linjc16/ctgov huggingface dataset:
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly

Study Overview
=================
Brief Summary
-----------------
Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase in morbidity and cost for the elderly. This study identifies risk factors affecting readmission rates for these patients and presents strategies to reduce it.

Detailed Description
-----------------
A retrospective analysis was conducted on patients with traumatic brain injuries (ICD-9-CM codes 800.20 - 801.86, 852.00 - 853.05) admitted between 2014 and 2016 at Genesys Regional Medical Center through the trauma service. From this group, the investigators selected patients admitted with traumatic SDH, and those patients were followed over the following 6 months as regards to readmission status. Patients who were readmitted versus patients who were not readmitted were compared. The risk of readmission within 6 months of discharge for SDH was analyzed adjusting for age, prior anticoagulation use, Injury Severity Score (ISS), Glasgow Coma Scale (GCS), gender, time to readmission and co-morbid conditions which included diabetes mellitus, cardiovascular disease, renal disease, chronic obstructive pulmonary disease, and osteoporotic/orthopedic fractures using Cox Proportional Hazards Regression analysis.

Official Title
-----------------
A Retrospective Analysis of Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly

Conditions
-----------------
Traumatic Subdural Hematoma

Intervention / Treatment
-----------------
* Other: Follow-up Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Traumatic Subdural Hematoma during time of study Exclusion Criteria: Patients who expired.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients without Readmissions<br>Patients with TSDH who were not readmitted within a 6-month time period following their initial visit. | |
| Patients with Readmissions<br>Patients with TSDH who were readmitted within a 6-month time period following their initial visit. | Other: Follow-up Care<br>* Follow up care provided upon readmission to patients who were diagnosed with a TSDH upon initial visit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants readmitted to the hospital | Number of patients diagnosed with TSDH who were readmitted to the hospital within a 6 month time frame | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subdural hematoma, readmission, risk factors
Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether routine imaging of the biliary system during routine gallbladder surgery alters clinical outcome

Official Title
-----------------
Is There a Role for Routine Intraoperative Cholangiography During Laparoscopic Cholecystectomy

Conditions
-----------------
Common Bile Duct Stones

Intervention / Treatment
-----------------
* Procedure: on table cholangiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients over the age of 18 with biliary colic or cholecystitis Exclusion Criteria: any history of allergic reaction to contrast material patients with abnormal liver function test results any clinical history of jaundice patients with a history of pancreatitis patients with a history of previous ERCP patients whose ultrasound showed common bile duct or intra-hepatic duct dilation all patients with previous major upper abdominal surgery all patients with acalculous cholecystitis or gallbladder polyps

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>routine surgery with cholangiography | |
| Experimental: 2<br>routine cholangiography | Procedure: on table cholangiography<br>* x-ray imaging of common bile duct<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of stones in common bile duct |  | at surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative complications |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gallstones, cholangiography
G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator

Study Overview
=================
Brief Summary
-----------------
Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Detailed Description
-----------------
The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

Official Title
-----------------
Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 2 or older Diagnosis of Type 1 diabetes or Type 2 diabetes Willing to participate in a clinic session involving venous sampling for evaluation of study end point Exclusion Criteria: Use of acetaminophen Known allergy to medical-grade adhesives Pregnancy Hematocrit outside specification of the study-assigned blood glucose meter

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| CGM Users<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.

Detailed Description
-----------------
This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.

Official Title
-----------------
A Phase 2 Study of Recombinant Human Thrombin (rThrombin) Administered Using a Spray Applicator in Subjects Undergoing Autologous Skin Grafting Following Burn or Traumatic Skin Injury

Conditions
-----------------
Surgical Hemostasis

Intervention / Treatment
-----------------
* Biological: rThrombin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury Exclusion Criteria: Known antibodies or hypersensitivity to thrombin or other coagulation factors

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>rThrombin | Biological: rThrombin<br>* 1000 U/mL applied topically<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of adverse events |  | Up to day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and grade of clinical laboratory abnormalities |  | Up to day 29 | 
| The incidence of anti-rThrombin product antibodies |  | Up to day 29 | 
| The incidence of hemostasis |  | Up to 20 minutes | 
| The percentage of graft take |  | Up to day 29 | 
| The incidence of re-grafting |  | Up to day 29 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemostasis, grafting, skin, hemostatics, phase 2
Prevalence of Masked Hypertension in Nephrological Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the percentage of patients with masked hypertension in a population with chronic kidney disease. The investigators goal is to register prospectively ambulatory blood pressure measurement results of patients of a nephrological outpatient clinic with normal office blood pressure to finally find the percentage of masked hypertension in this population.

Official Title
-----------------
Prevalence of Masked Hypertension in Nephrological Patients

Conditions
-----------------
Masked Hypertension

Intervention / Treatment
-----------------
* Other: Comparison ABPM with OBPM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20-90 years Known arterial hypertension and antihypertensive medical treatment Office blood pressure < 140 mmHg systolic and <90 mmHg diastolic Exclusion Criteria: Age <20 or >90 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| CKD patients<br>Patients with chronic kidney disease, with diagnosed arterial hypertension and normal blood pressure during office blood pressure measurement. Comparison of ambulatory blood pressure (ABPM) with office blood pressure measurements (OBPM). | Other: Comparison ABPM with OBPM<br>* No interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with uncontrolled masked hypertension assessed by comparison of ambulatory blood pressure with office blood pressure |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
masked hypertension, chronic kidney disease
Investigation of Neurocognitive Measures of Sport-Related Injury

Study Overview
=================
Brief Summary
-----------------
The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.

