linjc16/ctgov huggingface dataset:
Observational Study on Treatment of Metastatic Colorectal Cancer and the Role of K-Ras

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the treatments received and outcomes of patients with metastatic colorectal cancer, what percentage of these patients have K-Ras mutation of the tumor, and to describe the costs of treatments. Information will also be collected regarding risk factors, variables among treatment centers and patients, and explorative analyses will be done to try to identify factors that impact prognosis and factors that predict tolerability and response to treatment.

Official Title
-----------------
Multicentered Observational Prospective Cohort Study on the Treatment of Metastatic Colorectal Cancer and the Role of Evaluating K-Ras

Conditions
-----------------
Metastatic Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis colorectal carcinoma Metastatic disease Signed informed consent Exclusion Criteria: Prior treatment of metastatic colorectal cancer Refusal or incapability of providing 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| metastatic colorectal cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients enrolled in a clinical trial |  | two years | 
| percentage of patients who undergo K-Ras mutation study |  | 2 years | 
| Percentage of patients with K-Ras mutation |  | 2 years |
Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Study Overview
=================
Brief Summary
-----------------
Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.

Official Title
-----------------
Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children

Conditions
-----------------
Status Asthmaticus

Intervention / Treatment
-----------------
* Drug: terbutaline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus Modified Pulmonary Index Score (MPIS) of greater than or equal to 12 Age between birth and 18 years old Exclusion Criteria: Pre-existing cardiac or pulmonary disease Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation) Hemodynamic or cardiovascular instability requiring inotropic support The patient meets one of the criteria for withdrawal from the study due to patient safety concerns

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

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

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 |
| --- |
|Drug: terbutaline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission |  |  | 
| To prospectively analyze the side effects of terbutaline |  |  |
AD01 Follow up Extension Visit

Study Overview
=================
Brief Summary
-----------------
Patients who were vaccinated with AFFITOPE AD01 during AFFiRiS001 will undergo a long-term follow-up period to get more information regarding the safety profile of AFFITOPE AD01.

Official Title
-----------------
Observational Follow-up Extension Study-visit to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS001 in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer´s Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver. Patients having participated in AFFiRiS 001 and AFF003 and having received ≥1 vaccination with AFFITOPE AD01 Availability of a partner/caregiver knowing the patient Exclusion Criteria: Patients having received no vaccination with AFFITOPE AD01 History of questionable compliance to visit schedule
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AD01with or without adjuvant<br>Patients who have received at least one immunization of AD01 with or without adjuvant during AFF001 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term tolerability and safety of AFFITOPE AD01 | retrospective assessment of safety data | One year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AD01 follow-up extension
the Influence of Tidal Volume to Lung Strain

Study Overview
=================
Brief Summary
-----------------
Measure the lung strain in different tidal volume in ADRS patients to find the relationship between tidal volume and lung strain and find the most suitable tidal volume for each patient.

Detailed Description
-----------------
Purpose:Find the relationship between tidal volume and lung strain in ARDS patients.Then find the most suitable tidal volume for each patient according to the dividing value. Methods:Measure the lung strain in the tidal volume of 6mL/kg,8mL/kg,10mL/kg and 12mL/kg in each ARDS patient. Hypothesis:With the increase of the tidal volume,the lung strain develops.In the patient with larger lung compliance,the strain of the group of conventional tidal volume is less than 0.27 and there is no obvious difference between the group of small tidal volume.

Official Title
-----------------
the Influence of Different Tidal Volume to Lung Strain of ARDS Patients

Conditions
-----------------
Critically Ill, Acute Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-85,gender is not limited Needing Invasive ventilation Fit the definition of ARDS in 2012 Berlin Definition Sign the paper of informed consent Exclusion Criteria: pregnancy and at the end stage of tumour the COPD patients less than 24h of mechanical ventilation more than 5 days of mechanical ventilation FiO2>80% presence of air leaks organ dysfunction and hemodynamic instability including in other research

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the strain in different tidal volume | Use the GE ventilator to measure the EELV and calculate the lung strain(lung strain = VT/EELV) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days mortality | Follow up to determine the mortality in 28 days after inclusion | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute respiratory distress syndrome, lung strain, small tidal volume
Safety Demonstration of Microneedle Insertion

Study Overview
=================
Brief Summary
-----------------
Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety in patients. An alternative drug and vaccine delivery method is the use of hollow microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a result, they are better received by patients and do not induce needle anxiety. As the investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel, the purpose of this study is to observe their biocompatibility and inertness.

