linjc16/ctgov huggingface dataset:
Registry for Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in Duke University Health System, which will examine patient and treatment effects on cancer outcomes.

Official Title
-----------------
Registry to Evaluate Multi-modality Therapies for Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreatic cancer Exclusion Criteria: Younger than 18 years of age

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 pancreatic cancer<br>Patients diagnosed with pancreatic cancer evaluated at this institution. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Survival from Diagnosis to time of death | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | length of time with no evidence of disease | 10 years | 
| Metastasis | Radiographic or surgical evidence of disease spread beyond the pancreas (or resection bed if post surgery). | 10 years | 
| Local recurrence | Radiographic evidence of disease recurrence in the resection bed, if post surgery. | 10 years |
Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

Study Overview
=================
Brief Summary
-----------------
After spinal cord injury, patients have frequent urinary tract infections (UVI). Vitamin C is usually prescribed to prevent such infection, but the efficacy of the treatment is poorly documented. In the study, patients will be randomised either to receive vitamin C daily, or not, for one year, and clinical episodes of UVI will be registered. The null hypothesis is that vitamin C will not reduce the number of UVI episodes by 30%.

Detailed Description
-----------------
The study is an investigator-blind randomised parallel study on the efficacy of vitamin C to prevent urinary tract infections in stable, ambulatory spinal cord-injured patients. To be included, patients should have had at least 3 previous UVI episodes over the last two years. 40 patients are included. Patients are randomised to receive either 1 g vitamin C b.i.d. over 1 year, or no vitamin C. The main outcome is the number of clinical UVIs that have been treated with antibiotics.

Official Title
-----------------
Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured

Conditions
-----------------
Urinary Tract Infection, Spinal Cord Injury

Intervention / Treatment
-----------------
* Drug: vitamin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spinal cord injury 3 or more episodes of UVI over previous 2 years Exclusion Criteria: pregnancy age <18 continuous use of antibiotics, hippuric acid or crane berry juice

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 vitamin C<br>Vitamin C 1g bid | Drug: vitamin C<br>* vitamin C 1g bid for 1 year<br>|
| No Intervention: 2<br>Usual Care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical episodes of UVI treated by antibiotics |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silent bacteriuria |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
UVI, Spinal cord injury, Prevention, Vitamin C
Finances First: A Health Intervention in Low Income Single Mother Households

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, randomized, controlled three-year study is to compare the effect of a year-long financial education program versus usual care on health outcomes in single mother low income households.

Official Title
-----------------
Finances First: A Health Intervention in Low Income Single Mother Households. A Prospective, Randomized, Controlled Trial to Assess the Effect of Financial Education on Health Outcomes in Single Mother Households.

Conditions
-----------------
Financial Stress

Intervention / Treatment
-----------------
* Behavioral: Financial Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unmarried Currently employed Annual salary must be less than 200% of the Federal Poverty Guideline Supporting at least one child at home Able to read and speak either English or Spanish Exclusion Criteria: Currently abusing alcohol or recreational drugs Currently living in a domestic violence situation Pregnant or planning to become pregnant in the next year

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Financial Education Intervention<br> | Behavioral: Financial Education<br>* Participants randomized to financial education will undergo a year long financial education. This involves 9 weeks of weekly classes followed by one on one coaching for a year.<br>|
| No Intervention: No Financial Education Intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quality of Life as measured by the WHO QOL BREF survey | Changes in Quality of Life as measured by the WHO QOL BREF survey | Baseline and one year later | 
| Weight loss | The proportion of overweight or obese women that achieve a 5% or more reduction in weight | Baseline and one year later |
Mild Traumatic Brain Injury Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.

Detailed Description
-----------------
The Mild Traumatic Brain Injury Registry is a prospective study which includes patients who have been seen in the CMC ED with a diagnosis of mild brain injury or concussion and a negative CT scan. The investigators will be collecting blood samples, and administering cognitive and balance tests. The investigators will also be following symptoms and cognition throughout the first year to help define typical recovery, and guide prognosis.

