linjc16/ctgov huggingface dataset:
A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline

Study Overview
=================
Brief Summary
-----------------
To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)

Official Title
-----------------
A Rollover Study of Ixabepilone (BMS-247550) In Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline And Who Are Taxane Resistant Who Have Completed Study CA163107 And Who Are Benefiting From Continuation On Therapy With Ixabepilone

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

Intervention / Treatment
-----------------
* Drug: Ixabepilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 20 years or older Patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination Exclusion Criteria: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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: Ixabepilone<br> | Drug: Ixabepilone<br>* Lyophilized and solvent, IV, 10-50 mg/m²<br>* Other names: Ixempra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator |  | 21-day cycles until documented disease progression or unacceptable toxicity | 
| To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |  | 21-day cycles until documented disease progression or unacceptable toxicity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objectives will be assessed by combining data with the previous Phase II study CA163107 |  | 21-day cycles until documented disease progression or unacceptable toxicity | 
| To evaluate the antitumor response according to the RECIST criteria |  | 21-day cycles until documented disease progression or unacceptable toxicity | 
| To evaluate the duration of achieved responses |  | 21-day cycles until documented disease progression or unacceptable toxicity | 
| To evaluate time to progression (TTP) |  | 21-day cycles until documented disease progression or unacceptable toxicity |
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.

Official Title
-----------------
A Single-Dose Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions

Conditions
-----------------
Epilepsy, Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
* Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) | Drug: Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)<br> <br> |
| Active Comparator: 2<br>Depakote 500 mg DR Tablets (Abbott Laboratories, USA) | Drug: Depakote 500 mg DR Tablets (Abbott Laboratories, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 10 days |
Attachment Image Data Set Validation in Adolescent

Study Overview
=================
Brief Summary
-----------------
this study aims to validate a picture data set that particularly activates the attachment process and that could be used in attachment studies.

Detailed Description
-----------------
Pictures have been chosen to represent several emotions: distress, comfort, complicity and neutral.

Official Title
-----------------
Validation of an Attachment Picture Set in School-adolescent

Conditions
-----------------
Emotion Dysregulation

Intervention / Treatment
-----------------
* Behavioral: image visualization and quotation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescent going to high school not hospitalized Exclusion Criteria: mental retardation non comprehension of french visual deficit

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: image visualization and quotation|two sets of 60 pictures are shown to the adolescents. we ask them to quote for their valence, hedonicity, arousal and to characterize the emotion elicited in each picture. This evaluation takes approximately 1hour.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean score of valence in the SAM (self assessment manikin system) | the hedonicity is assessed for each picture. The characterization of the set is performed using the mean score of hedonicity for each type of picture (distress, comfort, complicity and neural) | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean score of arousal in the SAM (self assessment manikin system) | the hedonicity is assessed for each picture. The characterization of the set is performed using the mean score of arousal for each type of picture (distress, comfort, complicity and neural) | at inclusion | 
| mean score of dominance in the SAM (self assessment manikin system) | the hedonicity is assessed for each picture. The characterization of the set is performed using the mean score of dominance for each type of picture (distress, comfort, complicity and neural) | at inclusion | 
| emotional categorization of the picture | continuous scales for different emotions (distress, comfort, joy-complicity hate, horror) are presented. Subjects have to quote them for each picture. | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attachment, adolescent, picture
Evaluation of the Veriton SPECT/CT System

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate a new type of gamma camera (the Veriton system) that provides a significant gain in system sensitivity and improved image quality compared to a conventional gamma camera that can achieve equal or better image quality than a standard SPECT/CT system.

Official Title
-----------------
Evaluation of the Veriton SPECT/CT System

Conditions
-----------------
Focus of Study is Comparison of 2 Types of Gamma Cameras

Intervention / Treatment
-----------------
* Diagnostic Test: Veriton SPECT/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 years or older. Currently scheduled to undergo a nuclear medicine exam. Exclusion Criteria: Individuals under 18 years of age. Unwilling/unable to sign an informed consent form. Unable to lie on a Veriton imaging table for up to 40 minutes.

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: each patient will have 2 scans - one on a conventional system and one on the newer technology
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of the Veriton SPECT/CT system<br>To determine if the Veriton system can achieve equal or better image quality than a standard SPECT/CT system. | Diagnostic Test: Veriton SPECT/CT<br>* The Veriton system represents an FDA approved (510k cleared) new generation of SPECT/CT systems. It consists of 12 small gamma cameras arrayed in a circle around the patient, and is coupled to a 64-slice CT system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality | Assessment of relative image quality between the Veriton system and a conventional gamma camera as a function of the type of nuclear medicine exam. | 1 year |
CHD Patient's Concern on Cardiac Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Our study focuses on the question about primary cardiac rehabilitation (CR) patients with coronary heart disease are concerned about demonstrating the association between the patients' view of CR and social associated factors. In our study, all participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. The selectable questions can be categorized into five titles: the content or purpose of CR, the method of CR, the advantage of CR, the adverse effect of CR, and the expenditure of CR.

