linjc16/ctgov huggingface dataset:
Platelet Activation and Reactivity in Acute Exacerbations of COPD

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD) is known for development of severe cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets contribute to acute cardiovascular events and atherosclerosis. When platelets are activated, they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD is scarcely studied. This study aims to address this gap by investigating platelet function and coagulation in patients with AE-COPD and after convalescence.

Official Title
-----------------
Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)

Conditions
-----------------
COPD Exacerbation

Intervention / Treatment
-----------------
* Other: Blood is drawn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >40 years Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC < 70% and less than 12% on reversibility testing< Lower limit of normal (LLN)) ≥10 pack years of smoking Exclusion Criteria: Use of anti-coagulation or other platelet function inhibitors Asthma Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE) Malignancies

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood is drawn|Blood analyses|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation. |  | Measured at presentation with an AE-COPD and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet-monocyte interaction (CD14 cells positive for CD61) |  | Measured at presentation with an AE-COPD and after 8 weeks | 
| Monocyte activation (CD11b expression on CD14 positive cells) |  | Measured at presentation with an AE-COPD and after 8 weeks | 
| Tissue factor triggered thrombin generation capacity |  | Measured at presentation with an AE-COPD and after 8 weeks | 
| Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer |  | Measured at presentation with an AE-COPD and after 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Cardiovascular Disease, Platelets, Inflammation
A Study of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, multicenter, open-label, dose-escalation study of DCDT2980S administered by intravenous (IV) infusion to patients with relapsed or refractory hematologic malignancies. In addition, at selected sites, DCDT2980S will be studied in combination with rituximab.

Official Title
-----------------
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DCDT2980S in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia And DCDT2980S in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: DCDT2980S
* Drug: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Life expectancy of at least 12 weeks History of histologically-documented hematologic malignancy for which no effective standard therapy exists: indolent NHL (including Grades 1-3a FL; MZL [including splenic, nodal, and extra-nodal]; and SLL), Grade 3b FL, DLBCL, MCL, or CLL Must have at least one bi-dimensionally measurable lesion Exclusion Criteria: Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks prior to study treatment Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 2 weeks prior to of study treatment Completion of autologous stem cell transplant within 100 days prior to study treatment Prior allogeneic stem cell transplant

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: DCDT2980S<br>* Intravenous repeating dose<br>|
| Experimental: B<br> | Drug: DCDT2980S<br>* Intravenous repeating dose<br>Drug: rituximab<br>* Intravenous repeating dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of dose-limiting toxicities (DLTs) |  | Throughout study or until early discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response, defined as a partial response (PR) or complete response (CR) |  | Throughout study or until early discontinuation |
TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of candesartan cilexetil in preventing hypertension in people with high normal blood pressure. Patients will be randomized to either Candesartan or placebo for an initial 2-year period followed by a second 2-year period of placebo for all patients.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Multicenter, Long-term Trial of Preventing Hypertension Using Candesartan Cilexetil 16 mg in Patients With High Normal Blood Pressure (TROPHY)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: ATACAND


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between the ages of 30 and 65 (inclusive) at the time of the informed consent process have an average clinic BP in the high normal range of < 139/85-89 mmHg or 130-139/< 89 mm Hg (high normal BP range) (mean systolic and/or diastolic pressure based on 3 consecutive measurements) derived from the average of clinic visits 1,2 and 3. Exclusion Criteria: Have proteinuria >1 + (by dipstick method) have a stroke, myocardial infarction (MI), transient ischemic attack (TIA), the presence of any clinically significant evidence of atherosclerosis or hypertensive target organ involvement or any significant medical condition that may compromise participation in this study.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ATACAND|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether candesartan cilexetil 16 mg compared to placebo reduces the crude incidence of hypertension in a population with high normal BP evaluated after a 4-year study period consisting of 2 years of double-blind treatment followed by 2 years |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the reduction in BP after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP. |  |  | 
| To evaluate the incidence of hypertension after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP. |  |  | 
| To evaluate Health-related Quality of Life yearly during 2 years treatment with candesartan cilexetil 16mg vs placebo and yearly during a 2-year follow up period in patients with high normal BP. |  |  |
Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.

