linjc16/ctgov huggingface dataset:
iConquerMS™ - A Patient-Powered Research Network for Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
iConquerMS™ is a research initiative developed by and for people with multiple sclerosis (MS) to contribute their health data and ideas to advance and accelerate research into MS.

Detailed Description
-----------------
The purpose of this study is to create a Multiple Sclerosis Patient-Powered Research Network (MS-PPRN) that includes at least 20,000 people with multiple sclerosis (MS) who contribute data on their health and other topics. Survey data will be made available to research scientists who are studying MS and similar diseases. Our goal is to use this data to answer questions that researchers and people with MS have regarding the disease, including its causes, treatments, and other topics. The MS-PPRN will be part of a national network for conducting research called PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is supported by the Patient-Centered Outcomes Research Institute (PCORI). As the MS-PPRN is part of PCORnet, the data collected in surveys you complete may also be shared with researchers studying other diseases within the PCORnet network. While the MS-PPRN is focused on enrolling people with MS, people without MS are also welcome to participate in this research study. This study will be conducted online via the iConquerMS.org website. This is an ongoing study and will last for an indefinite period of time.

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 21 years of age or older at the time of informed consent. Exclusion Criteria: Unwilling or unable to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| People diagnosed with Multiple Sclerosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of people with multiple sclerosis who experience health-related quality-of-life changes |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS, Multiple Sclerosis
Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the effectiveness of a new surgical checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and to measure the frequency of compliance by surgical personnel at OHSU with specific daily safety protocols before and after introduction of the checklist. The investigators hypothesized that the use of an ESS specific surgical checklist will improve the frequency of compliance by surgical personnel at OHSU to internal safety concerns and protocols.

Detailed Description
-----------------
A total of 200 unidentified, non-randomized endoscopic sinus surgery cases will be observed and reviewed by research personnel (T.L.S, J.C.) within the Oregon Sinus Center, located within the Center for Health and Healing on the South Waterfront Campus of OHSU, under the direction of Timothy L. Smith, MD, MPH (PI). The first 100 surgical cases will be evaluated as pre-intervention cases by research personnel while the second 100 surgical cases will be evaluated as post-intervention cases after the introduction and discussion of the surgical checklist to operating room staff.

Official Title
-----------------
Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

Conditions
-----------------
Chronic Rhinosinusitis

Intervention / Treatment
-----------------
* Behavioral: Checklist introduction / Pause


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CRS defined by 2007 Adult Sinusitis Guidelines.13 Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS. Exclusion Criteria: Unable to complete surgical procedures due to perioperative complications.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical checklist<br>Compliance for surgical checklist | Behavioral: Checklist introduction / Pause<br>* Operating room staff will be introduced to a new checklist specifically designed to address concerns around protocols for endoscopic sinus surgery to raise awareness and attention to 11 specific areas of interest.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus surgery checklist | 11 dichotomous questions regarding observed operating room protocols for internal process improvement. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sinusitis, Disease, Chronic, Sinonasal
Fundus Changes in the Microphthalmy Eyes

Study Overview
=================
Brief Summary
-----------------
The goal is to describe the fundamental aspects of fundoscopic eye in patients with microphthalmia

Detailed Description
-----------------
Microphthalmos is a developmental ocular disorder defined as a small eyeball. The condition can be associated with abnormalities of anterior and posterior segments. The most common anterior characteristics include corneal opacities, angle-closure and a shallow anterior chamber and cataract. The main findings of posterior segment are uveal effusion, retinal folds, abnormalities of macular capillary vascularization, absence of foveal depression and peripheral retinoschisis. We performed on 3 patients with microphthalmos and their OCT features of posterior segment.

Official Title
-----------------
Fundus Changes in the Microphthalmy Eyes

Conditions
-----------------
Eye Diseases, Hereditary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of microphthalmia Exclusion Criteria: Eyes larger than 18mm

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 Years

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

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
-----------------
retina, fold, fovea
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. The definition of difficult cannulation is defined according to the literature.

Official Title
-----------------
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

Conditions
-----------------
Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
-----------------
* Device: Biliary cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study. Exclusion Criteria: Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pancreatic sphincterotomy<br>Pancreatic sphincterotomy performed in difficult cannulation | Device: Biliary cannulation<br>* Cannulation of biliary duct by sphincterotome<br>|
| Active Comparator: Pancreatic sphincterotomy + pancreatic stent<br>Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement | Device: Biliary cannulation<br>* Cannulation of biliary duct by sphincterotome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP pancreatitis rate |  | 30 days |
Effect of Valsartan on Proteinuria in Patients With Hypertension and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This is a study of whether valsartan affects levels of proteinuria in patients with type 2 diabetes and hypertension.

Official Title
-----------------
A Multi-center, Double Blind, Randomized, Parallel Group Study to Evaluate the Effects of Valsartan on Proteinuria in Hypertensive Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
PROTEINURIA, Hypertension, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Mild to moderate hypertension, Mild renal dysfunction, Type 2 diabetes, Exclusion Criteria: Pregnant or breast feeding, Type 1 diabetes Other protocol criteria apply

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urinary protein excretion after 30 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in circulating markers of blood vessel inflammation, insulin resistance, serum creatinine, diabetic control, and proportion of patients who return to normalization of protein excretion after 30 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proteinuria, hypertension, valsartan, type 2 diabetes
Anticardiolipin Autoantibodies and Mortality in Septic Patients

Study Overview
=================
Brief Summary
-----------------
The detection of antiphospholipid antibodies (aPL) is of interest because of their importance in the pathogenesis of arterial or venous thrombosis and their responsibility for a wide spectrum of clinical manifestations such as infection. The aim of the study was to assess the performance of antiphospholipid antibodies biomarker to predict in- hospital mortality in intensive care unit (ICU) septic patient's.

