linjc16/ctgov huggingface dataset:
Study Evaluating Isovorin in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.

Official Title
-----------------
Post-Approved Phase III Study of 1-LV/5FU Therapy

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Drug: Isovorin
* Drug: UFT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dukes C, Cure A colon cancer diagnosed histologically or cytologically Normal organ function of bone marrow, heart, liver and kidney Age 20-75 Other inclusion applies Exclusion Criteria: Serious bone marrow suppression, infection, heart disease or complication Familial adenomatous polyposis or hereditary nonpolyposis Pregnant or breastfeeding women Other exclusion applies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: Isovorin|nan|
|Drug: UFT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival time, survival time, safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon Cancer
Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to identify and validate predictive markers of anakinra responsiveness in RA patients by a transcriptomic approach. Patients with active RA (ACR criteria) were given subcutaneous anakinra (100mg/d) 3 associated with metotrexate. Anakinra efficacy was evaluated at week 12, using the EULAR response criteria. A blood sample was collected just before the onset of anakinra treatment and total RNAs were extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high density on nylon membranes. Data were normalized and filtered to allow the comparison between RNA samples. Statistical analyses were performed with the R software and hierarchical clustering was performed with the Cluster and Tree View softwares.

Official Title
-----------------
Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Response to anakinra associated with methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is age 18 years old or older Satisfies the 1987 American College of Rheumatology revised criteria for Rheumatoid arthritis Has active disease at the time of randomization as indicated by a DAS28> 5.1 Has a disease at least refractory to DMARDs whose methotrexate or leflunomide Is capable of understanding and signing an informed consent form Agrees to use a medically accepted form of contraception during the study Exclusion Criteria: Is pregnant or breast-feeding or without contraception Has significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the study, uncompensated congestive heart failure, significant active infection or any underlying diseases that could predispose subjects to infections (whose tuberculosis) Has renal disease (creatinin clearance level < 30 ml/min) Has allergy to anakinra Has leukopenia (white blood cells < 1.5 x 109 /l

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

| Intervention/Treatment |
| --- |
|Drug: Response to anakinra associated with methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auto-antibody level |  | One year |
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to conduct a pilot test of a new tracer in healthy human volunteers to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). The same radiopharmaceutical will then be tested in cancer patients.

Official Title
-----------------
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2

Conditions
-----------------
Breast Cancer, Non-Small-Cell Lung Cancer, Glioblastoma, Other Cancers

Intervention / Treatment
-----------------
* Drug: FPPRGD2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers: Must be 18 years of age or older. Must have no known medical problems and have had a full medical exam within 6 months of the study. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained. Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose. Cancer subjects: Greater than 18 years-old at the time of radiotracer administration Provides written informed consent Diagnosed with advanced NSCLC, breast cancer, pancreatic cancer and GBM; patients will undergo bevacizumab or Cyberknife therapy Able to remain still for duration of each imaging procedure (about one hour) Exclusion Criteria Less than 18 years-old at the time of radiotracer administration Pregnant or nursing

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

| Intervention/Treatment |
| --- |
|Drug: FPPRGD2|radiopharmaceutical administered for imaging, up to 14 mCi i.v.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of primary tumor to treatment after six weeks, based on each of 1. change in PET uptake from baseline 2. change in CT tumor size from baseline 3. PET EORTC response criteria 4. CT RECIST response criteria | We expect a 60-70% response rate to treatment. 20 subjects will provide 95% power at 5% error to detect a difference in SUV level between groups as small as two standard deviations. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
Dermacyd Delicata Pocket BR - Photo Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Delicata Pocket BR.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Delicata Pocket BR.

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

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin II and III Integral skin test in the region Exclusion Criteria: Lactation or gestation; Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection Diseases which can cause immunity decrease, such as HIV, diabetes Use of drug photosensitizer History of sensitivity or irritation for topic products Active cutaneous disease which can change the study results History or photodermatosis active Family or personal antecedent of cutaneous photoinduced neoplasias Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium Intense solar exposure in the study area Use of new drugs or cosmetics during the study 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
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactic acid (Dermacid)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type. |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hygiene
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.

