linjc16/ctgov huggingface dataset:
Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.

Official Title
-----------------
Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Fulvestrant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive HR or ER by immunohistochemistry Postmenopausal status at the time of treatment with fulvestrant Failure of at least one previous endocrine therapy before treatment with fulvestrant. Exclusion Criteria: Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Postmenopausal women with hormone-receptor positive, advanced breast cancer who have failed at least one previous endocrine therapy and who have been treated at any one of the participating centres with fulvestrant. | Drug: Fulvestrant<br> <br> * Other names: Faslodex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumour progression |  |  | 
| Objective response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment with fulvestrant |  |  | 
| Time and duration of response |  |  | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Breast Cancer, Hormone Therapy
Active Surveillance Magnetic Resonance Imaging Study

Study Overview
=================
Brief Summary
-----------------
This is a multi-centre, prospective, randomized phase III trial to determine if multi-parametric Magnetic Resonance Imaging (MRI) can improve selection of patients eligible for active surveillance through better detection of clinically significant cancer.

Official Title
-----------------
Active Surveillance Magnetic Resonance Imaging Study

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

Intervention / Treatment
-----------------
* Device: MRI assisted TRUS guided biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological confirmation of adenocarcinoma of the prostate candidate for active surveillance (favourable risk prostate cancer) as defined by the following: Clinical stage T1b, T1c, T2a or T2b at the time of diagnosis Clinical (diagnostic biopsy) Gleason sum < 6 PSA < 10.0 ng/ml (ug/L) Exclusion Criteria: Previous treatment for prostate cancer including surgery (excluding biopsy), radiation therapy, hormonal therapy (e.g. megestrol, medroxyprogesterone, cyproterone, DES), glucocorticoids (except inhaled or topical), LHRH analogues (e.g. Leuprolide, goserelin), ketoconazole, non-steroidal antiandrogens (e.g. bicalutamide, flutamide) and/or any 5α-reductase inhibitors within 3 months of randomization Planned anti-androgen therapy Inability to undergo TRUS biopsy Inability to undergo multi-parametric MRI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TRUS guided biopsy<br> | |
| Experimental: MRI Assisted TRUS guided biopsy<br> | Device: MRI assisted TRUS guided biopsy<br>* All subjects to have a confirmatory biopsy at one year. Those assigned ARM 1 to have a TRUS guided biopsy and those assigned to ARM 2to have a MRI assisted TRUS guided biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (3+4) or higher |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of subjects whose confirmatory biopsy is upgraded to Gleason score 7 (4 + 3) or higher |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
active surveillance, low risk prostate cancer
Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether the TUG device is safe and effective in patients with primary open angle glaucoma or ocular hypertension.

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked, 8-week Pilot Study Evaluating the Safety and Efficacy of the TUG (Therapeutic Ultrasound for Glaucoma) Compared to Sham in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Primary Open Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Device: TUG
* Device: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Diagnosis of primary open angle glaucoma or ocular hypertension in both eyes Be willing to discontinue disallowed products and/or medications during the period indicated prior to participation or throughout the study Be willing to provide written informed consent Be willing and able to follow instructions A negative urine pregnancy test and agree to an acceptable form of contraception for the duration of the study (if female of childbearing potential) Exclusion Criteria: Any form of glaucoma other than primary open angle glaucoma or ocular hypertension in either eye Prior or anticipated concurrent use of an investigational drug or device Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test Have a condition (ocular or systemic) or a situation which, in the Investigator's opinion, may put the subject at increased risk, may confound study data, or may interfere significantly with the subject's study participation

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TUG Device<br>1 time external application - device powered on | Device: TUG<br>* Therapeutic Ultrasound for Glaucoma<br>|
| Sham Comparator: Sham<br>1 time external application - device powered off | Device: Sham<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean IOP |  | through subject study completion; average 2 months | 
| Change in mean diurnal IOP |  | Week 4 (Visit 5) and Week 8 (Visit 7) | 
| Change in IOP from baseline |  | through subject study completion; average 2 months |
Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02)

Study Overview
=================
Brief Summary
-----------------
Study design: -The study will be a phase I like study to assess the extent to which prostate HistoScanning (PHS, the index test) can identify and characterize foci of prostate cancer when compared to histological samples harvested during radical prostatectomy (the reference test). The study will comprise 3 steps: first, defining the most suitable method for matching the TRUS (TransRectalUltrasonography) to histology (step 1); second, refining the algorithms (training set); third, verification of the PHS performances (test set). Study objectives: Primary Objective: To evaluate the extent to which PHS can discriminate between malignant lesions of the prostate versus non-malignant tissue in 3D RF TRUS data using radical prostatectomy histological step sectioning as the reference test. Secondary Objectives: To adapt and refine PHS tissue characterisation algorithms using RF data that were previously developed using grey-level data as input. To assess the accuracy of PHS in predicting the volume of prostate cancers determined by histology. To assess the ability of PHS to rule in or rule out the presence of cancer > or = 0.5 cc and of > or = 0.2 cc as determined by histology. To evaluate the ability to discriminate primary Gleason pattern 4 and 5 versus 3 or less in tumours > or = 0.5 cc and > or = 0.2 cc. To assess the ability of PHS to correctly risk stratify patients.

