linjc16/ctgov huggingface dataset:
Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized controlled trial looking at the utility of intraoperative transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy. Patients in the control group will have standard of care, patients in the TEE group will have standard of care and TEE monitoring throughout. Intraoperative and postoperative variables, such time to extubation, postoperative cardiac and pulmonary complications, intraoperative fluid and vasopressor use will be assessed.

Official Title
-----------------
Randomized Control Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care

Conditions
-----------------
Cardiac and Pulmonary Complications. Central Venous Line Insertion. Gastrointestinal Recovery

Intervention / Treatment
-----------------
* Other: Transesophageal echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients have elective radical cystectomy at The University of Chicago Hospital. Exclusion Criteria: Patient refusal, emergent surgery, preoperative mechanical ventilation, preoperative hemodynamic instability (intravenous vasopressor support), and/or esophageal/gastric pathology contraindicating insertion of the transesophageal echocardiography probe.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard of care, no intervention | |
| Active Comparator: Transesophageal echocardiography<br>Patients will have intraoperative transesophageal echocardiography along with standard of care for management. | Other: Transesophageal echocardiography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative central venous line insertion |  | 1 day after study enrollment | 
| postoperative return of bowel function via flatus or passage of stool |  | 5 days after study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased postoperative pulmonary and cardiac complications |  | approximately 5-7 days |
Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling

Study Overview
=================
Brief Summary
-----------------
Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.

Detailed Description
-----------------
Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23G-pars plana vitrectomy with membrane peeling is performed in all patients. Before surgery patients are randomized for BSS or air-tamponade. Optical coherence tomography (OCT) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.

Official Title
-----------------
Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Procedure: air arm
* Procedure: BSS arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epiretinal membranes and intraretinal cystoid changes Exclusion Criteria: macular edema due to other reason than epiretinal membrane hereditary ocular disease pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BSS arm<br>BSS is given at the end of surgery | Procedure: BSS arm<br>* epiretinal membranes are excised during membrane Peeling and BSS is left in the eye<br>|
| Experimental: air arm<br>air-tamponade is given at the end of surgery | Procedure: air arm<br>* epiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resorption of intraretinal cystoid changes after surgery | occurrence of intraretinal cystoid changes will be diagnosed by OCT | 3 months |
Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage

Study Overview
=================
Brief Summary
-----------------
Missed abortion is a condition where the fetus has perished but the miscarriage is not expelled. Women often present at a routine ultrasound or with a slight brownish discharge. Traditionally this condition has been treated with curettage or vacuum aspiration. Lately, medical treatment has become more common due to less risk of infection and other complications. The routine medical treatment is 800mcg of misoprostol administered vaginally. We wish to examine of repeated doses of 400mcg misoprostol after the initial 800mcg vaginal misoprostol increases efficacy of the treatment.

Official Title
-----------------
Repeated Doses of Misoprostol for Treatment of Missed Abortion

Conditions
-----------------
Missed Abortion

Intervention / Treatment
-----------------
* Drug: misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age healthy no contraindication to medical treatment visible fetal structures such as yolk sac or fetus Exclusion Criteria: empty gestational sac more than sparse bleeding or dilated cervix mental instability after diagnosis contraindication to medical treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: single dose<br>Patients receive the standard treatment with 800mcg of vaginal misoprostol | |
| Experimental: repeated doses<br>patients receive 800mcg of vaginal misoprostol. In addition to this they receive repeated doses of 400mcg oral misoprostol after 3 and 5 hours. Women of more than 9 weeks pregnancy according to last menstrual period will be given a choice of vacuum aspiration or further medical treatment with 2 additional doses of misoprostol given after 7 and 9 hours after the initial vaginal treatment. | Drug: misoprostol<br>* repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.<br>* Other names: Cytotec 200mcg Pfizer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Complete abortion as judged by ultrasound | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | questionnaire on future choice of treatment method. Surgical or medical treatment if free choice. If having to have medical would she choose repeated doses or single dose? | 1 day, 1 week, 2 weeks, 3 weeks, 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
missed abortion, miscarriage
Survival of Different Core Build-up Materials

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare three different core build-up materials for dental use. The study hypothesis is that there is no differences in survival rate of the different core build-ups.