Official Title
-----------------
CHD Patient' s Concern on Primary Cardiac Rehabilitation and Its Social Associated Factors

Conditions
-----------------
Coronary Heart Disease, Cardiac Rehabilitation

Intervention / Treatment
-----------------
* Behavioral: filling out the questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years old patients diagnosed as coronary heart disease able to participate in cardiac rehabilitation after medical judgments for the first time understand the questionnaire content agree to participant in the study and provide the written informed consent Exclusion Criteria: unable to complete the questionnaire patients who aren't willing or refuse to participate in the trial

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 |
| --- | --- |
| CHD patients participating in the cardiac rehabilitation<br> | Behavioral: filling out the questionnaire<br>* all participants in our study are invited to choose at least 1 question in 15 questions or provide their own questions regarding their doubt about the CR after filling in their personal information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of different selected questions | All participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. As a result, we calculate and collect the total number of different selected questions for each patients. | 5 minutes | 
| The variety of different selected questions | All participants are invited to choose at least 1 question in 15 questions or provide their questions regarding their doubt about the CR after filling in their personal information. As a result, we calculate and collect the variety of different selected questions for each patients. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac rehabilitation, coronary heart disease, social-psychological factor
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

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

Intervention / Treatment
-----------------
* Drug: P38 Inhibitor (4)
* Drug: P38 Inhibitor (4)
* Drug: P38 Inhibitor (4)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >18 years of age, with active RA; receiving treatment for RA on an outpatient basis; females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study. Exclusion Criteria: major surgery within 8 weeks prior to screening; rheumatic autoimmune disease or inflammatory joint disease other than RA; treatment with methotrexate within 8 weeks of baseline; concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: P38 Inhibitor (4)<br>* 50mg po qd<br>|
| Experimental: 2<br> | Drug: P38 Inhibitor (4)<br>* 150mg po qd<br>|
| Experimental: 3<br> | Drug: P38 Inhibitor (4)<br>* 300mg po qd<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* po qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 20 response |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 50/70 response. |  | Week 12 | 
| Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters. |  | Throughout study |
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency

Study Overview
=================
Brief Summary
-----------------
The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

Detailed Description
-----------------
The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.

Official Title
-----------------
Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)

Conditions
-----------------
Men With Low Testosterone Levels

Intervention / Treatment
-----------------
* Drug: Testosterone Enanthate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
The screening evaluation consisted of: medical history, which included the androgen deficiency of the aging male questionnaire physical examination multiphasic serum panel measurement of total serum testosterone and PSA levels Exclusion criteria included: use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis serum PSA level greater than 10.0 ng/mL refusal or inability to undergo prostate biopsies presence of prostate cancer on initial biopsy results.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone Enanthate<br>Testosterone | Drug: Testosterone Enanthate<br>* Testosterone Enanthate<br>* Other names: testosterone;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Chitodex Gel vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.

Detailed Description
-----------------
The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.

Official Title
-----------------
Head to Head Comparison of Chitodex Gel With Triamcinolone vs NexFoam With Triamcinalone on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis (CRS)

Conditions
-----------------
Chronic Rhinosinusitis

Intervention / Treatment
-----------------
* Device: Chitogel
* Device: Nexfoam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND ≥ 18 years to ≤ 90 years AND English speaking AND Able to give written informed consent AND Local residents who will be returning to this center for postoperative follow-up care AND Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 & 12 (± 2) weeks post-op. Exclusion Criteria: allergy to shellfish pregnant or breastfeeding Hepatitis or blood disorders any drug allergy allergy to potato starch (due to Nexfoam)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Chitogel<br>Chitodex gel plus Kenalog inserted into the middle meatus | Device: Chitogel<br>* post-operative dressing within standard of care<br>|
| Nexfoam<br>NexFoam plus Kenalog inserted into the middle meatus | Device: Nexfoam<br>* post-operative dressing within standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Scores on Endoscopy | Outcome measured based on the wound healing in the sinus openings made during surgery. | 12 (±2) weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Scores on Patients' Self-Directed Questionnaires | Outcomes measured based on patients' personal symptom assessment. | 12 (±2) weeks post surgery |