linjc16/ctgov huggingface dataset:
Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.

Official Title
-----------------
Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies

Conditions
-----------------
Coronary Artery Disease, Saphenous Vein Graft Patency

Intervention / Treatment
-----------------
* Drug: Rivaroxaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to coronary artery bypass graft and at least one saphenous vein graft Exclusion Criteria: Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy Stroke within 1 month or any history of hemorrhagic or lacunar stroke Estimated glomerular filtration rate (eGFR)<15 mL/min

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Anticoagulation+Antiplatelet<br>Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. | Drug: Rivaroxaban<br>* Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation<br>|
| Experimental: Oral Anticoagulation<br>Rivaroxaban 20 mg once daily | Drug: Rivaroxaban<br>* Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation<br>|
| Active Comparator: Antiplatet<br>Aspirin 100 mg once daily | Drug: Rivaroxaban<br>* Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death | 5 years | 
| Graft Patency | Time from randomization to the first occurence of saphenous graft oclusion | 5 years | 
| Major Bleeding | Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE, cardiovascular death | Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia | 5 years | 
| All-cause mortality | Time from randomization to first occurrence of all-cause mortality | 5 years |
Locally Advanced Colorectal Cancer and Local Recurrences in Västra Götaland

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to review the treatment strategies of locally advanced colorectal cancer and locally recurrent rectal cancer in Västra Götaland during 1995-2016. The aim is to evaluate time trends and outcome both related to morbidity and cancer specific survival, we will also evaluate the results after advanced reconstruction. The study will identify the population using the Swedish ColoRectal Cancer Registry and then the individual patient charts will be reviewed. The data will be collected in a clinical record form covering demography (age, sex, co-morbidity, BMI and diagnoses) as well as treatments strategy, surgical procedures, re-operations, complications, readmissions, hospital stay, stoma formation etc.

Official Title
-----------------
Locally Advanced Colorectal Cancer and Recurrence After Colorectal Cancer in Region Västra Götaland

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Surgery or treatment for local recurrence
* Procedure: Surgery for advanced colorectal cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced rectal cancer Local recurrence for colorectal cancer Curative treatment for colorectal cancer Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with local recurrence<br> | Procedure: Surgery or treatment for local recurrence<br>* Surgery or treatment for local recurrence<br>Procedure: Surgery for advanced colorectal cancer<br>* Surgery for advanced colorectal cancer<br>|
| Patients with advanced colorectal cancer<br> | Procedure: Surgery or treatment for local recurrence<br>* Surgery or treatment for local recurrence<br>Procedure: Surgery for advanced colorectal cancer<br>* Surgery for advanced colorectal cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after local recurrence |  | 3 years | 
| Risk factors for local recurrence |  | Preoperative data, about 1 month prior surgery | 
| Complications after urinary reconstruction surgery for locally advanced cancer |  | 90 days | 
| Patient experiences after local recurrence | Indepth interviews with patients with local recurrence | 3 years postopeartively after local recurrence |
Quality Improvement - Monitoring Alarm Optimization Study

Study Overview
=================
Brief Summary
-----------------
This project aims to reduce the frequency of duplicate, false and clinically insignificant alarms in hospital units, and subsequent alarm fatigue resulting from excessive alarm frequency. The investigators will implement evidence-based guidelines for alarm optimization according to patient-population specific parameters, and evaluate alarm frequency and staff perception of alarm fatigue at baseline and 60 days after implementation of this quality improvement initiative.

Official Title
-----------------
Quality Improvement - Monitoring Alarm Optimization Study

Conditions
-----------------
No Applicable Condition; Study of Physiologic Monitor Alarms

Intervention / Treatment
-----------------
* Other: Optimized alarm profiles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nursing staff at selected units at Duke University Hospital Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Hospital units where alarms have been optimized | Other: Optimized alarm profiles<br> <br> |
| No Intervention: Control<br>Hospital units where alarms remain unchanged | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of frequency of total alarms by hospital unit at 60 days |  | At baseline and 60 days following implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of number of alarms per bed |  | At baseline and 60 days following implementation | 
| Change from baseline of number of alarms per day per bed |  | At baseline and 60 days following implementation | 
| Change from baseline of perceived alarm fatigue, assessed using a questionnaire |  | At baseline and 60 days following implementation |
68Ga-Citrate PET of Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study investigates whole-body distribution kinetics of intravenously administered Gallium-69 (68Ga) citrate by positron emission tomography (PET)/computed tomography (CT). Thereafter, radiation dosimetry of 68Ga-citrate PET/CT will be determined.

Detailed Description
-----------------
Six healthy male volunteers are recruited in this study. Gallium-68 citrate radiopharmaceutical is intravenously injected as a bolus and whole-body distribution kinetics are studied by dynamic whole-body positron emission tomography/computed tomography. During imaging, serial venous blood samples are drawn, plasma is separated and radioactivity is measured by gamma counter. Immediately after imaging session, urine is voided and radioactivity is measured by gamma counting. As a final point, radiation dosimetry due to single Gallium-68 citrate injection is determined.