Official Title
-----------------
A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful completion of the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) Study. Exclusion Criteria: Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Months

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 |
| --- | --- |
| Active Comparator: Low dose<br> | Drug: pantoprazole<br> <br> |
| Active Comparator: High dose<br> | Drug: pantoprazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Laboratory Test Values of Potential Clinical Importance During Treatment Period | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Criteria are as follows: Potassium ≤ 3.0 mEq/L or ≥ 6.2 mEq/L; Carbon dioxide < 12 mEq/L or > 35 mEq/L; Total bilirubin > 1.5xULN; CPK > 3xULN; Gastrin ≥ 600 pg/mL; Neutrophils < 10% or > 80%; Platelet count < 100 x10 to the third power/ul or > 600 x10 to the third power/ul; Urine protein albumin > 2+ (dipstick) 100mg/dL or positive; Urine leukocyte esterase > 2+ (dipstick) moderate or positive. | 6 weeks | 
| Growth Parameters Z-scores | Z-Score is a statistical measure to evaluate how a single data point compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores primarily range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety
Interim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse large B-cell lymphoma based on the interim results of PET/CT.

Detailed Description
-----------------
R-CHOP is the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL). However, the standard number of cycles is uncertain. Recently, interim PET/CT was found to predict prognosis in DLBCL. The hypothesis of this study is to optimize the number of cycles based on the interim results of PET/CT in order to avoid treatment exposure.

Official Title
-----------------
Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma: a Exploratory Phase II Study Study

Conditions
-----------------
Diffuse Large B-cell Lymphoma

Intervention / Treatment
-----------------
* Drug: R-CHOP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated diffuse large B-cell lymphoma Age range 18-80 years old Eastern Cooperative Oncology Group performance status 0-2 Life expectancy of more than 3 months Adequate organ function Exclusion Criteria: Primary or secondary central nervous system involvement Previous serious cardiac disease History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: R-CHOP<br>rituximab 375mg/m2 day 0, cyclophosphamide 750mg/m2 IV day 1, doxorubicin 50mg/m2 IV day 1, vincristine 1.4mg/m2 IV day1 (maximum: 2mg), prednisone 50mg PO days 1-5 twice per day | Drug: R-CHOP<br>* rituximab 375mg/m2 day 0, cyclophosphamide 750mg/m2 IV day 1, doxorubicin 50mg/m2 IV day 1, vincristine 1.4mg/m2 IV day1 (maximum: 2mg), prednisone 50mg PO days 1-5 twice per day<br>* Other names: mabthera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progression-free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 6 months | 
| 3-year overall survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DLBCL, R-CHOP, PET/CT
The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children

Study Overview
=================
Brief Summary
-----------------
A prospective study designed to access changes in the intracuff pressure of a laryngeal mask airway (LMA) or cuffed endotracheal tube (cETT) during placement of an esophagogastroduodenoscopy (EGD) probe during an EGD in the pediatric population.

Official Title
-----------------
The Effect of EGD Probe Insertion on the Intracuff Pressure of the Laryngeal Mask Airway or Cuffed Endotracheal Tube in Children

Conditions
-----------------
Esophagogastroduodensocopy (EGD) Procedure

Intervention / Treatment
-----------------
* Device: Cuffed ETT
* Device: Cuffed LMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from 0-18 years old having EGD procedure with a LMA or cuffed ETT. Exclusion Criteria: Patients with a history of tracheomalacia, bronchomalacia or any other airway issues.

