linjc16/ctgov huggingface dataset:
Prevention of Stroke and Dementia in Primary Care

Study Overview
=================
Brief Summary
-----------------
In Western Countries, stroke and dementia are the main causes of long-term disability, dependency, and nursing home admission. Due to demographic trends a continuous increase of patient numbers can be expected. There is growing evidence that vascular risk factors which are implicated in the etiology of stroke also play important etiologic roles in both vascular dementia and Alzheimer disease. The present project is aimed at the reduction of stroke and dementia by means of a systematic detection and subsequent treatment of vascular risk factors by the family doctor based on established guidelines.

Official Title
-----------------
Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg

Conditions
-----------------
Stroke, Dementia, Disability

Intervention / Treatment
-----------------
* Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55 years or over Member of a particular health insurance plan (AOK) Resident of the district of Ebersberg Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evidence-based treatment, lifestyle counseling<br> | Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of long-term care disability |  | 8 years | 
| Incidence of stroke |  | 8 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of cardiovascular risk factors |  | 8 years |
A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor

Study Overview
=================
Brief Summary
-----------------
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.

Official Title
-----------------
A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed as solid tumor or malignant lymphoma patients receiving cyclic chemotherapy written informed consent hemoglobin concentration below 11 d/dL at enrollment life expectancy of more than 4 months Exclusion Criteria: hemolysis, gastrointestinal bleeding, postoperative bleeding iron deficiency megaloblastic anemia received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization any primary hematological disorder that could cause anemia prior treatment with KRN321 received erythropoetin therapy within 8 weeks before treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: darbepoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL |  |  | 
| To compare the proportion of subjects who receive red blood cell transfusions |  |  | 
| To compare the effectiveness of KRN321 based on quality of life scores |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
darbepoetin alfa, anemia, cancer patients, chemotherapy
Danish Quality Assurance Project on Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (COPD) in Outpatient Lung Clinics

Study Overview
=================
Brief Summary
-----------------
Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung Clinics

Detailed Description
-----------------
Study Hypothesis: Comparison(s): none

Official Title
-----------------
Danish Quality Assurance Project on Diagnosis and Treatment of COPD in Outpatient Lung Clinics

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient with the diagnosis or referral diagnosis of COPD. COPD must be the primary reason for this outpatient contact (for both new patients and controls). Exclusion Criteria: Any co-morbidity that hampers the diagnosis and treatment of COPD in accordance with the COPD guidelines used locally (e.g. malignant disease, dementia or sequelae of apoplexy). Asthma without the presence of COPD

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To optimise the diagnosis and treatment of COPD via a quality assurance project |  |  | 
| Increase the knowledge and use of diagnostic tools and treatment options |  |  | 
| Increase focus on COPD comorbidity |  |  |
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment

Study Overview
=================
Brief Summary
-----------------
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.

Detailed Description
-----------------
cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.

Official Title
-----------------
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment

Conditions
-----------------
Tachyarrhythmia, Arrhythmias, Cardiac

Intervention / Treatment
-----------------
* Other: Recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: candidate for ICD implantation candidate for an ICD DFT study candidate for an EP study Exclusion Criteria: age <18

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 |
| --- | --- |
| Interventions (recording)<br>Patients requiring Intracardiac defibrillator (ICD) implantation or Defibrillation Test (DFT) or Electrophysiology (EP) study with high probability of supra ventricular tachyarrhythmia. | Other: Recording<br>* The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ISSD algorithm detection rates | Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces | through study completion, expected at 15 months |
Markers and Calculation of Cardiovascular Risk in the Distinct Phenotypes of Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of anovulatory infertility among reproductive aged women. According to the revised criteria of 2003, four distinct phenotypes of PCOS can be diagnosed. However, there are emerging evidence supporting the existence of different levels of cardiometabolic risk between the four phenotypic groups of the syndrome. The purpose of this study is to determine the cardiovascular risk of i) normoweight and ii)overweight plus obese women of every one of the four phenotypes of the syndrome as well as the levels of low inflammation serum markers and the possible correlations of the between the outcomes.

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PCOS (criteria 2003) Healthy controls Exclusion Criteria: any condition mimicking PCOS any systematic disease

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 35 Years

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 |
| --- | --- |
| normoweight PCOS patients<br> | |
| normoweight controls<br> | |
| overweight plus obese PCOS patients<br> | |
| overwqeight plus obese controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high sensitivity C-Reactive Protein (hsC-RP) levels and differences between the phenotypes |  | 1 hour | 
| Lipoprotein-associated phospholipase2 (Lp-PLA2) levels and differences between the phenotypes |  | 1 hour | 
| Cardiovascular Risk Assessment and differences between the phenotypes |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, hsC-RP, Lp-PLA2, cardiovascular risk
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.