Official Title
-----------------
68Ga-Citrate Positron Emission Tomography (PET) of Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Gallium-68 citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy 18-100 year-old men Exclusion Criteria: ongoing infection/inflammation proven by blood or other tests

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gallium-68 citrate<br>Intravenous bolus injection of 200 MBq of Gallium-68 citrate | Other: Gallium-68 citrate<br>* Single intravenous bolus injection of 200 MBq of Gallium-68 citrate radiopharmaceutical<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole-body distribution of Gallium-68 citrate |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorbed dose | Absorbed ionisation radiation dose in critical organs due to intravenous bolus injection of 200 MBq of Gallium citrate | 4 hours |
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.

Official Title
-----------------
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Drug: Aripiprazole oral product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed as autism with irritability Exclusion Criteria: patients who has ever been treated with aripiprazole

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aripiprazole oral product|oral administration of aripiprazole|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. | Using caregiver-rated ABC-J, the degree of aberrant behaviors was scored on four levels ranging from 0 'not at all a problem', 1 'slight problem', 2 'moderately serious problem' to 3 'the problem is severe in degree' in irritability subscale (including 15 items describing symptoms of irritability, such as temper tantrums, aggression, mood changes, and self-injury). The irritability subscale score ranging from 0 to 45 was derived from the sum of the 15 items and higher values represent a worse outcome. | Baseline, Week 4, 8, 16, 24, 52 |
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.

Official Title
-----------------
An Open-Label, Single-Dose Pharmacokinetic Study of Liquid Subcutaneous Formulation of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Conditions
-----------------
NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: BIO89-100


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Age 21 to 65 Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria. Model for End-Stage Liver Disease (MELD) score < 12. Child-Turcotte-Pugh (CTP) score < 7 (Class A). Fibrosis stage F4 by FibroScan. Key Exclusion Criteria: History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation. Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure. known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion. Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, single dose, PK study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIO89-100 30 mg, Open Lable, Single Dose<br> | Drug: BIO89-100<br>* Subcutaneous Injections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Profile of liquid formulation of BIO89-100 | Determine maximum observed serum drug concentration (Cmax) | 22 days | 
| PK Profile of liquid formulation of BIO89-100 | Area under the serum drug concentration-by-time curve from time 0 to the time of the last quantifiable drug concentration (AUC0-t) | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of the BIO89-100 liquid formulation | Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) Number of subjects who discontinued due to AEs and due to related AEs | 22 days |
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Official Title
-----------------
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Dapagliflozin
* Drug: Glimepiride
* Drug: Dapagliflozin + Glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects with BMI of 18-32 kg/m2 Exclusion Criteria: Abnormal physical or lab findings Allergies to any sulfonylurea or related compounds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Dapagliflozin<br>* Tablets, Oral, 20 mg, once daily, single dose<br>|
| Active Comparator: Arm 2<br> | Drug: Glimepiride<br>* Tablets, Oral, 4 mg, once daily, single dose<br>|
| Active Comparator: Arm 3<br> | Drug: Dapagliflozin + Glimepiride<br>* Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together |  | plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride |  | for 72 hours after each administered dose | 
| Recorded adverse events |  | for 72 hours after each administered dose |
El Paso Public Health Biorepository

Study Overview
=================
Brief Summary
-----------------
The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.

Detailed Description
-----------------
As per summary above.

Official Title
-----------------
TTUHSC El Paso Public Health Biorepository (Research Core Laboratories Dental Biorepository)

Conditions
-----------------
Oral Disease, Bacterial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals seen at the City of El Paso dental or pediatric clinics ages 10-21 Healthy children and patients that are likely to be seen in the clinics within the predetermined follow-up time of 6 months Exclusion Criteria: Patients under 10 years of age and over 21 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 21 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of saliva bio-repository | Saliva will be collected from dental patients to be stored for research | Through study completion, an average of 3 years | 
| The study of oral bacteria | DNA of samples will be analyzed to determine if bacteria play a role in oral health | Through study completion, an average of 3 years |
Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney transplant.

Official Title
-----------------
A Retrospective Follow Up Study to Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Other: Observations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who withdrew from one of the qualifying studies (i.e. patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) due to kidney transplantation. Exclusion Criteria: - Patient has any kind of disorder that compromises the ability of the subject to give written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Kidney Transplant<br>All patients entered into the study will have received a kidney transplant. | Other: Observations<br>* This is a non-interventional study- only observational.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTH Values |  | 12 months post kidney translplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium and Phosphorus |  | 12 months post kidney transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplant