linjc16/ctgov huggingface dataset:
Evaluation of 18F-dopa and 123I-MIBG Uptake in the Patients With Neuroblastoma

Study Overview
=================
Brief Summary
-----------------
Neuroblastic tumors are childhood neoplasms that possess amino acid decarboxylase (AADC) activity and Meta-iodobenzylguanidine(MIBG), they can theoretically be imaged by (18)F-fluorodihydroxyphenylalanine ((18)F-FDOPA) and (123)I-Meta-iodobenzylguanidine((123)I-MIBG) PET, they are new and specific diagnostic and follow-up tools for neuroendocrine tumors. In this study, we explored the accuracy and clinical role of (18)F-FDOPA and (123)I-MIBG PET in neuroblastic tumors. METHODS: Patients with tissue-proven neuroblastic tumors receiving (18)F-FDOPA PET or (123)I-MIBG at initial diagnosis or during follow-ups were enrolled. The sensitivity and specificity of (18)F-FDOPA or (123)I-MIBG PET were compared to each other and compared to(18)F-FDG PET, using tumor histology as the standard.

Official Title
-----------------
The Evaluation of the 6-[18F]Fluoro-levo-dopa and 123I-MIBG Uptake in the Patients With Neuroblastoma

Conditions
-----------------
Neuroblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Diagnosed by clinical criteria(one of below) Proved as Neuroblastoma by a pathological section Bone meta with 24 hrs urine VMA(Vanillylmandelic acid )or HVA (Homovanillic acid) elevated CT or MRI found tumor around adrenal gland or Neuroblastic tumor (2) Age between 0-30 years old，Body weight over 2.5kg (3) Signed Inform Consent Form Exclusion Criteria: (1)AST and ALT > 200U/L、Cre > 2.5mg/dl (2)Allerg to 18F-dopa、123I-MIBG (3)Subject not fit this study(assessed by PI) (4)No more need to arrenge PET because disease progress, assessed by VS

Ages Eligible for Study
-----------------
Maximum Age: 30 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 |
| --- | --- | --- |
| The maximum standardized uptake value and tumor-to-liver uptake ratio | The maximum standardized uptake value and tumor-to-liver uptake ratio will be evaluated by specific Nuclear Medicine doctor. | Outcome will be measured in one week after performed. |
Drug-Drug Interaction Study in Health Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of K-877 on the pharmacokinetics of digoxin in healthy adult volunteers.

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

Intervention / Treatment
-----------------
* Drug: Digoxin
* Drug: K-877


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening. Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening. Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening. Exclusion Criteria: Subject has clinically relevant abnormalities in the screening or check in assessments. Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females). Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digoxin<br>Digoxin | Drug: Digoxin<br> <br> |
| Experimental: Digoxin with K-877<br>Digoxin with K-877 | Drug: Digoxin<br> <br> Drug: K-877<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration curve (AUC) |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult Volunteers
High Blood Pressure Strategy (HBPS)

Study Overview
=================
Brief Summary
-----------------
This program developed by the HSFO aims at helping people of Ontario and their primary healthcare providers better diagnose, manage and control high blood pressure. The High Blood Pressure Strategy brings together healthcare providers and patients to improve the way in which family doctors, nurse practitioners and pharmacists work together and with patients towards improved control of high blood pressure through the use of evidence-informed tools combined with local systems change.

Detailed Description
-----------------
Approximately 5,000 patients will participate in the study at 11 family practice sites throughout Ontario. Each of the 11 clinic sites will be randomised to either intervention or delayed intervention 9 months later. The intervention is a systems change involving interprofessional education and management tools to bring together physicians, nurses and pharmacists with the patient. Patients will be monitored by their family doctor or nurse practitioner at scheduled follow-up visits during a period of 36 months for an effect of the intervention over time on the patient's blood pressure.

Official Title
-----------------
High Blood Pressure Strategy: Hypertension Management Initiative Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Systems Change (High Blood Pressure Strategy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years or older History of elevated BP reading or primary hypertension diagnosis Exclusion Criteria: Major mental health illness of cognitive impairment Language barrier (unable to speak or read English) Lives in a long-term care home Secondary hypertension

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Systems Change (High Blood Pressure Strategy)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Blood Pressure
Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and bacteremia in NICU patients >3 days of age.

Detailed Description
-----------------
All infants in the Newborn Intensive Care Unit greater than three days old that had blood cultures sent were eligible for this study. Left-over blood from the time at blood culture was collected for research purposes. Study personnel separated the serum and stored samples at -80 degrees until analysis. Samples were analyzed in batch for neonatal sepsis biomarkers using an antibody-coated microsphere assay with dual laser detection. Clinical information collected included symptoms prompting the blood culture, CBC and culture results, and antibiotic therapy.

Official Title
-----------------
Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay

Conditions
-----------------
Neonatal Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NICU patients > 3 days of age Exclusion Criteria: less than 3 days old or no waste blood available

Ages Eligible for Study
-----------------
Minimum Age: 3 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates assessed for sepsis.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine response |  | Within the first twenty-four hours after blood cultures are obtained. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate characteristics |  | Within twenty-fours pre and post blood culture. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytokines, neonatal sepsis, diagnosis of sepsis, bacteremia, blood culture, clinical sepsis
Molecular Screening for Lynch Syndrome in Southern Denmark

Study Overview
=================
Brief Summary
-----------------
A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern Denmark. Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are offered genetic risk assessment and counselling. The study hypothesis is that molecular screening will identify more patients with Lynch Syndrome than the family history alone. Prospective data collection is performed using established clinical databases.

