linjc16/ctgov huggingface dataset:
The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants

Study Overview
=================
Brief Summary
-----------------
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. Different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation instability among premature infants therefore the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when are fed over 30 min vs over 2 hours, as documented by SpO2 histograms.

Official Title
-----------------
The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants

Conditions
-----------------
Premature Infant, Respiratory Disease

Intervention / Treatment
-----------------
* Procedure: Continuous gavage feeding
* Procedure: Bolus feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature Infants (GA<37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC) Feeding>100 ml/kg/day Exclusion Criteria: Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart disease. Instability because of: Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven sepsis Need for inotropic support for low blood pressure
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus feeding<br> | Procedure: Bolus feeding<br>* Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.<br>|
| Experimental: continuous gavage feeding<br> | Procedure: Continuous gavage feeding<br>* Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation instability | SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it | 9 hours (3 feeds) |
Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.

Official Title
-----------------
Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study

Conditions
-----------------
Fibrosis, Hepatitis C Chronic

Intervention / Treatment
-----------------
* Drug: Pirfenidone
* Drug: Matched equivalent placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay). Sign an informed consent form to allow the collection of liver biopsies before and after treatment. No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy. No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment. Exclusion Criteria: Patients with clinical contraindications to hepatic biopsy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pirfenidone<br>Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years. | Drug: Pirfenidone<br>* Pirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months.<br>* Other names: 5 methyl-1-phenil-2 (1H)-pyridone;|
| Placebo Comparator: Matched equivalent placebo<br>Matched equivalent placebo | Drug: Matched equivalent placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrosis staging | Fibrosis was evaluated according to Ishak fibrosis staging scale. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of necroinflammation activity | Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI). | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibrosis, necroinflammation, hepatitis C chronic
The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.

Detailed Description
-----------------
The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.

Official Title
-----------------
The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

Conditions
-----------------
Metastatic Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: Erlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metastatic chemotherapy-naïve pancreatic cancer patients histologically confirmed adequate samples for analysis Eastern Cooperative Oncology Group (ECOG) performance status <= 2 absolute neutrophil count (ANC) >= 1,500/mm3 platelet count >= 100,000/mm3 serum creatinine <= 1.5 mg/dL aspartate aminotransferase (AST) alanine aminotransferase (ALT) < 5 times the upper limit of normal Exclusion Criteria: absence of any other malignancy or serious medical or psychological illness that would preclude informed consent

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Gemcitabine<br> | |
| Experimental: Gemcitabine plus erlotinib<br> | Drug: Erlotinib<br>* Erlotinib 100 mg 1# PO qd till disease progression<br>* Other names: Tarceva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease control rate |  | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | eight weeks | 
| overall survival |  | one day | 
| progression-free survival |  | one day |
Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.

Study Overview
=================
Brief Summary
-----------------
Predicting no reflow in ppci of STEMI patients using mean platelet volume together with STEMI clinical risk scores

Official Title
-----------------
Mean Platelet Volume and STEMI Clinical Risk Scores in Prediction of Impaired Myocardial Perfusion In Acute STEMI Patients Undergoing PPCI.

Conditions
-----------------
No-Reflow Phenomenon

Intervention / Treatment
-----------------
* Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scores


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting with acute STEMI, within 24 hours of symptoms, fulfilling criteria for PPCI protocol in our facility Exclusion Criteria: patients presenting more than 24 hours of symptoms onset patients not eligible for PPCI program in our facility

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No complication<br>Thrombolysis in myocardial infarction flow grade III flow after PPCI, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores | Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scores<br>* Lab parameters<br>|
| No reflow<br>No reflow phenomenon after pci on STEMI patients, mean platelet volume, lymphocyte ratio, detailed echo within 24 hrs of admission, clinical STEMI risk scores | Other: Mean platelet volume, lymphocyte number, STEMI clinical risk scores<br>* Lab parameters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participents with No reflow after PPCI and in hospital mortality | No reflow: suboptimal myocardial reperfusion through a part of coronary circulation without angiographic evidence of mechanical vessel obstruction. In hospital mortality | Within 48 hours from admission |
The Screening and Analysis of Plasma Biomarkers in Irreversible PAH-CHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse the sensitivity and specificity of circulating endothelial cells to predict irreversible pulmonary arterial hypertension associated with congenital heart disease.

Detailed Description
-----------------
predict to recruit 100 patients with pulmonary arterial hypertension (PAH)associated with CHD，under the commitment of the children's parents，take 3-4ml central venous blood before the corrective surgery，then calculate the number of the circulating endothelial cells by flow cytometer AND detect the expression of micro RNAs to screen out the biomarker，through the 6 months follow-up, separated the reversible and irreversible PAH,then to carry on the statistics.

