linjc16/ctgov huggingface dataset:
Drug Use Investigation for HEPSERA (Adefovir) Tablet

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.

Official Title
-----------------
Drug Use Investigation for HEPSERA (Adefovir) Tablet

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Drug: Adefovir tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with chronic hepatitis B or hepatic cirrhosis B Subjects treated with adefovir tablets 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 |
| --- | --- |
| Subjects prescribed adefovir tablets<br>Subjects with chronic hepatitis B or hepatic cirrhosis B to whom adefovir tablets are administered | Drug: Adefovir tablets<br>* Administered according to the prescribing information in the locally approved label by the authorities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions |  | 1 year |
An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
An observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in patients with hypertension

Official Title
-----------------
A Post Marketing Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension

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

Intervention / Treatment
-----------------
* Drug: telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation Patients aged 18   under 80 Hypertension as described below: Newly diagnosed patients with hypertension Patients with current antihypertensive therapy Exclusion Criteria: Female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study Known or suspected secondary hypertension(e.g. pheochromocytoma) Patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SBP (Systolic Blood Pressure) | The change of the mean SBP | between baseline (visit 1) and after 12 weeks of treatment (visit 3) | 
| Change in DBP (Diastolic Blood Pressure) | The change of the mean DBP | between baseline (visit 1) and after 12 weeks of treatment (visit 3) | 
| Change in WHO-QOL (WHO-Quality Of Life) | World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed. Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS (Visual Analog Scale) | VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status) | between baseline (visit 1) and after 12 weeks of treatment (visit 3) |
Adenosine Cardioplegia; Improved Cardioprotection?

Study Overview
=================
Brief Summary
-----------------
60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.

Official Title
-----------------
Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study

Conditions
-----------------
Angina Pectoris

Intervention / Treatment
-----------------
* Drug: Adenosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective patients Ejection fraction > 40% Age 40-75 No release og TnT or CKMB within last week before CABG Pure CABG Exclusion Criteria: Age >75 or < 40 EF < 40% Emergency operations Unstable angina Release of TnT or CKMB within the week before operation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adenosine cardioplegia<br>Adenosine cardioplegia | Drug: Adenosine<br>* 1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution<br>|
| Active Comparator: Control<br>Standard hyperkalemic cardioplegia | Drug: Adenosine<br>* 1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Release of cardiac enzymes (TnT and CKMB) | Repeatedly measured postoperatively. | First 48 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PiCCO | Measurement of cardiac function and hemodynamics the first 24 hours postoperatively | First 24 hours postoperatively | 
| Endothelial injury | Measurements of markers of endothelial injury/dysfunction peroperatively. Blood will be sampled immediately before cross-clamping the aorta and after 5 minutes of reperfusion. | Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion) |
Genetic Determinants of Opioids Analgesia

Study Overview
=================
Brief Summary
-----------------
The response to opioids varies greatly among individuals. Some of these variability is accounted for by genetic factors. The present study was designed to evaluate the possibility that genetic polymorphism in the gene encoding for mu opioid receptor may explain variability in the response to alfentanil during lithotripsy.

Official Title
-----------------
The Effect of mu Opioid Receptor Polymorphism on the Response to Alfentanil During Lithotripsy

Conditions
-----------------
Nephrolithiasis

Intervention / Treatment
-----------------
* Drug: Alfentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 Exclusion Criteria: Regular use of opioid drugs Known hypersensitivity to alfentanil

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfentanil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total alfentanil dose used during the procedure. |  |  | 
| The extent of respiratory depression. |  |  |
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

Study Overview
=================
Brief Summary
-----------------
This is a safety and pharmacokinetic study of single-dose daptomycin in infants > 48 hours and < 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC <740 mch*hr/mL.

Official Title
-----------------
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

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

Intervention / Treatment
-----------------
* Drug: Daptomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 48 hours and <120 days of age at the time of daptomycin administration Sufficient venous access to permit administration of study medication Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry Availability and willingness of the parent/legally authorized representative to provide written informed consent Exclusion Criteria: History of anaphylaxis attributed to daptomycin Previous participation in the study Exposure to daptomycin in the month prior to the study Serum creatinine >1.0 mg/dL Concomitant administration of tobramycin

Ages Eligible for Study
-----------------
Minimum Age: 48 Hours
Maximum Age: 120 Days

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: Daptomycin cohort<br> | Drug: Daptomycin<br>* single dose of 6 mg/kg of daptomycin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of Daptomycin | Area under the curve | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events Will be Monitored. |  | 7 days following last dose of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infants, Daptomycin
Trimethylamine N-oxide in Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Trimethylamine-N-oxide (TMAO) is produced from the metabolism of gut microbiota and is reportedly pro-atherogenic and associated with cardiovascular events. The purpose of this study is to investigate the sequential change in TMAO levels by current optimal secondary prevention therapies in patients with ST-elevation acute myocardial infarction (STEMI) and the clinical impact of TMAO levels on the progression of atherosclerosis and subsequent cardiovascular events.

Detailed Description
-----------------
This study includes patients with their first STEMI. The investigators measure plasma TMAO levels using the frozen plasma at the onset of STEMI and 10 months later (the chronic phase). To assess plaque progression, residual SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score and chronic-phase SYNTAX score are measured. After the chronic-phase assessment of TMAO and SYNTAX score, patients are followed for cardiovascular events including death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization.

