linjc16/ctgov huggingface dataset:
DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure

Detailed Description
-----------------
The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.

Official Title
-----------------
DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure

Conditions
-----------------
Cataract, Corneal Graft

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent DMEK combined or not with cataract surgery Exclusion Criteria: patients with other ocular comorbidity, and those who had graft after a first graft failure

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Best visual acuity | logMar | Month 12 |
Placental Assessment in Diabetic Mothers

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus is one of the major heath problems

Detailed Description
-----------------
Maternal and fetal effects are edpected to be more than in diabetic mothers

Official Title
-----------------
Placental Assessment in Early and Late Pregnancy in Diabetic Women

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in control group A non diabetic pregnant women Exclusion Criteria: Diabetic pregnant women And the reverse in group B

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 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 |
| --- | --- |
| pregnant diabetic women<br>Fetal Ultrasound to diabetic pregnant women | Diagnostic Test: ultrasound<br>* Obstetric ultrasound to pregnant women<br>|
| non diabetic pregnant women<br>Fetal ultrasound to non diabetic pregnant women | Diagnostic Test: ultrasound<br>* Obstetric ultrasound to pregnant women<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of diabetic fetuses who will have undesirable effects | Number of fetuses with macrosomia and other diabetes effects | within 6 months |
Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
For verifying the phase lag entropy as the tool for measurement of level of consciousness, the investigators compared phase lag entropy to bispectral index. Using Target-Controlled Infusion pump, propofol was infused for sedation during the spinal anesthesia. The investigators measured Observer's Assessment of Alertness/Sedation Scale as the propofol concentration rises. At the same time, The investigators observed phase lag entropy score and bispectral index score.

Official Title
-----------------
Validation of Phase Lag Entropy(PLE) as an Indicator of Depth of Sedation in Patients Undergoing Spinal Anesthesia: Comparative Analysis With Bispectral Index

Conditions
-----------------
Surgery Requiring Spinal Anesthesia

Intervention / Treatment
-----------------
* Device: apply phase lag entropy sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who require sedation during the spinal anesthesia Exclusion Criteria: dementia, CVA patients, patients have problems with communication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compare bispectral index and phase lag entropy<br> | Device: apply phase lag entropy sensor<br>* apply phase lag entropy sensor as well as bispectral index sensor on forehead during the sedation using propofol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| phase lag entropy score | phase lag entropy score | through study completion, an average of 1 year |
Prevalence of Frailty Among People Aged 75 and Over Living at Home

Study Overview
=================
Brief Summary
-----------------
The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. In fact, many scales to measure frailty have emerged without gold standard. The SEGAm showed its usefulness in aged patients living at home.

Detailed Description
-----------------
The aim of the study is to describe prevalence of frailty in patients aged of 75 and more living at home.

Official Title
-----------------
Prevalence of Frailty Among People Aged 75 and Over Living at Home

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female aged of 75 and more living at home agreeing to participate in the study Exclusion Criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| aged of 75 and more living at home<br>aged of 75 and more living at home group: patients aged of 75 and more living at home | Other: Data collection<br>* frailty evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty | Frailty evaluated using SEGA modified scale (SEGAm). SEGAm includes 13 items (coded from 0 to 2) to obtain a global score out of 26 points. Patients with a score less than or equal to 8 are considered not fragile. Patients with a score between 8 and 11 are considered fragile. Patients with a score greater than or equal to 11 are considered very fragile. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frailty - SEGAm - living at home
Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital.

Detailed Description
-----------------
Colorectal cancer (CRC) is a relatively common and life threatening condition that affect one in thirteen individuals in their lifetime. Colonoscopy is the most used procedure to allow gastroenterologist to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords a greater chance for cure. However, low bowel cleanliness hinders polyp detection rates and therefore colonoscopy effectiveness. In the past, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality. Recently, the non-pharmacological factors have been found to have significant increases in bowel preparation quality. The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital.

Official Title
-----------------
Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Device: Aiddly (Web Site)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for a colonoscopy as outpatients Exclusion Criteria: Unable to speak English Unwilling to participate in reading online materials

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Web Group<br>Patients given web site (aiddly) instructions for colonoscopy | Device: Aiddly (Web Site)<br>* A website designed to better educate patients on how to prepare for their colonoscopies<br>|
| Paper Group<br>Patients given paper instructions for colonoscopy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Web-based instructions | Determine the effectiveness of Web-based instructions patients in preparing for colonoscopy by comparing the percentage of patients that achieved an excellent Boston Bowel Preparation Score when following the web-based instructions compared to historical control of paper written instructions. | Time 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benefit of web-based instructions | Determine through a survey the benefit to patients of this method of education. | Time 0 |
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.

Detailed Description
-----------------
During and six months after treatment with peginterferon alpha and ribavirin strict use of birth control is recommended (the producers advice two reliable forms) for both men and women because ribavirin has teratogenic and/or embryo-lethal effects in animal studies. In cases of pregnancies during paternal exposure to peginterferon alpha and ribavirin elective termination of the pregnancy is usually recommended. However three cases of births after paternal exposure are reported with no birth defects. Cases of abnormalities after paternal exposure to ribavirin are lacking. Also studies on the influence of ribavirin on sperm in human are lacking. The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa in men using these medication.

