linjc16/ctgov huggingface dataset:
Safety and Effectiveness of Giving SU5416 to HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give SU5416 to HIV-infected patients with AIDS-related Kaposi's sarcoma (KS). SU5416 may prevent the growth of KS tumors.

Detailed Description
-----------------
Groups of 3-6 patients are sequentially assigned to receive escalating doses of SU5416 in 33% increments. Study drug is administered as a twice-weekly intravenous injection for 4 weeks. In the absence of unacceptable toxicity, responding patients may continue on SU5416 in 4-week treatment cycles for a maximum of 1 year or until the presence of unacceptable toxicity or tumor progression.

Official Title
-----------------
A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Conditions
-----------------
Sarcoma, Kaposi, HIV Infections

Intervention / Treatment
-----------------
* Drug: SU5416


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. Have KS with at least 5 skin lesions. Have been in stable condition for at least 6 weeks prior to study entry, if receiving antiretroviral therapy. Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have had surgery within 4 weeks of study entry. Have taken certain medications, including therapy for KS, within 3 weeks prior to study entry. Have pulmonary KS (KS in your lungs). Have certain serious medical conditions, including liver or kidney problems, certain infections, and certain cancers. Are allergic to Cremophor. Have not recovered from previous cancer treatment (chemotherapy, radiotherapy, or immunotherapy). Are pregnant.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SU5416|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
-----------------
Skin Neoplasms, Sarcoma, Kaposi, Antineoplastic Agents
Pharmacokinetics of Carnosine

Study Overview
=================
Brief Summary
-----------------
The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults.

Official Title
-----------------
Pharmacokinetics of Carnosine

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Dietary Supplement: pure carnosine
* Other: Beef
* Other: Chicken
* Other: Chicken broth


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult normal hematological parameters, normal serum albumin, normal liver function, normal kidney function Exclusion Criteria: History of smoking or alcoholism

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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

Design Details

Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Carnosine(450 mg) | Dietary Supplement: pure carnosine<br>* one time dose of pure carnosine (450 mg)<br>|
| Experimental: 2<br>Beef (150g) | Other: Beef<br>* one time dose, 150 g of beef<br>|
| Experimental: 3<br>chicken (150g) | Other: Chicken<br>* One time dose, 150g of chicken breast<br>|
| Experimental: 4<br>Chicken broth (obtained from 150 g of chicken breast) | Other: Chicken broth<br>* one time dose of chicken broth obtained from 150g of chicken breast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma histidine-dipeptide |  | 0, 30, 60, 100, 180, 240, & 300 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
histidine dipeptides, carnosine, anserine
Metastatic Colorectal Cancer Database

Study Overview
=================
Brief Summary
-----------------
The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management in Centre Georges Francois Leclerc, Dijon.

Detailed Description
-----------------
The metastatic ColoRectal Cancer (mCRC) Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution, ...). This database allows easy access to information in a centralized and structured way. This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

Official Title
-----------------
Prospective and Retrospective Metastatic Colorectal Cancer Database

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Metastatic Colorectal Cancer Database


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic colorectal cancer Age >= 18 Exclusion Criteria: Non metastatic colorectal cancer Objection to the use of medical data records

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 |
| --- | --- |
| Metastatic Colorectal Cancer<br> | Other: Metastatic Colorectal Cancer Database<br>* Metastatic Colorectal Cancer Database<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | Overall survival and evolution over years | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patient and treatment characteristics | Collection of patient and treatment characteristics over years, to set up prospective and retrospective studies | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Colorectal Cancer
Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging

Study Overview
=================
Brief Summary
-----------------
Histological grade of hepatocellular carcinoma (HCC) is an important prognostic factor affecting patient survival. It has been divided into four grades from I to IV on the basis of histological differentiation. Grade I is the best differentiated consisting of small tumor cells arranged in thin trabeculae. Cells with higher grade are larger and less differentiated with hyperchromatic nuclei and loss of trabecular pattern. Ultrasound is an imaging modality frequently used to evaluate liver tumors because of its convenience, real-time, less expensive and no radiation exposure. However, ultrasonographic evaluation by conventional B-mode image is semi quantitative and subjective. It still cannot replace liver biopsy for the evaluation of HCC. This study is aimed to quantify the image characters of B-mode image and the scatterer properties using Nakagami distribution. Nakagami parameter is a general model to describe the distribution of scatterers. Therefore, the investigators hypothesized that Nakagami parameter may also reflect the histological changes in different grades of HCC. In this study, the resected HCC tumor samples will be collected from the participants who are going to receive surgical resection, and the tumor US images and Nakagami values will be obtained via the single-element ultrasound system. The correlation between the ultrasound backscatter parameter and the differentiation grade will be analyzed.

