linjc16/ctgov huggingface dataset:
Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis (IPF)

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: to determine if there are specific genetic traits that might explain why patients have developed pulmonary fibrosis; to determine if specific genetic traits account for differing patterns of inflammation and scar tissue that has formed in the patient's lungs.

Detailed Description
-----------------
Idiopathic pulmonary fibrosis (IPF) is a disease of unknown etiology that is characterized by the insidious development of lung fibrosis ultimately leading to distortion of the lung architecture, respiratory failure, and death. IPF is one of several entities associated with pulmonary fibrosis called the idiopathic interstitial pneumonias (IIP). Based on the histopathologic features of the fibrotic process, it is possible to identify four distinct entities: usual interstitial pneumonia (UIP) (synonymous with IPF), nonspecific interstitial pneumonia (NSIP), desquamative interstitial pneumonia DIP), and acute interstitial pneumonia (AIP) (Hamman-Rich lung). Each type appears to have different clinical progression and a different response to anti-inflammatory therapy. Our overall objective is to elucidate the molecular pathogenesis of IPF (UIP) by identifying factors that determine host susceptibility to this disease. We hypothesize that patients who develop pulmonary fibrosis, have a genetic propensity to abnormal lung repair that leads to fibrosis after acute lung injury. We further hypothesize that these genetic susceptibilities may determine if the pathologic process in the lung after an insult becomes UIP, AIP, NSIP, or DIP. To explore these hypotheses we propose to characterize the genetic polymorphisms in candidate genes involved in inflammation, matrix turnover, fibroblast proliferation and differentiation, and epithelial cell proliferation; and to correlate this with indices of disease progression.

Official Title
-----------------
Genetic Polymorphisms in Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Diagnosis of pulmonary fibrosis confirmed by physical examination, pulmonary function testing, chest X-ray, and computed tomography (CT) scans. Adult patients who are seeking treatment at the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease. Exclusion Criteria: Under 18 years of age Non-fibrotic ILD

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung[A04.400]
Spina Bifida in Daily Life: an Exploratory Study

Study Overview
=================
Brief Summary
-----------------
Spina Bifida can lead to physical neurocognitive and psychological symptoms. Still little is know about the daily impact of spina bifida on participation possibilities in social life. This exploratory research project want to investigate which lif choices patients with spina bifida has to make and in which way their daily life is organized. In a second part, quality of life will be measured and we hope to discover some dynamics in order to improve patient care.

Detailed Description
-----------------
This exploratory research project wants to investigate how patients with spina bifida live their daily life and which impact spina bifida has on their choices of life. This will be done by a survey that will ask questions about different domains in life: demographic variables, education, work, social functioning, spare time, housing, mobility, independency and quality of life. The survey is based on empirical findings in literature. The quality of life questioning is based on the SF36. The survey will be done once during a clinical consultation.

Official Title
-----------------
Spina Bifida in Daily Life: an Exploratory Study

Conditions
-----------------
Spina Bifida

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Spina Bifida Exclusion Criteria: Not able to read or write Dutch
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Spina Bifida<br>Adults with and parents of children with Spina Bifida followed by the team in UZ Leuven will be asked to complete a survey | Other: Survey<br>* Survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive statistics about life choices | Descriptive statistics about life choices measured by the answers of the survey of Spina Bifida patients | 1 year |
Radiologic Features of Invasive Pulmonary Aspergillosis

Study Overview
=================
Brief Summary
-----------------
Invasive pulmonary aspergillosis (IPA) is an opportunistic infection that primarily affects recipients of solid organ transplants (SOTs) and patients with chemotherapy- induced neutropenia.Although both of these populations are at high risk for IPA, they differ with regards to the specific defects in host defense mechanisms that increase their risk for IPA. Chemotherapy- induced neutropenia is the principal defect affecting patients with hematologic malignancies, whereas transplant recipients tend to have dysfunctional T cells and phagocytes, as a result of immunosuppressive drug therapy. Thus, the patterns of IPA-related infection and inflammation may differ according to the type of underlying immune defect. Although the clinical and radiological features of IPA in patients with neutropenia have been extensively studied, little is known about the characteristics of IPA in SOT recipients. The investigators therefore compared the IPA- related clinical and radiological findings in SOT recipients with those of neutropenic patients.

Official Title
-----------------
Retrospective Analysis of Radiologic Features of Invasive Pulmonary Aspergillosis in Transplant Recipients and Neutropenic Patients.Transplant Recipients and Neutropenic Patients

Conditions
-----------------
Hematologic Disease, Solid Organ Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IPA cases with solid organ transplant recipients and hematologic disease patients proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG criteria Exclusion Criteria: under 16 years old possible cases of invasive pulmonary aspergillosis

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| SOT recipients<br>solid organ transplant recipients with invasive pulmonary aspergillosis | |
| Hematologic disease<br>Hematologic disease patients with invasive pulmonary aspergillosis | |

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
-----------------
Invasive pulmonary aspergillosis, Solid organ transplantation, Hematologic disease
Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension

Study Overview
=================
Brief Summary
-----------------
This study is to describe the long-term antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome in China.

Detailed Description
-----------------
This study is to describe the long-term (3 to 5 years after the acute coronary syndrome index event) antithrombotic management patterns in a real-life setting for patients hospitalized with an acute coronary syndrome (i.e. ST-segment Elevation Myocardial Infarction, Non-ST-segment Elevation Myocardial Infarction, Unstable Angina) in China.

Official Title
-----------------
EPICOR Asia-China Extension. Long-term Follow-up of antithrombotIc Management Patterns in Acute Coronary Syndrome Patients in Asia-China Extension

Conditions
-----------------
Acute Coronary Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent has been provided. Contact Order Form has been provided Aged 18 years or older. Enrolled in EPICOR Asia study and completed the 2 year follow-up. Exclusion Criteria: Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances, alcohol or drug abuse). Already included in the EPICOR Asia-China Extension observational study. Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy. Current participation in an interventional clinical trial. Patients receiving ticagrelor beyond 12 months and other off label use.
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 |
| --- | --- | --- |
| Long-term antithrombotic management patterns in a real-life setting by assessing the medication and treatment prescribed by physicians |  | From 2 years after the acute coronary syndrome index event, assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes by record the number and type of cardiovascular and non-cardiovascular events |  | From 2 years after the acute coronary syndrome index event, assessed up to 5 years | 
| Health care resource consumption and related costs by assessing the detail hospitalization and outpatient cost. |  | From 2 years after the acute coronary syndrome index event, assessed up to 5 years | 
| Quality of life by assessing EQ-5D questionnaire. |  | 2 years,2.5years,3years,3.5years,4years,4.5years,5years after the acute coronary syndrome index event |
OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Study Overview
=================
Brief Summary
-----------------
Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.

Official Title
-----------------
OVATIO CRT and SITUS OTW LV Lead Post Approval Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NYHA Class III/IV Stable medical regimen QRS greater than or equal to 130 ms LVEF less than or equal to 35% Exclusion Criteria: VT of transient or reversible causes Incessant VT Currently implanted with a lead positioned through the coronary sinus (unless it is the SITUS OTW LV lead) Cardiac revascularization or angioplasty within the last month Heart failure due to correctable valve disease Chronic, medially refractory AT Enrolled in another clinical study that may confound the results of this study Life expectancy less than 6 months Inability to understand the purpose of the study or refusal to cooperate Inability or refusal to provide informed consent Unavailable for scheduled follow-up with the implanting practice Sensitivity to 1 mg dexamethasone sodium phosphate Less than 18 years of age Pregnancy

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 |
| --- | --- | --- |
| SITUS OTW LV lead complication free rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System complication free rate |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, cardiac resynchronization therapy
Acupressure in Hyperemesis Gravidarum

Study Overview
=================
Brief Summary
-----------------
To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum

Detailed Description
-----------------
A prospective RCT conducted at Department of Obst and Gynae, UKMMC. All pregnant women with a normal intrauterine pregnancy of ≤ 16 week gestation with hyperemesis gravidarum will be assessed by the medical officer/ specialist/ consultant in charge. Explanation regarding the research study will be given for patients who fulfill the inclusion and exclusion criteria. Patients who have understood the research study and consented will be recruited as subjects for the study.

Official Title
-----------------
A Randomised Controlled Trial On Effect Of Acupressure On Nausea And Vomiting In Women With Hyperemesis Gravidarum

Conditions
-----------------
Hyperemesis Gravidarum

Intervention / Treatment
-----------------
* Device: Acupressure band
* Other: Standard treatment hospital protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Onset of vomiting before 16 weeks Vomiting at least 2 times per day Ketonuria on admission Mid stream urine specimen that did not indicate infection Exclusion Criteria: Non viable pregnancy Molar pregnancy Overt clinical features of thyrotoxicosis Known case of medical illness that associated with nausea and vomiting Patient refusal or patients who are not able to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accupressure group<br>acupressure band apply to P6 (nei guan) point which located three fingers below the skin wrinkles of the anterior wrist. Acupressure band wear 3 times daily before breakfast, lunch and dinner for at least 10 minutes | Device: Acupressure band<br>* acupressure band apply to P6 (nei guan) point which located three fingers below the skin wrinkles of the anterior wrist. Acupressure band wear 3 times daily before breakfast, lunch and dinner for at least 10 minutes<br>|
| Placebo Comparator: Control group<br> | Other: Standard treatment hospital protocol<br>* Intravenous metaclopromide 10mg PRN Intravenous fluids as per protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of nausea and vomiting | measure the effect of acupressure using modified Pregnancy Unique Quantification of Emesis and Nausea (PUQE) | day 1 to day 3 |
Fimasartan Blood Pressure Lowering After Acute Stroke

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months.

Official Title
-----------------
A Multicenter Longitudinal Observational Study to Assess the Effectiveness of Fimasartan-based Antihypertensive Treatment and Prognosis in Post-Acute Phase of Ischemic Stroke or Transient Ischemic Attack

Conditions
-----------------
Hypertension, Ischemic Stroke, Transient Ischemic Attack

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months. Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure Suitable for administration of fimasartan The life expectancy should be over 6 months. Exclusion Criteria: Patients already treated with antihypertensive medications Hemorrhagic stroke patients

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| BP | Blood pressure control rate(<140/90 mmHg) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BP | Blood pressure control rate(<140/90 mmHg) | 4, 12 weeks | 
| BP | Blood pressure changes | 4, 12, 24 weeks | 
| mRS | mRS changes | 4, 12, 24 weeks | 
| Fimasartan-based treatment | Fimasartan-based treatment modalities | 24 weeks | 
| Fimasartan starting point | Fimasartan starting point after stroke | 24 weeks | 
| Stroke recurrence | Rate of stroke recurrence | 24 weeks | 
| Cardiovascular events | Incidence of cardiovascular events | 24 weeks | 
| Mortality rates from cardiovascular disease | Mortality rates from cardiovascular disease | 24 weeks | 
| Mortality rates of any cause | Mortality rates of any cause | 24 weeks | 
| Adverse events | Adverse events related to antihypertensive treatments | 24 weeks |
Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase.

Official Title
-----------------
A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD

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

Intervention / Treatment
-----------------
* Drug: Salmeterol/Fluticasone propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC. Exclusion Criteria: Hypersensitivity to Salmeterol + Fluticasone or any of its excipients Pregnancy, lactation or scheduled pregnancy during the observational period of the study Serious illness/disease, not adequately controlled, or with a potential to interfere with the patients' participation in the present study, according to the investigator/physician's judgment.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Salmeterol/Fluticasone propionate (50/500 μg)<br>Open label, 6 visits, single arm study | Drug: Salmeterol/Fluticasone propionate<br>* Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria) | Evaluate adverse events, vital sign reporting, and concomitant medications | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough FEV1, FVC and FEV1/ FVC ratio |  | every 26 weeks | 
| Health status as determined using the St George's Respiratory Questionnaire (SGRQ) |  | every 26 weeks | 
| Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria |  | every 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacovigilance, COPD
The Effect of a Structured Personalised Ergonomic Intervention for Hospital Nurses With Musculoskeletal Complains

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of a structured personalised ergonomic intervention program for hospital nurses with musculoskeletal complains.

Detailed Description
-----------------
In a randomised controlled trial 31 nurses with musculoskeletal complains were observed at work, and an intervention program was completed in 14 nurses with the other 17 acting as controls. The intervention included four meetings during three months. Outcome measures were collected before the intervention and post-tests were gathered three months after the determination of the program.

Official Title
-----------------
Study That Examined the Effect of a Structured Personalised Ergonomic Intervention Program for Hospital Nurses With Musculoskeletal Complains.

Conditions
-----------------
Musculoskeletal Diseases

Intervention / Treatment
-----------------
* Behavioral: Ergonomic plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A minimum of half-time work for at least one year musculoskeletal pain complaints agreement to participate in the interventional study. Exclusion Criteria: Male nurses nurses with previously defined job restrictions and pregnancy
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Ergonomic plan|participants in the intervention group were evaluated by the REBA and received an overall coaching that stretched over four meetings Each session paid special attention to, and included explanations about, the anatomy and physiology of body regions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of stress and control at work, measured by Karasek's questionnaire and Reba |  | 6 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence and the level of pain measured by Nordic Questionnaire |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nurses, Workload, Musculoskeletal System, Intervention