linjc16/ctgov huggingface dataset:
Impact of Medical Emergency Team and EMS in Tampere University Hospital

Study Overview
=================
Brief Summary
-----------------
Patients in general wards have abnormal physical values preceding in-hospital cardiac arrest or a transfer to intensive care unit (ICU). The purpose of Medical Emergency Team (MET) or EMS is to interfere early enough in deteriorating patient status to prevent adverse outcomes like cardiac arrest or transfer to intensive care unit. The aims of this study are to record and analyze the effects of EMS and department of emergency and both afferent and efferent limbs of MET activity in Finnish tertiary Hospital.

Official Title
-----------------
Impact of Medical Emergency Team and EMS on ICU Readmissions and Sudden Cardiac Arrests in Tampere University Hospital

Conditions
-----------------
Death, Sudden,Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 yrs or older Exclusion Criteria: under 18 yrs

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 |
| --- | --- |
| All MET calls<br>We make an Utstein type analyze to all MET calls | |
| All EMS calls<br>We make an Utstein type analyze to all EMS calls during June 2015 | |
| All patient in the emergency department<br>We make an Utstein type analyze to all Emergency visits during June 2015 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | patients are followed until death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rates of ICU readmissions |  | one month to six year | 
| The rates of DNAR orders |  | one month to six year | 
| The number of patients EMS or medical emergency team is called to treat | We are going to analyze the number of MET calls and their impact on sudden cardiac arrests in TAUH. The time frame is 1st Jan 2010 -31st Dec 2015. It is known fact that well working MET team inside the hospital should decrease the sudden cardiac arrests. We also analyze the EMS calls and the ED visits in June 2015 to see if patient detoriation is related to sudden in-hospital death. | one month to six years | 
| Patient mortality after 6 mo of discharge | The patients are followed 6 mo after hospital discharge which has happened in year 2010 | one month to six year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MET
An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.

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

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab Exclusion Criteria: non-metastatic colorectal cancer patients not recieved bevacizumab
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bevacizumab<br>Patients with metastatic colorectal cancer who accept treatment with chemotherapy and bevacizumab | Drug: Bevacizumab<br> <br> * Other names: avastin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | To evaluate the treatment response of bevacizumab in Chinese patients with mCRC in real clinical practice | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost | 3 months | 
| progression free survival | the follow-up visit of PFS will be performed every 6 weeks | 6 weeks | 
| Proportion of patients with bevacizumab treatment discontinuation | Proportion of patients with bevacizumab treatment discontinuation due to bevacizumab-related adverse events | 3 weeks | 
| resection rate | resection rate of tumor after chemotherapy plus bevacizumab | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bevacizumab, overall survival, adverse events, tumor resection rate
An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Detailed Description
-----------------
The duration of treatment is 10 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Added to Existing Atorvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.

Conditions
-----------------
Hypercholesterolemia, Coronary Disease

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: ezetimibe, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with elevated cholesterol and coronary heart disease Exclusion Criteria: Patients whose cholesterol levels measure within acceptable ranges as specified by the study requirements

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe|nan|
|Drug: Comparator: ezetimibe, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elevated Cholesterol
Anal Cancer Radiotherapy Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.

Official Title
-----------------
Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship

Conditions
-----------------
Anal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified anal squamous cell carcinoma Radiotherapy or chemoradiotherapy planned ECOG performance status 0-2 >= 18 years of age Signed informed consent and expected cooperation of the patients for treatment and follow up Exclusion Criteria: - Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment

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 |
| --- | --- | --- |
| Disease-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of local recurrence |  | 2 years | 
| Biomarker ability to predict local recurrence rate | Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence. | 5 years | 
| Improvement of faecal incontinence |  | 5 years | 
| Pain relief of palliative radiotherapy | Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy. | 5 years |
A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
A 12 week trial of Adalimumab in subjects with active erosive inflammatory OA who have ahd an inadequate response to NSAID therapy

Official Title
-----------------
A Pilot Trial of Adalimumab for the Treatment of Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 45 or older, >/=2 tender and 2 swollen joints, inadequate response to NSAID therapy, hand radiographs with evidence of erosive changes, acceptable form of birth control Exclusion Criteria: Autoimmune arthropathy, History of psoriasis, Previous TNF therapy, current use of any DMARD, evidence of TB, history of Hep C, B, or HIV

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Adalimumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% ACR response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis
Evaluation of the Fetal MPI in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.

Study Overview
=================
Brief Summary
-----------------
The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.

Detailed Description
-----------------
The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester. Study Hypothesis: In women with non reassuring fetal cardiotocography, myocardial performance index may predict fetal distress accurately. Study Question: In pregnant women in the third trimester with abnormal cardiotocography, Does myocardial performance index predict fetal distress accurately? Study Objectives: This study aims to assess the accuracy of myocardial performance index in predicting fetal distress in pregnant women with non reassuring cardiotocography in third trimester.

