linjc16/ctgov huggingface dataset:
The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.

Official Title
-----------------
The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass

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

Intervention / Treatment
-----------------
* Drug: Exendin 9,39
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of > 110 mg/dL Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB). Exclusion Criteria: Subjects taking thiazolidinediones Subjects with active systemic illness Subjects with active microvascular or macrovascular complications of their diabetes For female subject: positive pregnancy test at the time of enrollment in study

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exendin 9,39<br>Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes. | Drug: Exendin 9,39<br>* Exendin 9,39 is a competitive antagonist of endogenous GLP-1.<br>|
| Placebo Comparator: Placebo<br>Subjects randomized to this arm will receive a saline infusion for 360 minutes. | Drug: Placebo<br>* A saline infusion will be given to match the study drug infusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB) | The total disposition index equals the product of insulin secretion and insulin sensitivity. | baseline, 4 weeks post-operative intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Bypass, bariatric surgery, glucose metabolism
Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.

Official Title
-----------------
Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: FreeStyle Navigator Continuous Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History consistent with type 1 diabetes At least 18 years of age Available and capable of following the protocol instructions provided by the healthcare professional Signed and dated informed consent form Exclusion Criteria: Pregnancy Type 2, gestational, or secondary diabetes Known allergy to medical grade adhesives Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin Seizure disorder Myocardial ischemia History of stroke Severe hypoglycemia unawareness Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety

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 |
| --- | --- |
| Diabetes<br> | Device: FreeStyle Navigator Continuous Glucose Monitoring System<br>* Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study.<br>|

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
-----------------
Continuous glucose monitoring, Accuracy, Continuous glucose-error grid analysis
Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
The objectives of the PROTECT study are: To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE). To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE. To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE. To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE. To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute symptomatic Pulmonary Embolism (PE) confirmed by: CT pulmonary angiography positive for PE Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria) V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis. Exclusion Criteria: Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance < 30 ml/min). Informed consent not obtained. Pregnancy. Life expectancy of less than 3 months. Hemodynamic unstability defined as SBP < 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation. Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode. Participation in another clinical trial for treatment of PE.

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 |
| --- | --- |
| Stable PE patients<br>Hemodynamically stable patients with acute symptomatic pulmonary embolism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome considered will be death by any cause in the month following diagnosis. |  | 30 days after PE diagnosis |
Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

Study Overview
=================
Brief Summary
-----------------
This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).

Official Title
-----------------
A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion

Conditions
-----------------
Arterial Occlusive Diseases, Peripheral Vascular Diseases, Thrombosis

Intervention / Treatment
-----------------
* Drug: Alfimeprase


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days) Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow) Age 18 or above Able to consent Able to follow up

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients

Study Overview
=================
Brief Summary
-----------------
The aim of our study was to assess the effectiveness of contemporary knee arthroplasty in working-age patients (< 65 years) by conducting a prospective cohort study with 2-year follow up. Outcomes were measured comprehensively using various patient-reported outcome measures (PROMs) to provide information on the effect of knee arthroplasty on pain, satisfaction, physical activity, activities of daily living, and quality of life.

Official Title
-----------------
Effectiveness of Contemporary Knee Arthroplasty in Working-age Patients: a Prospective Study With 2-year Follow-up

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 65 or less and Scheduled for either TKA or unicondylar knee arthroplasty (UKA) Exclusion Criteria: rheumatoid arthritis or other inflammatory diseases unwilling to provide informed consent physical, mental, or neurological conditions that could comprise the patient´s ability and compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson's disease, multiple sclerosis (MS), etc.) known sensitivity to materials in the devices.

Ages Eligible for Study
-----------------
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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: working age patients<br>Prospective cohort of 250 patients. | Other: Knee arthroplasty<br>* Effectiveness of knee arthroplasty surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of contemporary knee arthroplasty in working-age patients | PROMs | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee arthroplasty, working-age, patient related outcome measures
Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Detailed Description
-----------------
Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Official Title
-----------------
Analysis of the Types and Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients at Erasto Gaertner Hospital, Curitiba, Brazil.

Conditions
-----------------
Lung Neoplasms, KRAS Gene Mutation, EGFR Gene Mutation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brazilian patients with metastatic non-small cell lung cancer. Exclusion Criteria: Small cell lung cancer and non-metastatic patients.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EGRF mutation status | results of presence or absence in all tumor samples (FFPE) obtained from patients | 3 years | 
| KRAS mutation status | results of presence or absence in all tumor samples (FFPE) obtained from patients | 3 years |
Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

Detailed Description
-----------------
Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Official Title
-----------------
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Radiotherapy in Breast Cancer With One to Three Positive Nodes

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: radiation
* Radiation: no radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ipsilateral histologically confirmed invasive breast cancer Undergone total mastectomy and axillary dissection T1-2 and one to three axillary lymph nodes positive A minimum of 10 axillary nodes dissected Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation Written,informed consent Exclusion Criteria: Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region Previous or concurrent malignant other than non-melanomatous skin cancer Unable or unwilling to give informed consent

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

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

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 |
| --- | --- |
| Experimental: radiotherapy<br>radiotherapy of 50Gy/25/f/5w to the ipsilateral chest wall and supraclavicular region | Radiation: radiation<br>* radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region<br>|
| Active Comparator: no radiotherapy<br>no radiotherapy | Radiation: no radiation<br>* no radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| loco-regional recurrence |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, mastectomy, one to three positive nodes, radiotherapy
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.

Conditions
-----------------
Diabetic Macula Edema

Intervention / Treatment
-----------------
* Procedure: Photocoagulation
* Drug: Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable medication for the management of diabetes within 3 months visual impairment due to focal or diffuse diabetic macula edema decreased vision due to diabetic macula edema and not other causes Exclusion Criteria: concomitant conditions in the study eye that could prevent the improvement in VA on the study active intraocular inflammation or infection in either eye uncontrolled glaucoma in either eye treatment with antiangiogenic drugs in the study eye within 3 months history of stroke and uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Ranibizumab with Photocoagulation<br> | Procedure: Photocoagulation<br>* Photocoagulation include focal/grid laser and/or panretinal photocoagulation<br>Drug: Ranibizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| best corrected visual acuity | Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed. | every month, up to 36 months |
Protocol to Obtain Blood and Bone Marrow Samples for Myeloma Research

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect a blood or bone marrow sample from patients with multiple myeloma and from volunteers without myeloma.

Detailed Description
-----------------
The blood and bone marrow samples will be used in the laboratory to perform focused studies on multiple myeloma.

Official Title
-----------------
Evaluation of Immune Parameters and Function in Multiple Myeloma Patients and Healthy Individuals' Blood and Marrow Samples

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant population is multiple myeloma patients over the age of 18 who are undergoing a scheduled bone marrow collection and/or blood drawing procedure as part of their routine treatment or follow up, and healthy volunteers over the age of 18 who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient. Exclusion Criteria: Patients, who in the opinion of their physician, would be adversely affected by removal of an extra15ml of blood and /or an extra 10ml of bone marrow.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Healthy volunteers who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient. | |
| Patients with multiple myeloma<br>Patients undergoing routine blood draw and bone marrow aspirates as part of their ongoing follow-up care for myeloma at the Norris Cotton Cancer Center of DHMC. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer cell response to molecular testing of killing cell parts. | This myeloma specific killing may help identify mechanisms, in vitro, of killing myeloma cells for the future use in clinical trials. | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma