linjc16/ctgov huggingface dataset:
Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)

Study Overview
=================
Brief Summary
-----------------
A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices

Official Title
-----------------
Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Admission for worsening of HF Discharged to home Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment Enrolled in Carelink® system and able to transmit data Able to participate for at least 3 months Exclusion Criteria: Post heart transplant or actively listed End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support Stage IV or V chronic renal dysfunction (GFR <25 mol/min per 1.73 M2) Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen Severe pulmonary hypertension not due to left-sided HF

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 |
| --- | --- |
| Optivol® Device in CareLink<br>A single cohort group of heart failure patients with already implanted Optivol® capable devices who are discharged home from the hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions | Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge. | 90 days from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Clinical Events | Track HF re-admissions and other clinical encounters between 30 and 90 days post discharge for HF. | 90 days from enrollment | 
| Assess Patient-Reported Quality of Life | Assess the association between the use of Cardiac Compass Report and OptiVol® and improved HF patient quality of life at both time points (30 and 90 days post discharge) utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 90 days from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, Optivol® cardiac device, Medtronic CareLink
Forecast Number of Covid-19 Cases Worldwide

Study Overview
=================
Brief Summary
-----------------
Coronavirus disease-19 (Covid-19) had an unprecedented effect on both nations and health systems. Time series modeling using Auto-Regressive Integrated Moving Averages (ARIMA) models have been used to forecast variables extensively mainly in statistics and econometrics. The investigators aimed to predict the total number of cases for Covid-19 using ARIMA models of time-series analysis.

Detailed Description
-----------------
Coronavirus Disease 19 (Covid-19) is an infectious disease initially defined in December 2019 before becoming pandemic. Respiratory disease is the main form of disease causing acute respiratory distress as the main cause of death. Increased number of cases worldwide had put an enormous load on public health resulting lockdowns, quarantines and curfews. Predicting number of cases is hard as the increment of cases between communities differ. Time series had been used in different fields of science to predict, such as signal processing, mathematical finance, weather prediction. In medicine, time series analysis were used in number of admitted patients to hospitals. Aim of this study is to predict the total number of Covid-19 cases worldwide using time series anaylsis.

Official Title
-----------------
Time Series Model For Forecasting the Number of Covid-19 Cases Worldwide - A Prospective Cohort Study

Conditions
-----------------
Covid-19

Intervention / Treatment
-----------------
* Other: Model Building
* Other: Model validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed case of Covid-19 Exclusion Criteria: Cases not reported
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Model Building<br>Number of Covid-19 cases from December 31, 2019 to June 1, 2020 were used to build ARIMA model using Hyndman-Khandakar algorithm. | Other: Model Building<br>* Model building<br>|
| Model Validation<br>Number of Covid-19 cases from June 2, 2020 to June 15, 2020 were used to forecast cases using the ARIMA model | Other: Model validation<br>* Model validation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Confirmed cases of Covid-19 |  | December 31, 2019 to June 15, 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, forecasting
OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.

Official Title
-----------------
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Tarceva (erlotinib HCl, OSI-774)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas;cancer which is unresectable, locally advanced or metastatic. Must have evidence of disease (clinical or radiological). Male or female, 18 years or older. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented. All toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization. Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- |
|Drug: Tarceva (erlotinib HCl, OSI-774)|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
-----------------
Tarceva, EGFR, erlotinib, OSI-774
Tumor Markers Study in Gastric Cancer for Cancer Immunotherapy (ONCO-RD 010 CRT)

Study Overview
=================
Brief Summary
-----------------
Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Despite advances in therapeutic intervention, the mortality from this disease remains high. As a result, most patients are now offered varying combinations of surgery, chemotherapy, and radiation therapy in order to derive benefits from a multidisciplinary approach. Unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary. Thus new therapeutic strategy is required for the treatment of gastric cancer. In the early 1980s, the discovery of cytolytic T cells (cytolytic T lymphocytes, CTLs) directed against an antigen presented on tumor cells was published. They can kill many invasive cells by recognizing the tumor specific antigens on the major histocompatibility complex (MHC) molecules. It is now generally agreed that although tumors express tumor antigens, they usually lack immunogenicity because of their inability to activate the immune response. The current view is that tumor cells are antigenic, but not immunogenic. If we can artificially activate the immune system against the tumor, it may be possible to eradicate the tumor. This approach is the basis of cancer immunotherapy. Many tumor antigens have been defined in terms of multiple solid tumors: MART-1/Melan-A, gp100, carcinoembryonic antigen (CEA), HER-2, mucins (i.e., MUC-1), prostate-specific antigen (PSA), and prostatic acid phosphatase (PAP) are just a short list. Some immune-based therapies targeting these tumor antigens are in phase III trials assessing whether immunizing against these antigens affects overall survival. In gastric cancer, some tumor antigens such as MAGE-A3, NY-ESO-1, and WT-1 have been reported to be expressed in substantial proportion of cases. They have the potential to be the targeting molecules for immunotherapy in the future. In this study, we aim to explore the expression levels of the four tumor markers (MAGE-A3, NY-ESO-1, WT-1 and PRAME) in gastric cancers of Korean patients and to examine the correlations of the expression levels of the four markers to clinic-patholoical factors.

