linjc16/ctgov huggingface dataset:
Development of a Hospital Service That Uses Critical Pathway (Protocolized) Care Plans to Provide High-Quality, High-Reliability, Evidence-Based Medical Care

Study Overview
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Brief Summary
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Our broad, long-term objective is to create a new non-resident (non-teaching) hospital service that uses patient-centered critical pathway care plans for treating patients in St. Marys Hospital. This innovative service, the Hospital Medicine (HOME) Team, will integrate three timely, high-priority concepts in healthcare: patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations. The target populations for the new model of service are patients hospitalized with pre-defined admission diagnoses who are expected to require only a brief, focused hospital stay of four days or less. Specifically, we will 1) Design the prototypical approach to be used for developing all critical pathway care plans by integrating patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations, 2) Systematically design the critical pathway care plans for two pre-defined admission diagnoses (community-acquired pneumonia and non-surgical low-back pain), and 3) Compare outcomes of this new service against respective historical patient cohorts for patients admitted with community-acquired pneumonia and non-surgical low-back pain. We anticipate that the prototypic methodology used to develop this patient-centered service will be replicated for other new hospital-service models. To our knowledge, there are currently no existing hospital services in the U.S. that have intentionally integrated principles of high reliability organizations into evidence-based critical pathways founded on patient-centered principles of uncompromising quality.

Official Title
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Development of Critical Pathway Care for Hospitalized Patients Using Principles of Patient-Centered Quality Care, Evidence-Based Medicine, and High Reliability Organizational Structure

Conditions
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Critical Pathways

Participation Criteria
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Eligibility Criteria
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Hospitalized patient with one of six medical diagnoses: community-acquired pneumonia, deep venous thrombosis or pulmonary embolism, cellulitis, alcohol withdrawal, pyelonephritis, low back pain. Ability and agreement to consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

Study Overview
=================
Brief Summary
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Investigators propose to develop hyperpolarized [13C]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study.

Detailed Description
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Investigators will perform a pilot study to test the translational feasibility by evaluating sensitivity and repeatability of hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate in healthy human subjects (n =10 each). Each subject will be imaged twice using the same hyperpolarized substrate with an interval (<45min) between the injections to evaluate repeatability. Finally, eight subjects will be imaged with both hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate for comparison.

Official Title
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Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

Conditions
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Brain Metabolism

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 18 through 60 years of age. Healthy, with no neurological abnormalities. Ability to understand and the willingness to sign a written informed consent. All races and ethnicities will be included; subjects must be able to read and speak the English language. Exclusion Criteria: Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning. Under influence of antiepileptic drugs at the time of MRI/MRSI scanning. Any contraindication per MRI Screening Form including Implants contraindicated at 3T, pacemakers Implantable Cardioverter Defibrillator (ICD) Claustrophobia Medically unstable including Heart failure Severe left ventricular outflow tract (LVOT) obstruction Unstable angina Pregnancy Lactating

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hyperpolarized [13C]pyruvate<br>Hyperpolarized stable isotope injection ([13C]pyruvate) during magnetic resonance spectroscopic imaging | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of 13C ratio maps in the brain of healthy participants | Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging | Measurements made during study scan |
Human Samples and Data Repository

Study Overview
=================
Brief Summary
-----------------
This protocol will enable IRB (institutional review board) review of proposed research using human samples and data collected under the terminated NIH studies 04-EI-0065 and 96-EI-0096. Data and samples may include demographic and personal health information, psychological or psychiatric testing, blood, urine, CSF or other body fluids or tissues and results of medical and physiological evaluation and medical imaging. Data and sample analyses are limited to those approved under the original protocols unless additional specific institutional review board approval is obtained.