Official Title
-----------------
Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome

Conditions
-----------------
Echocardiography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 30-40 weeks gestational age. Women pregnant in singleton fetus. Exclusion Criteria: Multiple pregnancies. Fetal congenital malformation.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abnormal CTG<br>This group includes pregnancies that showed abnormalities in CTG. | |
| Normal CTG<br>This group includes pregnancies that showed no abnormalities in CTG. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Fetal Myocardial Performance Index. | Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome. | 3rd Trimester CTG, immediately followed by Fetal Echocardiography at the same set | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal outcome observation | APGAR score at the first and fifth minute | Immediately postnatal (first five minutes after delivery) |
Energy-efficient and Health Promoting Light for Elderly People

Study Overview
=================
Brief Summary
-----------------
to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime

Detailed Description
-----------------
Lightning conditions seems to be important for the length and quality of sleep, as light have an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm. Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive retinal ganglion cells and these cells are sensitive to blue light. Based on previous research, blue light early in the day and abscence of blue light during evening is important for the entrainment. In this study, lightning conditions in the home of healthy subjects are set to either blue enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a randomization protocol in a cross-over study for 3 weeks in each condition, separated by a one week pause.

Official Title
-----------------
A Study of Two Different Light Conditions for Healthy Subjects Above 65 Years

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Other: blue light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 65 to 85 years Exclusion Criteria: Conditions which will interfere by the primary endpoint as evaluated by the medical doctor

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: red light<br>red light during the whole day | Other: blue light<br> <br> |
| Active Comparator: Blue light<br>Blue light during early day | Other: blue light<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep length | The mean of sleep length during the last week of each light period | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| actigraphy | mean sleep efficiency during the last week in each light period | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, circadian, melatonine, pupil response
Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance

Study Overview
=================
Brief Summary
-----------------
To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.

Detailed Description
-----------------
Hemodynamic characteristics of patients with obstructive jaundice are high cardiac output, low peripheral vascular resistance. The molecular basis for this feature is the increased production of NO. Methylene blue can increase peripheral resistance, the mechanism is: methylene blue is an oxidoreductase inhibitor, can inhibit the increased production of NO in the vascular endothelium, thereby increasing peripheral vascular resistance.

Official Title
-----------------
The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation

Conditions
-----------------
Obstructive Jaundice

Intervention / Treatment
-----------------
* Drug: Methylene Blue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18-60 years; American Society of Anesthesiologists（ASA） grade I III; TBIL>ULN and TBA>ULN; The patients with obstructive jaundice. Exclusion Criteria: Organs dysfunction(heart,lungs and etc); Mental disorders; in other clinical trial.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylene blue<br>2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction. | Drug: Methylene Blue<br>* 2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.<br>* Other names: Methylene blue injection;|
| No Intervention: saline<br>50ml of saline is administrated I.V before anesthesia induction. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral vascular resistance | the dose of vasoconstrictors used to Maintain Peripheral vascular resistance in the normal range (800   1200dyns / cm5) | through operation completion, an average of 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methylene blue; Peripheral vascular resistance
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

Study Overview
=================
Brief Summary
-----------------
The aim of the present trial is to assess the prospective results of protocol-based interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a group of selected patients where salvage surgery with clear resection margins was not possible.

Official Title
-----------------
SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY

Conditions
-----------------
Locally Recurrent Head and Neck Cancer

Intervention / Treatment
-----------------
* Radiation: Brachytherapy
* Other: Hyperthermia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed recurrent carcinoma of the head and neck region Stage rcT1-3 Tumor anatomy and location suitable for brachytherapy techniques. cN0/pN0 or rpN+ & R0 with <3 pos. LND & without invasion of capsula. M0 ECOG 0-2 Previous radiation therapy up to at least 50 Gy Previous radiation therapy completed more than 6 months ago Written study-specific informed consent Exclusion Criteria: cT4 rpN+ with >2 pos. LND or invasion of capsula Pregnant or lactating women Collagen vascular disease The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar Psychiatric disorders

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy<br>Brachytherapy d1-5(6) Hyperthermia d2 + 5 | Radiation: Brachytherapy<br>* Brachytherapy d 1-5(6)<br>Other: Hyperthermia<br>* Hyperthermia d 2 + 5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late side effects | Comparison late side effects to standard therapy | Effects are followed up to 5 years after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Assessment of quality of life with EORTC questionnaires | up to 5 years after therapy | 
| Rate of local recurrencies | Assessment of cumulative local recurrence rate | up to 5 years after therapy | 
| Overall survival | Rate of Overall survival | up to 5 years after therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
head and neck cancer, Locally recurrent head and neck cancer, Brachytherapy, Hyperthermia