linjc16/ctgov huggingface dataset:
IRIS-BioFreedom Cohort in the IRIS-DES Registry

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate effectiveness and safety of BIOFREEDOM™ FAMILY stent in the real world daily practice as compared with other drug-eluting stents.

Detailed Description
-----------------
BIOFREEDOM™ FAMILY stent means that Biofreedom stent, Biofreedom Ultra and the other stents with names starting with Biofreedom.

Official Title
-----------------
Evaluation of Effectiveness and Safety of BIOFREEDOM™ FAMILY Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Conditions
-----------------
Coronary Stenosis

Intervention / Treatment
-----------------
* Device: BIOFREEDOM™ FAMILY stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Patient with BIOFREEDOM™ FAMILY stent Exclusion Criteria: Intervention with BIOFREEDOM™ FAMILY stent and other drug eluting stent at the same time Life-expectancy less than 1 year Cardiac shock

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Consecutive percutaneous coronary intervention<br> | Device: BIOFREEDOM™ FAMILY stent<br>* Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 5 year | 
| Cardiac death |  | 5 year | 
| Myocardial Infarction |  | 5 year | 
| Composite event rate of death or myocardial infarction (MI) |  | 5 year | 
| Composite event rate of cardiac death or myocardial infarction (MI) |  | 5 year | 
| Target- Vessel Revascularization |  | 5 year | 
| Target- Lesion Revascularization |  | 5 year | 
| Stent thrombosis |  | 5 year | 
| Stroke |  | 5 year | 
| Procedural Success rate | Procedural success rate is defined as ≤ 50% final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization. | 5 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BioFreedom, Drug Eluting Stent, Coronary Artery Disease
Incidence and Outcome of Acute Diverticulitis in Finland

Study Overview
=================
Brief Summary
-----------------
The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.

Detailed Description
-----------------
Acute diverticulitis (AD) of colon is increasing in Finland. Incidence, prevalence and mortality of AD of colon are investigated during 10-year period (2009-2019) in whole country. Epidemiological data is compared to data of acute appendicitis. Nationwide data of patients with AD are asked from Finnish Institute for Health and Welfare (THL). To compare registry-based nationwide data, patient charts from electronic database of two hospitals (Mikkeli Central Hospital and Tampere University Hospital) are reviewed from same study period. Patient characteristics, medication, treatment (conservative vs surgery), recurrence of AD and long-term outcome are recorded.

Official Title
-----------------
Incidence of Acute Diverticulitis in Finland: Nationwide Register Study of Epidemiology and Outcome of Treatment Between 2009-19

Conditions
-----------------
Acute Diverticulitis

Intervention / Treatment
-----------------
* Other: patients with acute diverticulitis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with acute diverticulitis (K57) in Finland and in two hospitals Exclusion Criteria: other reasons for acute or chronic abdominal pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: patients with acute diverticulitis|registry and hospital charts of patients with acute diverticulitis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of annual incidence and prevalence of acute diverticulitis | how many patients with acute diverticulitis are treated in all hospitals in Finland | January 2009-December 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with surgical or conservative treatment | Number of patients with conservative or surgical treatment of acute diverticulitis in two hospitals | January 2009-December 2019 | 
| Number of treatment complications and survival of patients with acute diverticulitis | outcome of patients with acute diverticulitis in two hospitals | January 2009-December 2019 |
Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.

Official Title
-----------------
A Randomized, Controlled Study to Evaluate Safety and Efficacy of Fibrin Sealant VH S/D 4 S-APR (Artiss) for Tissue Adherence and Hemostasis and To Improve Wound Healing in Subjects Undergoing Endoscopic Browlift

Conditions
-----------------
Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Intervention / Treatment
-----------------
* Drug: Fibrin Sealant (Artiss)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects planned for endoscopic browlift, subjects who read, understand and sign the written informed consent, healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements Exclusion Criteria: Subjects who had previous browlift, subjects indicated for concurrent facial surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema on day 0, significant laboratory abnormalities, subjects with known bleeding or coagulation disorders, subjects treated with anti-coagulants.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Fibrin Sealant (Artiss)<br> | Drug: Fibrin Sealant (Artiss)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of ecchymosis and edema |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of ecchymosis and edema, incidence of hematoma/seroma |  | 30 days |
A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the safety and efficacy of voriconazole for the treatment of candidemia in critically ill non-neutropenic patients

Official Title
-----------------
A Randomized, Open Label, Comparative Multicenter Study Of Voriconazole Versus Conventional Amphotericin B Followed By Fluconazole In The Treatment Of Candidaemia In Non Neutropenic Subjects.

Conditions
-----------------
Candidiasis

Intervention / Treatment
-----------------
* Drug: VFENDÂ® I.V., Oral
* Drug: Conventional amphotericin B
* Drug: Diflucan IV, oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with candidemia Exclusion Criteria: Neutropenia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: VFENDÂ® I.V., Oral|nan|
|Drug: Conventional amphotericin B|nan|
|Drug: Diflucan IV, oral|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained clinical response for 12 weeks from end of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to negative blood cultures |  |  |
Quality of Life and Liver Metastases

Study Overview
=================
Brief Summary
-----------------
An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. The aim of this prospective study is to investigate the impact of surgery on health-related quality of life in this specific patient population operated for colorectal liver metastases.Furthermore, as the indications for hepatic resection are broadened and patients with more extensive liver disease are operated on, the chance of non operable disease at laparotomy will increase. The effects of such an event on HRQol are also studied.

Detailed Description
-----------------
In a prospective study several patients groups were identified. Patients undergoing liver resection and/or local ablative therapy. Patients with non operable disease at (explorative) laparotomy and outpatients with non operable disease as shown during work up for liver resection. Several validated instruments on HRQoL were ompleted preoperatively (baseline), a half month after operation and then every three months.

