linjc16/ctgov huggingface dataset:
A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients (SUnitinib Prospective CardiovasculaR Effect)

Study Overview
=================
Brief Summary
-----------------
While sunitinib can be very helpful to treat kidney cancer, these medications can also cause side effects, including heart damage. Studies performed in the past did not look at heart function in detail, so the investigators do not know what happens to the heart when people start sunitinib treatment. The aim of the study is to prospectively study acute effects of sunitinib on heart function, overall fitness and blood markers of heart disease.

Detailed Description
-----------------
Participants will undergo cardiac MRI, maximal exercise testing(VO2 peak), blood and urine samples before and after 2 treatments of sunitinib. An extra blood sample will be collected the 2nd week of the first treatment to check blood levels of sunitinib. We will also examine routine CT scans to study body composition.

Official Title
-----------------
A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients

Conditions
-----------------
Renal Cell Carcinoma, Cardiotoxicity, Heart Failure, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic diagnosis of metastatic renal cell carcinoma Eligible to receive first-line sunitinib Willingness to attend Cross Cancer Institute and University of Alberta for study-related assessments Karnofsky Performance Status (KPS)82 ≥ 70 Age ≥ 18 years of age Adequate creatinine clearance to receive gadolinium All patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to CPET; Fluent in English language No contraindication to MRI or other concern eg., metallic implants, claustrophobia Exclusion Criteria: Prior systemic therapy for mRCC Documented history of major cardiac event in last year i.e. MI, unstable angina, CABG, symptomatic CHF, CVA or TIA, or pulmonary embolism Pregnancy Other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate Unstable brain metastases

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 renal cell carcinoma scheduled to receive sunitinib | |

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
-----------------
sunitinib, cardiac MRI, maximal exercise testing, biomarkers, pharmacokinetics
Sunface Mirroring RCT in Brazil

Study Overview
=================
Brief Summary
-----------------
Randomized trial looking at the effects of a behavioral photoaging software intervention on sunscreen use in the city of Itauna, Brazil.

Official Title
-----------------
Randomized Trial of a Photoaging Mirroring Intervention for Skin Cancer Prevention in Secondary Schools in Brazil - Study Protocol

Conditions
-----------------
Skin Cancer

Intervention / Treatment
-----------------
* Behavioral: photoaging mirroring intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visiting a secondary school in Brazil. Exclusion Criteria: Not visiting a secondary school in Brazil.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>45 minutes seminar on skin cancer prevention and UV-protection in general. | Behavioral: photoaging mirroring intervention<br>* selfies of the students are photoaged showing them the consequences of their UV protection behavior on their own face<br>|
| No Intervention: Control<br>The control croup takes part in the survey but does not receive an intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prevalence of daily sunscreen use at six months | The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to six months follow-up vs. in the control group from baseline to six months follow-up. | 6 months | 
| Change in prevalence of daily sunscreen use at one months | The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to one months follow-up vs. in the control group from baseline to one month follow-up. | 1 month |
Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).

Official Title
-----------------
A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: Aranesp®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects with end stage renal disease (ESRD) on hemodialysis Exclusion Criteria: - Known hypersensitivity to Aranesp® (darbepoetin alfa) or any of its excipients - Participating in an investigational drug or device trial - Patient will not be available for follow-up assessment - Patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aranesp®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target hemoglobin (Hgb) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of hemoglobin (Hgb) values by week |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End Stage Renal Disease (ESRD), Kidney Disease, Dialysis, Aranesp®, rHuEPO, Anemia, Hemoglobin, Dosing, Amgen
Doctor's Health - Health Behavior of Physicians in Germany

Study Overview
=================
Brief Summary
-----------------
This is an observational study to assess the health behavior of Physicians from medical practices in Germany. Physicians will be asked by a questionnaire (self-report) on health behavior, self-diagnostics and self-medication in case of sickness. We will send the questionnaire to 1000 General Practitioners and to 300 medical specialists in Germany. We expect a response rate of 25-30 %. After electronically data-entry we will run a descriptive analysis for primary outcome. Results may provide a better understanding of the Physicians health behavior.