Detailed Description
-----------------
the investigators conducted a prospective single-center observational study including consecutive critically ill septic adults admitted to the intensive care unit. Clinical and laboratory data including chemiluminescence immunoassay for antiphospholipid antibodies [anticardiolipin (aCL), antiphosphatidylserine (aPS)] were obtained. Blood samples were collected on days 1, 3, 5, 8 and 10 of hospitalization. The primary study endpoint was ICU mortality defined as death before ICU discharge. Secondary end points included correlation between SOFA score and biological parameters.

Official Title
-----------------
Anticardiolipin Autoantibodies as Useful Biomarker for the Prediction of Mortality in Septic Patients

Conditions
-----------------
Morality

Intervention / Treatment
-----------------
* Biological: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients, admitted to the ICU for sepsis and older than 18 years Exclusion Criteria: pregnancy clinical history of antiphospholipid syndrome auto-immune diseases immunosuppressive treatment

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 |
| --- |
|Biological: Blood samples|Blood samples were collected in dry tubes on days 1, 3, 5, 8 and 10 of hospitalization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Mortality was defined as death before ICU discharge Multivariate logistic regression modeling will beperformed to found factors associated with higher mortality | mortality at day 14 of hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between SOFA score and antiphospholipid antibodies. | assess correlations between serum levels of both aCL and aPS and SOFA score | on days 1, 3, 5, 8 and 10 of hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-phospholipid, sepsis, intensive care unit
Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture

Study Overview
=================
Brief Summary
-----------------
This study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level.

Detailed Description
-----------------
This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017. Multivariate logistic regression analysis was performed to identify independent effects of univariate predictive variables on the occurrence of mortality.

Official Title
-----------------
Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture: A Cross-sectional Analysis Based on Trauma Registered Data

Conditions
-----------------
Femoral Fractures

Intervention / Treatment
-----------------
* Other: Survival
* Other: Death


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a fall from ≥1 m as well as those for whom incomplete data were available. Exclusion Criteria: those patients with a fall from ≥1 m patients with incompleted data

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elderly Patients with Femoral Fracture<br>Elderly patients with fall-induced femoral fracture. Patients were categorized into two groups: death (n = 42) and survival (n = 2,365). | Other: Survival<br>* Elderly patients with fall-induced femoral fracture who were survived.<br>Other: Death<br>* Elderly patients with fall-induced femoral fracture who were dead.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality was used as the primary outcome. | up tp 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femur fracture, trauma, fall, elderly, mortality, respiratory complication
National Bacterial Meningitis Study

Study Overview
=================
Brief Summary
-----------------
Bacterial meningitis is a major cause of morbidity and mortality in childhood. Antibiotic treatment recommendations are based on epidemiological and susceptibility data. The epidemiology of bacterialméningitis has changed in recent years, mainly owing to widespread use of different conjugate vaccines. The aim of this prospective national survey is to describe epidemiology of bacteria implicated in bacterial meningitis in children.

Official Title
-----------------
National Observatory of Bacterial Meningitis in Children and Newborns

Conditions
-----------------
Antibiotic Treatment, Case Fatality Rate, Meningitis, Children, Only, Pneumococcal Conjugate Vaccine, Meningococcal Vaccines, H. Influenzae Vaccine, Neonatal Infection

Intervention / Treatment
-----------------
* Other: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical signs of meningitis, associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing (Escherichia coli K1, N. meningitidis serogroups B, A, C, Y and W-135, group B streptococci, Hib, or S. pneumoniae), and/or positive CSF polymerase chain reaction (PCR), and/or positive blood culture with CSF pleocytosis (> 10 cells/µL). purpura fulminans Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort of bacterial meningitis in children<br> | Other: observational study<br>* observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | Number of death according to age and bacteria | before the hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment failures | Number of antibiotic treatment failures according to bacteria after the control of lumbar puncture | 48 hours after the antibiotic treatment and new lumbar puncture | 
| impact of vaccines | Number of vaccination failures according to age, number of doses and bacteria | before the hospital discharge |
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on urinary symptoms and female sexual function.

Detailed Description
-----------------
To get the objective urodynamic and sonographic effects of IncontiLaseTM procedure on women with stress urinary incontinence; and its impact on urinary symptoms and female sexual function.

Official Title
-----------------
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence

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

Intervention / Treatment
-----------------
* Procedure: the IncontiLaseTM procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive sexually active and parous adult women with the complaint of stress urinary incontinence Exclusion Criteria: < 20 years old female

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

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

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

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: stress urinary incontinence<br>Women with stress urinary incontinence | Procedure: the IncontiLaseTM procedure<br>* Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of pad weight from baseline | The change of pad weight from baseline after IncontiLaseTM procedure | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of maximum urethral closure procedure from baseline | The change of maximum urethral closure procedure from baseline after the IncontiLaseTM procedure by urodynamic studies | 3 months |