linjc16/ctgov huggingface dataset:
Microparticles in Pediatric Inflammatory Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide data correlating levels of microparticles that circulate in the blood and disease activity in children with inflammatory bowel disease (IBD). The hypothesis is that circulating microparticles will be higher in children with active IBD, show inflammatory activity, and will be low in patients in remission as well as in healthy controls.

Detailed Description
-----------------
Once the response of microparticles to inflammation is defined in this patient population, the microparticles can be used as biomarkers of disease activity and could potentially use microparticles as targets of therapeutic agents. This cross sectional study will enroll 15 Crohn's patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric Crohn's disease activity index), 15 Ulcerative Colitis patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric ulcerative colitis activity index), and 10 healthy controls.

Official Title
-----------------
Microparticles in Pediatric Inflammatory Bowel Disease

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with IBD based on endoscopic, histologic, radiologic, or laboratory data Ages between 8 and 17 years old Exclusion Criteria: Anyone with a concurrent illness since infection can affect microparticle levels

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

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

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

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
-----------------
Pediatric IBD, Microparticles
Health2016: Monitoring Chronic Disease and Risk Factors in the General Population

Study Overview
=================
Brief Summary
-----------------
Health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar studies have been performed in 2006, 2010, and 2013.

Detailed Description
-----------------
A random sample of 18-69 year-olds living in 10 municipalities in the Capital Region of Denmark is invited to a health examination including measurements of anthropometry, lifestyles, symptoms and diagnoses of diseases, blood pressure, resting heart rate, muscle strength, fitness, lung function, allergy tests, and biochemistry (lipids, liver and kidney function, vitamin D status, salt excretion, iodine status). Trends in these parameters over time will be assessed.

Official Title
-----------------
Helbred2016: Monitorering af Kroniske Sygdomme og Risikofaktorer i Befolkningen

Conditions
-----------------
Micronutrient Deficiency, Cardiovascular Disease, Allergy, Respiratory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years. Danish citizenship, born in Denmark Exclusion Criteria: pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in micronutrient status from 2006 to 2016 | Serum 25-OH Vitamin D status (nmol/l) in serum from 2006 to 2016 | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C from 2006 to 2016 | Changes in HbA1C from 2006 to 2016 | 10 | 
| Change in allergic respiratory disease from 2006 to 2016 | Changes in prevalence of skin prick test reactivity to inhalant allergens | 10 years | 
| Change in prevalence of hypertension from 2006 to 2016 | Blood pressure above 140/90 or treatment for hypertension | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
micronutrients, blood pressure, allergy, lung function
Early Breastfeeding Cessation - is It Possible to Prevent?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if a postnatal public health breastfeeding intervention relying on the importance of the psychosocial factors can prolong the period with exclusive breastfeeding duration among mothers who want to breastfeed.

Detailed Description
-----------------
Breastfeeding is a complex learned behaviour and not a capability which comes naturally with motherhood. Different types of professional recommendations have been used to support the new mother in this process. Randomised studies have shown that postnatal support can influence the breastfeeding duration positively. Various studies has offered different kinds of interventions with home visits and/or telephone calls as the generally used approach, but the proper follow-up on the breastfeeding support in the postnatal period after the mother leaves the hospital is not yet clear.

Official Title
-----------------
A Randomised Community Based Experimental Trial in the Health Visitor's Practice Field

Conditions
-----------------
Breastfeeding, Practice, Maternal Behaviour, Self-Efficacy

Intervention / Treatment
-----------------
* Behavioral: community based trial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Danish mother, single child, gestational age of not less than 37 full weeks Exclusion Criteria: Mothers with an ethic background other than Danish, preterm delivery,twin birth

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: community based trial|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding duration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the breastfeeding period |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychosocial factors, breastfeeding, postnatal intervention, health visitor
The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device

Study Overview
=================
Brief Summary
-----------------
There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals.

Official Title
-----------------
The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device

Conditions
-----------------
Normal Hearing (76 Subjects), Subjects With Hearing Loss (15 Subjects)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hearing thresholds less than 25 dB at all frequencies of pure tone audiometry, with differences between the ears, by frequency, or less than 10 dB. The group with bilateral sensorineural hearing loss was made up of adults with hearing thresholds changed from 25 to 60 dB HL for the frequencies 2000-8000 Hz for pure tone audiometry. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 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 |
| --- | --- |
| Normal hearing (experimental 1)<br>76 Normal hearing subjects, male and female, adults, , evaluated by new device | |
| Normal hearing (experimental 2)<br>15 Normal hearing subjects, male and female, adults, , evaluated by new device | |
| Hearing loss (experimental 3)<br>15 hearing loss subjects, male and female, adults, evaluated by new device | |
| Gold standard 1<br>15 Normal hearing subjects, male and female, adults, evaluated by gold standard device | |
| Gold Standard 2<br>15 hearing loss subjects, male and female, adults, evaluated by gold standard device | |

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
-----------------
Evoked Potentials, Adult, Hearing Loss
Vascular Occlusion in Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass than resistance training alone. The investigators speculate this training strategy could be beneficial in patients with osteoarthritis.