Official Title
-----------------
Prostate HistoScanning for the Non-invasive Detection and Staging of Prostate Cancer and Characterization of Prostate Tissues (PHS-02)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: >or=18 year-old Histologically (positive biopsy) proven prostate cancer with primary and secondary Gleason patterns attributed. Patient planned to undergo radical prostatectomy Prostate cancer is deemed to be organ confined (T1-T2, Nx or No, Mx or Mo) No prior treatment for prostate cancer, including any type of hormonal therapy No major calcification is noted during the TRUS (i.e. (Diameter >or=5 mm, spread all over the prostate or blocking to much of the ultrasound signal). Patient willing to give written informed consent Exclusion Criteria: Patients who are either unsuitable or unwilling to enter the study or to proceed to surgical investigation.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prostate cancer<br>Patients with histologically proven prostate cancer (positive biopsy) and who are planned to undergo radical prostatectomy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army

Study Overview
=================
Brief Summary
-----------------
Each year, military epidemiological surveillance counts approximately 1,000 acute acoustic injuries. Most are caused by exposure to weapon noise during training sessions while military personnel are provided with hearing protection. Several hypotheses could explain the occurrence of acute acoustic trauma despite wearing protections: A lack of practices or knowledge about the use of hearing protection equipment that could facilitate the occurrence of acute acoustic trauma (improper fitting, use of an inappropriate type of protection, dropping of protectors, inappropriate removal) A failure to seal the external ear canal due to an inappropriate plug size. These hypotheses will be explored using a questionnaire distributed to a population of Army soldiers training to shoot. The main objective is to determine the predictive factors corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma in a population of Army soldiers.

Official Title
-----------------
Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army

Conditions
-----------------
Acoustic Trauma

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be a member of the Army Having performed at least one shooting session in the last 12 months Exclusion Criteria: Inability to read and/or write in French language

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|The participants will have to fill in a questionnaire about their knowledge and their attitude regarding auditory risk.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the importance of variables corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma. | The importance of variables will be measured thanks to a random forest algorithm. | At enrollment |
Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.

Official Title
-----------------
Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation

Conditions
-----------------
Kidney Transplant Rejection, Skin Graft

Intervention / Treatment
-----------------
* Procedure: Skin allotransplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with end-stage renal disease undergoing renal transplantation; 18-60 years old; Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes); The participants had good compliance, volunteered to participate in the test and signed the informed consent form. Exclusion Criteria: Untreated or disseminated malignant tumor; Active period of infectious diseases; Serious cardiovascular disease occurred recently; Combined with other important organ failure; History of mental illness or cognitive impairment;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Kidney and skin transplataiton<br> | Procedure: Skin allotransplantation<br>* Sentinel skin grafts from the same donor source will be carried on in the meantime of kidney transplantation for assisting to detect acute renal rejection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2017 Banff Kidney Transplantation Rejection Rating | A rating evaluation on kidney rejection | Through study completion, an average of 1 year | 
| 2007-edition Banff skin containing allogeneic composite histopathological diagnosis grading | Skin histopathological diagnosis | Through study completion, an average of 1 year | 
| Renal function testing | Blood Cr and Bun testing | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal ultrasound diagnosis | Renal ultrasound diagnosis | Through study completion, an average of 1 year | 
| Complications | Complications assessment | Through study completion, an average of 1 year |
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to <17 years, when administered as part of post-Rabies Exposure Prophylaxis (PEP).

Official Title
-----------------
Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies

Conditions
-----------------
Rabies

Intervention / Treatment
-----------------
* Drug: KamRAB - HRIG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children (male and female) ages 0 months to <17 years. Have been exposed or possibly exposed to rabies. Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection. Have documented informed consent from the child's parent(s) or legal guardian(s) and assent from the child if appropriate. Exclusion Criteria: History of previous administration of rabies vaccine or human rabies immune globulin (HRIG) Rabies exposure or possible rabies exposure more than seven days prior to initiation of PEP, or timing of exposure unknown

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 17 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 |
| --- | --- |
| Experimental: 20 IU/kg KamRAB + Active Anti-Rabies Vaccine<br> | Drug: KamRAB - HRIG<br>* wound infiltration or IM injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment |  | Within 14 days from treatment | 
| Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment |  | Within 84 days of treatment |
Opinions of Healthcare Providers About Neuromodulation

Study Overview
=================
Brief Summary
-----------------
The goal of this online survey is to gain further insight in the goals, expectations and definition of success for neuromodulation for pain, according to healthcare providers.

Official Title
-----------------
Opinions of Healthcare Providers About Neuromodulation for Pain: an Online Survey

Conditions
-----------------
Neuromodulation, Pain, Survey

Intervention / Treatment
-----------------
* Behavioral: Filling in an online survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Male and female adults who are involved in the management of chronic pain and more specifically in neuromodulation for pain (including but not limited to anesthesiologists, neurosurgeons, nurses). Exclusion Criteria: - Not involved in management of chronic pain through neuromodulation.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physicians using neuromodulation<br> | Behavioral: Filling in an online survey<br>* Physicians are asked to fill in an online survey regarding 1) goals to treat patients with neuromodulation for pain, 2) factors that respondents expect to change according to neuromodulation for pain and 3) their definition of success of neuromodulation for pain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician goals, evaluated with a self-constructed question. | Goals of physicians to treat patients with neuromodulation for pain. | Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September. | 
| Physician expectations, evaluated with a self-constructed question. | Factors that respondents expect to change according to neuromodulation for pain. | Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September. | 
| Physician definition of success, evaluated with a self-constructed question. | Physician definition of success of neuromodulation for pain. | Cross-sectional evaluation during 2nd Joint Congress of the INS European Chapters (e-INS 2021) in Paris in September. |