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 |
| --- | --- |
| Cuffed ETT<br>Airway secured using a cuffed endotracheal tube. | Device: Cuffed ETT<br>* Cuffed endotracheal tube.<br>|
| LMA 2<br>Airway secured using a size 2 laryngeal mask airway. | Device: Cuffed LMA<br>* Cuffed laryngeal mask airway.<br>|
| LMA 2.5<br>Airway secured using a size 2.5 laryngeal mask airway. | Device: Cuffed LMA<br>* Cuffed laryngeal mask airway.<br>|
| LMA 3<br>Airway secured using a size 3 laryngeal mask airway. | Device: Cuffed LMA<br>* Cuffed laryngeal mask airway.<br>|
| LMA 4<br>Airway secured using a size 4 laryngeal mask airway. | Device: Cuffed LMA<br>* Cuffed laryngeal mask airway.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracuff Pressures During Probe Insertion | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion. | At time of EGD probe insertion | 
| Intracuff Pressure With Probe in Place | Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place. | At time of EGD while probe is in place | 
| Intracuff Pressure After Probe Removal | Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed. | Immediately after probe removal |
Evaluation of an Interventional Module to Assist Physicians Introducing ACP to Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients

Detailed Description
-----------------
Investigators hypothesize that compared to ACP brochure alone, educational module plus ACP brochure is effective in assisting the physicians to introduce ACP to the patients and completion of AD documentation

Official Title
-----------------
National Taiwan University Hospital,Taiwan (R.O.C)

Conditions
-----------------
Cancer Patients

Intervention / Treatment
-----------------
* Other: For interventional module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria and Exclusion Criteria Inclusion Criteria Older than 20-years-old Diagnosed with cancer Have not signed any form of AD or DNR Exclusion Criteria Under 20-years-old Can not speak or listen, difficult communication Signed AD or DNR

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Shared decision making (SDM) process through Advance Care Planning (ACP) consultation with cancer patients
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A had watching educational module plus ACP brochure | Other: For interventional module<br>* Using vedio to assist physicians introducing advance care planning to cancer patients<br>|
| Active Comparator: Group B<br>Group B ACP brochure only | Other: For interventional module<br>* Using vedio to assist physicians introducing advance care planning to cancer patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sign DNR (Do-Not-Resuscitate) | After intervention cancer patients willing sing DNR | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion AD(Advance directive) documentation | After intervention cancer patients completion of a new AD documentation | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer patients, ACP brochure, Interventional Module, Advance directive
Endothelialized ePTFE Graft by Nanobiotechnology

Study Overview
=================
Brief Summary
-----------------
The replacement of autologous blood vessels by artificial grafts is urgently needed in clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most clinically used artificial blood vessels because of its chemical and mechanical stability. But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts have a high failure rate of 40% in three years in vivo because of the functional lack of an intact endothelial cell layer. Here we developed a two-step modification including chemical etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg. cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE grafts. Functional peptide immobilization significantly increased the adherence and growth of HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were demonstrated by SEM and histological analysis. These preliminary data showed the potential to grow an intact endothelial layer to improve the patency rate of the modified ePTFE grafts.

Official Title
-----------------
Endothelialized ePTFE Graft by Nanobiotechnology

Conditions
-----------------
The Apparatus for Processing the Tubular Graft Modification Will be Designed and Evaluated., The On-site Capturing of the Endothelial (Progenitor) Cells by Peptide-mediated Selective Adhesion in Vitro and in Vivo Will Also be Elucidated., The Patency Rate of ITRI-made Artificial Blood Vessels Will be Evaluated by the Porcine Animal Model.

Participation Criteria
=================
Eligibility Criteria
-----------------
Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation) Times - sampled 20   40ml / time, 2 to 3 times / month

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| EPCs<br>No proliferation and no differentiation on the ePTFEs | |
| Modified ePTFE<br>EPCs adherence, proliferation and differentiation on the ePTFEs. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolate and expand EPCs from peripheral blood | Obtained from the peripheral blood leukocyte thick liquid (Hsinchu Blood Center, Taiwan Blood Services Fundation) | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Expanded polytetrafluoroethylene( ePTFE)