linjc16/ctgov huggingface dataset:
PAINED: Project Addressing INequities in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Racial and ethnic inequities in health care quality have been described across a broad range of clinical settings, patient populations, and outcomes. Our overarching goal is to eradicate health care inequities through evidence-based interventions. The objectives of this proposal are to develop and test the impact of two interventions on overcoming clinician implicit bias and mitigating inequities in the management of pain among children seeking care in the emergency department for the treatment of appendicitis or long bone fractures.

Official Title
-----------------
PAINED: Project Addressing INequities in the Emergency Department

Conditions
-----------------
Pain, Appendicitis, Bias, Racial, Fractures, Bone

Intervention / Treatment
-----------------
* Behavioral: Department-level audit and feedback and electronic health record-embedded clinical decision support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Children's National Hospital Emergency Department clinicians Exclusion Criteria: None

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: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: The study design is a pragmatic clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Department-level audit and feedback and electronic health record-embedded clinical decision support<br>Clinicians will receive monthly pooled, department-level 'Equity Report Cards' that will provide aggregate information on clinical data stratified by patient race/ethnicity. Subsequently, for all visits that may be related to appendicitis or long bone fracture, clinicians will then receive real-time, electronic health record-embedded clinical decision support regarding pain management. | Behavioral: Department-level audit and feedback and electronic health record-embedded clinical decision support<br>* This intervention will provide clinicians with Equity Report Cards and clinician decision support on mitigating disparities in quality of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Percentage of patients with pain reduction, pain is measured on a 0 to 10 scale, 0 is the minimum and 10 is the maximum, a lower score is a better outcome. | Equity Report Cards provided monthly to clinicians over a 24-month period | 
| Analgesia use | Rate of analgesia use | Equity Report Cards provided monthly to clinicians over a 24-month period |
Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to measure the number of calories delivered from fluids used in continuous renal replacement therapy (CRRT). We are doing this research study because the fluids used in this treatment may deliver an important number of calories. In the future this could help better estimate how much nutrition patients in the Critical Care Unit should get every day from other sources like tube feeding or nutrition through a person's veins.

Detailed Description
-----------------
The goal of this study is to quantify the specific metabolic contribution of standard continuous renal replacement protocols (including citrate anticoagulation) in the intensive care unit patient population at Mayo Clinic in Rochester, Minnesota utilizing a prospective, observational study. This data will allow practitioners to better tailor caloric provision with nutrition support programs, minimizing the risk of overfeeding in this complex critical care patient population.

Official Title
-----------------
Quantification of Systemic Metabolic Contribution From Continuous Renal Replacement Therapy (CRRT) Utilizing Regional Citrate Anticoagulation

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Patients in an intensive care unit anticipated to receive greater than or equal to 24 hours of continuous venovenous hemofiltration. Receiving regional citrate anticoagulation with ACD-A solution. Exclusion Criteria: Vulnerable adults Pregnant BMI > 40 Patient on extracorporeal membrane oxygenation therapy Reversal of port connections on the dialysis catheter and dialysis circuit lines

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 |
| --- | --- | --- |
| Quantify net glucose uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration |  | Two days | 
| Quantify net citrate uptake from citrate and dextrose-containing fluids from continuous venovenous hemofiltration |  | Two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, CRRT, CVVH, citrate, anticoagulation, caloric uptake
Peak Cough Flow and Cough Clearance in Patients With Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
This study is to determine whether physiologic measures (peak cough flow, measures of respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict spontaneous cough clearance (as measured by a nuclear medicine study) in children with neuromuscular disease. It will also determine whether airway clearance is augmented by high frequency chest wall oscillation.

