linjc16/ctgov huggingface dataset:
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The investigators will examine efficacy and toxicity of gefitinib in Korean patients with EGFR wild tumors diagnosed with direct sequence test.

Official Title
-----------------
A Phase II Trial of Gefitinib Monotherapy in Pretreated Patients With Advanced Non-small Cell Lung Cancer Not Harboring Active EGFR Mutations

Conditions
-----------------
Nonsmall Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: salvage iressa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven NSCLC Ineligibile for curative treatment (namely, stage IIIb or IV) History of one to three prior systemic chemotherapy tumors without active EGFR mutations (exon 19 deletion, L858R mutation in exon 21) At least one lesion that was unidimensionally measurable by computed tomography (by RECIST 1.1) 18 years old or older Performance status ECOG 0-2 Adequate organ function as evidenced by the following: Absolute neutrophil count > 1.0 x 109/L Platelets > 75 x 109/L Total bilirubin ≤ 1.5 UNL AST and/or ALT < 5 UNL Creatinine clearance ≥ 45mL/min Exclusion Criteria: Previous EGFR TKI therapy history Systemic anticancer therapy within the previous 3 weeks Other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer Other concurrent illness that would preclude study participation (severe heart disease) Other concurrent physical condition (e.g., infectious disease) that would preclude study participation Pregnant or nursing

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iressa for EGFR wild group<br>salvage Iressa therapy for patients with EGFR mutation negative NSCLC patients | Drug: salvage iressa<br>* Iressa 250mg per day until progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine disease control rate at 8 weeks will be 35% or higher in the the study group |  | 6 months after the enrollment of the last patients | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients who live longer than 6 months after enrollment |  | 6 months after the enrollment of the last patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gefitinib, EGFR mutation negative, NSCLC
Evaluation of Sores Treatment by Oxygenotherapy

Study Overview
=================
Brief Summary
-----------------
Patient with chronic wounds are selected to receive NATROX system ; it's a continous diffusion of oxygen therapy delivery system. This one is put on the wound during a consultation at the hospital and will be followed in home medical care. Every 2 days a nurse renew the application at home and patient recharge the system with oxygen every day. The complete treatment is prescribe for 4 weeks and at the end patient comes to hospital to have a consultation with the doctor.

Official Title
-----------------
Evaluation of Sores Treatment by Oxygenotherapy

Conditions
-----------------
Ulcer Venous

Intervention / Treatment
-----------------
* Device: system NATROX (device name)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years accepted to participate Patients followed in vascular medicine and entrusted to the home medical care for the bandages of chronic wounds with apathetic ulcers, not presenting of granulation tissue on their surface Exclusion Criteria: infected ulcers necrosed ulcers Arterial ulcers requiring a revascularisation. Ulcers whose surface is superior in 10x10 cm.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Each patient included receive the experimental device system NATROX during 3 to 4 weeks | Device: system NATROX (device name)<br>* system NATROX (device name) application on the wounds of lower limbs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients received the entire treatment (3 to 4 weeks of oxygenotherapy) in home medical care | Patients who have received the entire treatment. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients who can receive skin graft after the therapy | patient eligible to skin graft after the therapy indicate the success of the NATROX system | 1-2 month | 
| percentage of patient who stopper the treatment | number of patients who have to stop the treatment because of non tolerability among all included patient | 4 weeks |
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.

Official Title
-----------------
Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy

Conditions
-----------------
Cardiovascular Diseases, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
* Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years of age Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg Existing coronary heart disease and cholesterol > 4.0 mmol/l Exclusion Criteria: Uncontrolled diabetes Elevated liver function tests Elevated creatine kinase (ck) Triglycerides (tg) > 4.5 mmol/l Drug or alcohol dependency within 6 months prior to visit 1 Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study Woman of childbearing potential not using an acceptable method of birth control Women who are pregnant or breast feeding

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: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks|nan|
|Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in ldl-c at end-point after 6 weeks. |  |  |
Metabolic Viral Host Properties

Study Overview
=================
Brief Summary
-----------------
Patients' metabolic properties may affect their immune response. This study aims to assess the effect of hosts' metabolic properties to viral infection.

