linjc16/ctgov huggingface dataset:
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year.

Official Title
-----------------
An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Biological: VEGF Trap-Eye (BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years with type 1 or 2 diabetes mellitus Subjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye BCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye Exclusion Criteria: Active proliferative diabetic retinopathy (PDR) in the study eye Uncontrolled diabetes mellitus, as defined by HbA1c >12% Only 1 functional eye even if that eye is otherwise eligible for the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VTE 2Q4 first, then VTE 2Q8<br>VEGF Trap-Eye [BAY86-5321; EYLEA (aflibercept) Injection] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8) | Biological: VEGF Trap-Eye (BAY86-5321)<br>* Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event collection |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BCVA (best corrected visual acuity) letter score |  | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Macular Edema, DME, VEGF Trap-Eye, best-corrected visual acuity (BCVA)
Survey in Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to describe long-term tolerance as seen under current conditions of use for anastrozole.

Official Title
-----------------
A Report Upon a Cohort of Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy for Hormone-dependant Breast Cancer. Long-term Tolerance Evaluation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman treated with anastrozole as adjuvant therapy for hormone-dependant breast cancer in post-menopausal women with positive hormone-receptors
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, anastrozole
Medical and Psychiatric Co-Morbidity Among Treatment Resistant Patients With Major Depression Disorder

Study Overview
=================
Brief Summary
-----------------
Assessing psychiatric and physiological co-morbidity in TRD and non-TRD patients

Conditions
-----------------
Major Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of MDD Received at least one adequate treatment Exclusion Criteria: -

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 |
| --- | --- | --- |
Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis

Study Overview
=================
Brief Summary
-----------------
The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis

Official Title
-----------------
Multicenter Study for Evaluation of Efficacy and Safety of Perennial Specific Immunotherapy With a Depot House Dust Mite Allergen Extract (D. Pteronyssinus 100%) in Patients With House Dust Mite Sensitivity

Conditions
-----------------
House Dust Mite Allergy

Intervention / Treatment
-----------------
* Biological: House dust mite Novo Helisen Depot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive skin prick test to house dust mite, Positive RAST test to house dust mite, Positive provocation test result to house dust mite, Exclusion Criteria: Serious chronic diseases, Other perennial allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Intervention/Treatment |
| --- |
|Biological: House dust mite Novo Helisen Depot|nan|

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
-----------------
Allergy, House dust mite,
Prevention of Overfeeding During Infancy

Study Overview
=================
Brief Summary
-----------------
The overall goal of this project is to identify strategies to prevent overfeeding during infancy. One objective is to evaluate the impact on intake of allowing the infant greater control over the amount consumed when feeding from a bottle. This will be accomplished via the use of a novel nipple that mimics (functionally) the nipple of a human breast and allows the infant to self-regulate milk flow. The second objective is to evaluate the relationship between parental feeding styles and infant intake.

Official Title
-----------------
Prevention of Overfeeding During Infancy

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

Intervention / Treatment
-----------------
* Behavioral: Use of baby bottle nipple


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant born at > 37 weeks gestation Infant weighed >2500 g at birth Infant is apparently healthy Mother speaks English Mother is 18 years of age or older Mother/infant pair lives within a 10-mile radius around the UC Davis Medical Center in Sacramento, CA Mother plans to use a bottle (at least occasionally) to feed her infant before he/she is 3 months old.

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel nipple<br> | Behavioral: Use of baby bottle nipple<br>* Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle<br>|
| Active Comparator: Coventional nipple<br> | Behavioral: Use of baby bottle nipple<br>* Participants will be assigned to either a novel nipple or a conventional nipple to use when feeding their infants with the bottle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake |  | per feed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth |  | 4 months |
Dissecting How Peripheral Lymphocytes Are Lost During Sepsis

Study Overview
=================
Brief Summary
-----------------
There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis.

Detailed Description
-----------------
There is an observational, clinical study. We recruit patients with diagnosis of new onset sepsis within 24h, collect and record clinical characteristics： ①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T, RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of ICU-acquired infection and prognosis.The blood samples were collected for apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte loss in different condition.

Official Title
-----------------
Dissecting How Peripheral Lymphocytes Are Lost During Sepsis

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health volunteers Exclusion Criteria: History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Sepsis<br>Diagnosis of new onset sepsis within 24h without history of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization. | |
| Health control<br>Health vonlunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lymphocyte loss | ratios of T cells loss by different mechanism in different subgroups | day of inclussion and 7th day after inclussion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis | 28-day prognosis:survive or not | 28-day after inclussion | 
| Complicated organ dysfunction | duration and surpport therapy | during 28 days after inclussion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, lymphocyte
Remote Food Photography Method in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if digital photography on a Smartphone and the Remote Food Photography Method (RFPM) can estimate infant formula intake. This is a validation study; there is no hypothesis.