Detailed Description
-----------------
Core build-ups replace dental structures which are decayed through caries or tooth fractures. Often there are necessary before insertion of dental restorations. In clinical practice, there are two main material groups: glass ionomer cements and composites. Because of there good physical properties the composite materials claimed to fulfill the expected criteria of core build-ups. However, some of these composite core build-ups get lost before insertion of definite prosthetic restorations. The current prospective, randomized controlled study should investigate the survival rate of three different composite materials: Rebilda DC, Clearfil Core DC / Plus and Multicore Flow. The statistical analysis will performed with logistic regression performed by the institute of institute of Medical Biometry and Informatics, university of heidelberg. The study hypothesis is that there is no differences in the survival rate.

Official Title
-----------------
Core Build-up Materials: a Randomized Clinical Study

Conditions
-----------------
Dental Prosthesis Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients need a single crown or fixed dental prostheses patients are able to signed inform consent form, more than 18 years, Exclusion Criteria: no pregnant women insufficient oral hygiene

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Rebilda DC<br> | |
| Clearfil Core DC / Plus<br> | |
| Multicore Flow<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the performance and anatomic outcomes of the Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular surgery. Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps have a larger platform and micro-abrasions along the forcep surface to increase grasping ability and potentially limit trauma to the retina surface compared to the Grieshaber forceps. This project may also serve as an education tool for fellows learning the basics of ILM peeling.

Official Title
-----------------
Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Conditions
-----------------
Epiretinal Membrane, Macular Holes

Intervention / Treatment
-----------------
* Device: Sharkskin
* Device: Grieshaber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular pathology Exclusion Criteria: No prior vitreoretinal surgery

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sharkskin Arm<br> | Device: Sharkskin<br>* Use of Sharkskin ILM forceps<br>|
| Placebo Comparator: Grieshaber Arm<br> | Device: Grieshaber<br>* Use of Grieshaber ILM forceps<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time |  | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of peeling - surgeon | Use of standardized questionnaire to the surgeon. | During surgery | 
| Ease of peeling - masked grader | Use of standardized questionnaire to the masked grader. | Through study completion, up to one year |
Increasing the Yield of Blood Cultures in Neonates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.

Official Title
-----------------
Increasing the Yield of Blood Cultures in the Neonatal Intensive Care Unit- A Prospective Controlled Trial

Conditions
-----------------
Bacteremia

Intervention / Treatment
-----------------
* Other: 1cc of blood in a single aerobic culture bottle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All blood cultures taken in the NICU during the study period. Exclusion Criteria: Bacteria that are normal flora of the skin such as Coagulase negative staphylococci or Streptococci Viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 0.5cc 2 Bottles<br> | |
| Active Comparator: 1cc single bottle<br> | Other: 1cc of blood in a single aerobic culture bottle<br>* The efficacy of using 1cc of blood in a single aerobic bottle for cultures in neonatal bacteremia will will be compared with the traditional 0.5cc of blood in 2 Bottles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles. |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| utility of the routine use of anaerobic bottle for blood cultures in newborns |  | 6 months | 
| Comparison of time to positivity of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles (aerobic and anaerobic) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacteremia, Blood Cultures, Sepsis
Assessment of Variations of The Number of Roots &Amp; Root Canal Configurations of Maxillary Premolars and Their Relation to the Floor of the Maxillary Sinus

Study Overview
=================
Brief Summary
-----------------
Assessment of Variations of The Number of Roots &amp; Root Canal Configurations of Permanent Maxillary Premolars and their Relation to the Floor of the Maxillary sinus

Detailed Description
-----------------
Assessment of Variations of The Number of Roots &amp; Root Canal Configurations of Permanent Maxillary Premolars and their Relation to the Floor of the Maxillary sinus in a Sample of Egyptian Population using CBCT: An Observational Cross-Sectional Study

Official Title
-----------------
Assessment of Variations of The Number of Roots &Amp; Root Canal Configurations of Maxillary Premolars and Their Relation to the Floor of the Maxillary Sinus in a Sample of Egyptian Population Using CBCT: An Observational Cross-Sectional Study

Conditions
-----------------
Root Canal Configurations of Permanent Maxillary Premolars

