linjc16/ctgov huggingface dataset:
Improving Safety by Basic Computerizing Outpatient Prescribing

Study Overview
=================
Brief Summary
-----------------
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.

Official Title
-----------------
Improving Safety by Basic Computerizing Outpatient Prescribing

Conditions
-----------------
Adverse Drug Events

Intervention / Treatment
-----------------
* Other: Basic Clinical Decision Support
* Other: Routine Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: provider practicing at sites implementing order entry with basic clinical decision support using either the longitudinal medical record (LMR) or Medical Gopher Exclusion Criteria: provider or practice unwilling to participate
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Routine Care<br>Usual care of patients in the ambulatory setting | Other: Routine Care<br>* Routine Care<br>|
| Experimental: Basic Clinical Decision Support<br>Providers use basic clinical decision support | Other: Basic Clinical Decision Support<br>* The computerized physician order entry (CPOE) intervention provides physicians with a menu of medications from the formulary, default doses, and a range of potential doses for each medication. Physicians were required to enter dosage, route, and frequency for all orders. Also, CPOE ensured that all orders were legible and included the prescribing physician's signature. For a number of medications, the system displayed relevant laboratory results on the screen at the time of ordering. Other features included consequent orders, which are orders that should follow from other orders, and drug-allergy checking, drug-drug interaction checking, and drug-laboratory checking. This included checking for the most frequent drug allergies, about 80 carefully selected drug-drug interactions, and several drug-laboratory combinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Events | Adverse drug events are measured through use of a computerized surveillance system augmented by focused structured human review | 6 months | 
| Medical Errors | Medical Errors are identified through a computerized surveillance system with structured human review | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse drug events, medical errors, computerized physician order entry, clinical decision support
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.

Study Overview
=================
Brief Summary
-----------------
Patients will be treated with hemodiafiltration (HDF) in postdilution mode, as a control therapy, during 9 weeks. During week 5 the 1st intervention treatment, predilution hemofiltration (HF) or predilution HDF, will be performed as a midweek session. After 4 additional weeks of control therapy the other intervention treatment will be performed. Samples will be taken during week 4, 5 and 9: from inlet blood flow (0, 30, 60, 120 and 240 min), from outlet blood flow and dialysate outflow (30, 60, 120 and 240 min).

Official Title
-----------------
Clinical Study on Optimised Removal of Protein-bound Uremic Toxins With Convective Dialysis Treatment.

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable on hemodialysis >= 6 months of which presently on high-flux HD >= 1 month 18 years < age < 85 years blood flow rate >= 300ml/min Exclusion Criteria: expected survival < 1 year expected transplant within < 1 year infectious diseases pregnancy chronic inflammation condition treated with single needle dialysis presently treated with hemodiafiltration or low-flux hemodiafiltration expected intradialytic body weight gain >= 4kg

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration|Performance of predilution hemofiltration, predilution hemodiafiltration or postdilution hemodiafiltration is followed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate what is more effective for convective removal of protein-bound solutes - predilution or postdilution of blood? |  | Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min. | 
| To check which respective roles diffusion and convection play in the removal of protein-bound uremic toxins? |  | Samples taken at week 4, 5 and 9. Bloodsamples taken at 0, 30, 60, 120 and 240 min. Dialysate taken at 30, 60, 120 and 240 min. |
Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation after coronary artery bypass graft is a common complication. The investigators have thought that the mechanism of temporarily postoperative atrial fibrillation is closely related to the autonomic nervous system imbalance. In a last several years, cryoablation was substituted for atrial incision in many reports to simplify the maze procedure. However, there has been no comparative study to delineate the feasibility of the use of cryoablation.

Detailed Description
-----------------
Modified maze procedures that use energy sources for the ablation of atrial fibrillation concomitant with cardiac surgery have been shown to improve outcomes in patients with atrial fibrillation. Cryoablation of atrial fibrillation recently has been shown to lead to outcomes that were at least equivalent to those reported for other energy modalities over both short- and medium-term follow-up times.

Official Title
-----------------
Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi

Conditions
-----------------
Complication of Coronary Artery Bypass Graft, Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Two sites cryoablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery graft bypass patient sinus rhythm Exclusion Criteria: Patients using antiarrhythmic severe hypotension after surgery ( systolic blood pressure <90mmHg) history of atrial fibrillation

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two sites cryoablation group<br>Two ganglionic plexi around atrium was performed with 90-second cryoablation. | Procedure: Two sites cryoablation<br>* Two ganglionic plexi around atrium was performed with 90-second cryoablation.<br>|
| No Intervention: Control group<br>No Intervention group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom of atrial fibrillation or other atrial arrhythmia | check the occurrence of atrial fibrillation through EKG monitoring And bradycardia(<40/min) or tachycardia(>110/min) does not occur | 5 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery bypass graft, cryoablation, ganglionic plexi, Atrial fibrillation
Usage of Biological Patch Versus Plastic in the Laparoscopic Repair of Hiatal Hernias

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the effective and safety in the laparoscopic repair of hiatal hernia using biological patch versus plastic.