Official Title
-----------------
Doc's Health - Doctor as a Patient - An Observational Study on Health Behavior of Physicians in Germany

Conditions
-----------------
Chronic Diseases, Chronic Illnesses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians in German ambulatory setting Exclusion Criteria: any

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| General Practitioner / Family Physician in German Primary care<br> | |
| Medical Specialists<br>Working in the ambulatory setting | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians health behavior | questionnaire | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians medication use | questionnaire | 1 day | 
| Physicians preventive care | questionnaire | 1 day |
Measurement Of Endotracheal Tube Cuff Pressure In Emergency Department Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to measure the endotracheal tube cuff pressure in patients who have been endotracheally intubated emergently in the emergency department or in the field by prehospital personnel. Overinflation of ETTc pressure is associated with injury, and we seek to determine if the phenomenon of excessively inflated ETTc can be detected in endotracheally intubated patients in the ED. There is no experimental aspect to this study, it is only descriptive. Measurement of ETTc pressure is already performed by respiratory therapy/respiratory care. We simply seek to assess these measurements to determine if any patients in fact have high ETTc pressure. If it is found that patients do have ETTc with high pressures, this might allow emergency department staff or prehospital personnel such as paramedics or EMTs to use this information to seek methods by which endotracheal intubation can be improved and patients can be intubated without excessive ETTc pressure. This is a pilot study. We have conducted several in vitro studies, which have all demonstrated that paramedics, EMTs, and emergency department physicians practice endotracheal intubation in a method that might result in excessively inflated ETTc.

Official Title
-----------------
MEASUREMENT OF ENDOTRACHEAL TUBE CUFF PRESSURE IN EMERGENCY DEPARTMENT PATIENTS

Conditions
-----------------
Intubation, Intratracheal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient emergently endotracheally intubated with a cuffed endotracheal tube. Exclusion Criteria: Endotracheal intubation procedure performed in a setting other than the prehospital (field) or emergency department of participating institution. This specifically excludes endotracheally intubated patients transferred from another hospital, chronic care facility, or other location. Non-emergent or elective endotracheal intubation.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal, intubation, tracheal, pressure, cufflator
Health Disparities on the Labor Floor

Study Overview
=================
Brief Summary
-----------------
The Agency for Healthcare Research and Quality (AHRQ) defines a disparity as a difference or a gap that exist between two groups, which is both statistically significant, larger than 10%, and indicates poor quality for the minority (non-referent) group. Despite advances in public health initiatives and medicine, disparities in healthcare are persistent. For example, in the United States, maternal mortality ratio has doubled since 1987 to 2009 where African American women were 4 times as likely to die from childbirth. Although there was no observed racial disparity in maternal deaths at University of Alabama Birmingham, there is anecdotal experience that may suggest health disparities do exist on the labor floor when examining neuraxial utilization and effectiveness. This retrospective study will seek to examine the successful extension of labor analgesia for cesarean section as it relates to insurance status.

Official Title
-----------------
Health Disparities on the Labor Floor

Conditions
-----------------
Pain, Pregnancy Related

Intervention / Treatment
-----------------
* Other: Retrospective Electronic Medical Record Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy Age >/= age 18 years Exclusion Criteria: Women less than age 18 will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Patients with private insurance<br> | Other: Retrospective Electronic Medical Record Review<br>* Patients will be assessed retrospectively for evidence of successful or failed epidural extension in the setting of need for cesarean section<br>|
| Patients with public/self-payer insurance<br> | Other: Retrospective Electronic Medical Record Review<br>* Patients will be assessed retrospectively for evidence of successful or failed epidural extension in the setting of need for cesarean section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful extension of labor epidural catheter for cesarean section | labor epidural activation in the setting of cesarean section | from the time of admission to the time of delivery |
Extension Study of PRX-102 for up to 60 Months

Study Overview
=================
Brief Summary
-----------------
To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.

