linjc16/ctgov huggingface dataset:
Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

Study Overview
=================
Brief Summary
-----------------
In clinical practice, many patients are not able to modify their habits to achieve a high level of diuresis and fluid intake and therefore are at an elevated risk for stone recurrence. The investigators think that Ure-Na (osmotic agent) taking could help to increase urine volume and decrease urine concentration, which would be of benefit in the prevention of kidney stones.

Official Title
-----------------
Research Project: Pilot Study on Oral Urea Use in Patients at High Risk of Kidney Stone Recurrence

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Drug: Ure-Na


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 60 years of age High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.) Diuresis < 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months) Exclusion Criteria: Patient does not meet 1 of the 3 inclusion criteria Pregnancy or breastfeeding Lack of understanding about the protocol and effects of Ure-Na Expected inability to adequately increase fluid intake on Ure-Na

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label<br>The study provides for a single group, which will be its own control (pre/post intervention study). Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) for 1 month | Drug: Ure-Na<br>* Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day) Treatment will continue for approximately 1 month.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in urine output at 1 week and 1 Month | variation in 24-hour diuresis and urine biochemistry | 1 week and 1 month |
Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.

Detailed Description
-----------------
T1D is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. Impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan. The investigators will compare baseline, 12 month and 24 month changes in High-resolution peripheral quantitative computed tomography/micro-finite element analysis (HR-pQCT/μFEA)-based estimates of bone strength and bone turnover by biochemical measurements in 40 T1D children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). The investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (CGM).

Official Title
-----------------
Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength

Conditions
-----------------
Type1diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (T1D and Controls): - Children within 2 years preceding the onset of the pubertal growth spurt Inclusion Criteria (T1D participants): - documentation of β-cell autoimmunity and need for insulin replacement Exclusion Criteria: Estimated glomerular filtration rate (eGFR)< 60 ml/mim 25(OH)D level < 20 ng/ml. Celiac disease Autoimmune thyroid disease Addison's disease History of pathological fractures -- Disorders associated with altered skeletal structure or function Bone active drugs in past year Diabetes of other or unclear etiology

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 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 |
| --- | --- |
| Group 1<br>Those with Type 1 Diabetes. | |
| Group 2<br>Those without Type 1 Diabetes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microarchitecture by HR-pQCT | Measures of HRpQCT | Two Years | 
| Change in bone mineral density by Dual X-ray Absorptometry (DXA) | Measures of DXA | Two Years |
The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant properties. It has been proven to decrease oxidant stress and to cause the regression of atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very important in preventing atherosclerosis. The study will try to prove that a polyphenolic extract from pomegranate (POMx) has the same desired effects.

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Drug: POMx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males HBA1C>7% Drug therapy given for DM Exclusion Criteria: Age<18 Inclusion in another study

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: POMx|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minors, Enrollment in another study, Males, HBA1C greater than 7, Drug therapy for DM
Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The investigators will study this potential anti-inflammatory activity in healthy subjects.

Official Title
-----------------
Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male non-asian subjects Exclusion Criteria: Patients with increased liver function tests, elevated serum creatinine, patients on anti-inflammatory or immunomodulating drugs

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 39 Years

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

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

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
-----------------
Statins, anti-inflammatory, Healthy subjects study
NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an experimental alternative imaging method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory system to examine the breasts for cancer. The NIR system uses light beams to produce an image or picture of the inside of the breast. The respiratory system will help researchers get more information about the breast tissue by changing the amount of oxygen the tissue receives during NIR imaging.

Official Title
-----------------
NIR (Near Infrared Spectral Tomography)Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NORMAL cohort Breast size and epithelial integrity adequate to allow NIR imaging exams No serious associated psychiatric illnesses Female, ≥25 and <76 years old Written informed consent UNDER TREATMENT cohort Locally advanced breast cancer, with or without metastatic disease, defined as being clinically appropriate for neoadjuvant therapy Breast size and epithelial integrity adequate to allow NIR imaging exams No serious associated psychiatric illnesses Female, ≥25 and <76 years old Written informed consent Exclusion Criteria: both cohorts Pre-existing respiratory conditions: severe chronic obstructive pulmonary disease (including chronic bronchitis and/or emphysema) Other respiratory or lung conditions which would place the patient at risk presence of any other significant cardiac or pulmonary symptoms, such as moderate or severe dyspnea on exertion, orthopnea, or paroxysmal nocturnal dyspnea Congestive heart failure Intolerance of hyperoxia or hypercarbia as delivered by the RespirAct breathing circuit Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 76 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Under Treatment<br>Patients with locally advanced breast cancer, defined as being clinically appropriate for neoadjuvant therapy | |
| Normal Cohort<br>Healthy female volunteers with breast size and epithelial integrity adequate to allow NIR imaging exams | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor. | Analyze captured data from use of dynamic NIR topographic oximetry (in a cohort of women receiving conventional anthracycline/taxane based adjuvant chemotherapy).Quantify pathological and clinical outcomes. | 18 weeks approximately |
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

Study Overview
=================
Brief Summary
-----------------
21 patients were randomised to receive instructions and coaching or no intervention on the use and intake of ganciclovir. Intake of medication was measured by an electronic pill box. The duration of the study was 100 days.