Detailed Description
-----------------
Blood samples were drawn from patients with Gaucher disease and healthy individuals, with and without HCV. Blood samples were tested for protein specific T cell proliferation, IFNg and IL-10 using ELISPOT assays, serum IFNg, IL-2, IL-6, IL-10 and IL-4 levels. FACS analysis was used for evaluation of lymphocytes subsets.

Conditions
-----------------
HCV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inform consent Exclusion Criteria: at patients request

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
Learning Effect of Computerized Balance Evaluation System

Study Overview
=================
Brief Summary
-----------------
Thirty healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, will be recorded. Postural sway and limits of stability parameters will evaluate with computerized balance evaluation system (BERTEC) for seven times .

Detailed Description
-----------------
Thirty healthy individuals will be participants of the study. Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass, will be recorded. Postural sway and limits of stability parameters will evaluate with computerized balance evaluation system (BERTEC) for seven times. Every seven evaluations will be repeated while participants in combination of the condition including eyes open, eyes closed, normal surface and perturbated surface.

Official Title
-----------------
Investigating the Learning Effect of Computerized Balance Evaluation System

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Want to participate Exclusion Criteria: Have passive joint limitation at extremities Surgery at last 5 year Systemic problems such as neurologic disorders, rheumatoid disorders… Another orthopedic anomalies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 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 individuals<br> | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance evaluation | Assessment of ability of protect the balance in conditions including eyes open, eyes closed, normal surface and perturbated surface. | Initially evaluation at first minute,5 minutes(mns) after the initially evaluation, 10 mns after initially evaluation,15 mns after initially evaluation,20 mns after initially evaluation,25 mns after initially evaluation,30 mns after initially evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postural Balance
The Hypotensive Effect of Propofol: an Observational Study

Study Overview
=================
Brief Summary
-----------------
Hypotension is a recognized frequent complication of induction of anesthesia. The intent of this research is to determine the incidence of hypotension in patients receiving anesthetic induction with propofol. This investigation seeks to examine how normal clinical practice or a real world understanding of the usual response to propofol affects hemodynamics without isolating or standardizing other variables. The current research concerns hypotension in normal clinical practice where variability exists. This project aims to gather information and data in an attempt to form a foundation upon which each of the other variables affecting blood pressure may be subsequently assessed.

Official Title
-----------------
The Hypotensive Effect of Propofol: an Observational Study of Hypotension With Anesthetic Induction by Propofol in the General Population Under Standard of Care Anesthesia

Conditions
-----------------
Hypotension, Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ASA 1-3 patients who are to receive propofol induction for general anesthesia Exclusion Criteria: Allergy to propofol ASA 4 and above

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 |
| --- | --- |
| Propofol Induction<br>All patients receiving propofol induction of anesthesia who are ASA 1-3 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The systolic, diastolic, and mean arterial pressure. | The systolic, diastolic, and mean arterial pressure will be measured every minute for twenty minutes. Blood pressure readings of Mean Arterial Pressure less than 65mmHg, Systolic Blood Pressure less than 80mmHg, or Diastolic Blood Pressure less than 40mmHg will be considered as hypotension. | Within first 20 minutes after anesthesia induction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, Induction, Hypotension, General population
Effects of Berry Nectars Sweetened With Inverted Sugar on Post-meal Blood Sugar

Study Overview
=================
Brief Summary
-----------------
Berries have been shown to improve postprandial glucose and insulin responses to sucrose. During processing and storage of berry products, sucrose is inverted to glucose and fructose. The effects of berries on the glycemic response induced by inverted sugar are not known. The purpose of this study is to determine whether berries are effective in lowering the postprandial glucose and insulin responses induced by inverted sugar.

