linjc16/ctgov huggingface dataset:
Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial

Study Overview
=================
Brief Summary
-----------------
Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.

Official Title
-----------------
Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART

Conditions
-----------------
Dry Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Device: Rheopheresis / double filtration plasmapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 to 85 years old diagnosis of AMD in both eyes must have dry AMD in the study eye Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8 peripheral veins allowing vascular access to establish the extracorporal circuit. Exclusion Criteria: other retinal or choroidal disorders than AMD optic nerve disease, glaucoma conditions that limit the view of the fundus acute bleeding in any eye General exclusion criteria for the treatment of Rheopheresis: anaemia haemorrhagic diathesis or coagulopathy diabetes serious acute or chronic kidney or liver failure hypotension systolic < 100 mmHg chronic viral infection (HIV, hepatitis B, C) epilepsia, psychosis or dementia a malignant disease or any other condition with life expectancy < 12 months known history of alcohol or drug abuse and long term serious nicotine abuse

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks | Device: Rheopheresis / double filtration plasmapheresis<br>* Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.<br>* Other names: Double filtration plasmapheresis;|
| No Intervention: 2<br>No treatment control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups. |  | 30 weeks (7.5 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheopheresis, Dry Age Related Macular Degeneration, AMD, apheresis, microcirculation
COPD Research Registry

Study Overview
=================
Brief Summary
-----------------
The COPD Research Registry is a confidential database of individuals diagnosed with COPD or at risk of developing COPD. The Registry was established in 2007 by the COPD Foundation with the purpose of providing a mechanism for researchers to boost enrollment in clinical trials and other research studies. The COPD Foundation is working with National Jewish Health in Denver, Colorado to serve as the Registry's Data Coordinating Center and to ensure strictest confidentiality of participant information.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD. Exclusion Criteria: -Individuals under the age of 18

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 |
| --- | --- | --- |
| The COPD Foundation expects to assist at least 8 researchers (with patient recruitment) annually. |  | Up to 20 years |
High-flow Nasal Cannula Flow Rates, Severe Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
Objective: The investigators aimed to compare the heated humidified high-ﬂow nasal cannula (HHHFNC) flow rate of 1-L/kg/min (1L) with 2-L/kg/min (2L) in patients with severe bronchiolitis presenting to the pediatric emergency department. Study design: The investigators performed a study in which all patients were allocated to receive these two flow rates. The primary outcome was admitted as treatment failure, which was defined as a clinical escalation in respiratory status. Secondary outcomes covered a decrease of respiratory rate (RR), heart rate (HR), the clinical respiratory score (CRS), rise of peripheral capillary oxygen saturation (SpO2) and rates of weaning, intubation and intensive care unit (ICU) admission. Keywords: Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate

Official Title
-----------------
Comparison of Heated humidiﬁed High-flow Nasal Cannula Flow Rates (1-L/kg/Min vs 2-L/kg/Min) in the Management of Severe Bronchiolitis

Conditions
-----------------
Non-invasive Ventilation, Pediatric Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Heated humidiﬁed high-flow nasal cannula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of severe bronchiolitis Must be less than 24 months Must have presented to the emergency department Exclusion Criteria: Immediate invasive ventilation and/or intensive care unit admission Congenital heart disease, Chronic lung disease Neuromuscular disease Netabolic disease Craniofacial anomalies Immunocompromised Bacterial pneumonia Pneumothorax Nasal trauma

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 2 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 with acute bronchiolitis<br> | Device: Heated humidiﬁed high-flow nasal cannula<br>* Non-invasive ventilation with a nasal cannula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure rate | We compared the treatment failure between the 1-L/kg/min flow rate with 2-L/kg/min rate in patients with severe bronchiolitis | Within 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiolitis, Emergency department, High-flow nasal cannula, Flow rate
Comparison of the ProAdjuster Analysis to the Penning Method of Determining Intersegmental Motion of the Cervical Spine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the ProAdjuster system of analysis can be used to determine cervical spine instability using the Penning system of radiographic marking as a standard of comparison.

Detailed Description
-----------------
This study will utilize the ProAdjuster Device as a method of assessing the motion of the cervical spine in participants with instability as determined by a Penning Radiographic analysis. Only participants with existing radiographic studies will be included in the study. No additional Radiographic will be required.

Conditions
-----------------
Cervical Spine Instability

Intervention / Treatment
-----------------
* Device: motion analysis by durometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Logan student, staff, or faculty with no history of ankle injury; 2. Age 18 - 60 yoa. Exclusion Criteria: 1. Logan student, staff, or faculty ; 2. Local infection, injury or other malignancy affecting the cervical spine; 3. Any unstable joints of the cervical spine than require immobilization ; 4. Any manipulation to cervical spine within 48 hours; 5. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: motion analysis by durometer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical spine instability, Penning Study
Clinical Hypnosis Before External Cephalic Version (ECV)

Study Overview
=================
Brief Summary
-----------------
Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?

Detailed Description
-----------------
Prospective off-center randomisation of clinical hypnosis or neuro-linguistic programming intervention prior to a external cephalic version treatment.