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fully maturated and erupted maxillary permanent premolars of Egyptian patients, males or females. Intact maxillary premolars' roots without fractures or cracks. Maxillary Premolars without posts or previous root canal treatment. CBCT scans of different fields of view could be included as long as it shows maxillary premolars. CBCT scans of 0.2 mm voxel resolution {the maximum voxel size accepted for endodontic imaging} Exclusion Criteria: Maxillary premolars with: Developmental anomalies. External or internal root resorption. Root canal calcification. Previous root canal treatment Post restorations. Root caries especially reaching the bifurcation area. Evidence of apicectomy or periapical surgery CBCT images of poor quality or artifacts interfering with the assessment of the root canals.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of roots maxillary premolars | Detection of number of maxillary roots in Egyptian population | up to 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the relationship between maxillary premolars roots and the maxillary sinus floor | Recording of the relationship between maxillary premolars roots and the maxillary sinus floor | up to 2020 |
Patient Outcomes of Clinic Transition From Face to Face Encounter to Telemedicine in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Adult patients with Cystic Fibrosis who are seen at the specialty CF clinic at University of Virginia will be given an option to utilize telemedicine instead of in-person visits for standard clinic visits. Health information from standard of care visits including FEV1, exacerbations, leading to oral or intravenous antibiotics, laboratory results, hospitalization records, and responses to health questionnaires will be recorded for research purposes. Data collected for the research study will be compared to baseline and previous years to determine if there are any deleterious effects for those who transition to telemedicine clinic visits.

Official Title
-----------------
Impact on Patient Outcomes of Clinic Transition From Face to Face Encounters to Telemedicine in the Cystic Fibrosis (CF) Adult Population at UVA

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (18-year-old and older) with CF seen in the UVA adult CF clinic who agree to participate in the study. Exclusion Criteria: Patients who cannot consent to the research study. In addition, prisoners will not be included.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care Telemedicine Cohort<br>This cohort will have telemedicine visits in lieu of in-person clinic visits | |
| Standard of Care In-Person Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 stability | A change of 10% or more in FEV1 percent predicted will be considered significant; FEV1 pre and pos covid telemedicine implementation will be compared | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exacerbation rate | Exacerbation rate pre and pos covid telemedicine implementation will be compared | 12 months |
Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery

Study Overview
=================
Brief Summary
-----------------
Observational cohort study examining the perioperative course of copeptin in patients undergoing elevated-risk surgery.

Official Title
-----------------
Perioperative Copeptin: Predictive Value and Risk Stratification in Patients Undergoing Major Surgery

Conditions
-----------------
Perioperative Myocardial Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18 years Type of surgery for patients 1 to 30: abdominal aortic aneurysm repair, suprainguinal and infrainguinal vascular surgery, carotid surgery Type of surgery for patients 31 to 500: surgeries with elevated risks in general (as specified by 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management [Kristensen]) Exclusion Criteria: acute coronary Syndrome (ACS) at presentation (clinical assessment or documentation) Congestive heart failure at presentation (clinical assessment or documentation) Documented severe aortic stenosis (valve area <1cm2) Kidney dysfunction (clearance <50ml/min) Reduced left ventricular ejection fraction (LVEF) (<40%); if no LVEF is available, it will be assumed to be >40% Cancelled surgery Unwilling or unable to provide consent Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

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 |
| --- | --- | --- |
| perioperative copeptin concentrations | copeptin concentrations for the perioperative time course as measured by the ThermoFisher assay at induction, at 0h, 2h, 4h, 6h, 8h, as well as on the postoperative day 1 and 3. | perioperative from induction of anesthesia to the third postoperative day | 
| composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE) | MACCE defined as:non-fatal cardiac arrest, acute coronary syndrome (including MINS), congestive heart failure requiring hospitalization or transfer to a higher unit of care, and stroke | 12 months | 
| myocardial injury in non-cardiac surgery (MINS) |  | 3 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | 12 months | 
| composite events composed of all-cause mortality and/or major adverse cardiac and cerebrovascular events (MACCE) | MACCE: non-fatal cardiac arrest, acute coronary syndrome (including MINS), congestive heart failure requiring hospitalization or transfer to a higher unit of care, and stroke | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Copeptin, human