Official Title
-----------------
The Screening and Analysis of Plasma Biomarkers in Irreversible Pulmonary Arterial Hypertension Associated With Congenital Heart Disease

Conditions
-----------------
Hypertension,Pulmonary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only those patients with systolic PAP (sPAP) >65mmHg before surgery were included. Exclusion Criteria: Patients with trisomy 21 (Down syndrome) were not included

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- |
| reversible PAH group<br>reversible PAH was defined as sPAP decreasing to 40 mmHg after follow-up more than 6 months through echocardiography. | |
| irreversible PAH group<br>irreversible PAH was defined as 6 months after surgery through echocardiography ，the sPAP remaining 40 mmHg or up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of Circulation endothelial cells and the detective count of microRNAs | the number of Circulation endothelial cells and the detective count of microRNAs in the biomarkers in both groups differd significantly. | 6 months after corrective surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers，pulmonary arterial hypertension
Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

Detailed Description
-----------------
ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Official Title
-----------------
Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

Conditions
-----------------
Glaucomas, Pterygium

Intervention / Treatment
-----------------
* Device: OculusGen Biodegradable Collagen Matrix Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or over Patient able to cooperate with study procedures and able to perform tests reliably Patient willing to sign informed consent Patient able and willing to complete postoperative follow-up requirements Glaucoma：one/both eyes are affected by glaucoma Pterygium： patient with pterygium Exclusion Criteria: Known allergic reactions to collagen

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OculusGen Biodegradable Collagen Matrix Implant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effectiveness via the reduction of IOP and the incidence of pterygium recurrence |  | 180 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the safety via the incidence of complications and adverse events. |  | 180 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, Aeon Astron, ologen
Validity and Reliability of Turkish Version of Marx Activity Rating Scale

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate Turkish validity and reliability of Marx Activity Rating Scale for patients with knee disorders.

Detailed Description
-----------------
The aim of the study is to investigate Turkish validity and reliability of Marx Activity Rating Scale for patients with knee disorders.The study will include 30 patients with different types of knee disorders such as traumatic meniscal and ligament injuries,fractures,osteoarthtiris and patellofemoral joint pain.This study will conduct at Palmer&Still Physiotherapy Clinic.The original English form will be translated into Turkish according to guidelines.Subjects will complete translated Marx Activity Rating Scale,International Knee Documentation Committee (IKDC) subjective knee form and EuroQol EQ5D.Re-testing will be obtained after 1 month.

Official Title
-----------------
Validity and Reliability of the Turkish Marx Activity Rating Scale for Knee Disorders

Conditions
-----------------
Knee Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years can read and write Turkish have knee disorders such as traumatic mensical and ligament injuries,fractures,patellofemoral pain syndrome and/or mild osteoarthritis Exclusion Criteria: Individuals with multiple ligament injuries, large osteochondral fractures, large focal cartilage defects requiring surgery, malignancy, and advanced osteoarthritis.

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 |
| --- | --- |
| Patients with Knee Disorders<br>Patients with knee disorders such as traumatic meniscal and ligament injuries,fractures,osteoarthritis,patellofemoral joint pain | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marx Activity Rating Scale (MARS) | Knee-specific patient-reported outcome measure assesses the frequency of participation in sports-related activities for an adult population. It has a 5-point scale referring to the frequency of performing these activities in the past year. The maximum score is 16, while the minimum score is 0 for the patient. A higher score means more frequent sports-related participation. | 1 month |
Qp/Qs Ratio by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation

Study Overview
=================
Brief Summary
-----------------
In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation. This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated using variables obtained from blood sample.

Detailed Description
-----------------
Blood sampling will be performed in both arterial and central venous lines.

Official Title
-----------------
The Accuracy of Qp/Qs Calculated by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation

Conditions
-----------------
Anesthesia, General, Congenital Heart Disease, Blood Gas Monitoring, Transcutaneous, Blood Gas Analysis

Intervention / Treatment
-----------------
* Other: Qp/Qs ratio monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation) preoperative SpO2<97% Exclusion Criteria: unable to measure pulse oximeter or cerebral oximeter signal unable to measure SaO2 or SmvO2 unstable vital sign

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Qp/Qs ratio monitoring<br>Qp/Qs ratio monitoring | Other: Qp/Qs ratio monitoring<br>* Op/Qs -monitor will be calculated using SpO2 and cerebral oximetry Op/Qs -blood will be calculated using ABGA and VBGA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference between Qp/Qs-monitor and Qp/Qs-blood | the difference between Qp/Qs-monitor (measure by pulse oximeter and NIRS) and Qp/Qs-blood (measured by blood gas analysis) | within 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference between SpO2 and SaO2 | the difference between SpO2 (measure by pulse oximeter)and SaO2 (measured by blood gas analysis) | within 1 week after surgery | 
| the difference between cerebral oximeter score and and SmvO2 | the difference between cerebral oximeter (measure by NIRS)and SmvO2 (measured by blood gas analysis) | within 1 week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Qp/Qs ratio, Pediatric congenital heart disease
Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection

Study Overview
=================
Brief Summary
-----------------
Background: Aortic stent-graft is useful to occlude intimal tear and prevent further dilatation of the false lumen in patients with aortic dissection. The long-term benefit of aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well demonstrated, especially in patients at high risk of aneurysmal change and death. Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft insertion performed just after the acute phase into the descending thoracic aorta in patients with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.

Conditions
-----------------
Aortic Dissection, Aortic Aneurysm, Stent-graft

Intervention / Treatment
-----------------
* Procedure: Aortic stent-graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uncomplicated distal aortic dissection Initial false lumen diameter >= 22 mm Exclusion Criteria: Old age (> 75 years old) Other comorbidity or malignancy with life expectancy < 5 years Complicated dissection requiring aortic surgery or intervention Sudden death in acute phase Marfan syndrome

Ages Eligible for Study
-----------------
Maximum Age: 75 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: Early intervention<br>Early intervention: stent-graft just after acute phase | Procedure: Aortic stent-graft<br>* Early intervention with aortic stent-graft<br>|
| No Intervention: Conservative<br>Conservative: medial follow-up without early intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic aneurysm and death |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Events and complications | paraplegia cerebrovascular accident aorta surgery | 4 years |