Official Title
-----------------
Baby Bottle: Remote Food Photography Method in Infants

Conditions
-----------------
Estimating Infant Food Intake

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age Willing to complete 2 study visits at Pennington Biomedical (PBRC)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>All participants enrolled between November 2012 and March 2013 under the original protocol. | |
| Cohort 2<br>After Cohort 1 was completed, the study investigators changed the protocol to eliminate the photograph/weight of the powdered formula alone in each bottle to reduce burden. All other protocol procedures remained the same. Cohort 2 participants enrolled between April 2013 and May 2014. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles | Kilocalorie (Kcal) Difference in prepared infant formula intake detected in a bottle between the Remote Food Photography Method (RFPM) and direct weighing Kilocalorie difference between the Remote Food Photography Method and direct weighing with all bottles that were prepared included Kilocalorie difference is Remote Food Photography Method - Direct Weighing | Measures will be performed twice about 5-10 days apart | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kilocalorie (Kcal) Difference Between Different Bottle Sizes | Kilocalorie difference between the Remote Food Photography Method and direct weighing separately analyzed by the four different bottle sizes that were prepared (2 oz bottles only, 4 oz bottles only, 6 oz bottles only, and 8 oz bottles only). Each participant prepared 3 sets of 2 oz bottles, 3 sets of 4 oz bottles, 3 sets of 6 oz bottles, and 3 sets of 8 oz bottles and all bottles of the specified size were included in the analysis. Kilocalorie difference is Remote Food Photography Method - Direct Weighing | Measures will be performed twice about 5-10 days apart |
Stress Hyperglycemia and Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.

Detailed Description
-----------------
Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases. The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.

Official Title
-----------------
Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients

Conditions
-----------------
Stress Hyperglycemia

Intervention / Treatment
-----------------
* Other: standard protocol for stroke patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke within 24 hours of onset of symptoms Exclusion Criteria: subdural hematoma Transient ischemic attack Subarachnoid hemorrhage Hemorrhagic stroke Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar (RBS) < 150 mg/dl) within 24 hours with insulin therapy, diabetic Ketoacidosis RBS less than 70 mg/dl on admission

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| Normal RBS<br>Normal RBS on ICU admission and controlled blood sugar within 24 hours | Other: standard protocol for stroke patients<br>* Standard protocol for stroke patients<br>* Other names: no specific intervention;|
| High RBS<br>High RBS on ICU admission and uncontrolled blood sugar during first 24 hours | Other: standard protocol for stroke patients<br>* Standard protocol for stroke patients<br>* Other names: no specific intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale (NIHSS) | The NIHSS score categorized into: no stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days mortality | Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality | 30 days |
A Study of the Safety of Atezolizumab in Participants With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina

Study Overview
=================
Brief Summary
-----------------
This is a study of the safety and effectiveness of atezolizumab in participants with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Participants also will have progressed on an appropriate approved targeted therapy if their tumor has epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities treated in common clinical practice settings in Argentina.

Official Title
-----------------
An Observational Study of the Safety of Atezolizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT) Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) Have received at least one dose of atezolizumab as per local label and clinical practice Exclusion Criteria: Contraindicated atezolizumab therapy
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 |
| --- | --- | --- |
| Percentage of Participants With Adverse Events |  | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to approximately 2 years | 
| Percentage of Participants With a Confirmed Objective Response (ORR) of Complete Response (CR) or Partial Response (PR) |  | Up to approximately 2 years | 
| Duration of Response (DOR) |  | Up to approximately 2 years | 
| Progression-Free Survival (PFS) |  | Up to approximately 2 years |
Chinese Acute Ischemic Stroke Treatment Outcome Registry

Study Overview
=================
Brief Summary
-----------------
This is a multi-center registry study. The investigators will include 10,000 patients with confirmed acute ischemic stroke in China. The aim of the study is to survey current treatment situation in China and compare the effectiveness and safety between different intervention regimens.

Detailed Description
-----------------
Stroke is a common disease in China. Compared to western countries, there are many treatment regimens used in clinical practice in China. But their treatment effects are not well validated. The aim of the study is to survey current treatment situation in China and compare the effectiveness and safety between different intervention regimens.

Official Title
-----------------
Chinese Acute Ischemic Stroke Treatment Outcome Registry

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Other: treatment following current guideline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 yesrs confirmed diagnosis of an ischemic stroke admission within 1 week after onset of stroke or within treatment time window for patients of thrombolysis treatment signed informed consent Exclusion Criteria: with intracerebral hemorrhage with severe morbid (estimated survival duration less than 3 months) could not provide follow-up information

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 |
| --- | --- |
| treatment following current guideline<br> | Other: treatment following current guideline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death or severe disability |  | 90 days |