for at least 2 years and compare them with AMH levels in healthy women. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate AMH levels with other parameters | Correlate serologic AMH levels with antral follicle count (AFC). Verify serologic AMH levels in previously FHA patients after resumption of spontaneous menstruation, i.e., at 6 months | 12 months |
Biomolecular Analysis for Predicting Response to Regorafenib

Study Overview
=================
Brief Summary
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The study envisages NGS analysis on tumor tissue from patients treated with regorafenib for recurrent glioblastoma as per standard care, with the aim to identify predictive biomarkers for response.

Official Title
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Tumor Biomolecular Analysis for Defining Predictive Factors for Response to Regorafenib in Recurrent Glioblastoma

Conditions
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Glioblastoma, Glioblastoma, IDH-wildtype

Intervention / Treatment
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* Diagnostic Test: Biomolecular tumor analysis


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: recurrent glioblastoma after surgery and chemoradiation with temozolomide; indication to treatment with regorafenib per standard of care; written informed consent. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years

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

Accepts Healthy Volunteers
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No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biomolecular tumor analysis<br>NGS, IHC, methylome and other molecular studies | Diagnostic Test: Biomolecular tumor analysis<br>* NGS analysis, other molecular analyses on FFPE tumor tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | through study completion, an average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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NGS, regorafenib, predictive biomarker
Learning Curve and Optimization of Robotic Gastrectomy

Study Overview
=================
Brief Summary
-----------------
we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery.

Official Title
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Enlightenment of Robotic Gastrectomy From 527 Patients With Gastric Cancer in the Minimally Invasive Era: 5 Years of Optimizing Surgical Performance in a High-volume Center

Conditions
-----------------
Gastric Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Case inclusion criteria: (1) patients with pathologically confirmed gastric adenocarcinoma; (2) no distant metastases; and (3) R0 resection was performed. Exclusion Criteria: Case exclusion criteria: (1) the presence of distant metastases was found ; (2) preoperative neoadjuvant chemotherapy was administered; and (3) clinical information was incomplete.
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 |
| --- | --- | --- |
| The LN dissection rate | The LN dissection rate was defined as the number of the LN station was examined divided by the total number of retrieval LN station. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LN noncompliance | LN noncompliance was defined as the absence of LNs from more than 1 LN station. | 30 days |
the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy

Study Overview
=================
Brief Summary
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It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome. The purpose of this study is to : Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants. Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care 1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks. 2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.

Official Title
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Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy

Conditions
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Pharmacological Action of Drug

Intervention / Treatment
-----------------
* Drug: Caffeine citrate
* Drug: Amikacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All preterm infants with respiratory distress syndrome. Exclusion Criteria: Preterm admitted to NICU for other reasons rather than respiratory distress Major congenital anomalies spontaneous intestinal perforation Endocrinal Dysfunctions

Ages Eligible for Study
-----------------
Minimum Age: 32 Weeks
Maximum Age: 35 Weeks

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS | Drug: Amikacin<br>* it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group<br>|
| Active Comparator: Caffeine-treated group<br>It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection. | Drug: Caffeine citrate<br>* It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreasing NEC rates | decreasing NEC rates and stage ≥2 and death. | 1 year |
Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Study Overview
=================
Brief Summary
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This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-2811 when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

Official Title
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A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-2811 When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

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

Intervention / Treatment
-----------------
* Drug: DA-2811
* Drug: Forxiga


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Subjects with 7.0%≤HbA1c≤10.0% at screening Subjects treated with 1,000mg/day or higher dose of metformin for at least 8 weeks prior to screening Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study Exclusion Criteria: Subjects with fasting plasma glucose≥240mg/dL at screening Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus Subject with ALT and AST 3 times or higher than upper normal range Subject with history of myocardial infarction, cerebral infarction within 3 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 19 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: DA-2811<br>DA-2811 + Forxiga placebo | Drug: DA-2811<br>* DA-2811 Group: DA-2811 + Forxiga placebo<br>|
| Active Comparator: Forxiga<br>Forxiga + DA-2811 placebo | Drug: Forxiga<br>* Forxiga Group: Forxiga + DA-2811 placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c(%) |  | Change from baseline at 24 weeks |
The Efficacy of Combination of Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized controlled trial was designed to evaluate the effectiveness and safety of the comprehensive traditional Tibetan medicine program combined with remote ischemic conditioning on high altitude polycythemia.

Official Title
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A Randomized Controlled Trial of the Efficacy of Combining Traditional Tibetan and Remote Ischemic Conditioning on High Altitude Polycythemia

Conditions
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High Altitude Polycythemia

Intervention / Treatment
-----------------
* Device: Remote Ischemic Conditioning
* Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients with high-altitude polycythemia aging 18 to 65 years. Exclusion Criteria: Allergic to Tibetan medicine ingredients; Inappropriate to receive Tibetan medicine treatment and/or remote ischemic conditioning.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tibetan Medicine Group<br> | Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)<br>* Comprehensively Tibetan medicine for 28 days, including Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills and Qiwei Tiexue Pill, dosage of which are 1.5g daily.<br>|
| Experimental: Tibetan Medicine-Remote Ischemic Conditioning Group<br> | Device: Remote Ischemic Conditioning<br>* Remote ischemic conditioning conducted by an electric auto-control device will be performed twice a day for 14 days, each session including 5-min ischemia and 5-min reperfusion.<br>* Other names: An electric auto-control device to perform remote ischemic conditioning.;Drug: Tibetan Medicine (Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills, Qiwei Tiexue Pill)<br>* Comprehensively Tibetan medicine for 28 days, including Shiliu Jianwei Powder, Ershiwuwei Yuganzi Pills and Qiwei Tiexue Pill, dosage of which are 1.5g daily.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of effective treatment | The hemoglobin levels decreased ≥20% after treatment compared to pre-treatment. | Baseline and 1 month after treatment. |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis- Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
CAPTIVA-MRI is an observational multimodal MR imaging study that is ancillary to the CAPTIVA trial [a 3-arm, double-blind Phase III trial conducted at approximately 115 StrokeNet sites randomizing patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.] The primary goal of this ancillary study is to determine if MRI biomarkers can potentially identify ICAS patients who fail best medical management. The CAPTIVA-MRI study leverages the CAPTIVA trial design and implementation to capture information that will inform and facilitate the next generation of ICAS trials and the management of patients with ICAS.

Official Title
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Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis- Magnetic Resonance Imaging

Conditions
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Stroke, Intracranial Atherosclerotic Stenosis (ICAS)

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in the CAPTIVA trial: nondisabling symptomatic ischemic infarct stroke within 30 days secondary to 70-99% stenosis of the intracranial ICA, MCA, BA or VA Ability to obtain baseline study MRI within 14 days of CAPTIVA enrollmen Exclusion Criteria: Unable or unwilling to undergo MRI, including pacemaker or other MRI contraindications per American College of Radiology guidelines62 Gadolinium contrast allergy or acute or chronic kidney disease with eGFR<30 ml/min/1.73m2

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAPTIVA-MRI Group<br>CAPTIVA patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (ICAS) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban. | Other: MRI<br>* Additional MRI to the CAPTIVA study at baseline and 12 months follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish ICAS hemodynamic and plaque MRI biomarkers as reliable predictors of recurrent ischemic stroke in the vascular territory of the index stroke. | Recurrent ischemic stroke, defined as symptomatic infarct in the vascular territory of the index stroke artery. This outcome is centrally adjudicated in CAPTIVA using an American Heart Association definition of ischemic stroke | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Stroke, intracranial atherosclerotic stenosis (ICAS)