linjc16/ctgov huggingface dataset:
Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy

Study Overview
=================
Brief Summary
-----------------
To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure

Official Title
-----------------
An Open Label, Non-Comparative, Phase II Study of ZD1839 (Iressa) as First-Line Treatment in Subjects With Relapsed Prostate Cancer Following Radical Prostatectomy or Radiotherapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed prostate cancer after prostatectomy or radiotherapy PSA levels below 10 ng/mL Lymph node negative Metastasis negative Withdrawal of hormone therapy at least 6 months before entry into the study Written informed consent Exclusion Criteria: Metastatic disease Hormonal treatment 6 months before study entry Concomitant radiotherapy, surgery and/or chemotherapy ILD

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

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA response rate at statistical study closure based on the percentage of subjects experiencing PSA normalization or a > 50% reduction in PSA levels compared with study entry sustained for 3 months (i.e. three consecutive measurements) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TTF (failure defined as a need for additional/alternative therapy due to PSA progression, metastases or AEs) |  |  | 
| Duration of PSA response |  |  | 
| PFS (progression defined as doubling in PSA levels compared with the PSA level at study entry) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer of the Prostate
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.

Official Title
-----------------
An Observational. Non-interventional Study to Observe the Safety and Efficacy of MIRCERA in the Treatment of Chronic Renal Anemia in Maintenance ESA Treated Patients on Haemodialysis (STABILE)

Conditions
-----------------
Anemia, Kidney Disease, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Stage IV chronic kidney disease, on haemodialysis Chronic renal anemia, on maintenance ESA treatment Hemoglobin concentration between 10.0 an 12 g/dL Continuous maintenance epoetin therapy with the same dosing interval during the previous month Exclusion Criteria: Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension) Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) Anemia due to hemolysis, pure red cell aplasia

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels |  | Baseline; Weeks 8, 16, 24, 48 |
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease

Study Overview
=================
Brief Summary
-----------------
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Official Title
-----------------
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease

Conditions
-----------------
Chronic Graft Vs. Host Disease

Intervention / Treatment
-----------------
* Drug: INCA34176


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: INCA34176|Treatment with axatilimab includes receiving intravenous (IV) doses of axatilimab every 2 weeks|

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
-----------------
Chronic Graft Vs. Host Disease, cGVHD
Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity

Study Overview
=================
Brief Summary
-----------------
Exercise is an effective strategy to manage juvenile obesity; however this ideal exercise training mode is still unclear. In this study, the investigators compared the health-related effects of high intensity interval training versus endurance training in obese children.

Official Title
-----------------
Comparative Study of High Intensity Interval Training and Endurance Training in Juvenile Obesity

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

Intervention / Treatment
-----------------
* Other: Endurance training
* Other: High intensity interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 8 and 12 years Body mass index (BMI) = 95th percentile, according to the First National Health and Nutrition Examination Survey no pharmacological treatment no evidence of metabolic, hormonal, orthopedic, and cardiovascular disease at the time of the study's commencement no participation in any regular exercise training program (except physical education classes, two days a week) at least 6 months before the commencement of the study and throughout the protocol. Exclusion Criteria: non-obese participants physically active participants participants with cardiovascular diseases or any other condition that could preclude the participation in the the exercise training program

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity interval training<br> | Other: High intensity interval training<br>* 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.<br>|
| Experimental: Endurance training<br> | Other: Endurance training<br>* 30 to 60-minute continuous exercise at 80% of the peak heart rate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index (BMI) |  | 12 weeks | 
| aerobic conditioning (VO2max) |  | 12 weeks | 
| insulin sensitivity (HOMA-index) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, overweight, children
The STAR Prospective Clinical Series

Study Overview
=================
Brief Summary
-----------------
Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

Official Title
-----------------
The DFINE STAR™ Tumor Ablation Prospective Clinical Series

Conditions
-----------------
Metastasis to Vertebral Column

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. Exclusion Criteria: The device is contraindicated in subjects with heart pacemakers, or other electronic device implants. The device is contraindicated in vertebral body levels C1-7.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 Lesions to the spine<br>Patients over the age of 18 receiving treatment using the DFINE Inc. STAR tumor ablation system for palliation of painful metastases of the spine. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Mean change from baseline in worst pain score per NRPS at one month | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP) | 3 months | 
| Change if Quality of Life | Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7) | 3 months | 
| Change in Function | Change from baseline at each visit using Modified Oswestry Disability Index (MODI) | 3 months |
Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP

Study Overview
=================
Brief Summary
-----------------
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course. Diagnosis is based on clinical presentation and electrophysiological findings in accordance with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown to be effective in several placebo-controlled trials. Once IVIg therapy produces a response and is well tolerated, some patients are able to continue their treatment in the home setting. The HOME LINK system offers an integrated, global solution based on telemonitoring technology providing continuous, remote monitoring of Privigen® infusions administered at home.