Official Title
-----------------
Tumor Markers Study in Gastric Cancer for Cancer Immunotherapy

Conditions
-----------------
Stomach Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric carcinoma received gastrectomy Exclusion Criteria: neoadjuvant 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 |
| --- | --- | --- |
| overall survival |  | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MAGE-A3 protein, NY-ESO-1 protein, WT1 Proteins, PRAME protein
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.

Official Title
-----------------
A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Device: formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary Patients who have a current diagnosis of asthma Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. historical reversibility) or demonstrate a >12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit 1. The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry. Exclusion Criteria: Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device. QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies Other protocol-defined inclusion and exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: formoterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card. |  |  | 
| Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, formoterol multi-dose dry powder inhaler (MDDPI)
A Prospective, Multi-center, Real-world Study of Ovarian Metastatic Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This prospective, multi-center, real-world study is conducted to investigate the impact of different treatment strategies (systemic chemotherapy combined with oophorectomy or with other local treatment or chemotherapy alone) on the prognosis of ovarian metastatic colorectal cancer patients.

Detailed Description
-----------------
This study prospectively collects data of patients diagnosed with ovarian metastatic colorectal cancer, meeting inclusion criteria and signing the informed consent. Patients' treatment strategies and survival outcome in the real world will be faithfully recorded.

Official Title
-----------------
Impact of Different Treatment Strategies on the Prognosis of Ovarian Metastatic Colorectal Cancer Patients: a Prospective, Multi-center, Real-world Study

Conditions
-----------------
Ovarian Metastasis, Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed colorectal adenocarcinoma; Histologically or radiologically diagnosed with ovarian metastasis, whether or not combined with metastases in other organs; Women ≥18 years of age; Eastern Cooperative Oncology Group performance status score ≤2; Available imaging data if the disease is measurable according to RECIST criteria version 1.1; patients are eligible if there is no measurable lesion. Complete medical records; Informed consent form signed. Exclusion Criteria: Not ovarian metastatic colorectal cancer confirmed by radiology or histology; Drug abuse or other medical, psychological and social disorders that would interfere with cooperation with the requirements of the study; Other conditions that would influence patient compliance; Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures.

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

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 |
| --- | --- | --- |
| Ovarian specific overall survival | Calculated from the date of diagnosis with ovarian metastasis to death (caused by cancer) or last follow-up time. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian specific objective response rate | Response rate of ovarian metastases to systemic chemotherapy | 6 months | 
| Extra-ovarian specific objective response rate | Response rate of extra-ovarian metastases to systemic chemotherapy | 6 months | 
| Progression free survival | Survival time from treatment start to disease progression or death. | 6 months | 
| Quality of life questionnaire | Quality of life during treatment | 6 months |
Specimen Collection Study for H. Pylori Testing

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.

Detailed Description
-----------------
This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).

Official Title
-----------------
Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia

Conditions
-----------------
Helicobacter Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 21 and to 75 years. Able to read, speak, and understand English or have access to a translator in subject's native language. Patients without prior H. pylori eradication treatment. Currently not on proton pump inhibitors, antibiotics or bismuth Discontinuation at least 2 weeks prior to endoscopy and specimen collection. Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain] Undergo gastric biopsies as part of routine care Physician able to provide histology and rapid urease result on biopsy specimens. Exclusion Criteria: Aged less than 21 years old or older than 75 years Unable to provide consent. Patients with a history of prior H. pylori eradication therapy. Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y. Any unstable or poorly-controlled medical or psychiatric condition.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Non-invasive collection procedure | This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics. | 1 year |
Comparative Study of Insulin Therapy Between Inner and Outer Upper Thigh

Study Overview
=================
Brief Summary
-----------------
To observe the patient's preference, pain perception, and usability between inner and outer upper thigh for insulin therapy. To add another injection site for insulin therapy.

Detailed Description
-----------------
The most common injection site is the abdomen (or stomach). The back of the upper arms, the upper buttocks or hips, and the outer side of the thighs are also used. These sites are the best to inject into for two reasons: They have a layer of fat just below the skin to absorb the insulin, but not many nerves - which means that injecting there will be more comfortable than injecting in other parts of your body. But while the needle for insulin therapy is becoming shorter, it is possible to inject insulin at the inner thigh site.

Official Title
-----------------
Comparison of Patient's Preference, Pain Perception, and Usability Between Inner and Outer Upper Thigh for Insulin Therapy

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

Intervention / Treatment
-----------------
* Other: insulin injection site


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients more than 18 years age old with diabetes that need insulin therapy Exclusion Criteria: Those diabetes with psychologic diseases and those patients won't be injected at thigh

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 |
| --- | --- |
| inner thigh insulin injection<br>inject insulin at inner thigh site is the intervention arm. So we inject insulin at this site to see if this site is suitable for insulin injection. | Other: insulin injection site<br>* insulin injected site between inner thigh and out thigh<br>|
| outer thigh insulin injection<br>outer thigh site for insulin therapy is the usual site | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | the pain degree the patient feel while insulin injected using Visual Analog scale | immediately after injection, 1-5minutes | 
| bleeding | if bleeding occurs after insulin injected just by using Yes or No | immediately after injection, 1-5minutes | 
| leaking | if there is leaking after insulin injected just by using Yes or No | immediately after injection, 1-5minutes |