linjc16/ctgov huggingface dataset:
Registry to Evaluate Maintenance Treatment With Venofer in Pediatric Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The current registry is being undertaken to assess the long-term (12 month) safety and tolerability of Venofer in the pediatric population with chronic kidney disease that requires intravenous iron maintenance therapy.

Detailed Description
-----------------
This will be a multicenter, observational, prospective registry collecting long-term (12-month) safety, tolerability, and laboratory data. Subjects will be screened for inclusion criteria if on hemodialysis (HD), peritoneal dialysis (PD) or have non-dialysis dependent (NDD) chronic kidney disease (CKD). Treatment-emergent adverse events (adverse events starting from the time of the 1st dose of Venofer administered on study) will be collected via site entry of data into a web-based system. Each research investigator will be responsible for entering adverse event information on the appropriate clinical research form as well as reporting such events to the sponsor. Number of Subjects: 50 evaluable subjects (i.e., took at lease one dose of Venofer and have safety data recorded at the 12 month time point).

Official Title
-----------------
A Multicenter Registry to Evaluate the Long-term Safety and Tolerability of Maintenance Treatment With Iron Sucrose (Venofer) in Pediatric Patients Ages ≥ 2 to ≤ 17 Years With Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 2 to less than or equal to 17 years Subjects must have a diagnosis of either NDD-CKD, PD-CKD or HD-CKD Dialysis patients must be on a stable periotoneal (PD) or hemodialysis (HD) regimen for 1 month Patient agrees to participate in the registry (i.e., provide adverse event information) for 12 months Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Treatment- emergent adverse events (TEAE) | Adverse Events starting from from the 1st dose of Venofer adminstered on study through 12 month observation | 1st Venofer dose through 12 month observation |
Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Many inflammatory disorders in the body are linked to oxidative tissue damage. Anti-oxidants that are present in many natural food sources may provide protection from such damage. Beta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae Dunaliella is particularly rich in beta carotene. In this prospective trial we want to investigate whether beta carotene from Dunaliella may prevent exacerbations of Crohn's disease.

Detailed Description
-----------------
Patients with documented Crohn's disease who are at least 2 months in remission (CDAI<150) will be randomized to receive 60 mg beta carotene/day vs. placebo for 1 year. The study medication will be taken in addition to regular treatment for Crohn's disease. The protocol includes 5 visits (months 0, 3, 6, 9, 12). Each visit lasts 30-60 minutes and includes a brief interview, standard questionnaires, physical examination, and blood tests. Exacerbation of Crohn's disease is defined as CDAI>150. The study hypothesis is that less patients treated with beta carotene will suffer an exacerbation than patients treated with placebo.

Official Title
-----------------
Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: beta carotene from Dunaliella algae


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with documented Crohn's disease in remission (CDAI<150) for at least two months, age 17-75 years Exclusion Criteria: active Crohn's disease (CDAI>150), partial bowel obstruction, impending surgery, pregnancy, serious other diseases

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: beta carotene from Dunaliella algae|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI score measured 3-monthly during treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, remission, beta carotene
Assessment of Pelvic Floor Function in Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the importance of functional assessment of the pelvic floor (AFA) in older women, as prognostic factor for Urinary Incontinence (UI).

Detailed Description
-----------------
Incontinence elderly assessment

Official Title
-----------------
Assessment of Pelvic Floor Function in Women With Urinary Incontinence

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly women Urinary incontinence Exclusion Criteria: Cesarean surgery

Ages Eligible for Study
-----------------
Minimum Age: 58 Years
Maximum Age: 87 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 |
| --- | --- |
| G2<br>G2 = control group (no incontinence) | |
| G1<br>G1 = urinary incontinence | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All patients were submitted for review physiotherapeutic through palpation bidigital and quantification of contraction pelvic, was performed using a my feedback of pressure |  | Only one measure at the begging of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary incontinence, pelvic floor, functional evaluation
Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).

Official Title
-----------------
A European Trial Evaluating the Safety and Effectiveness of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Left Atrial Appendage Closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (AF). 2. Subject must be ≥18 years of age. 3. Subject has a calculated CHA2DS2-VASc score of 2 or greater. 4. Subject must be clinically stable on warfarin (or other anticoagulant) therapy for a minimum of three months. 5. Subject must have at least two International Normalized Ratios (INRs); 2-3, if on Warfarin. 6. Subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy. Exclusion Criteria: 1. Subject who requires anticoagulation for a condition other than AF. 2. Subject with a New York Heart Association (NYHA) classification equal to IV. 3. Subject with a history of or implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device that would interfere with the investigational device placement. 4. Subject with valvular disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Left Atrial Appendage Closure<br>* Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF<br>* Other names: Left Atrial Appendage Occlusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from device or procedure related serious adverse events |  | 7 days | 
| Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE |  | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism |  | 45 days and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left Atrial Appendage Closure
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants

Study Overview
=================
Brief Summary
-----------------
The researchers want to determine if ambient light, plethysmographic , can monitor reliably heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.

Detailed Description
-----------------
The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window. Heart rate and oxygen saturation will be extracted from the plethysmographic signal off the cheek, forehead or hand while the respiration rate may be retrieved from the plethysmographic signal off the chest area.