Official Title
-----------------
Quality of Life After Surgical Treatment of Colorectal Liver Metastases

Conditions
-----------------
Colorectal Liver Metastases, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colorectal liver metastases (operable and non operable disease) and participation by means of filling in quality of life instruments Exclusion Criteria: drop out and therefore loss of quality of life instruments

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: quality of life|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
-----------------
colorectal, liver, metastases, health-related quality of life, surgery
Lipids and Other Bioactive Compounds of Human Breast Milk

Study Overview
=================
Brief Summary
-----------------
The biochemical differences in the composition of breast milk and formula have not been profoundly established in all compound groups. Increased understanding of breast milk composition, the normal variation of various bioactive compounds and their levels is required to be able to develop formulas better corresponding the breast milk, and ensure the optimal development of also the formula-fed babies.

Official Title
-----------------
Lipids and Other Bioactive Compounds of Human Breast Milk and Infant Formulas.

Conditions
-----------------
Breast Milk Collection

Intervention / Treatment
-----------------
* Other: Breast-milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast-fed child was born full-time and is healthy. age of the breast-fed child is 0-6 months Exclusion Criteria: breast-fed child was born prematurely (gestation week <37)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast-feeding women<br>A single breast-milk sample will be collected from 20 women who breast-feed their child (0-6 months old). | Other: Breast-milk<br>* A single breast-milk sample will be collected from 20 women. Milk samples will be pooled for analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative proportions (%) of regioisomers within selected molecular species (acyl carbon number:number of double bonds 50:1 and 52:2) in triacylglycerols. | Isolation of lipids from the milk with solvent extraction. Isolation of triacylglycerols with solid phase extraction. Negative ionization of the triacylglycerols with ammonia. Selection of the molecular weight species in the first quadruple of the MS/MS. Fragmentation of the selected ions with argon. Separation of the fragment ions in the second quadrupole of the MS/MS. Calculation of the relative proportions of regioisomers with a computer software. | 11/2018-12/2019 | 
| Relative proportions (%) of fatty acids in triacylglycerols of human milk. | Isolation of lipids from the milk with solvent extraction. Isolation of triacylglycerols with solid phase extraction. Quantitation with gas chromatograph coupled with flame ionization detector in relation to external standards. | 11/2018-12/2019 | 
| Quantity (mg/ml) of lipid soluble compounds in triacylglycerols of human milk. | Isolation of lipids from the milk with solvent extraction. Gravimetric analysis of the lipids. | 11/2018-12/2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast milk, lipids, bioactive compounds, infant formula
Clinical Assessment Study in Crigler-Najjar Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a Pre-Phase 1 prospective, non-interventional clinical assessment study to evaluate Crigler-Najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.

Official Title
-----------------
LUSTRO: A Clinical Assessment Study in Crigler-Najjar Syndrome

Conditions
-----------------
Crigler-Najjar Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subject has a diagnosis of Crigler-Najjar syndrome resulting from a confirmed mutation in the UGT1A1 gene Subject is aged equal or greater than 1 year of age Subject receives daily phototherapy for a minimum of 6 hours within a 24-hour period (daily illumination time) Exclusion Criteria: Subject is currently participating in an interventional study or has received gene or cell therapy Subject has received a whole liver, partial liver, or hepatocyte transplant; or subject has a liver transplant scheduled within the planned participation period of this study Subject has significant cholestatic disease, in the opinion of the investigator Subject is receiving phenobarbital or other known inducer of UGT1A1 within 30 days of screening Subject has any clinically significant underlying liver disease (other than Crigler-Najjar syndrome), in the opinion of the investigator Subject has a history of, or currently has, a clinically important condition other than Crigler-Najjar syndrome, in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Characterize the disease course and natural history of subjects with Crigler-Najjar syndrome |  | Up to 2 years | 
| Assess variation in bilirubin levels over the course of the study and the variation of bilirubin levels over a 24-hr period |  | Up to 2 years | 
| Assess phototherapy usage over the course of the study |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the humanistic and clinical burden of disease in Crigler-Najjar subjects and caregivers as measured by PedsQL |  | Up to 2 years |
Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer. Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.

Detailed Description
-----------------
A phase I/II dose escalating study to determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.

Official Title
-----------------
A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma

Conditions
-----------------
Non-small Cell Lung Cancer, Extensive Stage Unresectable

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Irinotecan
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60% Exclusion Criteria: untreated CNS metastases

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|nan|
|Drug: Irinotecan|nan|
|Drug: Carboplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Small Cell Lung Cancer
Reproducibility of HbA1c Measurement on the Aina HbA1c Monitoring System

Study Overview
=================
Brief Summary
-----------------
A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites: Forsyth Institute in Cambridge, MA Orange County Research Center in Tustin, CA ActivMed Practices & Research in Methuen, MA

Detailed Description
-----------------
Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.

Official Title
-----------------
A Multicenter Study to Evaluate the External Precision of the Aina HbA1c Monitoring System in Quantitative Measurement of Glycosylated Hemoglobin (HbA1c)

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Aina HbA1c Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agree to the terms of this consent form Sign this consent form Be 18 years or older Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15% Provide blood samples from your arm and finger Come in in the morning of the study visit Exclusion Criteria: Not have a recent history of anemia or hemoglobin concentration above 20% Not be pregnant Not have previously given a blood sample to the Study Sponsor for a study

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 |
| --- |
|Device: Aina HbA1c Monitoring System|Monitoring test for quantitative determination of HbA1c|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision (as measured by %CV) of HbA1c measurements | HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site. | Each sample was measured in triplicate, twice per day, over the course of five days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HbA1c