Official Title
-----------------
Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial

Conditions
-----------------
Breech Presentation at Term

Intervention / Treatment
-----------------
* Other: Clinical hypnosis or neuro-linguistic programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton breech presentation gestation age above 36 weeks + 6 days Exclusion Criteria: multiples cannot understand German language

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical hypnosis<br>20 minutes tape recorded clinical hypnosis intervention | Other: Clinical hypnosis or neuro-linguistic programming<br>* 20 minutes tape recording intervention<br>|
| Active Comparator: Neuro-linguistic programming<br>20 minutes tape recording of nouro-linguistic programming intervention | Other: Clinical hypnosis or neuro-linguistic programming<br>* 20 minutes tape recording intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful ECV | Rate of cephalic presentation three hours after external cephalic version. | 3 hours after ECV treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire |  | before and 30 minutes after ECV | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breech presentation at term, pregnancy, external cephalic version (ECV), clinical hypnosis, neuro-linguistic programming (NLP)
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation

Study Overview
=================
Brief Summary
-----------------
This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.

Detailed Description
-----------------
Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation

Official Title
-----------------
Assessing the Content Validity of a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation

Conditions
-----------------
Opioid-induced Constipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving a stable maintenance opioid regimen (total daily dose of 30-1000mg of oral morphine, or equianalgesic amounts of 1 or more other opioid therapies) for a minimum of 4 weeks for non-cancer related pain. Development of constipation symptoms since starting opioids. Taken laxatives to help with bowel movements for at least four days over the past 2 weeks. Exclusion Criteria: Receiving opioid regimen for treatment of pain related to cancer. Participated in any clinical trial or research study relating to opioid use and/or constipation within the past year. History of cancer within 5 years from the time of screening. Has medical condition(s) and/or treatment(s) associated with diarrhea, intermittent loose stools, or constipation (e.g., fecal incontinence or chronic idiopathic constipation). Has irritable bowel syndrome (IBS) or chronic functional constipation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 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 |
| --- | --- |
| Subjects with opioid induced constipation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semi-structured discussion guide | Using a semi-structured discussion guide during a single one-on-one interview, qualitative information will be collected from subjects that relates to their experience with Opioid Induced Constipation symptoms and to their understanding and perception of a verbally-administered stool symptom screener. | Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid-induced constipation
Clinical Outcomes and Cost of Gram Negative Bacteremia

Study Overview
=================
Brief Summary
-----------------
This study examines the clinical outcomes and healthcare costs associated with gram negative bacteremia at Duke University Medical Center from 2002-2015.

Detailed Description
-----------------
Specific Aim 1: Define the clinical impact of gram negative bacterial (GNB) bloodstream infections (BSI). In this objective, the investigators will describe the prevalence, source of bacteremia, and location of acquisition (i.e., community-acquired, healthcare-associated, hospital-acquired) of GNB BSI. The investigators will also examine the outcomes associated with GNB BSI including length of hospital stay, length of ICU stay, in-house mortality, and hospital costs. Specific Aim 2: Describe antibiotic resistance patterns in GNB BSI, and explore associations between antibiotic resistance and clinical and economic outcomes. In this objective, the investigators will describe the prevalence and antibiotic susceptibility profiles of multidrug resistant phenotypes including MDR bacteria, which are defined by resistance to three or more drug classes, ESBL-producers, and CRE. The investigators will examine the differences in mortality, resource use (length of hospital stay, length of ICU stay), and direct medical costs between cases with and without antibiotic resistance.

Official Title
-----------------
Epidemiology, Outcomes, and Costs Associated With Gram Negative Bacteremia

Conditions
-----------------
Gram-negative Bacteremia, Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Since January 2002, one investigator (VGF) has received daily reports from the clinical microbiology laboratory on all hospitalized patients at Duke University Medical Center with one or more blood culture(s) positive for gram negative rods. Patients were then evaluated within 36 hours of the detection of bacteremia for clinical evidence of infection Exclusion Criteria: Patients were excluded from the study for the following reasons: age less than 18 years, polymicrobial infection (blood culture positive for more than one pathogen), neutropenia (white blood cell count less than 1.0 x 109/L), or death prior to the return of positive blood cultures. In order to preserve the independence of observations, only the initial episode of gram negative bacteremia was included in the analysis (e.g., patients were only included once). The study was approved by the Duke University Medical Center Institutional Review Board.

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 |
| --- | --- | --- |
| Mortality | The investigators are measuring in-hospital mortality | Up to 1 year |
Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results

Study Overview
=================
Brief Summary
-----------------
First Sense Medical®, LLC is a medical device company developing a novel breast cancer screening tester called the First Sense Breast Exam® Tester. This radiation free tester is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. When the tester is in production, a test will take approximately 7 minutes and will be performed in a doctor's office.

Detailed Description
-----------------
This study is designed to evaluate the First Sense Breast Exam® test and the analysis by Therma-Scan. The First Sense Breast Exam® test is an adjunct to a mammogram. Currently, mammography is the standard of care in screening for breast cancer, and manual thermology is an adjunctive screening method. All of the study costs will be incurred by the sponsor and the subject will incur no costs to participate in the study. The First Sense Tester is a non-significant risk device where the tester's imaging camera makes no contact with the subjects during the entire procedure.

Official Title
-----------------
Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: First Sense Medical®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female, over the age of 18 years of age. Asymptomatic women and women who are being screened for breast abnormality. Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system. Not pregnant or breast feeding. Signed Informed consent. Exclusion Criteria: Subject does not meet inclusion criteria, noted above. Use of niacin or niacin patch. Use of nitroglycerin. Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study. Patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.). History of breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First Sense Breast Exam<br> | Device: First Sense Medical®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology) |  | Up to 12 months |
Neurobiology of Opioid Dependence: 4 - 4

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of chronic naltrexone pre-treatment on the response to yohimbine in healthy volunteers.

Official Title
-----------------
Neurobiology of Opioid Dependence: 4

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Naltrexone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral, physiological, neuroendocrine response to yohimine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid disorders