linjc16/ctgov huggingface dataset:
Specimens for Septin 9 Performance

Study Overview
=================
Brief Summary
-----------------
Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Epigenomics is currently developing a blood based CRC screening test based on Septin 9 and is performing a large prospective clinical trial showing its clinical utility in a population at average risk for CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop pre-analytical and analytical workflows as well as molecular assays making possible the use of Septin 9 methylation in the clinical routine.

Official Title
-----------------
Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay

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

Intervention / Treatment
-----------------
* Other: Blood Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years of age or older at the time of the blood draw Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon or rectum CRC defined as invasive adenocarcinoma Exclusion Criteria: Previous personal history of colorectal cancer Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery) prior to blood draw, including neoadjuvant treatment Known infection with HIV, HBV or HCV Subject concurrently receiving intravenous fluid at the time of the specimen collection

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRC Group<br> | Other: Blood Sample<br>* Blood sample collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the Epi proColon test | The primary objective of the investigation is to determine the safety and effectiveness of the Epi proColon test in precision and reproducibility studies and varying conditions including interfering substances and co-morbidities associated with the testing population. The specimens collected as described in this protocol will be used in the experiments needed to achieve this objective. Validate the Stability of the Septin 9 Biomarker. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stability of the Septin 9 biomarker, Epi Pro Colon Test, CRC
I USE LR in the ED

Study Overview
=================
Brief Summary
-----------------
To study the difference in mortality and major adverse kidney events during and after treatment in the emergency department with intravenous fluids per standard of care at 30 days before and after the system-wide implementation.

Official Title
-----------------
Intermountain Utah Study Evaluating the Implementation of Lactated Ringers as Standard Resuscitation Fluid Starting in Emergency Department

Conditions
-----------------
Kidney Injury

Intervention / Treatment
-----------------
* Other: Data Inclusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥18 years) receiving a minimum of 1000ml of intravenous fluids starting in the emergency department per standard of care Exclusion Criteria: Patients aged ≤17 years Previously enrolled patients with >1 ED admission within the 30-day follow-up period

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

| Intervention/Treatment |
| --- |
|Other: Data Inclusion|Patients in this group will be included in the project|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with major Adverse Kidney Events | death from any cause, new renal replacement therapy or persistent renal dysfunction | within 30 days or at hospital discharge | 
| LR IV Fluids administered | Proportion of LR IV fluids following implementation | Through study completion (an average of 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hospital admission and readmission |  | Within 30 days of initial ED encounter | 
| Cost | Direct costs of ED care and hospitalization | Through study completion (an average of 1 year) |
Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

Study Overview
=================
Brief Summary
-----------------
This study evaluates the performance of a blood glucose monitoring system at high altitudes (approximately 10,000 feet). The performance is assessed via a reference method for glucose analysis (Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer).

Detailed Description
-----------------
This study will be a non-randomized study conducted to assess the accuracy and performance of the Dario Blood Glucose Monitoring System at an elevated altitude. 50 subjects will be enrolled in this study. Participation includes a 15-20 minute visit to the clinical site where they will be consented. The participant will then receive a fingerstick to obtain capillary blood used to test the performance of the BGMS and to obtain a comparative glucose measurement on the reference method, the Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer.

Official Title
-----------------
Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation

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

Intervention / Treatment
-----------------
* Device: Blood Glucose Monitoring System Altitude Performance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to speak and read English Exclusion Criteria: Pregnant Has any condition that the principle investigator believes may interfere in the subject's participation in the trial.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Altitude<br>Single arm study Blood Glucose Monitoring System Altitude Performance | Device: Blood Glucose Monitoring System Altitude Performance<br>* Performance as assessed against a reference method at an altitude of approximately 10,000 feet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Successful Glucose Readings | The success criterion for the performance of the Blood Glucose Monitoring System at high altitude (approximately 10,000 feet above sea level) means that 95% of the blood glucose readings fall within 15mg/dL of the YSI reference value (for reference values less than 75 mg/dL) and within 20% (for reference values greater than or equal to 75 mg/dL). | One day |
H.E.R.O.S. Study: An Observational Study of the Cardiac Safety of Herceptin (Trastuzumab) in Patients With HER2-Positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.