Official Title
-----------------
Pilot Study of Cough Peak Flow And Airway Clearance in Pediatric Patients With Neuromuscular Disease

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-21; able to cooperate with study procedures Duchenne Muscular Dystrophy OR Becker Muscular Dystrophy Exclusion Criteria: Need for mechanical ventilation during the day Recent (within 2 weeks) lower respiratory tract infection

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 Years

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

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 |
| --- | --- | --- |
| Spontaneous cough clearance |  | Assessed at multiple time points over 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peak Cough Flow, Duchenne Muscular Dystrophy, Airway Clearance
Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation

Study Overview
=================
Brief Summary
-----------------
Check in gastric ultrasound for lack of stomach insufflation during preoxygenation with high-flow nasal cannulas

Official Title
-----------------
Evaluation of Gastric Insufflation Measured by Ultrasound of the Antral Surface During Optiflow Preoxygenation

Conditions
-----------------
Gastric Ultrasound

Intervention / Treatment
-----------------
* Procedure: Preoxygenation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults Volunteers Exclusion Criteria: History of gastric surgery Facial or oropharyngeal abnormality

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoxygenation<br> | Procedure: Preoxygenation<br>* preoxygenation with high flow nasal cannula at 40l/min for 5min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no gastric insufflation | Number of Participants with no gastric insufflation | From date of randomization until the date of first documented progression, whichever came first, assessed up to 6 months |
Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. The aim of this study is to assess the rate of this lymph node metastasis and to reveal its prognostic value for colon cancer located at hepatic flexure and right half of transverse colon. Meanwhile, we can evaluate the safety and feasibility of this extented lymphadenectomy in right hemi-colectomy.

Official Title
-----------------
Infrapyloric (No.206) and Greater Curvature (No.204) Lymph Node Metastasis in Adenocarcinoma Located at Hepatic Flexure and Right Half of Transverse Colon

Conditions
-----------------
Colorectal Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 75 years American Society of Anesthesiologists (ASA) score I to III A biopsy proven histological diagnosis of colorectal carcinoma tumor located at hepatic flexure and right half of transverse colon Undergoing right hemi-colectomy with extented lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node Preoperative staging cT2-4aN0M0 or cTanyN+M0 Willing to participate and informed consent signed Exclusion Criteria: Pregnant or lactating women Synchronous colorectal carcinoma History of colorectal cancer or other malignant tumors Clinical evidence of metastasis Preoperative staging cT1N0 or cT4bNany Emergency procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| metastasis rate | metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node | an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lymphadenectomy time | time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node | an average of 1 year | 
| intraoperative complication | intraoperative complication | an average of 1 year | 
| postoperative complication | postoperative complication | an average of 1 year | 
| 3-year DFS | 3-year disease free survival | an average of 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colon adenocarcinoma, lymph node metastasis, right hemi-colectomy
Head to Head Study Against Sevelamer Hydrochloride

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Detailed Description
-----------------
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Official Title
-----------------
A Prospective, Multicenter, Open-label, Randomized, Cross-over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease

Conditions
-----------------
Chronic Kidney Disease, Stage 5

Intervention / Treatment
-----------------
* Drug: Fosrenol (Lanthanum Carbonate)
* Drug: Sevelamer hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with end stage renal disease who are receiving dialysis Exclusion Criteria: Subjects with significant gastrointestinal disorders Subjects who are pregnant or nursing Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride Subjects who are HIV positive Subjects with clinical significant liver disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Fosrenol (Lanthanum carbonate) | Drug: Fosrenol (Lanthanum Carbonate)<br>* The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.<br>* Other names: FOSRENOL;|
| Active Comparator: 2<br>Sevelamer hydrochloride | Drug: Sevelamer hydrochloride<br>* The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Phosphorus Levels at 4 Weeks |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Calcium Levels at 4 Weeks |  | 4 weeks | 
| Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks |  | Baseline and 4 weeks | 
| Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks | Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L) | 4 weeks |
Hormone Deficiency in Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to describe the prevalence of Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

Detailed Description
-----------------
Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive. Consistent data coming from several independent groups have documented the reduced activity of most anabolic axes in HF with reduced ejection fraction. To date, no study has addressed the prevalence the presence and the prevalence of the Multiple Hormone Deficiencies in Heart Failure with preserved Ejection Fraction.