Official Title
-----------------
A Pilot Study Using Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Device: Plethysmographic monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infant in NICU at CHOC hospital Exclusion Criteria: non-infant

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 1 Week

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 |
| --- | --- |
| Plethysmographic monitoring<br>Plethysmographic monitoring | Device: Plethysmographic monitoring<br>* Plethysmographic monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ambient light, PPG can monitor reliably heart rate, respiration rate and oxygen saturation (SpO2) |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
monitoring
Reducing Edema Following Refractive Surgery

Study Overview
=================
Brief Summary
-----------------
Determine if edema plays a role in refractive surgery

Detailed Description
-----------------
Prospective, comparative study

Official Title
-----------------
Reducing Edema Following Refractive Surgery

Conditions
-----------------
Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent bilateral Refractive surgery for myopic correction. Age 18-60. Evidence of an epithelial defect. Uncorrected visual acuity at study visit better than 20/40 Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits. Exclusion Criteria: Any other anterior segment abnormality other than that associated with Refractive surgery. Any abnormalities associated with the eye lids. Prior laser treatment of the retina. Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery. Diagnosis of glaucoma. Active diabetic retinopathy. Clinically significant inflammation or infection within six (6) months prior to study. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device. Intolerance or hypersensitivity to topical anesthetics A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

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 |
| --- | --- |
| 1<br>Bilateral post refractive procedure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Thickness |  | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractive surgery
NovellusDx Tissue Collection Protocol

Study Overview
=================
Brief Summary
-----------------
NovellusDx is developing a diagnostic platform for the personalized cancer therapy based on patient derived tumor tissue. The assay is able to sense activating mutations by monitoring their effect on a chip-based device.

Official Title
-----------------
An Observational Study to Assess the Oncogenic Status of Colorectal Cancer Patients That Have Undergone Surgery

Conditions
-----------------
Patients That Have Been Diagnosed With Colorectal Cancer, Patients Eligible for Tumor Biopsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that have been diagnosed positive for colon cancer. available treatment follow up during cancer treatment Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Correct identification of tumor mutant genes | Correct identification of tumor mutant genes, in over 85% of the cases | up to 12 month |
CT Analysis of the Patellofemoral Joint in Patients Having Knee Surgery

Study Overview
=================
Brief Summary
-----------------
The primary hypothesis is that measures of patellofemoral alignment obtained from the investigational cone beam CT scanner will be reduced, but still correlated to those obtained from the conventional CT scan.

Official Title
-----------------
Comparison of a Novel Weight Bearing Cone Beam Computed Tomography (CT)Scanner Versus a Conventional CT Scanner for Measuring Patellar Instability

Conditions
-----------------
Patellar (or Kneecap) Instability and Mal-alignment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been diagnosed with acute or chronic patellar malalignment. At least 16 years old Be willing and able to provide informed consent Exclusion Criteria: Open growth plates Previous knee surgery on the affected knee Pregnancy (females) Fracture of the patellofemoral joint Knee ligament injury (other than medial patellofemoral ligament) Have greater than Grade II degenerative changes of the patellofemoral joint Inability to bear weight on the extremity during the CT scan

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Congruence Angle CBCT |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tilt Angle |  | Baseline | 
| Tibial Tuberosity Trochlear Groove |  | Baseline |
Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

Study Overview
=================
Brief Summary
-----------------
Trauma patients are at risk for serious head trauma. The consequences of serious head trauma are often life altering. Currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the CT scan. This time consuming test requires transportation of a potentially unstable patient to the CT scanner. The investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. Brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. The investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as CT scan in doing this. The investigators study aims to demonstrate that ultrasound of the optic nerve is as good as CT scan in ruling out clinically significant elevations in pressure within the brain. After consent has been obtained, any trauma patient who has an indication to undergo CT scan of the brain will also undergo ultrasound of the eye. A radiologist will then review the CT scans to determine if signs of elevated intracranial pressure are present. The investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure. **Update August 2009** Currently, deferred consent has been obtained from our REB allowing us to defer consent for this intervention of minimal risk. As well, REB has also approved phone consent in the interim.

Official Title
-----------------
Measurement of Optic Nerve Sheath in Traumatic Raised Intracranial Pressure

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater or equal to 16 involved in blunt trauma. Patient is to undergo a CT of the head to evaluate suspected closed head injury Consent and ultrasound can be preformed within 1 hour before or after CT of the head Exclusion Criteria: Penetrating trauma to the head or significant ocular trauma Patients not expected to survive transfer out of the emergency room department Patient is too unstable to undergo a CT of the head or ultrasound of the optic nerve

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Elevation in intracranial pressure as estimated by CT scan or ICP monitor |  | Immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracranial pressure, intracranial hypertension, ultrasound, emergency, traumatic brain injury, ocular ultrasound
Evaluative Research in the Process of Implementation of an Alternative Device to Hospitalization for People Homeless With Severe Psychiatric Disorders

Study Overview
=================
Brief Summary
-----------------
The research project aims to analyze the implementation of a new health care system - alternative device to hospitalization and crisis home for people without home - whose objective is to provide the homeless and suffering from severe psychiatric disorders adequate care to prevent situations from seeking care or complication of their disease. This device, if it has the administrative and legal structure of the Twin Stop Health Care (LHSS), is based on the original concept of Soteria House. This will build tools for evaluating the performance of care device by a process evaluation describing and analyzing what activity involves the device, This research seeks to analyze the experimental device in the early stages of its implementation. The observation and analysis of the program period will adjust the management arrangements of the device. The data and conclusions from this research will identify the contributions and benefits of such a device and analyze the difficulties encountered in its implementation.

Official Title
-----------------
Evaluative Research in the Process of Implementation of an Alternative Device to Hospitalization for People Homeless With Severe Psychiatric Disorders

Conditions
-----------------
Severe Psychiatric Disorders

Intervention / Treatment
-----------------
* Other: interview and observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults without home with severe psychiatric disorders utilizing the structure, adults who master the French language Exclusion Criteria: adults not mastered the French language

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

| Intervention/Treatment |
| --- |
|Other: interview and observation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| socio-anthropological survey | Biographical interviews and three du'entretiens targeted series on the course therapy will be conducted | 1 year |