Official Title
-----------------
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

Conditions
-----------------
Cytomegalovirus Infections

Intervention / Treatment
-----------------
* Behavioral: instructions and coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women between 18 and 65 years old de novo kidney transplant patients patients who need CMV prophylaxis with ganciclovir during 3 months patients who gave informed consent after an oral explanation of the study Exclusion Criteria: patients who are seronegative for CMV virus and who received a kidney from a CMV negative donor patients with a creatinin clearance of less than 10 ml/min

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>instructions and coaching on the use and intake of ganciclovir | Behavioral: instructions and coaching<br>* instructions and coaching or no intervention on the use and intake of ganciclovir<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation |  | weekly follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation between compliance and the instructions which a patient gets about intake of medication |  | weekly follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
the effect of information on compliance of medication
Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor

Study Overview
=================
Brief Summary
-----------------
A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.

Official Title
-----------------
Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive PPG-based Monitor in the Cardiac ICU

Conditions
-----------------
Acute Cardiac Event, Acute Cardiac Failure, Acute Cardiac Pulmonary Edema

Intervention / Treatment
-----------------
* Device: Non-invasive Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 years and above admitted to the Cardiac ICU due to an acute cardiac event. Exclusion Criteria: Pregnant women, subjects under the age of 18 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non-invasive Monitoring|Wearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of cardio-respiratory changes | Detection of acute cardio-respiratory/hemodynamic changes during hospitalization and during interventional procedures conducted in the cardiac ICU. | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Workflow assessment. | Nursing staff will be asked - using questionnaires - to assess whether the use of these devices helps in reducing burden of work and increase other interactions with the patients. | Through study completion, an average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Catdiac Events; Remote Patient Monitoring
COMPLEX Post Market Surveillance Electronic Registry

Study Overview
=================
Brief Summary
-----------------
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.

Detailed Description
-----------------
This Post Market Surveillance Registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial aneurysms treated with the Trufill DCS Orbit detachable platinum coils.

Official Title
-----------------
COMPLEX Post Market Surveillance Electronic Registry

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: Endovascular Embolization Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with angiographically documented aneurysms, Either ruptured or unruptured, Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization Exclusion Criteria: 1) Patient / Treatment outside of the approved labeling, indications for use.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trufill Detachable Coil System<br>There is only one treatment arm in the registry and it is all patients receiving treatment with Trufill Detachable Coil System. The use of bare platinum coils for the endovascular occlusion of cerebral aneurysms. | Device: Endovascular Embolization Device<br>* The TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils are each an embolic coil system that consists of a platinum detachable coil, a delivery system (delivery tube and coil introducer) and a syringe. Each system has been designed to deliver, position and detach embolic coils in order to embolize intracranial aneurysms<br>* Other names: TRUFILL® DCS and TRUFILL DCS ORBIT Detachable Coils;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms |  | Between 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and product complaints |  | Ongoing throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracranial aneurysm
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
Resistant hypertension is defined as hypertension not controlled (i.e. blood pressure not below 140/90 mmHg) with the use of adequate doses of at least three different anti-hypertensives including a diuretic. Resistant hypertension is abundant. In the ALLHAT trial 34% of patients did not reach the blood pressure goal of 140/90 mmHg. One possible mechanism of resistance is the aldosterone-escape phenomenon. During aldosterone escape, aldosterone plasma levels are normal or even elevated despite therapy with ACEIs or ARBs. The prevalence is about 30-50%. Possible reasons for aldosterone escape are alternative ways of aldosterone stimulation (hyperkalemia, adrenomedullin, ACTH), local aldosterone production or primary aldosteronism. Aldosterone has deleterious blood pressure independent effects on cardiac, vascular and renal damage. Hypothesis: Eplerenone is effective to improve hypertensive target organ damage in patients with resistant hypertension.

Detailed Description
-----------------
see above

Official Title
-----------------
Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Casual blood pressure >=140/90 despite effective triple therapy including an ACEI/ARB and a diuretic Exclusion Criteria: Contraindication for eplerenone Creatinine-Clearance < 60 ml/min Diabetes mellitus

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: placebo<br>* od<br>|
| Active Comparator: 2<br>Eplerenone | Drug: eplerenone<br>* 50mg od<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of left ventricular mass | MRT assessment of left ventricular mass | 3 months vs. baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential hypertension