Official Title
-----------------
A Multicenter Pilot Study to Determine Criteria for Evaluating the Effectiveness of Two Comparative Monitoring Methods in the Management of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Receiving Home-based Treatment With IVIg (Privigen®)

Conditions
-----------------
Chronic Inflammatory Demyelinating Polyneuropathy

Intervention / Treatment
-----------------
* Device: HOME LINK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of CIDP as per EFNS/PNS criteria. Patient already receiving home-based treatment with Privigen® Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HOME LINK|Telemonitoring system which include web platform and connected devices.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate HOME LINK telemonitoring system for patients receiving home-based IVIg therapy | The conventional method of home monitoring requires using a visiting nurse. HOME LINK is a telemonitoring system that is an alternative to this conventional method offering remote at-home monitoring. HOME LINK monitors the patient's health parameters from home. In this way it enables an adjustment of the infusion conditions or intervention of a qualified healthcare professional in the event of an incident. Home Link will be evaluated for failure rate of connection to the telemonitoring platform, failure rate of transmission of self-measurements to the telemonitoring platform, failure rate of transmission of documents relating to home-based treatment, and failure rate of contacting one of the healthcare professionals involved in patient care during the at-home infusions. | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CIDP, Telemonitoring, Telemedicine
Study to Compare Different Formulations of AZD3355

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.

Official Title
-----------------
A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: AZD3355


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Female subjects with no childbearing potentials or using highly efficient contraceptive methods Clinically normal physical findings Exclusion Criteria: Clinically significant illness within 2 weeks prior to the first dose of investigational product History of clinically significant disease Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>IR Formulation 65 mg | Drug: AZD3355<br>* Single dose<br>* Other names: Lesogaberan;|
| Experimental: 2<br>IR Formulation 150 mg | Drug: AZD3355<br>* Single dose<br>* Other names: Lesogaberan;|
| Experimental: 3<br>MR formulation, 1h 65 mg | Drug: AZD3355<br>* Single dose<br>* Other names: Lesogaberan;|
| Experimental: 4<br>MR Formulation, 1h 150 mg | Drug: AZD3355<br>* Single dose<br>* Other names: Lesogaberan;|
| Experimental: 5<br>MR Formulation, 2h 150 mg | Drug: AZD3355<br>* Single dose<br>* Other names: Lesogaberan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific AE questions |  | During 0-4 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling up to 36 hours post dose | 
| Safety variables (other adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reflux Inhibitor, GERD, formulations
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

Study Overview
=================
Brief Summary
-----------------
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.

Official Title
-----------------
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients

Conditions
-----------------
Renal Transplant

Intervention / Treatment
-----------------
* Drug: Mycophenolate sodium (enteric coated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301 Exclusion Criteria: Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mycophenolate sodium (enteric coated)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients. |  |  | 
| Efficacy of enteric-coated mycophenolate sodium |  |  | 
| Safety of enteric-coated mycophenolate sodium based on AE reporting. |  |  | 
| Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Transplant, adults, immunosuppressant
Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

Study Overview
=================
Brief Summary
-----------------
Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization and mortality worldwide. The most common etiologic agents of ARI's, especially in children, are viruses. The study objective is to determine the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection in South East Asia. This is a laboratory based surveillance study, in which the archival specimens from hospitalized patients will be tested for respiratory pathogens other than influenza viruses Standard descriptive statistics will be used to present the findings

Detailed Description
-----------------
This study will test 1400 specimens from 1200 patients at the following laboratories: National Hospital of Pediatrics, Hanoi National Institute of Infectious and Tropical Diseases, Hanoi Siriraj Hospital, Bangkok National Institute of Health Research and Development, Jakarta Hospital for Tropical Diseases, HCMC Children Hospital #1, Ho Chi Minh City Children Hospital #2, Ho Chi Minh City Queen Sirikit National Institute of Child Health

Official Title
-----------------
Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

Conditions
-----------------
Lower Respiratory Tract Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adequately stored respiratory specimens obtained from hospitalized patients suspected of lower respiratory tract infection and were tested for influenza. Exclusion Criteria: Specimens stored at insufficient temperature Specimen volume is insufficient No demographic data available Specimen unsuitable for testing for other technical reasons
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lower respiratory tract infection, non influenza, PCR assay
Evaluation of New Items in Cardiac Echography

Study Overview
=================
Brief Summary
-----------------
Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system has image processing and left ventricular function quantification software which are different from the precedent model Philips IE33.Left ventricular function quantification and myocardial distortion are the main medical examination influencing doctor's decisions. EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial distortion quantification software also has been modified with new cut off and different calculation method. The aim of this study is to compare the quality of images and the quantification of cardiac ejection fraction with these new software in order to choose the more reliable and reproducible for patient.

Official Title
-----------------
Evaluation of New Items in Cardiac Echography

Conditions
-----------------
Cardiac Echography, Cardiac Ultrasound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient accepting to stay 15 min more Age > 18 years old Exclusion Criteria: patient not accepting this procedure

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac left ejection fraction | Evaluation of left ejection fraction by 3D | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echographic images evaluation |  | day 1 |