Official Title
-----------------
H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Histologically confirmed HER2-positive breast cancer Eligible to receive Herceptin as per Summary of Product Characteristics Exclusion Criteria: Contra-indications according to Summary of Product Characteristics

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | up to approximately 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic congestive heart failure (NYHA class II, III and IV) |  | up to approximately 4.5 years | 
| Incidence of asymptomatic LVEF decline |  | up to approximately 4.5 years | 
| Frequency of treatment discontinuations/interruptions |  | up to approximately 4.5 years |
HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey

Study Overview
=================
Brief Summary
-----------------
The point prevalence survey aims at defining the until now unknown real prevalence of hypophosphatemia (defined as blood phosphate value < 0.8 mmol/l) in international critical care settings

Detailed Description
-----------------
The survey will be conducted on one single day in each centre (D-day), within a week defined by the project coordinator (International PI). On D-Day, the local investigators will be asked to complete questions aiming at describing their ICU (number of beds, number of patients present on D-Day, type medical/surgical/other, local phosphate reference value, presence of an hypophosphatemia treatment protocol in the ICU and route of phosphate delivery in case of hypophosphatemia) to indicate how many patients had a blood phosphate <0.08 mmol/l, for each patient with hypophosphatemia, to record the exact lowest value on D-Day, and to record age, number of days in ICU on D-Day, presence (or not) of artificial nutrition and continuous renal replacement therapy, if any phosphate administration is ongoing Data will be recorded in and electronic Case Report Form (e-CRF) in REDCap, and analysed with descriptive statistics No outcome data will be recorded (pure point-prevalence) There is no intervention

Official Title
-----------------
Hypophosphatemia in the ICU - A One-day Point Prevalence Survey

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Dietary Supplement: No intervention - pure observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: blood phosphate value < 0.8 mmol - Exclusion Criteria: Blood phosphate value >0.8 mmol/l -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: No intervention - pure observation|Phosphate administration (yes or no)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of hypophosphatemia | Blood value < 0.8 mmol/l | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phosphate
The Relationship Between Allergic Rhinitis and Geographic Tongue

Study Overview
=================
Brief Summary
-----------------
Allergic rhinitis is a complex chronic inflammatory disease, it always presents with nasal obstruction, nasal itching, sneezing and runny nose. Whether in adults or children, rhinitis is a complex disease. The prevalence of allergic rhinitis in Taiwan is about 24-29%. Taiwan is a developing country. It is a hot and humid country. In developing countries, industrialization, air pollution makes the constantly increasing number of patients with rhinitis. Penghu in 1994 for children aged 7 to 14 by the study found that among 7599 people, 1766 people have allergic rhinitis, about 23.2%. Allergic rhinitis is a complex chronic disease. So, it become a diagnostic challenge, its prevalence always underestimated. The prevalence of rhinitis has increased in recent years. The phenomenon of underestimate is caused by variety of personal and environmental factors. Allergic rhinitis had increased direct and indirect social and economic burden. Geographic tongue is a benign tongue performance. Geographic tongue has been reported their relevance to allergy. Geographic tongue is a chronic tongue situation. The causes of geographic tongue still remains unknown. Allergic rhinitis is a diagnostic challenge to clinicians. The investigators hope that geographic tongue could play a role in the diagnostic of allergic rhinitis. The prevalence of geographic tongue in the United States is about 1.8%, white Americans and Mexicans have a higher incidence rate. This study will investigate the relevance between allergic rhinitis and geographic tongue. The investigators will analyze the relevant gender, age, severity of inspection reports. The research results wound provide an important reference to the diagnosis of allergic rhinitis.

Conditions
-----------------
Allergic Rhinitis, Geographic Tongue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rhinitis and non-rhinitis patients willing to complete the study no limitation of tongue movement Exclusion Criteria: more than 90 years old or younger than 20 years old unable to complete the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 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 |
| --- | --- |
| Allergy rhinitis<br>Allergy rhinitis patients group | |
| Non- Allergy rhinitis<br>Non- Allergy rhinitis patients group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events |  | 8th month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy rhinitis, Geographic tongue
Functional Lung Imaging With DECT and 4DCT

Study Overview
=================
Brief Summary
-----------------
The basic premise of this pilot study is to enroll 40 patients over 3 years who have Stage III or IV non-small cell lung cancer and are planned for definitive treatment with concurrent chemoradiation where a contrast enhanced 4DCT is planned..

