linjc16/ctgov huggingface dataset:
Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease

Study Overview
=================
Brief Summary
-----------------
A 15-gene lung signature was created to identify predictive and prognostic biomarkers for Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and low risk cohorts with significantly different survivals. Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater. The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.

Detailed Description
-----------------
Patients with early stage NSCLC will be consented prior to surgery so that any excess tissue collected during surgery can be collected in one of the three tissue formats (Fresh Frozen, FFPE, RNAlater) and sent to the Sponsor for testing.

Official Title
-----------------
Research and Development Study: Tissue Collection From Patients Who Are Undergoing Surgery for Non-Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC) Must have resectable disease and complete surgical resection planned Histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma NSCLC No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer Tumor specimen samples must be collected within 1 hour of surgery Patient must be at least 18 years of age Patient must sign and date an approved study consent form Exclusion Criteria: Patients with psychiatric or addictive disorders that would preclude obtaining study consent Informed consent obtained the same day as surgery Absence of histological diagnosis of lung cancer Known infectious disease History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue Collection, Lung Cancer, Non-Small Cell Lung Cancer, Early Stage Lung Cancer
Proton Beam Therapy for Unresectable Liver Metastasis

Study Overview
=================
Brief Summary
-----------------
The investigators performed the present study to evaluate the role of proton beam therapy for liver metastasis which is unresectable and unsuitable for radiofrequency ablation (RFA) in terms of local control and safety.

Official Title
-----------------
Proton Beam Radiotherapy for Unresectable Liver Metastasis: Prospective Phase II Trial

Conditions
-----------------
Local Control Rate, Side Effect

Intervention / Treatment
-----------------
* Radiation: PBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathologically diagnosed cancer patient confirmed liver metastasis via computed tomography (CT) or magnetic resonance imaging (MRI) or biopsy unresectable or unsuitable for RFA solitary liver metastasis or less than 3 metastatic lesions if the distance is less than 3 cm between metastatic lesions case discussed by surgeon, radiologist, and radiation oncologist Eastern cooperative oncology group performance status 0 to 2 optimal liver and renal function (Child-Pugh score 10 or less) informed consent agree to be contraceptive for the duration of the study and for the next 6 months Exclusion Criteria: uncontrolled ascites or hepatorenal syndrome status of pregnancy or breast-feeding less than 12 weeks of expected survival combined disease known to have high radiation side effects serious acute illness that is not treated other than liver disease

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
Interventional Model Description: Proton beam radiotherapy : 5 fractions of 12 GyRBE or 10 fractions of 7 GyRBE
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBT arm<br> | Radiation: PBT<br>* Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month local control rate | local control rate (except local progression) | at the point of 6 month follow-up after proton beam therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | overall survival rate | at the point of 2 year follow-up after proton beam therapy | 
| 6 month side effect | side effect | at the point of 6 month follow-up after proton beam therapy |
Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of patients with multiple myeloma stage III with bone lesions related to Cancer.

Official Title
-----------------
Open-label Study, to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Bone Lesions Secondary to Multiple Myeloma.

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

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. Confirmed Diagnosis of Durie-Salmon Stage III Multiple Myeloma, with the following clinical characteristics: A. At least 1 osteolytic bone lesion demonstrable in a conventional X-ray film. B. The patient will have to be receiving treatment for primary neoplasia, at the time of the start of this trial. - Ambulatory patients aged ≥ 18 years. Exclusion Criteria: Treatment with bisphosphonates in any moment during the last 12 months before visit 1. except for those patients that received only one dosis of bisphosphonates for any indication and when the administration has been 14 days before or older. Patients with an absence of a bone lesion clearly related to the primary cancer, and that is detectable in a conventional bone X-ray (simple film). Patients with a Serum Calcium level of ≤ 8 g/dl (2.00 mmol/L) or ≥ 12 mg/dL (3.00 mmol/L) Treatment with other investigational drugs within 30 days before inclusion in the trial. Serum Creatinine levels of > 3 mg/dl (265 umol/L). Total Billirubin levels of > 2.5 mg/dl (43 umol/L) Patients with a heart condition that has the NYHA criteria for a Grade III and IV functional class Other protocol-defined inclusion/exclusion criteria may apply.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic acid|nan|

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
-----------------
Bone Lesions, Multiple Myeloma, zoledronic acid
Epidemiologic Analysis for the Prevalence of Chronic Airway Diseases in Old Population

Study Overview
=================
Brief Summary
-----------------
Aim: To evaluate the spirometric data and the prevalence of chronic airway disease in old population (> 60 yrs) in Korea. List to do History taking physical examination Routine blood test All spirometric data In subgroup: further evaluation of allergic airway disease

Official Title
-----------------
Epidemiologic Analysis for the Prevalence of Chronic Airway Diseases in Old Population in Korea

Conditions
-----------------
General Population, Spirometric Data, Medical Records

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 60 yrs olds no known specific respiratory diseases Exclusion Criteria: taking any medication for respiratory diseases History of diagnosis as a respiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
Biomagnetic Signals of Intestinal Ischemia

Study Overview
=================
Brief Summary
-----------------
The lack of blood flow to the small intestine causes mesenteric ischemia. Using a Superconducting QUantum Interference Device (SQUID) which measures the magnetic field of the small intestine, we are hoping to identify abnormalities without surgical intervention.

Detailed Description
-----------------
The electrical activity of the small intestine may contain important information that will help us diagnose gastrointestinal diseases. The major impediment to reducing mortality of mesenteric ischemia is the lack of a noninvasive diagnostic test that identifies the syndrome before extensive necrosis occurs. Mesenteric ischemia is caused by the lack of blood flow to the intestine. The Superconducting QUantum Interference Device (SQUID) measures the magnetic field of the intestinal smooth muscle. By comparing normal smooth muscle and that of patients with mesenteric ischemia, we hope to identify abnormal disease states without surgery.