Official Title
-----------------
Multiple Hormone Deficiency Syndrome in Heart Failure With Preserved Ejection Fraction

Conditions
-----------------
Heart Failure, Hormone Deficiencies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients of affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy left ventricle ejection fraction > 50% or more Exclusion Criteria: severe liver disease serum creatinine levels >2.5 mg/dl history of active cancer with life expectancy below 1 year acute coronary syndrome in the previous 6 months

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with HFpEF<br>Male patients with heart failure with preserved ejection fraction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Hormone deficiency |  | 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Heart failure with preserved ejection fraction, GH deficiency, Testosterone deficiency, Low- T3 syndrome, Multiple Hormone Deficiencies
JAYDESS Drug Utilization Study in Sweden

Study Overview
=================
Brief Summary
-----------------
To describe characteristics (demographic, clinical, social) of first time users of Jaydess To estimate the duration of use of Jaydess To study switching patterns, e.g. what are the hormonal contraceptive methods used before and what are the methods after discontinuing Jaydess To study off-label use of Jaydess

Official Title
-----------------
Pharmacoepidemiological Study (Drug Utilization Study) of JAYDESS Use in Routine Clinical Practice in Sweden

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Swedish women who were dispensed a JAYDESS from a Swedish Pharmacy anytime 2014-2017 Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Group 1<br>Women prescribed JAYDESS in Sweden | Drug: Levonorgestrel (Jaydess, Skyla, BAY86-5028)<br>* Women use Levonorgestrel (Jaydess, BAY86-5028) .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of use of JAYDESS |  | Up to 6 years | 
| Indication for use |  | At insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age at insertion and removal |  | Up to 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Utilization Study
A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies

Study Overview
=================
Brief Summary
-----------------
We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.

Official Title
-----------------
A Prospective Randomized Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies With Random Biopsies in the Detection of Specialized Columnar Epithelium in Barrett's Esophagus

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Other: Fluorescence-aided confocal endomicroscopy guided biopsy.
* Other: Random four-quadrant biopsies.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18. Barrett's esophagus Acid suppressive therapy Endoscopic surveillance Exclusion Criteria: Pregnancy or lactation Allergy to fluorescein Endoscopic esophagitis Los Angeles classification A to D Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion Obvious mass lesions or cancer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEM<br>Biopsies obtained with fluorescence-aided confocal endomicroscopy. | Other: Fluorescence-aided confocal endomicroscopy guided biopsy.<br>* Fluorescence-aided confocal endomicroscopy guided biopsy.<br>|
| Other: RFQ<br>Random four-quadrant biopsies. | Other: Random four-quadrant biopsies.<br>* Random four-quadrant biopsies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether specialized columnar epithelium was detected. |  | At biopsy on Day 0. |
Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

Study Overview
=================
Brief Summary
-----------------
Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.

Conditions
-----------------
Gallstone Disease

Intervention / Treatment
-----------------
* Procedure: Cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cholelithiasis confirmed by preoperative ulrasound No significant co-morbidities The ASA physical status classification 1 or 2 Age 18 to 65 yrs. BMI less than 35 Less than a one hour journey from hospital to home Patient´s own motivation to daysurgery Exclusion Criteria: Elevated liver laboratory tests Earlier jaundice A suspicion or verified stones in the common bile duct Acute cholecystitis A history of pancreatitis Hepatic cirrhosis Suspicion of cancer Previous open upper abdominal surgery Asthma Peptic ulcer Bleeding disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Other: Minilaparotomy<br>Minilaparotomy cholecystectomy as a day surgery | Procedure: Cholecystectomy<br> <br> |
| Other: Laparoscopy<br>Laparoscopic cholecystectomy as a day surgery | Procedure: Cholecystectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic post-surgical pain |  | Five year outcome | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | Five year outcome | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
5-year outcome after cholecystectomy