linjc16/ctgov huggingface dataset:
Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.

Detailed Description
-----------------
Intermittent courses of Melphalan and Prednisone (MP) have been the first line therapy in multiple myeloma, for many years. Advances in systemic and supportive therapy increased remission rates and overall survival, but multiple myeloma still remains an incurable haematological malignancy. Several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60%. Due to its activity, Thalidomide will be evaluated in association with MP in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy.

Official Title
-----------------
Phase III, Prospective, Open Label, Multicenter, Randomized Trial of Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone as First Line Therapy in Myeloma Patients Aged >65.

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

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: untreated myeloma patients age >65 years of age or younger but excluded from transplant procedure Durie & Salmon stage II or III myeloma and measurable disease. Patients agreed to use contraception Exclusion Criteria: other cancer psychiatric disease and any grade 2 peripheral neuropathy
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: Thalidomide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  |  | 
| Progression Free Survival |  |  | 
| Event Free Survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Overall Survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myeloma, Thalidomide, Diagnosis, Elderly patients
The Impact of Indocyanine Green-enhanced Fluorescence Imaging on Bowel Transection in Left-sided Colorectal Resection

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the impact of fluorescence imaging on the location of colorectal transection lines based on evaluation of perfusion with indocyanine green, how it's going to affect surgical planning and its possible benefits in reducing anastomotic leakage.

Detailed Description
-----------------
During surgery, the line of intended bowel transection would be determined by the surgeon. Then the anesthesiologist will administer a bolus of 5mg ICG intravenously (2.5mg/ml, 2ml), followed by 10ml normal saline flush. The perfusion of colon will be assessed via fluorescence angiography. The actual bowel transection, after ICG fluorescence study, would be compared with the intended bowel transection site. The difference in terms of distance and either more proximal or distal is recorded. Then bowel anastomosis is completed in the usual manner.

Official Title
-----------------
A Prospective Study to Investigate the Impact of Using Indocyanine Green-enhanced Fluorescence Imaging on the Location of Bowel Transection in Patients Undergoing Left-sided Colorectal Resection

Conditions
-----------------
Anastomotic Leak

Intervention / Treatment
-----------------
* Drug: indocyanine green
* Device: Fluorescence imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All left-sided colorectal resection involving division of inferior mesenteric artery Exclusion Criteria: Patients with a history of adverse reaction or known allergy to ICG, iodine, or iodine dyes. Pregnant and/or lactating patients.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG<br>Administering indocyanine green during surgery and the use of ICG fluorescence imaging to assess bowel perfusion during surgery | Drug: indocyanine green<br>* Injection of indocyanine green and using fluorescence imaging to assess perfusion of bowel before bowel transection and anastomosis<br>Device: Fluorescence imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with operative decisions changed after the use of ICG enhanced fluorescence imaging |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leak |  | up to 2 weeks after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICG, colectomy, anastomotic leak, anastomotic leakage rate, surgical decision
Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice

Study Overview
=================
Brief Summary
-----------------
We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. For this purpose we will include both patients that are treated with Symbicort® Turbuhaler® the classical maintenance only treatment approach as well as those treated with the SMART approach.

Official Title
-----------------
Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with persistent asthma treated with Symbicort® Turbuhaler® in line with its label non-pregnant females existing maintenance only treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg, 160 μg/4,5 μg or 320 μg/9 μg for at least 1 month existing SMART treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg or 160 μg /4,5 μg for at least 1 month Exclusion Criteria: patients not being treated with Symbicort® Turbuhaler® patients treated with Symbicort® Turbuhaler® for COPD

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 |
| --- | --- |
| 1<br>patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month | |
| 2<br>patients with SMART treatment with Symbicort Turbuhaler for at least 1 month | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control |  | three times: 0, 3, 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the number of maintenance and reliever inhalations of Symbicort® Turbuhaler®, as well as the concomitant usage of a separate reliever inhaler even in the case of SMART treatment approach |  | three times: 0, 3, 6 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, SMART, Symbicort Turbuhaler, asthma control
Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

Study Overview
=================
Brief Summary
-----------------
The study will evaluate and refine a breast screening and diagnosis device.

Detailed Description
-----------------
The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.

Official Title
-----------------
Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

Conditions
-----------------
Breast Cancer, Mass Cystic, Benign Mass

Intervention / Treatment
-----------------
* Procedure: 3D Tomosynthesis and ultrasound imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To participate in this research study you must be a female over the age of 25 Have had a normal mammogram or are scheduled for a breast biopsy Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy. Exclusion Criteria: Male Under the age of 25 Documented breast cancer

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D Tomosynthesis & 3D Ultrasound for breast masses<br>Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound. | Procedure: 3D Tomosynthesis and ultrasound imaging<br>* 3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue<br>|
| Experimental: 3D Tomosynthesis/ 3D Ultrasound for healthy subjects<br>Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound. | Procedure: 3D Tomosynthesis and ultrasound imaging<br>* 3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position. |  | To be determined later. |
Raman Spectroscopy and Endometriosis

Study Overview
=================
Brief Summary
-----------------
We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.

Detailed Description
-----------------
Endometriosis is a chronic disease whose molecular basis is still unknown and diagnostic methods are controversial. The diagnosis is still invasive and there are no accepted ways which are molecular-based and noninvasive. Raman spectroscopy is a vibrational spectroscopy technique which can analyze specific spectral patterns, substances and molecular changes with high specificity. We aimed to use Raman spectroscopy to detect differences between healthy controls and patients with surgically proven endometriosis.