Official Title
-----------------
Pilot Study to Assess Lung Function Using Perfusion Blood Volume Dual Energy CT and 4DCT Derived Lung Ventilation Imaging

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: contrast enhanced 4DCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients have histologic diagnosis of non-small cell lung cancer Patients have AJCC stage II, III or IV disease were the plan is to receive definitive concurrent chemoradiation to 60 Gy or higher Age > 18 years of age Patients are able to provide informed consent No additional lung radiation is planned until after the 2nd CT on this study (i.e. patient does not have a solitary pulmonary nodule or second primary that the plan is to undergo SBRT) Patient must have adequate kidney function to receive IV contrast (following institutional policy supplied by radiology). The cutoff level for serum creatinine is 1.6 mg/dL Negative urine pregnancy test before every CT scan Exclusion criteria: Allergy to IV iodine contrast Severe claustrophobia Further thoracic radiation therapy is planned.

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 |
| --- | --- |
| contrast enhanced 4DCT<br> | Procedure: contrast enhanced 4DCT<br>* Functional Lung Imaging with DECT and 4DCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the reproducibility of PBV DECT imaging and 4DCT derived lung ventilation for evaluating lung function |  | 3 years | 
| correlate changes of PBV DECT and 4DCT lung function images seen at  6 months with radiation dose and with patient reported outcome quality of life |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To propose a novel biologic (i.e. functional) dose volume algorithm to reduce PBV and 4DCT lung function changes |  | 3 years |
The Pilot Study Evaluate the Safety and Efficacy of Sirolimus in Patients With PIK3CA Mutation and/or PIK3CA Amplification Refractory Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study is a single-arm, phase II study of sirolimus in patient with PIK3CA mutation and PIK3CA amplication Refractory solid tumors. sirolimus 1mg will be administered orally qd daily. To investigate the efficacy of sirolimus in patients with PIK3CA mutation and PIK3CA amplication Refractory solid tumors.

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of fully informed consent prior to any study specific procedures. Patients must be ≥20 years of age. PIK3CA amplification and/or PIK3CA mutation Refractory Solid Tumors. ECOG performance status 0-2. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator. Adequate Organ Function Laboratory Values Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases) creatinine ≤1.5 x UNL Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing. Adequate heart function. Exclusion Criteria: Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years. Has known active central nervous system (CNS) metastases. Has an active infection requiring systemic therapy. Pregnancy or breast feeding Patients with cardiac problem.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: sirolimus<br>sirolimus 1mg daily | Drug: sirolimus<br>* sirolimus 1mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | 24 weeks | 
| overall survival |  | 24 weeks | 
| Time to progressive |  | 24 weeks | 
| Number of subjects with Adverse Events as a measure of toxicity profile |  | 24 weeks |
Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.

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

Intervention / Treatment
-----------------
* Dietary Supplement: L plantarum DSM 9843 or placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age ≥19 and ≤45 years Hb >117g/L Exclusion Criteria: Gastrointestinal diseases Metabolic diseases Use of other probiotic products during the study and 2 weeks before the study start Pregnant or breast-feeding A serum ferritin level >60 µg/L Medication (oral contraceptives allowed) Intake of dietary supplements (incl. iron) during the study and two weeks before the study start No blood donation in the last 2 months High C-reactive protein levels

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L plantarum DSM 9843<br> | Dietary Supplement: L plantarum DSM 9843 or placebo<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: L plantarum DSM 9843 or placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron absorption ratio in blood samples | Iron absorption will be estimated by measuring the isotope ratio (55Fe/59Fe) in blood after addition of iron isotopes in test meals (55Fe in placebo meal, 59Fe in L plantarum DSM 9843 meal). | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iron absorption, healthy females, child bearing age