Official Title
-----------------
Mild Traumatic Brain Injury Registry

Conditions
-----------------
Brain Injury, Traumatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have defined history of CHI (closed head injury) which produced an altered state of consciousness or mood Must be awake and alert (Glasgow Coma Scale 13-15) Must be enrolled within 72 hours of injury Must have CT or MRI neuroimaging performed Exclusion Criteria: Diabetes Mellitus with severe complications Intoxication at time of enrollment Major psychiatric disorder that is poorly controlled Prior stroke History of Social Security defined disability Uncontrolled Seizure Disorder Incarceration or arrest Concurrent Injury requiring hospitalization Use of anticoagulant drugs Any condition the investigator deems as inappropriate for patient enrollment Personality disorder Heart, liver or kidney failure defined using common clinical practice guidelines Baseline cognitive impairment Homelessness TBI associated with interpersonal violence Pregnancy Long bone fracture requiring surgical stabilization

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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 |
| --- | --- |
| Mild TBI<br>Patients who have been diagnosed with a mild brain injury. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine which biomarkers and/or clinical variables correlate with long term symptoms of mild traumatic brain injury. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain concussion
AVAI: Atrial Ventricular Arrythmia Incidence

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

Detailed Description
-----------------
The purpose of this observational study is to collect data regarding the population of patients implanted with a St. Jude Medical ICD. Data regarding Slow Ventricular Tachycardia Episodes, Atrial Fibrillation Episodes and the devices programmed parameters will be collected during two years after the implant.

Official Title
-----------------
Study of Slow Ventricular Tachycardia and Atrial Fibrillation Incidence Documented by Intracardiac Electrogram in Patients Implanted With an Implantable Cardiac Device (ICD) .

Conditions
-----------------
Ventricular Tachycardia, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been implanted with a St Jude Medical ICD, mono,bicameral or cardiac resynchronization therapy - Defibrillator (CRT-D) according the American College of Cardiology (ACC), American Heart Association (AHA), National Standards for Physical Education (NASPE) guidelines. (min. 24 hours - max. 2 months) Patient has signed the study specific Informed consent document. Patient is older than 18 years of age Exclusion Criteria: Patient has a permanent Atrial Fibrillation Patient has a documented slow ventricular Tachycardia Episodes previous to the ICD implant. Patient not programed with a ventricular Tachycardia (VT) zone upper than 120 bpm. Patient requires cardiac resynchronization Patient has Brugada Syndrome Patient has long QT Syndrome Patient has a device replacement; Patient is pregnant or nursing Patient is unable to attend the follow-up visits

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 |
| --- | --- | --- |
| Slow Ventricular Tachycardia Episodes Devices Detected (Between 120-150 Bpm and > 30sec) Atrial Fibrillation (AF) Episodes Devices Detected (> 30 Sec) | Slow Ventricular Tachycardia episodes will be considered as a tachycardia episodes detected by the device between 120-150 bpm and with more than 30sec of duration AF Episodes will be considered only when their duration is >30sec | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Mortality Hospitalization Rate Due to Cardiovascular Reasons or Heart Failure |  | 24 months |
Cutaneous Microcirculation and Diabetic Foot

Study Overview
=================
Brief Summary
-----------------
15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.

Official Title
-----------------
Cutaneous Microcirculation and Diabetic Foot

Conditions
-----------------
Diabetic Foot Proned Patients

Intervention / Treatment
-----------------
* Drug: Lidocaine/prilocaine 1g (topical administration)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Men and Women Presence of diabetes Signed acknowledgement form Exclusion Criteria: No signed acknowledgement form patients under 18 year-old

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetic patients with MPP<br> | Drug: Lidocaine/prilocaine 1g (topical administration)<br>* Cutaneous blood flow measurement using laser Doppler<br>|
| Other: Diabetic patients without MPP<br> | Drug: Lidocaine/prilocaine 1g (topical administration)<br>* Cutaneous blood flow measurement using laser Doppler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous blood flow |  | Within 3 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of neuropathy on PIV impairment | Difference in skin vascular response to local application of pressure (PIV) with and without topical application of a local anesthetic cream Lidocaine / prilocaine in all diabetic patients (with and without MPP). | Within 3 months after inclusion |
Lower Extremity Proprioception Sensory and Functionality in Hemiparetic

Study Overview
=================
Brief Summary
-----------------
The loss of sensorial feedback causes gait impairment in hemiparesis. The studies show that proprioceptive impairment of knee is related to falling in these patients. The aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.