Official Title
-----------------
An Open-labelled, Randomised, Parallel Group, Multicentre, Multinational Efficacy and Safety Comparison of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 as Meal Related Insulin in a Twice Daily Regimen in Type 1 and Type 2 Diabetic Subjects

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: biphasic human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months Current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months Body mass index (BMI) below or equal to 35.0 kg/m^2 HbA1c below or equal to 11.0% Exclusion Criteria: Total daily insulin dose at least 1.4 IU/kg Treatment with oral hypoglycaemic agents within the month prior to inclusion Recurrent severe hypoglycaemia (as judged by the investigator) Active proliferative retinopathy Impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl) History of pancreatitis

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 |
| --- | --- |
| Experimental: A<br> | Drug: biphasic insulin aspart<br>* Injected subcutaneously (under the skin) twice daily<br>|
| Active Comparator: B<br> | Drug: biphasic human insulin<br>* Injected subcutaneously (under the skin) twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin A1c) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8-point blood glucose profiles |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Occurrence of adverse events |  |  |
The Role of Clinical Pharmacist in Management of DDIs in CHF Patients

Study Overview
=================
Brief Summary
-----------------
Drug-drug interactions (DDIs) are common in patients with chronic heart failure (CHF) and their incidence increases with the number of drugs that the patients are prescribed for treatment of their condition. Data bases often detect DDIs that are of high clinical relevance. The investigators have performed this study in order to detect clinically significant DDIs and to diminish their occurrence by sending notification about DDIs to attending physician.

Official Title
-----------------
The Role of Clinical Pharmacist's Intervention in Management of Clinically Relevant Drug-drug Interactions in Patients With Chronic Heart Failure

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Advice on DDIs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted with diagnosis of CHF I50.0 - I50.9 and I11.0 - I11.9 (ICD-10) patients treated with at least two drugs Exclusion Criteria: Patients admitted to other conditions
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advice on DDIs<br>Attending physician will be randomly assigned to intervention arm care as usual; in the intervention arm, he/she will receive advice about DDIs between medications prescribed to patients on top of general heart failure advice. | Behavioral: Advice on DDIs<br> <br> |
| No Intervention: General advice<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the difference in frequency and severity of clinically significant DDIs in control arm and interventional arm between admission and discharge | We will measure the difference in clinically significant DDIs between admission and discharge. The doctors in control group will not receive the advice about DDIs between drugs prescribed to patient, while the doctors in interventional group will. With this will will assess the impact of the advice in the occurence of DDIs between admission and discharge for both groups. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic heart failure, drug-drug interactions, pharmacist's intervention
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.

Official Title
-----------------
Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Colchicine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with a diagnosis of acute coronary syndrome who are > 18 years old and who do not have any contraindication to colchicine. Exclusion Criteria: Contraindication to colchicine including any of the following: hypersensitivity to colchicine severe renal, hepatic or gastrointestinal disorder blood dyscrasias (myelodysplasia cytopenias etc) Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol) Known severe liver disease and/or elevated transaminases > 1.5x the upper limit of normal Estimated GFR < 50 ml/min Pregnant or lactating women or women not protected by a reliable contraception method Current treatment with colchicine at enrollment Active infection or systemic inflammation eg active rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Colchicine 1mg daily oral | Drug: Colchicine<br>* 1mg once daily<br>|
| Placebo Comparator: 2<br>Placebo 1 capsule daily oral | Drug: Placebo<br>* 1 capsule daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of low dose colchicine on hs-CRP. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events |  | 30 days |
An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.

Official Title
-----------------
FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients

Conditions
-----------------
Myasthenia Gravis

Intervention / Treatment
-----------------
* Drug: tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed as myasthenia gravis Those whose MG symptoms are not controlled by the treatment with prednisone Exclusion Criteria: Those who had undergone thymectomy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 64 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. tacrolimus<br> | Drug: tacrolimus<br>* Oral<br>* Other names: Prograf;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of clinical symptoms |  | 28 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of daily activity |  | 28 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Myasthenia Gravis
Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection for Early Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve Disease-free survival ？

Detailed Description
-----------------
Patients with early stage of gastric cancer(T1a/T1bN0M0,NCCN2014.V1) will depart into two group randomized double-blind, then experimental group accept Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection ,and control group accept Endoscopic Submucosal Dissection only.The follow-up time is from operation to recrudescence.

Official Title
-----------------
Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection:a New Therapy for Early Gastric Cancer

Conditions
-----------------
Early Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: ESD AND LRLD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cT1a：ulcer（+）and lesion diameter>3cm and differentiated type. Any ulcer and lesion diameter d>2cm and poorly differentiated type. cT1b: Submucosal injection (+) Exclusion Criteria: metastasis recrudescence
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESD and LRLD<br>The experimental group accept Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection. | Procedure: ESD AND LRLD<br>* A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.<br>|
| No Intervention: Endoscopic Submucosal Dissection (ESD)<br>The group accept Endoscopic Submucosal Dissection only. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS | Follow-up Disease-free Survival | Five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopic Submucosal Dissection, Laparoscopic Regional Lymph node Dissection, early gastric cancer, Disease-free survival