Official Title
-----------------
Safety Demonstration of Microneedle Insertion

Conditions
-----------------
Allergic Reaction to Nickel

Intervention / Treatment
-----------------
* Device: Gold- or silver-coated, or uncoated nickel microneedles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven nickel allergy Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Nickel allergic<br>Participants have proven nickel allergy | Device: Gold- or silver-coated, or uncoated nickel microneedles<br>* The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reaction as measured by a contact dermatitis classification system | Allergic patch-test based grading will be done according to the Wilkinson DS et al 1970 reference. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microneedles, Biocompatibility, Allergy, Metal, Nickel, Contact dermatitis
Everolimus- Versus Biolimus-Eluting Stents in All-Comers

Study Overview
=================
Brief Summary
-----------------
This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.

Detailed Description
-----------------
A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The primary endpoint was a composite of death, myocardial infarction (MI) and target vessel revascularisation (TVR) at two-year follow-up.

Official Title
-----------------
Long-Term Comparison of Everolimus-Eluting and Biolimus-Eluting Stents in All-Comer Patients

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with at least one BES or EES for de novo stenosis Exclusion Criteria: patients with at least one non-study stent patients with both study stent patients with life expectancy < 3 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| everolimus-eluting stents (EES)<br>Second-generation everolimus-eluting stents (EES) have been shown to be superior to the first-generation paclitaxel eluting stents (PES) in terms of safety and efficacy. | |
| biolimus-eluting stents (BES)<br>Third generation biolimus-eluting stents (BES) have been shown to be superior to the PES and non inferior to first-generation sirolimus eluting stents in terms of safety and efficacy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Death, Myocardial Infarction and Target Vessel Revascularization | The primary outcome is the above mentioned composite of adverse events in order to measure their cumulative incidence (i.e. the rate of occurrence of such events in the study population over a predefined time periode). | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | up to 24 months | 
| Any Revascularization |  | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug-eluting coronary stent, percutaneous coronary intervention
Retrospective Postoperative ARDS Study at Vanderbilt University

Study Overview
=================
Brief Summary
-----------------
By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS.

Detailed Description
-----------------
Acute respiratory distress syndrome (ARDS) is a pulmonary disease process that affects post-surgical patients in the intensive care unit and leads to significant patient morbidity and mortality and hospital cost. Extensive research has been conducted in the diagnosis and treatment of ARDS. To date, however, very little research examining the effect of the operative course on the development of ARDS has been reported. By examining the intraoperative anesthetic characteristics of patients who developed ARDS postoperatively, we hope to identify variables which have a positive or negative association on the development of ARDS. Once identified, the variables can be confirmed by future studies and encourage change in clinical care to decrease the occurrence of ARDS in surgical patients.

Official Title
-----------------
Intraoperative Anesthetic Characteristics and the Development of ARDS

Conditions
-----------------
ARDS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS post-surgical ventilator Exclusion Criteria: rib fracture pneumonia sepsis

Ages Eligible for Study
-----------------
Minimum Age: 11 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 |
| --- | --- |
| 1<br>Control -- postoperative mechanical ventilation patients without ARDS | |
| 2<br>Cases -- postoperative mechanical ventilation patients with ARDS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARDS |  | data pulled from 10/2000 - 08/2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Acute respiratory distress syndrome, Adult respiratory distress syndrome, respiratory distress
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Detailed Description
-----------------
Kaposiform hemangioendothelioma (KHE) and tufted angiomas (TA) are rare vascular tumors, which are apparent predominantly in infancy or early childhood. Currently, no standard treatment regimens exist for KHE/TA. The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Official Title
-----------------
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma: a Single Arm Prospective Study

Conditions
-----------------
Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma

Intervention / Treatment
-----------------
* Drug: Tacrolimus ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA) Exclusion Criteria: Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients treated with Tacrolimus ointment<br> | Drug: Tacrolimus ointment<br>* topical application of tacrolimus for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in the size of the lesion | Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters. | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adverse events | using the measurement of ratio to evaluate the rate of adverse events of topical application of tacrolimus (such as ratio of Acne vulgaris, pruritis and rash etc.). | 2.5 years |
Myocardial Perfusion in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries. Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1) and after optimization of medical treatment four months later (Phase 2).

Detailed Description
-----------------
Early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated with an impairment in endothelium-dependent dilation of the coronary microvasculature, indicating that the pathophysiological consequences of atherosclerosis may extend into the coronary microcirculation. The investigators will evaluate three parameters of myocardial quantification with contrast Stress echocardiography and correlate with HbA1C levels.

Official Title
-----------------
Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.

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

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Normal echocardiogram Absence of obstructive epicardial coronary disease Exclusion Criteria: Obstructive coronary disease Heart valve disease COPD Cardiac Arrhythmias Cardiomyopathy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetes<br>Type 2 diabetes patients without obstructive coronary disease. Interventional group: lifestyle changes and treatment with metformin. | Drug: Metformin<br>* Metformin 850mg<br>* Other names: Glucophage;|
| No Intervention: Control<br>Control group - normal, healthy individuals. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial blood flow velocity, myocardial blood flow reserve |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Myocardial perfusion imaging, Heart diseases, Echocardiography, Endothelium