Official Title
-----------------
A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder

Conditions
-----------------
Autism Spectrum Disorder, Sleep Disorder, Neurological Disorder, Sleep Disturbance

Intervention / Treatment
-----------------
* Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required). A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances. The sleep disturbance must not be a result of another diagnosable disorder or medication. Male or female between 2 and 65 years of age, inclusive. Willing and able to comply with study requirements and restrictions. Exclusion Criteria: Inability to dose daily with tasimelteon or previous intolerance to tasimelteon. Indication of impaired liver function. Evidence of increased risk of self-harm. Pregnant or lactating females. A positive test for drugs of abuse. Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 65 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: Tasimelteon<br>Drug: Tasimelteon | Drug: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension<br>* Once Daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep time over the treatment period, as measured by sleep diary. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires. |  | 12 weeks | 
| Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior). |  | 12 weeks | 
| Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). |  | 12 weeks |
Assessment of Right Ventricular Function by Cardiac MRI in Patients With Pulmonary Arterial Hypertension (IRMA)

Study Overview
=================
Brief Summary
-----------------
Pulmonary hypertension (PH) is a pathophysiological condition defined by an increase in pulmonary arterial pressure above 20mmHg, which encompasses many very dissimilar conditions. Right ventricular function is the major determinant of survival in these patients. Currently, right ventricular function is estimated by trans-thoracic echocardiography via the measurement of standardised parameters. However, cardiac magnetic resonance imaging is now the reference technique for non-invasive quantification of volumes, mass, function of the right ventricle but can also be useful for the consideration of the pulmonary circulation. Thus, indices of function can be extracted and it plays an increasing role in the prognostic evaluation of the right heart function at diagnosis and at re-evaluation under treatment of pulmonary arterial hypertension. This work will initially focus on the assessment of right ventricular myocardial work by echocardiography and cardiac magnetic resonance imaging in comparison with invasive haemodynamic data.

Official Title
-----------------
Assessment of Right Ventricular Function by Cardiac Magnetic Resonance Imaging in Patients With Pulmonary Arterial Hypertension (IRMA)

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Procedure: cardiac magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with pulmonary arterial hypertension (group 1) Patient with cardiac MRI, echocardiography and right heart catheterisation within 1 month of each other Exclusion Criteria: Patient with features of venous/capillary involvement Pulmonary arterial hypertension associated with with congenital heart disease Patient's decline to participate in the study

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

| Intervention/Treatment |
| --- |
|Procedure: cardiac magnetic resonance imaging|all patients had magnetic resonance imaging at baseline and during follow-up.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplantation-free survival |  | 12 months |
Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas

Study Overview
=================
Brief Summary
-----------------
This study aims to collect perioperative diagnosis and treatment information of patients undergoing abdominal surgery at plateau and plain areas , collect blood and others samples for laboratory testing when necessary, analyzing the data to clarify the incidence and risk factors of pulmonary complications in patients undergoing abdominal surgery at different altitudes, so as to reduce the risk of pulmonary complications and even death in clinical practice.

Official Title
-----------------
Differences in Incidence and Risk Factors of Postoperative Pulmonary Complications Between Patients Undergoing Abdominal Surgery in Plateau and Plain Areas

Conditions
-----------------
Postoperative Pulmonary Complications;Abdominal Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old； scheduled for elective abdominal surgery under general anesthesia； ASAⅠ-Ⅲ Exclusion Criteria: Patients and their family members refused to be enrolled； patients were unable to communicate because of language disorders such as dementia and hearing impairment； patients were admitted to ICU 48 hours before operation； preoperative diagnosis of ARDS, aspiration pneumonia, pulmonary embolism or pulmonary edema or other acute respiratory diseases； mechanical ventilation within one week before operation； death or discharge within 24 hours after operation； second operation due to postoperative complications

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with pulmonary complications following abdominal surgery<br> | |
| Patients without pulmonary complications following abdominal surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and risk factors of pulmonary complications |  | 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilation duration,length of stay in ICU and Hospital Stay and death |  | within the 30 days after surgery | 
| incidence of Major Extrapulmonary Complications |  | within the 30 days after surgery | 
| Biomarkers |  | 1 week after surgery | 
| incidence and risk factors of various specific pulmonary complications |  | 1 week after surgery |
AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect and safety of AZD6244(ARRY-142886)versus pemetrexed in the second or third line treatment of advanced Non-Small Cell Lung Cancer. Following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the US will be treated with either AZD6244 or pemetrexed. Treatment will be continued for as long as patients receive clinical benefit.

Official Title
-----------------
A Phase II, Open, Randomised Study to Assess the Efficacy and Safety of AZD6244 Versus Pemetrexed (Alimta®) in Patients With Non-small Cell Lung Cancer, Who Have Failed One or Two Prior Chemotherapy Regimen

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: AZD6244
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with non-small cell lung cancer Previously received one or two chemotherapeutic treatments Exclusion Criteria: Previous therapy with MEK inhibitor or pemetrexed Any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pemetrexed | Drug: Pemetrexed<br>* oral<br>* Other names: Alimta®;|
| Experimental: 2<br>AZD6244 | Drug: AZD6244<br>* oral vial<br>* Other names: ARRY-142886;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess tumor growth |  | assessed every 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety and tolerability of AZD6244 |  | assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, Advanced Non-Small Cell Lung Cancer, AZD6244