Official Title
-----------------
The Role of Raman Spectroscopic Analysis for Endometriosis Diagnosis

Conditions
-----------------
Endometriosis, Endometrioma

Intervention / Treatment
-----------------
* Diagnostic Test: raman analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven endometriosis Exclusion Criteria: having additional health conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control<br>healthy controls | Diagnostic Test: raman analysis<br>* negative or pozitive<br>|
| Experimental: patient<br>patients diagnosed with endometriosis | Diagnostic Test: raman analysis<br>* negative or pozitive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic specificity | differentiating endometriosis patients from healthy controls by computer based technology designed with raman data | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, raman analaysis
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.

Official Title
-----------------
Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy in Patients Who Have Been Treated With HB110E Hepatitis B DNA Vaccine

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: HBsAg vaccine with Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening. positive HBsAg at screening serum HBV DNA level below 300copies/mL at screening ALT level within 2 x ULN at screening voluntarily provide the informed consent Exclusion Criteria: participation in other study within 30 days of screening subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine. any other conditions that are considered inappropriate for the study by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Other: HBsAg vaccine with Entecavir<br> | Drug: HBsAg vaccine with Entecavir<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: HBV specific T-cell response by ELISPOT | sample for immunologic assay will be collected at each visit; VS( 4week), VT1(0week), VT2(8week), VF(16week. T-cell response will be measured by ex-vivo & cultured ELISPOT. | Change from Baseline in HBV specificic T-cell response at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBsAg titer | sample for HBsAg will be collected at each visit; VS( 4week), VT1(0week), VT2(8week), VF(16week. Change from baseline in HBsAg titer will be measured at VF. | Change from baseline in HBsAg titer at 16 weeks |
Study of Cognitive Inhibition Disorders in Depressed Older Suicide Attempters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the cognitive inhibition deficit among depressed older suicide attempters compared to depressed older suicide non-attempters.

Detailed Description
-----------------
The main objective consists in examining the association between cognitive inhibition and suicide attempt in depressed older adults (> 65 year old).

Official Title
-----------------
Etude Des Troubles de l'Inhibition Cognitive Chez le Sujet âgé déprimé Suicidant

Conditions
-----------------
Suicide, Attempted, Cognitive Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 65 years old Score of Mini-Mental State Examination (MMSE) > 23 Score of Hamilton Depression Scale >27 For Group 1 (depressed older suicide non-attempters): No history of suicide attempt For Group 2 (depressed older suicide attempters) : History of suicide attempt Exclusion Criteria: Neurological history or medical-surgical affection in the past 3 months. Dependence or alcohol abuse. Use of neuroleptics

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Group 1<br>Depressed older suicide non-attempters | |
| Group 2<br>Depressed older suicide attempters | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive inhibition deficit |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suicide, Attempted, Cognitive Symptoms
Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases

Study Overview
=================
Brief Summary
-----------------
This study describes the elevation of CPK in patient treated for solid tumors by TKI

Official Title
-----------------
National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)

Conditions
-----------------
Cancer, Solid Tumor

Intervention / Treatment
-----------------
* Biological: CPK dosage
* Other: Clinical exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with solid tumor treated by inhibitor of tyrosin kinase for at least 1 week Patient examined AND with a routine blood test planned Patient informed of procedure for the study who was not opposed to it Exclusion Criteria: Patient treated for malignant hemopathy Patient no treated by inhibitor of thyrosine kinase or for less than 1 week Patients with no routine blood laboratory tests planned

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 |
| --- | --- |
| Patient treated by TKI<br>Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week | Biological: CPK dosage<br>* CPK dosage during a blood sample realized at least one week after the begining of the treatment<br>Other: Clinical exam<br>* Examination of the patient for myalgia, cramps, medical history and concomitant medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the prevalence of the CPK increase | Dosage of CPK during standard blood sampling. The increase of CPK is defined when CPK value > USL | Within 3 days after a clinical exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation myalgia/CPK increase | To determine the correlation between myalgia and CPK blood, taking into account the risk factors leading to CPK increase | During the clinical exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyrosine kinase inhibitor, phosphokinase creatinin, myalgia
Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Multi-center Study of GB-0998 for Treatment of Systemic Sclerosis

Conditions
-----------------
Scleroderma, Systemic

Intervention / Treatment
-----------------
* Drug: High-dose intravenous immunoglobulin (Venoglobulin-IH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have sclerosis located proximal to the elbow joint with diffused systemic scleroderma. Patients who have not less than 20 points of TSS. Patients with no appropriate therapeutic treatment. Exclusion Criteria: Patients with severe hepatic disorder, severe renal disorder or severe heart disorder. Patients with malignant tumors. Patients who have the anamnesis of shock or hypersensitivity to this drug. Patients who have the anamnesis of cerebral infarction or symptom of these diseases. Patients who have been diagnosed as IgA deficiency in their past history. Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant. Patients who had any dose increase or new dosing of steroid within 12 weeks before consent. Patients who were administered other investigational drug within 12 weeks before consent.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: High-dose intravenous immunoglobulin (Venoglobulin-IH)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in TSS at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in joint motion, oral aperture, active hand spread, fingertip-to-palm distance, health assessment questionnaire, histological analysis of dermal section at 12 weeks.; Adverse events and laboratory test. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scleroderma, Systemic