linjc16/ctgov huggingface dataset:
Chemotherapy of NSCLC With or Without Icotinib

Study Overview
=================
Brief Summary
-----------------
Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.

Official Title
-----------------
Icotinib as Maintenance Treatment After Chemotherapy for Patients Undergoing Resection of EGRF Mutation-positive Non-small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing completely resection of EGRF mutation-positive NSCLC Staging ⅠB (with high risk factor) to ⅢA PS = 0 or 1 Adequate hematological, biochemical and organ functions Exclusion Criteria: Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Chemotherapy<br>patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle). | |
| Experimental: Chemotherapy & Icotinib<br>patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).Two weeks after chemotherapy completed, patients assigned to the consolidation therapy group began oral icotinib treatment (125 mg, thrice daily). Icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity. | Drug: Icotinib<br>* Patients in experimental group will receive oral Icotinib for 4-8months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Effects |  | duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years |
Computer Modeling With Reconstruction of Maxillofacial Skeleton

Study Overview
=================
Brief Summary
-----------------
Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.

Detailed Description
-----------------
The concept of open reduction and internal fixation of facial fractures is well accepted. However, there are situations in which an accurate reduction and restoration of facial symmetry is challenging. In these more difficult cases, the PI uses computer aided design/modeling software as well as intra-operative computer aided surgical navigation systems to assist with repair of these complex injuries. A retrospective review of these cases has not previously been performed.

Official Title
-----------------
Is Computer Modeling and Intra-Operative Navigation Helpful With Reconstruction of the Maxillofacial Skeleton?

Conditions
-----------------
Maxillofacial Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: specific complex maxillofacial trauma Exclusion Criteria: must meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 50 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
computer aided design, maxillofacial fracture, orbital design
Dyslipidemia in Type 2 Diabetes (0767-034)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the lipid-altering effects of MK0767, glipizide, and pioglitazone after 12 weeks of treatment. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Dyslipidemia, Diabetes Mellitus, Type II

Intervention / Treatment
-----------------
* Drug: MK0767


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and non-pregnant females Age greater than or equal to 21 years Stop current diabetes therapy (if applicable) Stop current statin therapy (if applicable) Exclusion Criteria: History of type 1 diabetes mellitus or ketoacidosis who are currently being treated with insulin Patients on a weight loss program with ongoing weight loss, or starting an intensive exercise program within the last four weeks Patients requiring treatment with corticosteroids for more than 14 consecutive days Patients taking warfarin or warfarin-like anti-coagulants Patients undergoing surgery within 30 days of Visit 1 Patients with Hepatitis B, Hepatitis C, active liver or gallbladder disease Patients with history of pancreatitis or uncontrolled high blood pressure

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0767|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
West Virginia WISEWOMAN Focus Groups

Study Overview
=================
Brief Summary
-----------------
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Official Title
-----------------
West Virginia WISEWOMAN Focus Groups

Conditions
-----------------
CVD Risk

Intervention / Treatment
-----------------
* Behavioral: Women's health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NBCCEDP Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Women's health|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children

Study Overview
=================
Brief Summary
-----------------
Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children.

Detailed Description
-----------------
The Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children that were treated with closed or open reduction.

Official Title
-----------------
Multi-center Study on Surgical Treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children

Conditions
-----------------
Lateral Condyle Fractures,Humerus,JakobⅡ Classification,Reduction

Intervention / Treatment
-----------------
* Procedure: Closed reduction
* Procedure: Open reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with fractures that met these criteria, underwent definitive surgery and had complete clinical and radiographic follow up until fracture union at either institution were included in this study. Exclusion Criteria: Pathologic fractures, and fractures in patients with osteogenesis imperfecta, neuromuscular disorders or any systemic disease that was associated with a predisposition to fractures or altered fracture healing were excluded.

Ages Eligible for Study
-----------------
Maximum Age: 14 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 |
| --- | --- |
| Closed reduction<br>The children were treated with closed reduction. | Procedure: Closed reduction<br>* The children were treated with closed reduction.<br>|
| Open reduction<br>The children were treated with open reduction. | Procedure: Open reduction<br>* The children were treated with Open reduction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic union | Radiographic union in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children. | Up to 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture displacement | Fracture displacement in surgical treatment for the Displaced JakobⅡ Classification Humerus Lateral Condylar Fractures in Children. | Up to 12 weeks. |
Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.

Official Title
-----------------
Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials

Conditions
-----------------
Peripheral Arterial Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient randomized, treated and alive at the end of the phase I-II study participation, irrespective of their treatment group, Who signed the TALISMAN survey informed consent (or for deceased patients, the informed consent was signed the legal representative/family member as per national regulations - except in countries where Ethics Committee approval only is required for retrospective data collection). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 from phase I-II studies<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Deaths | Including all causes of deaths | From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake | 
| Incidence of safety events of interest | Safety events of interest when gene therapy is used i.e. development of any new/recurrent cancer, immunogenicity reactions | From the end of their participation in the phase I-II study until 36 months (+/- 3 months) after their first study drug intake |
Change of Nasalance After Tonsillectomy in Thai Adult

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the change of nasalance after tonsillectomy in Thai adults.