Official Title
-----------------
Effects of Strength Training Associated With Vascular Occlusion in Patients With Knee Osteoarthritis

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

Intervention / Treatment
-----------------
* Other: Exercise training
* Other: Resistance training with vascular occlusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women BMI <39 Knee Ostearthritis type II and III VAS (visual analogue scale) between 2 and 8 Exclusion Criteria: Hip osteoarthritis Use of NSAID

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low intensity resistance training<br> | Other: Exercise training<br>* 12 weeks of resistance training twice a week.<br>|
| Experimental: High intensity resistance training<br> | Other: Exercise training<br>* 12 weeks of resistance training twice a week.<br>|
| Experimental: Low intensity resistance training with vascular occlusion<br> | Other: Resistance training with vascular occlusion<br>* 12 weeks of resistance training with vascular occlusion twice a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 12 weeks |
Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: dutogliptin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1) Age 18 to 85 years, inclusive. Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1) HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1) Exclusion Criteria: Type 1 diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>dutogliptin/PHX1149T | Drug: dutogliptin<br>* 400 mg<br>* Other names: PHX1149T;|
| Placebo Comparator: 2<br>Plabeco | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline. |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate safety and tolerability of dutogliptin |  | 26 weeks | 
| • Demonstrate changes in fasting plasma glucose |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, DPP4 inhibitor, dutogliptin
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease

Study Overview
=================
Brief Summary
-----------------
In Qena university hospital a prospective, randomized study was carried out on 100 COPD patients, all were divided into; conventional therapy without NIV (C group) 50 patients or with prophylactic NIV(N group) 50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery . Primary endpoint was the acute respiratory events (ARE) .Secondary endpoints were acute respiratory failure (ARF), intubation rate, mortality rate, infectious and non-infectious complications, and ICU stay.

Official Title
-----------------
Postoperative Noninvasive Ventilation After Upper Abdominal Surgery in Chronic Obstructive Lung Disease

Conditions
-----------------
Acute Respiratory Failure Post Surgical (Diagnosis)

Intervention / Treatment
-----------------
* Device: NIV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age˃18 years, scheduled for upper abdominal surgery under general anesthesia. Moderate to very severe COPD (GOLD II to IV). ASA functional status II or greater. Exclusion criteria: Contraindications to the application of NIV. Sleep apnea syndrome. Facial deformation. Inability to follow the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group N<br>50 patients.NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery | Device: NIV<br>* NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery<br>|
| No Intervention: group C<br>50 patients recieved conventional oxygen therpy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute respiratory events | patients % | 28days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute respiratory failure | patients % | 28 days | 
| intubation rate | patients % | 28 days | 
| ICU mortality | patients % | 28 days | 
| ICU length of stay | days | 28 days | 
| infectious and non infectious complications | patients % | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, noninvasive ventilation, acute respiratory failure
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

Study Overview
=================
Brief Summary
-----------------
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.

Conditions
-----------------
Patent Ductus Arteriosus (PDA)

Intervention / Treatment
-----------------
* Device: Device closure with AMPLATZER Duct Occluder
* Other: Objective Performance Criteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a demonstrated patent ductus arteriosus Body weight > 5 Kilograms Exclusion Criteria: Pulmonary vascular resistance above 8 Woods units or a Rp/Rs >0.4. Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease. Pelvic vein or inferior vena cava thrombosis Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement. History of repeated pulmonary infection Demonstrated intracardiac thrombi on echocardiography • Inability to obtain informed consent

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: implant to close PDA<br> | Device: Device closure with AMPLATZER Duct Occluder<br>* Device closure with AMPLATZER Duct Occluder<br>Other: Objective Performance Criteria<br>* Compare results of device closure to objective performance criteria<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reporting of Late Adverse Events Relating to the Device. |  | Long term follow up for data captured at 5, 6 or 7 years post implant | 
| Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure | The number of participants with a residual shunt (efficacy) | Long term follow up data captured at 5, 6 or 7 years post implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patent ductus arteriosus (PDA)
Lung Health of Early COPD: A Multi-center Cohort Study

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, prospective, cohort study in early COPD patients. This study aims to elucidate the lung function decline and its association with smoking and other risk factors. Other biomarkers and image markers from chest CT scan are also analyzed to investigate the lung function in early COPD patients.

Official Title
-----------------
Lung Health of Early Chronic Obstructive Pulmonary Disease: A Multi-center Cohort Study

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Behavioral: smoking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: male or female Age: 35-75 years old post-bronchodilator spirometry: FEV1/FVC < 0.8 and FEV1%pred ≥80% Exclusion Criteria: Other diseases may affect lung function, like lung cancer, bronchiectasis, interstitial lung disease or chest surgery. BMI > 35 kg/m2 Dementia or other severe neurological disease Pregnancy Conditions that contraindicated lung function test

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Smokers with Pre-COPD<br>Smoking history ≥ 10 pack-years 0.7≤ FEV1/FVC<0.8 and FEV1%pred ≥ 80% (post-bronchodilator) | Behavioral: smoking<br>* Smoking history and spirometry are used to define groups<br>|
| Smokers with Mild-COPD<br>Smoking history ≥ 10 pack-years FEV1/FVC<0.7 and FEV1%pred ≥ 80% (post-bronchodilator) | Behavioral: smoking<br>* Smoking history and spirometry are used to define groups<br>|
| Non-Smokers with Pre-COPD<br>Smoking history < 10 pack-years or never-smokers 0.7≤ FEV1/FVC<0.8 and FEV1%pred ≥ 80% (post-bronchodilator) | |
| Non-Smokers with Mild-COPD<br>Smoking history < 10 pack-years or never-smokers FEV1/FVC<0.7 and FEV1%pred ≥ 80% (post-bronchodilator) | |
| Healthy Controls<br>Healthy volunteers without smoking history FEV1/FVC ≥ 0.8 and FEV1%pred ≥ 80% (post-bronchodilator) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function decline in Pre-COPD and Mild-COPD patients | FEV1 decline in Pre-COPD and Mild-COPD patients | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function decline in smokers with Pre-COPD and Mild-COPD | FEV1 decline in smokers with Pre-COPD and Mild-COPD | 2 years | 
| Lung function decline in non-smokers with Pre-COPD and Mild-COPD | FEV1 decline in non-smokers with Pre-COPD and Mild-COPD | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early COPD, spirometry, lung health