Detailed Description
-----------------
observation indicator: incidence rate of complications, postoperative hospital stay readmission rate in 1st month after operation recurrence rate after operation hospitalization costs Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Official Title
-----------------
Randomized Control Trial (RCT) That the Usage With Biological Patch Versus Plastic in the Laparoscopic Repair

Conditions
-----------------
Hiatal Hernia

Intervention / Treatment
-----------------
* Procedure: Biological patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Hiatal hernia Consistent with operation indications throughout the guideline of hiatal hernia by the Chinese Medical Association in 2003 randomly select patch agreed by patients and family members Exclusion Criteria: Poor general condition severe organ dysfunction No-tolerate anesthesia No-suitable for operation Emergency operation needed Serious adverse events appeared during the operation Sever intraperitoneal adhesion existed glucocorticoid with long-term use immunocompromised patients spirit disease patients automatically exit women who pregnant

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological patch<br>Use biological patch (Biodesign Surgisis Tissue Graft from Cook Biotech Incorporated) to repair hiatal hernia laparoscopically | Procedure: Biological patch<br>* Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically<br>|
| Placebo Comparator: Plastic patch<br>Use plastic patch (Parietex Composite from Sofradim Production) to repair hiatal hernia laparoscopically | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of complications in all case |  | five years |
Burnout Among Members of AAGL

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine the burnout rate among minimally invasive gynecologic surgeons (MIGS) as well as to evaluate other personal, professional, and psychosocial factors associated with this condition. An anonymous electronic survey will be sent to the American Association of Gynecologic Laparoscopists (AAGL) members. The survey will contain items that will inquire about socioeconomic background, professional characteristic, and about physical and psychologic well-being.

Official Title
-----------------
Burnout and Associated Factors Among Members of the American Association of Gynecologic Laparoscopists

Conditions
-----------------
Burnout, Professional

Intervention / Treatment
-----------------
* Other: survey respondents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: members of the AAGL Exclusion Criteria: not a member of the AAGL
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 |
| --- | --- |
| Members of the AAGL<br>Physicians and other providers who are members of the AAGL. | Other: survey respondents<br>* all survey participants will be asked to complete a questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burnout as assessed by questionnaire | questionnaire assesses several factors associated with burnout including productivity and self-reported status of mental health | day 1 |
Social and Behavioral Influence (SBI)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to improve patient-physician communication and clinical decisions in the context of serious illness that may affect important clinical outcomes. The investigators will examine how variations in communication patterns and clinical decisions are affected by patient demographics (e.g age, sex), patient interactional style (e.g. communication behaviors) and physician characteristics (e.g. attitudes, background, training).

Detailed Description
-----------------
This will be a randomized field experiment. Physicians will receive two unannounced covert standardized patient (SP) visits during the 12-24 months after enrollment. SPs are trained actors who will pose as patients to assess physician behavior and communication. Each SP will present just like a real patient, and will have a standardized fabricated scenario and identity. The SP visit will be unannounced; the physician will not be informed at the time of the visit that they are seeing an SP. The visits will be covertly audio-recorded. This is being conducted at 3 sites: University of Rochester, Rochester, NY; Purdue, IN; and University of Michigan.

Official Title
-----------------
Social and Behavioral Influences on Clinical Care

Conditions
-----------------
Communication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently in clinical practice Do not plan on moving during the next year Exclusion Criteria: Non-physicians
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Roles<br>Physician communication styles will be evaluated with different patient roles. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians Communication Style | To examine the degree to which physicians communication style (ex inclusive, authoritative) and clinical decisions (ex. aggressive,passive) differ according to patient characteristics. Unit of Measure: Audio recordings of office visits, will be transcribed, deidentified, and coded. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Communication Moderators (Sex,Class) | To examine how patients participating in their care reduces these patient-specific differences in physician communication behaviors and decisions. Unit of Measure: Audio recordings of office visits, will be transcribed, deidentified, and coded. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physicians
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.

Official Title
-----------------
Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants

Conditions
-----------------
Nosocomial Infections

Intervention / Treatment
-----------------
* Drug: Talactoferrin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weights ranging from 750 to 1500 grams Entry before 24 hours of age Informed-consent form signed by parent(s) or legal guardian Able to take liquid medication by mouth or feeding tube Exclusion Criteria A major birth defect or malformation syndrome Chromosomal or inherited disorder Proven presence of an immunodeficiency Antenatal exposure to illicit substances Birth asphyxia HIV or other congenital viral, bacterial, or fungal infection Lack of parental consent or refusal of attending neonatologist to allow participation Discretion of the investigator The legal representative of the infant or the patient's primary physician are not committed to providing full, aggressive life support

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 24 Hours

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 |
| --- | --- |
| Experimental: 1<br>Talactoferrin | Drug: Talactoferrin<br>* Enteral, 150 mg/kg twice per day<br>* Other names: rhLF;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Oral, twice per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) |  | 1-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEC Scares, the Neonatal Sepsis Syndrome |  | 1-3 months | 
| Length of stay: The number of days of hospitalization from the date of birth until the day of discharge from the NICU |  | 1-3 months | 
| Mortality during hospitalization |  | 1-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-term infants, Pre-term infants 750 to 1500 grams
Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptomite) in Extremities

Study Overview
=================
Brief Summary
-----------------
Safety and performance of the study devices in extremities over a time period of 6 months after intervention.

Official Title
-----------------
Safety and Performance of PEEK Anchors (Dynomite, Spyromite, Raptormite, Footprint Ultra PK SL) in Extremities

Conditions
-----------------
Bunionectomy, Medial or Lateral Instability Repairs/Reconstructions, Hallux Valgus Repairs, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Scapholunate Ligament Reconstructions, Ulnar, Lateral Epicondylitis Repair, Bicep Tendon Reattachments

Intervention / Treatment
-----------------
* Device: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have undergone extremity joint repair using the study devices. Subjects aged 18 years and older at the time of surgery. Exclusion Criteria: Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative. Subjects who are < 3 months post-operative

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL|Observational, post-market, clinical follow-up study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and performance of the study devices in extremities over a time period of 6 months after intervention. | Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and performance of the study devices in extremities over a time period of 12 months after intervention | Clinical success is defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Raptormite, Wrist, Dynomite, Spyromite, Foot, Ankle, Hand, Elbow