Official Title
-----------------
Microbiota-derived Trimethylamine N-oxide as Residual Risk After ST-elevation Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who admitted to the Yokohama City University Medical Center with the diagnosis of their first STEMI and who underwent primary percutaneous coronary intervention within 12 hours after onset and received follow-up coronary angiogram 10 months after the index intervention. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| MACE | death, myocardial infarction, ischemic stroke, and unstable angina pectoris with coronary revascularization | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary plaque progression | the highest tertile of change in SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score. Higher SYNTAX score indicates more complicated coronary plaque. minimum 0, maximum 80. | 10 months |
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO)

Study Overview
=================
Brief Summary
-----------------
This study is designed to show that pharmacotherapy guided by eNO and clinical standard of care produces a superior outcome to trial-based therapy guided by clinical standard of care alone.

Detailed Description
-----------------
Patients with persistent, moderate to severe asthma will be randomized to receive therapy guided by either eNO and clinical standard of care (eNO group) or clinical standard of care (control group). An eNO treatment algorithm will be established for each patient in the eNO group at Baseline (Visit 1). Enrollment is estimated to be six months with a follow up period of twelve months.

Official Title
-----------------
Management of Asthma Patients Guided by Exhaled Nitric Oxide (eNO) Using the Apieron NO Analyzer

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

Intervention / Treatment
-----------------
* Device: Apieron Insight eNO monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-existing diagnosis of asthma Persistent, moderate or severe asthma as classified by NAEPP Sub-optimally controlled asthma Initiated ICS therapy for at least the past 30 days and a history of improvement of asthma control on steroids Exclusion Criteria: Active cigarette smoking or ≥ 10 pack-years smoking history Xolair taken in the past 6 months prior to enrollment Oral prednisone taken in the last 4 weeks prior to enrollment Cystic Fibrosis, COPD, ciliary dyskinesia, chest wall deformities or scoliosis Subject is currently enrolled in another investigational drug study

Ages Eligible for Study
-----------------
Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: eNO group<br>eNO measurement is used to inform asthma management decisions | Device: Apieron Insight eNO monitor<br>* The Apieron Insight(tm) eNO monitor is used to measure exhaled nitric oxide, and asthma is managed to keep eNO below an individualized target.<br>|
| No Intervention: control group<br>Asthma is managed according to existing standard of care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control days |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, inflammation, nitric oxide, eNO, FENO
Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients

Study Overview
=================
Brief Summary
-----------------
TRACE is a Multicentre Retrospective Study planned to gather follow up data for a period of 1 year in order to understand anti-thrombotic management patterns and outcomes of Acute Coronary Syndrome patients in India. This retrospective study is designed to provide a rapid and quick analysis of the existing database of ACS patients. So as to ensure quality check in the study, a pilot study will be conducted with around 500 patients at 10 centres across India and based on the meaningful results of the pilot study, full retrospective multi-centric study will be initiated at various selected centres across India. This study will use available registry data from a defined time period of Jan 2007-Dec 2009.

Official Title
-----------------
A Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients in India

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of the age of 18 years or older and hospitalized for ACS within the previous 3 years. Diagnosis of STEMI, NSTEMI or UA using Standard and Universal Definition of Myocardial Infarction Exclusion Criteria: UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI. UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons

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 |
| --- | --- | --- |
| Anti thrombotic strategies used in ACS patients |  | Jan 2007-Dec 2009 | 
| Anti-thrombotic treatment strategies in a 'real-life' observational setting across different sites in India. |  | Jan 2007-Dec 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACS outcomes with respect to: -Revascularization -Angina/ Re-infarction -Cardiogenic shock/Heart failure/Cardiac arrest -Atrial fibrillation/flutter -Ventricular Fibrillation/ Sustained V Tachycardia -Stroke -Mortality -Bleeding |  | Jan 2007-Dec 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACS: Acute coronary syndrome Retrospective Registry
National Cancer Institute Thai Cancer Anemia Survey

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a large Thailand database documenting the severity of anemia and its management in the cancer population.

Detailed Description
-----------------
Thai Cancer Anemia Study (TCAS) is a prospective survey that will track anemia management in an adult cancer population. This survey is not intended to interfere with standard medical practices for handling anemia. Information on laboratory values including target and achieved hemaglobin (Hb) levels during chemotherapy cycles, use of blood transfusions, iron supplementation, and epoetin will be collected in addition to information on cancer status and treatment. Data on the level that triggers clinicians to decide on the need for anemia therapy will also be collected. Each patient included in the survey will be followed for six months. Observational Study - No investigational drug administered

Official Title
-----------------
Anemia Survey in Cancer Patients Study

Conditions
-----------------
Anemia, Cancer

Intervention / Treatment
-----------------
* Other: Adult Cancer Patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cancer Exclusion Criteria: N/A

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 |
| --- | --- |
| 001<br> | Other: Adult Cancer Patients<br>* Tracking anemia management in Adult Cancer Patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients that have anemia during cancer therapy |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of patients example treatment duration, type of chemotherapy used, grade of anemia |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Anemia Survey, Thai National Cancer Institute