Official Title
-----------------
Lower Extremity in Hemiparetic Proprioception Sensory and Functionality: A Comparative Study

Conditions
-----------------
Hemiparesis Proprioceptive Disorders Gait, Hemiplegic, Healthy Individual, Comparative Study

Intervention / Treatment
-----------------
* Other: Proprioseption in hemiparetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 20-65 and discharged from the hospital, Diagnosed with hemiparesis at least 4 weeks ago, First time and unilateral hemiparesis, Modified Rankin Score ≤ 3, Hodkinson Mental Test ≥ 6, Individuals who agree to receive treatment will be included in the study. Exclusion Criteria: Having vision and hearing problems, Having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis, Medically unstable, Diseases that will affect the lower extremity sense, Individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Proprioseption in hemiparetics<br>Proprioception on balance and gait functions in hemiparetic individuals | Other: Proprioseption in hemiparetics<br>* Proprioception on balance and gait functions in hemiparetic individuals<br>|
| Healthy Individual<br>Proprioception on balance and gait functions in healthy individuals | Other: Proprioseption in hemiparetics<br>* Proprioception on balance and gait functions in hemiparetic individuals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensorial Assessment-1 | Semmes-Weinstein Monoflament | 2 minutes | 
| Sensorial Assessment-2 | Position test for lower extremity | 2 minutes | 
| Sensorial Assessment-3 | Kinestesia (Electrogoniometer) | 2 minutes | 
| Balance assessment | Static balance via SportKAT-550 | 30 second | 
| Gait parameters | BTS G-Walk Spatiotemporal gait parameters | 1 minute |
An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).

Official Title
-----------------
An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe rheumatoid arthritis RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry) Exclusion Criteria: History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug Active, severe infection or history of recurrent clinically significant infection Pregnancy Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit Methotrexate intolerance

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Disease Activity Score (DAS 28) |  | 12 months | 
| Pain: Visual Analogue Scale (VAS) pain scale |  | 12 months | 
| Physical Function: Health Assessments Questionnaire (HAQ) |  | 12 months | 
| Incidence of patients with all-cause discontinuation of tocilizumab |  | 12 months |
Painless Myocardial Ischemia in Diabetic Patients.

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the relationship between the concentrations of blood orphanin, norepinephrine and the morbidity of painless myocardial ischemia in patients with diabetes mellitus. Hopefully, the biomarker(s) in the blood of diabetic patients can be found for screening high risk patients in the diabetes sufferers to prevent the painless myocardial ischemia.

Official Title
-----------------
Changes of Plasma Orphanin and Norepinephrine Levels in Patients With Painless Myocardial Ischemia and Diabetes Mellitus.

Conditions
-----------------
Painless Myocardial Ischemia

Intervention / Treatment
-----------------
* Diagnostic Test: ELISA Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has diabetes Exclusion Criteria: History of myocardial ischemia Symptoms of myocardial ischemia（ECG changes except）

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary angiography group<br>In diabetic patients without symptoms of myocardial ischemia, coronary angiography showed no stenosis or stenosis less than 75%. | Diagnostic Test: ELISA Test<br>* The levels of orphanin and norepinephrine in blood of diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy were measured.<br>|
| Coronary angiographic stent implantation group<br>Coronary angiographic stenosis was more than 75% in diabetic patients without myocardial ischemia symptoms, and coronary stents were implanted. | Diagnostic Test: ELISA Test<br>* The levels of orphanin and norepinephrine in blood of diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy were measured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood orphanin content | Blood orphanin levels in painless diabetic patients with myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy. | 24 hours | 
| Blood norepinephrine content | Blood norepinephrine levels in diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy | 24 hours |