Detailed Description
-----------------
Objective: This protocol will enable prospective IRB review of research using human samples and data collected under other branch protocols. Study population: Participants that were followed in terminated branch protocols under which data or samples were collected. Design: Samples and data will be brought under this protocol, analyzed and stored for uses specified in the original protocols and as additionally approved by the IRB. Outcome: The outcome of this protocol will be the storage, tracking, and utilization of samples and data obtained under terminated protocols. Purpose: The purpose of this protocol is to enable prospective IRB review of research using human samples and data collected under other branch protocols. Participants: Participants who previously participated in NIH protocols whose wishes regarding use of their samples or data for research other than that specified in the initial protocol is not known may be enrolled in this protocol. At this time, there are no additional analyses planned outside of the original protocols, apart from those listed below. Participant consent or IRB approval for a waiver of additional informed consent will be sought prior to initiation of additional analyses.

Official Title
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Laboratory of Immunology/National Eye Institute Repository

Conditions
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Uveitis, Scleritis

Participation Criteria
=================
Eligibility Criteria
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Data Analysis Study
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Scleritis, Intermediate Uveitis, Posterior Uveitis, Intraocular Inflammatory Disease, Data Analysis, Data Collection, Sample Analysis
IVN-CAT-001A Performance of CAST With Different Allergens in Patients With Cat Dander Allergy

Study Overview
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Brief Summary
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Primary objective of the trial: To determine at which concentration the fusion protein MAT Fel d1 degranulates basophils of cat dander allergic patients, in comparison to a cat dander extract and to Fel d1 alone

Official Title
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Performance of CAST With Different Allergens in Patients With Cat Dander Allergy

Conditions
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Allergy to Cats

Intervention / Treatment
-----------------
* Behavioral: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 1. Patient with Cat Dander Allergy evidenced by positive history 2. Age: 18 to 75 years Exclusion criteria: 1. Use of oral corticosteroids, Chromoglycin, Ketotifen, or any immunosuppressive drugs within the last 2 months 2. Psychiatric disorder resulting in malcompliance 3. Neg. IgE to Cat dander

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

| Intervention/Treatment |
| --- |
|Behavioral: Blood sample|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia

Study Overview
=================
Brief Summary
-----------------
our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

Detailed Description
-----------------
our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation. This randomized controlled study will compare the effect of Lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.

Official Title
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Nebulized Lidocaine Versus Placebo to Prevent Cough at Emergence From Anesthesia: a Double Blind Prospective Randomised Trial

Conditions
-----------------
Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat

Intervention / Treatment
-----------------
* Drug: Lidocaine 2%
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years ASA status I or II Exclusion Criteria: Unexpected difficult laryngoscopy Surgery>3 hours

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
Interventional Model Description: 2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine group<br>the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia | Drug: Lidocaine 2%<br>* the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia<br>|
| Placebo Comparator: Placebo group<br>the patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia | Drug: Normal saline<br>* Normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of cough at emergence from general anesthesia | evaluation of incidence of cough at emergence from general anesthesia | 30 minutes after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of sore throat | evaluation of incidence of sore throat | 24 hours after tracheal extubation |
CRRT for Glutamate Elimination After Cardiac Arrest

Study Overview
=================
Brief Summary
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Glutamate is known to be a mediator for apoptosis after brain hypoxia e.g. due to cardiac arrest. This pilot trial evaluates the possibility of elimination of Glutamate by CRRT after cardiac arrest.

Official Title
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Pilot Trial Concerning Glutamate Elimination With CRRT for Neurological Outcome After Cardiac Arrest

Conditions
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Reperfusion Syndrome

Intervention / Treatment
-----------------
* Procedure: Continuous renal replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post cardiac arrest Exclusion Criteria: hemodynamic instable in-hospital cardiac arrest

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 |
| --- | --- |
| Active Comparator: CRRT after cardiac arrest<br>Continuous renal replacement therapy (CRRT) after cardiac arrest for 72 hours for elimination of Glutamate. Repetitive testing of blood Glutamate levels. | Procedure: Continuous renal replacement therapy<br> <br> |
| No Intervention: control<br>Repetitive testing of blood Glutamate levels without CRRT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glutamate blood concentration in intervention arm over the time | Reduction of blood Glutamate concentration by renal replacement therapy | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with abnormal outcome parameters |  | up to 14 days |
Prospective Sinonasal Cancer Multi-institution Study

Study Overview
=================
Brief Summary
-----------------
This is a multi-institution prospective study of patients with sinonasal malignancies. The goal of this study is to learn more about the course of sinonasal cancer, treatment outcomes, and patient quality of life. In addition, central mutational and genomic analysis of tumor tissue will be evaluated.