Official Title
-----------------
Biomagnetic Signals of Intestinal Ischemia II

Conditions
-----------------
Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal Subjects and those diagnosed with mesenteric ischemia Exclusion Criteria: Subjects who report a tendency toward claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Good blood flow<br>Group with normal blood flow to small intestine | |
| Poor blood flow<br>Group with partial ischemia to small intestine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To observe a difference in the magnetic activity between normal and diseased smooth muscle |  | 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Supply, Mesentery
The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)

Study Overview
=================
Brief Summary
-----------------
Systemic lupus erythematosus (SLE) is a chronic multi-system inflammatory autoimmune disease. Vitamin D has potent immunomodulatory properties that have promoted its potential use in the treatment of autoimmune conditions, including SLE. We assessed vitamin D status in SLE patients and determined alterations in inflammatory, hemostatic markers as well as disease activity before and after vitamin D supplementation. 248 SLE patients were enrolled in this randomized placebo-controlled study. Patients were randomized 2:1 to receive either oral cholecalciferol 2000 IU/day or placebo for 12 months. Outcome measures included assessment of alterations in levels of IL-1, IL-6, IL-18, TNF-alpha, Anti-dsDNA, ANA, fibrinogen and von Willebrand Factor (vWF) before and after 12 months supplementation. Disease activity was measured by the SLEDAI. Vitamin D levels were measured by Liaison immunoassay; (normal 30-100ng/ml). Serum levels between 10-30 ng/ml were classified as vitamin D insufficiency, and levels < 10 ng/ml as vitamin D deficiency.The mean 25(OH) D level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: vitamin D 25(OH)D
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal women and males of the same body mass index and ethnicity Exclusion Criteria: Patients with: other inflammatory disorders, hepatic disease renal disease malignant disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br> | Drug: vitamin D 25(OH)D<br>* 2000IU/day for 12 months<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 2000IU/day of vitamin D will be compared to similar looking tablets of placebo for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in SLE disease activity |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SLE, disease activity markers, vitamin D
Short Term Group Therapy for Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
Assessing Anxiety in patient suffering from anxiety disorders (NOT OCD or PTSD)before and after group therapy

Conditions
-----------------
Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: Group therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anxiety disorder (other than OCD or PTSD) Eligibility to participate in group therapy Exclusion Criteria: OCD PTSD Suicidal thoughts Psychotic state Severe hostile personality disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Group therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension

Official Title
-----------------
An 8-week Multi-center, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren (150 mg and 300 mg) Administered Alone and in Combination With Valsartan (160 mg and 320 mg) in Patients With Hypertension

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

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension Patients who are eligible and able to participate in the study Exclusion Criteria Severe hypertension History or evidence of a secondary form of hypertension History of Hypertensive encephalopathy or cerebrovascular accident Other protocol-defined exclusion criteria may apply.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after week 8 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after week 8 |  |  | 
| Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks |  |  | 
| Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks |  |  | 
| Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Aliskiren
A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of fluconazole versus placebo in preventing the development of active coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4 lymphocyte counts < 250 cells/mm3 who are living in the coccidioidal endemic area.

Detailed Description
-----------------
Patients are randomized to receive either fluconazole or placebo daily.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study of Fluconazole in the Prevention of Active Coccidioidomycosis and Other Systemic Fungal Infections in HIV-Infected Patients Living in the Coccidioidal Endemic Area

Conditions
-----------------
Mycoses, HIV Infections, Coccidioidomycosis

Intervention / Treatment
-----------------
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection. CD4 count < 250 cells/mm3. No active coccidioidomycosis or other fungal disease requiring systemic antifungal therapy. Residence in area considered to be endemic for Coccidioides immitis. Consent of parent or guardian if under legal age of consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Unable to take oral medication. Positive serum cryptococcal antigen. Concurrent Medication: Excluded: Systemic antifungal therapy. Patients with the following prior conditions are excluded: History of hypersensitivity to azole or imidazole compounds. Prior Medication: Excluded: Systemic antifungal agents within 2 weeks prior to study entry.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

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

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
-----------------
Mycoses, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Coccidioidomycosis
Evaluating the Clinical Efficacy and Safety of Colflex

Study Overview
=================
Brief Summary
-----------------
This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.

Official Title
-----------------
Evaluating the Clinical Efficacy and Safety of Colfelx

Conditions
-----------------
Personal Satisfaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: availability to give written consent age 18-60, men and women (who are not pregnant or nursing) people in good health able to follow protocol must be experiencing a sore throat or cold at least once a year Exclusion Criteria: smokers liver and kidney disease inflammatory bowel disease pancreatitis gallbladder or biliary disease neurolgical/psychological disease bleeding disorders platelet abnormatilies gastrointestinal disorders that could interfere with fat absorption serum triglycerides > 500 mg/dL and/or total cholesterol > 300 mg/dL hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 Hg BMI >30 consume or planned to consume anticoagulant, hypertension, or lipid lowering medications reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence reported use of experimental medication within 1 month prior to the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Frequency and duration of colds/sore throats | Using a self-reported scale to assess the frequency and during of colds and sore throats at screening, and at baseline and endpoint of treatments | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of oral pathogenic bacteria | A mouth swab will be taken to measure pathogenic bacteria (Straph, Strep), and a mouth swab will be used for the BANA test to test for periodontal disease causing bacteria. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral health, Mouth health, Halitosis, Oral bacteria, Sore throat, Colds