Official Title
-----------------
Change of Nasalance After Tonsillectomy in Thai Adult

Conditions
-----------------
Voice Quality, Tonsillectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thai adults age over 18 years who were perform bilateral tonsillectomy The pathological are not malignancy Exclusion Criteria: Craniofacial anomalies Neurological problems History of Peritonsillar abscess Performed other operation beside tonsillectomy Can't read Thais Visual problem that effect reading Nasal disease that cause nasal obstruction

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?
-----------------
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
-----------------
tonsillectomy, nasalance, tonsil volume, Thai, adult
Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy

Study Overview
=================
Brief Summary
-----------------
Traditionally the watertightness of urethrovesical anastomosis after robotic radical prostatectomy is controlled by cystogram. However, clinical observations and one previous study showed that patients with anastomotic leakage have red coloured urine. If the investigators can verify this finding, the most of the cystograms can be avoided. In this study the investigators estimate urine colour after cystogram and take a picture from urine collecting pag. Later on the pictures are digitally analyzed and compared to cystogram finding.

Official Title
-----------------
Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy

Conditions
-----------------
Prostatic Neoplasm, Anastomosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous robotic radical prostatectomy Catheter removal visit Exclusion Criteria: No urine in urinary collecting bag

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Urine colour | correlation of urine colour to cystogram finding | 1 week |
Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To establish quantitative values of myocardial blood flow (MBF) in normal, healthy volunteers .

Detailed Description
-----------------
We seek to establish quantitative values of myocardial blood flow in 20 normal, healthy volunteers using our existing 2D PET camera (Positron Attrius) and invasively validated software package (HeartSee) in order to 1) establish institutional values for which clinical patients can be compared to and 2) add to the collective data of the scientific community. Values to be measured will be resting myocardial blood flow (MBF), stress MBF and coronary flow reserve.

Official Title
-----------------
Quantification of Myocardial Blood Flow by Positron Emission Tomography in Healthy Volunteers

Conditions
-----------------
Normal Healthy Volunteers Without Chronic Medical Conditions

Intervention / Treatment
-----------------
* Procedure: cardiac PET stress test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥18 and <40 years old Participants must be able to give informed consent. Ability to abstain from caffeine for 48 hours Exclusion Criteria: Any chronic cardiac disease or condition (e.g. hypertension, hyperlipidemia) Any chronic systemic disease or condition (e.g. diabetes, systemic lupus, rheumatoid arthritis) Tobacco use Family history in a first degree relative with clinical coronary artery disease (history of myocardial infarctio, percutaneous intervention or coronary artery bypass grafting) in men <55 years old or women <65 years old Severe claustrophobia Positive urine pregnancy test Inability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal volunteers<br>Normal, healthy volunteers with undergo cardiac PET stress testing. | Procedure: cardiac PET stress test<br>* Volunteers will undergo cardiac PET stress testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute myocardial blood flow at rest and stress in cc/min/g | resting and stress MBF are in units of cc/min/g | measured at the time of the cardiac PET stress scan |
Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use.

Detailed Description
-----------------
Symbicort Turbuhaler 30/60 Clinical Experience Investigation for treatment with Symbicort as maintenance therapy and as needed in response to symptoms

Official Title
-----------------
Symbicort Turbuhaler 30/60 Clinical Experience Investigation for Treatment With Symbicort as Maintenance Therapy and as Needed in Response to Symptoms

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symbicort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event incidence |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchial asthma, Symbicort Turbuhaler
Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
These laboratory trial studies the development and treatment of a mouse model for acute myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about cancer and how well patients will respond to treatment.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine the rate of engraftment of pediatric FMS-Like Tyrosine Kinase-3 (FLT3)-internal tandem duplication (ITD) acute myeloid leukemia (AML) samples in NOD scid gamma (NSG) mice. II. To determine the efficacy of treatment of FLT3-ITD xenografts with tyrosine kinase inhibitors. OUTLINE: Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry.

Official Title
-----------------
Development of Pediatric Acute Myeloid Leukemia Xenograft Models for the Testing of Targeted Therapeutic Agents

Conditions
-----------------
Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis
* Drug: quizartinib
* Drug: sorafenib tosylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cryopreserved human AML samples FLT3-ITD samples with high allelic ratios
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (xenograft models)<br>Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry. | Other: laboratory biomarker analysis<br>* Correlative studies<br>Drug: quizartinib<br>* Via gavage<br>* Other names: class III receptor tyrosine kinase inhibitor AC220;Drug: sorafenib tosylate<br>* Via gavage<br>* Other names: SFN;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment ratio of human AML cells to murine cells | We will measure total leukemic burden from harvested femurs, tibias, and spleen by quantitative flow cytometry, estimate engraftment, and describe 95% confidence intervals. The total AML cell count of the control and treatment cohorts will be compared using an analysis of variance (ANOVA) test. | Up to 9 months | 
| Efficacy of sorafenib or quizartinib to inhibit AML proliferation in vivo |  | Up to 9 months |