Detailed Description
-----------------
An open-label study to evaluate the ongoing safety, tolerability and efficacy parameters of PRX-102 in adult Fabry patients (≥18 years of age). Patients enrolled received 1.0 mg/kg of PRX-102 as an intravenous infusion every 2 weeks (+/- 3 days) for up to 60 months and no less than 36 months.

Official Title
-----------------
A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients

Conditions
-----------------
Fabry Disease

Intervention / Treatment
-----------------
* Biological: PRX-102 (pegunigalsidase alfa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of study PB-102-F02 The patient signs informed consent Female patients and male patients whose co-partners were of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used throughout the duration of the study and for 3 months after termination of treatment. Exclusion Criteria: Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRX-102 (pegunigalsidase alfa)<br>PRX-102 (pegunigalsidase alfa) 1.0 mg/kg IV every 2 weeks (+/- 3 days) | Biological: PRX-102 (pegunigalsidase alfa)<br>* PRX-102 1 mg/kg every 2 weeks<br>* Other names: Recombinant human alpha galactosidase-A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | Results represent the number of treatment-emergent adverse events (TEAE) that were considered definitely, probably or possibly related to study treatment. | Every two weeks up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRX-102, pegunigalsidase alfa, Fabry Disease
Prevention of Renal Failure in Children With Urinary Tract Infections

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure.

Detailed Description
-----------------
The aim of the study is to describe the current clinical management of young children with urinary tract infections in Dutch primary care and also to describe the possibilities for improvement and potential cost-efficiency of improved care in the light of preventing renal failure. The 4 phases of the study contain the following questions: Phase 1: What is the current clinical management of urinary tract infections in young children in primary care? Phase 2: What are the possibilities for improving the clinical management of urinary tract infections and are these improvements practically achievable? Phase 3: What is the cost-efficiency of the several interventions for improving clinical management of urinary tract infections Phase 4: What is the influence of the intervention on clinical management?

Official Title
-----------------
Prevention of Renal Failure in Children With Urinary Tract Infections in General Practice: Current Clinical Management, Possibilities for Improvement and Potential Cost-Efficiency

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Behavioral: Written information for parents
* Behavioral: Distance learning package for General Practitioners
* Behavioral: Distance learning package for practice assistants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children between 0-12 years of age with a proven urinary tract infection in general practice Exclusion Criteria: -

Ages Eligible for Study
-----------------
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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Written information for parents|nan|
|Behavioral: Distance learning package for General Practitioners|nan|
|Behavioral: Distance learning package for practice assistants|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of antibiotic prescriptions |  | 10 days after 1st contact with GP | 
| Number of referrals |  | 10 days after 1st contact with GP | 
| Number of follow-up appointments |  | 10 days after 1st contact with GP | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal scarring, Urinary tract infections, Renal failure, Prevention, Primary Care, General Practice, Intervention Studies, Children
Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Official Title
-----------------
The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid

Conditions
-----------------
Uterine Fibroids, D-chiro-inositol, Inositol, Epigallocatechin Gallate, Vitamin D, Vitamin B6

Intervention / Treatment
-----------------
* Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids eligible for surgery symptoms like menometrorrhagia or pelvic pain Exclusion Criteria: BMI>30 currently pregnant or breastfeeding diabetic suspect of malignancy diagnosis of cancer

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women with uterine fibroids
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EGCG, Vit D, DCI, Vit B6<br>Women with uterine fibroids randomized to treatment group | Dietary Supplement: Epigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol<br>* The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D<br>|
| Placebo Comparator: Placebo<br>Women with uterine fibroids randomized to placebo group | Dietary Supplement: Placebo<br>* Maltodextrines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter | Greater diameter of the diagnosed uterine fibroids | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume | Total volume of the diagnosed uterine fibroids | 3 months | 
| Need for surgery | The percentage of patients that decide to avoid surgery | 3 months | 
| pVEGF-R | the phosphorilation of VEGF receptor | 3 months | 
| Marker of cellular proliferation | expression of ki67, ER, PR | 3 months |