Official Title
-----------------
Molecular Screening for Lynch Syndrome in Southern Denmark

Conditions
-----------------
Colorectal Cancer, Lynch Syndrome, HNPCC

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of colorectal adenocarcinoma Diagnosed at one of the five departments of pathology in the region Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All colorectal cancer patients<br> | Other: Observation<br>* Observation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Early Predictors of Necrotizing Enterocolitis in Neonates

Study Overview
=================
Brief Summary
-----------------
The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive measures as well as biochemical markers to identify neonates early in the disease process. Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to institute or test treatments in the long term to prevent the progression of the disease in these infants.

Detailed Description
-----------------
The study will enroll premature, low birth weight infants in the Neonatal Intensive Care Units (NICU). Potential study subjects will be identified upon delivery, or transfer to the NICU, and notification by the neonatology service. Infants born at less than 30 weeks gestational age, birth weight less than or equal to 1500 grams will be eligible for enrollment in the study. The purpose of the study designed is to compare the splanchnic tissue oxygenation index and gut inflammatory biomarkers of patients with any stage of NEC with healthy controls. Since we will not be able to determine which patients will develop NEC a priori, we will anticipate enrolling up to 450 neonates to identify 15 neonates with NEC.

Official Title
-----------------
Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates

Conditions
-----------------
Necrotizing Enterocolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born at ≤30 weeks gestational age and/or Infants with a birth weight ≤1500 grams Exclusion Criteria: gestational age at birth greater than 30 weeks obvious dysmorphic syndromes any abdominal wall defect including omphalocele or gastroschisis any known intestinal atresia complex cardiac abnormalities any known lethal chromosomal abnormalities

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| splanchnic tissue oxygenation in population at high risk for NEC |  | 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NEC, tissue oxygenation, gut inflammation
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: Hydroxypropyl Guar Galactomannan
* Drug: 0.1% sodium hyaluronate ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less. Exclusion Criteria: Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye. Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AL-43546 0.15% | Drug: Hydroxypropyl Guar Galactomannan<br>* One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.<br>|
| Experimental: 2<br>AL-43546 0.25% | Drug: Hydroxypropyl Guar Galactomannan<br>* One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.<br>|
| Active Comparator: 3<br>AL-43546 0%(Vehicle) | Drug: Hydroxypropyl Guar Galactomannan<br>* One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.<br>|
| Active Comparator: 4<br>0.1% sodium hyaluronate ophthalmic solutio | Drug: 0.1% sodium hyaluronate ophthalmic solution<br>* One drop per one time in both eyes, once daily (at each visit).One instillation daily in one period and a total of 4 instillations over 4 periods.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds). |  | Up to 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular comfort |  | After installation |
To Investigate the Safety and Efficacy of DE-104 Ophthalmic Solution to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To investigate the intraocular pressure (IOP)-lowering effect and safety of DE-104 ophthalmic solution in patients with Primary Open-Angle Glaucoma or Ocular Hypertension

Official Title
-----------------
A Randomized, Double-Masked, Parallel-Group Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DE-104 ophthalmic solution
* Drug: DE-104 vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open-angle glaucoma or ocular hypertension. Provided signed, written informed consent. If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: 1<br> | Drug: DE-104 ophthalmic solution<br> <br> |
| Experimental: 2<br> | Drug: DE-104 vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

Study Overview
=================
Brief Summary
-----------------
Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

Detailed Description
-----------------
We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.

Official Title
-----------------
Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

Conditions
-----------------
Pneumonic-type Adenocarcinoma (P-ADC), Lung Adenocarcinoma With Bronchiolo-alveolar Feature

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically / cytologically proven ADC-P Non-resectable disease 3-month expected survival No prior radiotherapy or chemotherapy Age >= 18 years old Performance status < 4 (WHO) Adequate blood biological parameters Exclusion Criteria: Abnormal initial fibroscopy

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Gefitinib<br>* Gefitinib 250 mg/day, until progression or severe toxicity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate after 3 months of treatment |  | Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 3-month | 
| Time to progression |  | month | 
| Survival |  | month | 
| Prediction disease control by clinical and biological markers |  | month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenocarcinoma, Bronchiolo-Alveolar
Ten-year Outcomes After AF Ablation

Study Overview
=================
Brief Summary
-----------------
Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients do not respond favorably to medical therapy. Successful procedures are accomplished in the majority of patients, but the outcome after many years of follow-up after ablation is unknown.

Detailed Description
-----------------
A prospectively identified cohort of 445 patients who demonstrated freedom from AF for at least one year following ablation (single procedure in 391, 87.9%) was followed for 66.0 ± 34.0 months. Patients were seen at least annually as outpatients, and underwent regular ECG monitoring, especially if there were symptoms suggestive of recurrent arrhythmia. Continued absence of arrhythmia was defined as freedom from AF or flutter > 30 secs.

Official Title
-----------------
Long-term Outcome After Initially Successful Catheter Ablation of Atrial Fibrillation by Pulmonary Vein Isolation: a Ten-Year Cohort Study

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior AF ablation procedure No AF for one year post ablation Exclusion Criteria: Geographic inaccessibility Longstanding persistent AF Recurrent AF within one year of ablation Prior AF ablation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Post-successful ablation<br>Patients who had undergone PVI ablation for AF and were free of AF for at least one year | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation or flutter > 30 secs |  | More than one year after successful primary ablation or redo procedure within 6 mos |