Official Title
-----------------
Sinonasal Cancer Study to Evaluate Oncologic Outcomes and Quality of Life

Conditions
-----------------
Sinonasal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between the ages of 30 days (non-inclusive) and 99 years (inclusive) Patients with a diagnosis of sinonasal cancer Patients undergoing treatment at Mayo Clinic Exclusion Criteria: Healthy individuals Unwilling to sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 30 Days
Maximum Age: 99 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 |
| --- | --- | --- |
| Oncologic outcomes as measured by overall survival, disease specific survival and recurrence free survival |  | Through study completion, an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life outcomes including the University of Washington Quality of Life Questionnaire (UW-QOL v4) and the Sinonasal Outcome Test 22 (SNOT22) |  | Through study completion, an average of 5 years | 
| Describe the molecular foundation of sinonasal malignancies utilizing RNA sequencing to identify transcriptomic tumor profiles |  | Through study completion, an average of 5 years |
Daily Home Spirometry for Early Detection of Pulmonary Complications in Patients With COVID19

Study Overview
=================
Brief Summary
-----------------
The aim of this preliminary study is to describe the potential decline in forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) as measured by home spirometry in high-risk subjects infected with COVID-19. We hypothesize that the magnitude of such a decline in FEV1 and/or FVC may be associated with clinical deterioration and hospitalization. The study will ultimately inform a larger subsequent RCT that will evaluate the efficacy of home spirometry in the early detection (pre respiratory symptoms) of respiratory complications and therefore prompt early medical attention which is a key for improving outcome.

Official Title
-----------------
A Descriptive Pilot Study of Daily Home Spirometry for Early Detection of Pulmonary Complications in High Risk Patients With COVID19

Conditions
-----------------
COVID 19

Intervention / Treatment
-----------------
* Diagnostic Test: home spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: without dyspnea and with no evidence of pneumonia, ARDS, organ failure or requiring admission to ICU. All patients ≥55 years age or ≥1 risk factor for disease complications (prior pulmonary, kidney or cardiovascular disease, diabetes mellitus, hypertension, bone merrow suppression, solid organ transplant, HIV with CD4<250, heavy smoker, BMI >30). All participants will sign a written informed consent. Exclusion Criteria: Patients unable to perform spirometry contraindications for spirometry (hemoptysis, active tuberculosis, syncope associated with forced exhalation or increased risk for spirometry) adhere to the follow-up protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: home spirometry|portable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | participants that are hospitalized | number of participants hospitalized in a time frame of a year |
Sperm Preparation Prior to Intrauterine Insemination Study

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.

Detailed Description
-----------------
Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.

Official Title
-----------------
The Sperm Preparation Prior to Intrauterine Insemination Study (PIoUS)

Conditions
-----------------
Infertility, Infertility Secondary, Infertility Unexplained, Anovulation, Fertility Disorders, Reproductive Issues

Intervention / Treatment
-----------------
* Device: Zymot Multi sperm separation device
* Other: Density gradient centrifugation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing intrauterine insemination Patient assigned female at birth with age <41 Exclusion Criteria: Any significant disease or psychiatric disorder that would interfere with the consenting process Prior intrauterine insemination Use of frozen donor sperm Non-English speaker

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Density gradient centrifugation<br>Patients will undergo sperm preparation by density gradient centrifugation | Other: Density gradient centrifugation<br>* Sperm preparation with density gradient centrifugation<br>|
| Active Comparator: Zymot sperm separation device<br>Patients will undergo sperm preparation by the Zymot sperm separation device | Device: Zymot Multi sperm separation device<br>* Sperm preparation with Zymot Multi sperm preparation device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative clinical pregnancy rate | The clinical pregnancy rate by treatment group over the course of IUI treatment | 3 treatment cycles, an average of 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrauterine Insemination, Insemination, Fertility, Infertility