Official Title
-----------------
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Conditions
-----------------
Sperm Motility (Focus of Study)

Intervention / Treatment
-----------------
* Procedure: peginterferon alpha and ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Treatment with peginterferon and ribavirin in the presence of a chronic Hepatitis C infection Exclusion Criteria: Preexisting semen abnormalities. Concurrent use of drugs influencing sperm concentration,motility and morphology. Less then one million spermatozoa/ml in semen at screening.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: peginterferon alpha and ribavirin|sperm collection|

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
-----------------
sperm chromatin structure integrity, sperm concentration, sperm motility, sperm morphology, peginterferon, ribavirin, hepatitis C
Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve the investigators ability to diagnose von Willebrand Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening blood test used to determine if a person has VWD. This new screening blood test can determine a diagnosis more rapidly than current blood tests. Also this test could be available at local hospital labs rather than require samples to be sent to bigger more specialized labs.

Detailed Description
-----------------
This investigation will be a prospective, multicenter trial to validate the clinical utility of a novel screening assay as a diagnostic screening assay for VWD variants: Type 1C, 2A, 2B, 2M and 2N. Once the subject is enrolled into the study, a minimum of 0.5ml of citrated plasma will be collected and analyzed at the Bleeding and Clotting Disorders Institute Laboratory in Peoria Illinois. Results will be collected: phenotype function profiles will be determined, statistically analyzed and compared to the qualitative data from Blood Center of Wisconsin. Data is expected to correlate as previously shown in prior studies and will confirm the utility of this assay.

Official Title
-----------------
Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)

Conditions
-----------------
Von Willebrands Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New subjects undergoing evaluation for the diagnosis of VWD determined to have a VWF:Ag or VWF: RCo < 50 IU/dl and or a VWF:RCo/VWF:Ag of <0.7. Also subjects will be included if Type 2 N VWD is clinically suspected Exclusion Criteria: Those subjects whose lab results do not meet the inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| Validate the novel ELISA-based VWF functional screening assay as a diagnostic screening assay to assign VWD phenotypes 1C, 2A, 2B, 2M and 2N. |  | planned analysis at 2 years and 4 years with study duration estimated at 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further development of the VWF functional screening assay through investigating the incorporation of VWF:CB6 (binding to collagen VI) |  | study duration 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VWF, Bleeding Disorder, inherited, Von Willebrands Disease, Hematologic Test, VWD
The Relationships Between Gene Polymorphisms of LTA4H and Dexamethasone Treatment for Tuberculous Meningitis

Study Overview
=================
Brief Summary
-----------------
The study aimed to evaluate the relationships between the gene polymorphisms of leukotriene A4 hydrolase(LTA4H) and Dexamethasone treatment for tuberculous meningitis in Chinese patients.

Conditions
-----------------
Tuberculous Meningitis

Intervention / Treatment
-----------------
* Drug: Dexamethasone acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients were eligible to enter the study if they met the diagnositic criteria for possible, probable or definite Tuberculosis meningitis(TBM). Exclusion Criteria: Patients were excluded if they were infected with HIV, diagnosed as carcinomatous meningitis, viral meningitis, purulent meningitis, cryptococcus meningitis.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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: treatment of dexamethasone group<br> | Drug: Dexamethasone acetate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI | whether MRI show infarction, hydrocephalus, meningeal enhancement | 6 month | 
| changes of cerebrospinal fluid |  | 1 year | 
| changes of clinical symptoms | headache duration, duration of fever,presence of cranial nerve damage | 1 year |
Stavanger University Hospital Inflammatory Bowel Disease Trial

Study Overview
=================
Brief Summary
-----------------
The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined. Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.

Detailed Description
-----------------
none considered needed

Official Title
-----------------
Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue

Conditions
-----------------
IBD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed IBD Exclusion Criteria: previous IBD with specific treatment within 10 year inability to consent inability to adhere to treatment protocol

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Clinical efficacy of IBD drug therapy | Endoscopic, clinical and biochemical response | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue in patients with coeliac disease - substudy | Fatigue severity and prevalence at diagnosis and after one year of gluten free diet | 1 year | 
| Fatigue in IBD | Fatigue severity and prevalence at diagnosis and during follow-up | 5 years | 
| IBD and the intestinal microbiome | Microbiome/eukaryome profiles associated with disease activity and treatment response from diagnosis and during follow-up | 5 years |
Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes.

Detailed Description
-----------------
This is chart review at UPMC. There is no human interaction.

Official Title
-----------------
Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli

Conditions
-----------------
Enterobacteriaceae Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Review whether ESBL-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated or community-associated. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isolates, infection, E coli isolates
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 25 y/o No occurrence of intra- or post-operative cardiopulmonary arrest Not consuming drugs affecting atrial rhythm Having sinus rhythm before surgery Lack of paroxysmal atrial fibrillation history Only undergo heart valve surgery Lack of considerable heart ischemia needed atorvastatin use Routine cares in ward, post-operative ward, and intensive care unit were done Exclusion Criteria: Lesser than 25 y/o History of atrial fibrillation History of taking anti-arrhythmic drugs History of implementing pacemakers Severe heart failure Renal failure Hepatic failure Severe pulmonary diseases Heart block or bradyarrhythmia Routine cares in ward, post-operative ward, and intensive care unit were not done Performing concomitant cardiac surgery except valve repair Having considerable heart ischemia needed atorvastatin use

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery | Drug: Atorvastatin<br> <br> |
| Placebo Comparator: Control<br>Placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation Incidence After Open Cardiac Valve Repair |  | Within 5 days after open cardiac valve repair |