Official Title
-----------------
Postprandial Glycemic Response to Berry Nectars Containing Inverted Sugar

Conditions
-----------------
Hyperglycemia, Postprandial

Intervention / Treatment
-----------------
* Dietary Supplement: Blackcurrant Nectar
* Dietary Supplement: Lingonberry Nectar
* Dietary Supplement: Reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 20-28 kg/m2 Normal fasting plasma glucose Exclusion Criteria: Smoking Diabetes or other chronic disease Antibiotic medication within the past 3 months Blood donation within the past month

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blackcurrant nectar<br>Contains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose | Dietary Supplement: Blackcurrant Nectar<br>* Consumption of a single dose (300 ml)<br>|
| Experimental: Lingonberry nectar<br>Contains 17.5 g glucose and 17.5 g fructose representing 35 g completely inverted sucrose | Dietary Supplement: Lingonberry Nectar<br>* Consumption of a single dose (300 ml)<br>|
| Active Comparator: Reference<br>Sugar control, contains 17.5 g glucose and 17.5 g fructose in water | Dietary Supplement: Reference<br>* Consumption of a single dose (300 ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose response | 0, 15, 30, 45, 60, 90, 120 minutes post-meal | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma insulin response | 0, 15, 30, 45, 60, 90, 120 minutes post-meal | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Berries, Blackcurrant (Ribes nigrum), Lingonberry (Vaccinium vitis-idaea), Sucrose, Inverted sugar, Postprandial glucose response, Postprandial insulin response
Olanzapine in the Treatment of Hair Pulling (Trichotillomania)

Study Overview
=================
Brief Summary
-----------------
Trichotillomania (TTM) or hair-pulling has been considered as part of the obsessive compulsive disorder (OCD) spectrum, although treatment with OCD medications has largely been unsuccessful. Tics/Tourrettes' Syndrome (TS) is a disorder, which appears to be related to TTM, but is treated with a different class of medications than used in OCD, namely antipsychotics such as olanzapine. This is a study of the safety and efficacy of olanzapine in the treatment of hair pulling.

Official Title
-----------------
A 12-Week, Double-Blind Trial of Olanzapine and Placebo in the Treatment of Trichotillomania

Conditions
-----------------
Trichotillomania

Intervention / Treatment
-----------------
* Drug: Olanzapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary DSM-IV trichotillomania; CGI-Severity ≥ 4 Exclusion Criteria: Any other Axis I primary diagnosis; CGI-S < 4; current comorbid: OCD, MDD, alcohol or substance abuse; lifetime hx of: schizophrenia, bipolar affective disorder or dementia; current pregnancy/lactation; current suicidality or homicidality; major medical problems or clinically unstable medical disease; hx of: seizures, stroke or head trauma; prior use of neuroleptics

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI)-Improvement Scale ≤ 2 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-Severity Scale, Mean change from baseline in: Yale-Brown Obsessive Compulsive Scale for TTM, the Massachusetts General Hospital Hair Pulling Scale |  |  |
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.

Official Title
-----------------
A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: oleoyl-estrone (MP 101)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be a male or female between the ages of 18 and 65 years, inclusive Female subjects must be either surgically sterile or at least 2 years postmenopausal Have a BMI of 27 - 38.9, inclusive Have a stable weight for the past 30 days per subject report Be otherwise healthy and have an acceptable medical history Have negative urinalysis test results for drugs of abuse and alcohol Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions Exhibit stable behavior patterns with regard to smoking and exercise Subject who has at least one factor of the metabolic syndrome Exclusion Criteria: Be pregnant or nursing Have taken exclusionary medication in the past 30 days Have any clinically significant abnormal laboratory test as determined by the investigator Have a clinically significant illness during the 30 days before enrollment Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer Have a previous diagnosis of diabetes Be otherwise unsuitable for the study, in the opinion of the investigator Have an allergy to safflower seeds or its byproducts (e.g., safflower oil) Have any postmenopausal bleeding within the last 6 months Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days Currently working night shifts Have a history of known multiple miscarriages

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oleoyl-estrone (MP 101)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the preliminary efficacy |  |  |