Official Title
-----------------
Investigation of Neurocognitive Measures of Sport-Related Injury

Conditions
-----------------
Concussion, Brain

Intervention / Treatment
-----------------
* Other: Cervical spine musculature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-30 year old competitive or recreational athletes Exclusion Criteria: Pre-existing condition preventing the ability to perform neck range of motion or a neck strength assessment Recent exposure to head lice Known or suspected pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical spine musculature<br> | Other: Cervical spine musculature<br>* Previously established cervical spine musculature training methodology will be utilized to develop a concussion prevention training program.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood metabolite profile | Blood metabolite profile change from baseline blood draws will be analyzed to determine what blood biomarkers (e.g. amino acids, glycerophospholipids (mg/dL) ) are most sensitive to the presence of a concussion. | Through study completion, an athletic season average of 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain, concussion, neck, strength, sport, prevention
Variation in Acute Appendicitis During COVID-19 Pandemic in Italy

Study Overview
=================
Brief Summary
-----------------
retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern Italy, compared with the same period in the previous 2 years.

Official Title
-----------------
Variation of Incidence and Clinical Presentation of Acute Appendicitis During a Pandemic.

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Procedure: Appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute appendicitis Exclusion Criteria: other diagnosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pandemic period<br>patients admitted in hospital for acute appendicitis | Procedure: Appendectomy<br>* comparison between operative and conservative treatment<br>* Other names: Conservative treatment;|
| control period<br>patients admitted in hospital for acute appendicitis | Procedure: Appendectomy<br>* comparison between operative and conservative treatment<br>* Other names: Conservative treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complicated appendicitis | Number of patients with complicated acute appendicitis | 2 months |
Vitamin D Substitution During Winter Time

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)

Detailed Description
-----------------
Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.

Official Title
-----------------
Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)

Conditions
-----------------
Vitamin D Substitution

Intervention / Treatment
-----------------
* Drug: Colecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with inflammatory bowel disease Exclusion Criteria: Liver disease Renal disease Hypercalcemia Hyperparathyreoidism Chronic pancreatitis Concomitant vitamin D medication Pregnancy Sarcoidosis Malignancy Inability to obtain valid data from subject

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: IU/Day<br>This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight | Drug: Colecalciferol<br>* Drug<br>|
| Active Comparator: IU/Kg/Day<br>This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight | Drug: Colecalciferol<br>* Drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vitamin D blood level after follow-up interval | Change of the D vitamin level after follow-up interval in groups substituted according to weight or in fixed daily dose. | 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vitamin D after follow-up interval according to weight | Change in vitamin D after follow-up interval according to weight. Superiority of weight base dosing to fixed daily dose. | 4 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Inflammatory Bowel Diseases
Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.

Official Title
-----------------
Pilot Study to Investigate the Clinical Effect of Orally Inhaled AP301 on Treatment of Primary Graft Dysfunction (PGD) in Mechanically Ventilated Patients After Primary Lung Transplantation

Conditions
-----------------
PGD Primary Graft Dysfunction

Intervention / Treatment
-----------------
* Drug: AP-301
* Drug: saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a male or female recipient on the AKH's waiting list for primary single or double LuTX PGD score ≥ 1 within 72 hours after LuTX Informed consent is available Exclusion Criteria: History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product Postoperative ECMO support Paediatric /adolescent recipients (< 18 years) Lobar transplantation Retransplantation Combined solid organ transplants Participation in other drug trials

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 |
| --- | --- |
| Experimental: AP301<br>Treatment group | Drug: AP-301<br>* orally delivered doses of 87.6 mg AP301 (dose per subject, 5 ml nebulizer filling dose) are inhaled every 12 hours for a total of 7 days<br>|
| Placebo Comparator: Saline solution<br> | Drug: saline solution<br>* placebo solution (0.9 % physiologic NaCl, 5 ml nebulizer filling dose) is inhaled every 12 hours for a total of 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P/F ratio | The changes of the P/F ratio from T0 (time of PGD diagnosis) to day 7 of the treatment or to extubation of the patient | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVLW | Measurement of extravascular lung water | 7 days or until extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peptide
Late Mesh Complications After 3258 Incisional Hernia Operations

Study Overview
=================
Brief Summary
-----------------
The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DHD to uncover risk factors for long-term (30 days postoperative and later) readmission, reoperation, death and reoperation for recurrence after incisional hernia repair with use of a synthetic mesh.

Detailed Description
-----------------
All principal incisional hernias registered in the Danish Hernia Database are included in the study. The included patients have been followed for more than 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Official Title
-----------------
Late Mesh Complications After 3258 Incisional Hernia Operations

Conditions
-----------------
Incisional Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incisional Hernia Repair

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Danish Hernia Database<br>Patients registered in the Danish Ventral Hernia Database during January 1st 2007 to december 31st 2010 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | Riskfactors for reoperation (any procedure) more than 30 days after incisional hernia repair | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Riskfactors for readmission later than 30 days after incisional hernia repair | Up to 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incisional Hernia, Complications, Long-term