Official Title
-----------------
Histological Differentiation Grade Predicted by Ultrasound Backscatterer Imaging

Conditions
-----------------
Neoplastic Disease, Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21 to 75 Patients with HCC who underwent surgery The resected tumor was measured larger than 3 cm Exclusion Criteria: Patients who have received other treatment in 6 months Patients who couldn't regular follow-up

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular carcinoma<br>patients HCC who are going to receive surgical resection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | Suspected recurrences will be confirmed by CT or MRI. | within two years after surgery | 
| Liver-related mortality |  | five years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma(HCC), Ultrasound, Backscatter, Differentiation grade, Survival
Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures

Study Overview
=================
Brief Summary
-----------------
This study, conducted in children with typical or atypical absence epilepsy, will consist of noninvasive recording of the metabolic activity of the brain concomitantly with electroencephalographic recording during seizures without the need for any additional examination. This examination will be performed by combining near-infrared spectroscopy (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording. Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a functional point of view and is used in the routine follow-up of epileptic children. Optical imaging is a recent and promising medical imaging technique, which uses near-infrared light. This rapid, noninvasive and harmless quantitative technique can be easily used at the child's bedside or in the ward and provides metabolic information on brain functioning.

Official Title
-----------------
Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures: Near-infrared Spectroscopy (NIRS) Coupled to Electroencephalography (EEG)

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: Near Infra Red Spectroscopy (NIRS)
* Device: Electroencephalography (EEG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 3 to 14 years Featuring absence epilepsy with typical or atypical seizures characterized by the presence of spontaneous spike-wave flashes with standard EEG Exclusion Criteria: All children with severe congenital malformation Any refusal of a parent or child Any child with a serious deterioration in the general condition and vital functions Any child with dermatitis of the face or scalp Children under 3 years old or over 14 years

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 14 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 |
| --- | --- |
| epilepsy<br>children with absence epilepsy presenting either typical or atypical seizures | Device: Near Infra Red Spectroscopy (NIRS)<br> <br> Device: Electroencephalography (EEG)<br>* Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemodynamic changes | haemodynamic changes by optical imaging, during the 4 interictal, preictal, ictal and postictal phases of absence seizures as defined by EEG analysis | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spectroscopy, Near-Infrared, Electroencephalography, children
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.

Detailed Description
-----------------
Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

Official Title
-----------------
Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial

Conditions
-----------------
Hematological Neoplasms, Tumors

Intervention / Treatment
-----------------
* Drug: Filgrastim
* Drug: Pegfilgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion Adequate organ function Written informed consent. Exclusion Criteria: Use of other experimental drugs Active infection

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 |
| --- | --- |
| Active Comparator: Filgrastim<br>Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days) | Drug: Filgrastim<br>* 5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution<br>* Other names: Granulokine;|
| Experimental: Pegfilgrastim<br>Pegfilgrastim administered the day after autologous stem-cell reinfusion | Drug: Pegfilgrastim<br>* 6 mg/day sc at day +1<br>* Other names: Neulasta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of aplasia period |  | At time of discharge from Unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological reconstitution |  | 1 year after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High-dose chemotherapy, Growth factor, Pegfilgrastim
Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.

Official Title
-----------------
The EXTEND Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.

Conditions
-----------------
Thromboembolism

Intervention / Treatment
-----------------
* Drug: EXANTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, Female or male aged 18 years and over Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture. Exclusion Criteria: History of heparin-induced thrombocytopenia Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency. Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority for the prevention of VTE or VTE related death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion. |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery
Diffusion Tensor Breast MRI (DTI)

Study Overview
=================
Brief Summary
-----------------
The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.

Official Title
-----------------
Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Diffusion tensor imaging (DTI) in Breast MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female of any race, ethnicity and lifetime risk. Eighteen years or older. Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side. Self-detected lump suspicious for breast cancer that it has not been biopsied yet. Exclusion Criteria: Inability to understand the consent form Pregnant or nursing Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention Physically unable to lie down on her belly for at least 10 minutes. Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.

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

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

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: Diffusion tensor imaging (DTI) in breast MRI<br> | Other: Diffusion tensor imaging (DTI) in Breast MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI
Colposcopy Education Using Operant Learning

Study Overview
=================
Brief Summary
-----------------
Images will be collected during routine colposcopy and paired with their pathology results to be used for resident education

Detailed Description
-----------------
Identifying information will be removed and operant learning techniques will be applied to better educate residents on colposcopy.

Official Title
-----------------
Colposcopy Education Using Operant Learning

Conditions
-----------------
Educational Problems, Cervix, Dysplasia

Intervention / Treatment
-----------------
* Other: Colposcopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to give informed consent age 21or older undergoing clinically indicated colposcopy Exclusion Criteria: under 21 years of age

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Colposcopy|prospective resident education for colposcopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resident accuracy in identifying sites for biopsy during Colposcopy | using colposcopic images obtained during routine patient care residents will complete quiz from images with immediate results of the test to assess the accuracy of visual cues to biopsy | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colposcopy, resident education