linjc16/ctgov huggingface dataset:
Sleep Inertia and Functional Connectivity

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the functional connectivity between the brain regions of the default mode network before and after a 40 min nap slot in the afternoon. The hypothesis is that connectivity between brain regions will be decreased after the nap as compared to before the nap.

Official Title
-----------------
Sleep Inertia and Functional Connectivity Between Brain Regions at Awakening : a Functional Magnetic Resonance Imaging (fMRI) Study

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

Intervention / Treatment
-----------------
* Other: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 > age > 18 high or law dream recall frequency Exclusion Criteria: history of psychiatric or neurologic or sleep pathologies counter indication for MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects with a high dream recall frequency<br> | Other: fMRI<br>* fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the CONN toolbox of the Statistical Parametric Mapping (SPM) software.<br>|
| Other: Subjects with a law dream recall frequency<br> | Other: fMRI<br>* fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the CONN toolbox of the Statistical Parametric Mapping (SPM) software.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change of correlation values between the BOLD (Blood Oxygenation Level Dependent) signal time series of the brain regions of the default mode network (DMN) between the scans before and after the nap slot. | The hypothesis is that connectivity between the brain regions of the default mode network will be decreased after the nap as compared to before the nap and that it will be more the case for subjects with a high dream recall frequency as compared to subjects with a law dream recall frequency. fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the functional connectivity toolbox (CONN) of the Statistical Parametric Mapping (SPM) software. | fMRI scans will be acquired 5 min before, 5 min after and 25min after the nap slot. |
Radiofrequency in Onychomycosis

Study Overview
=================
Brief Summary
-----------------
Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies.

Detailed Description
-----------------
Treatments with antifungals may not be successful due to several factors, including the long time required to apply topical medications, the side effects of systemic drugs, and the application of insufficient medication to the target area. Non-ablative radiofrequency devices can be used to treat onychomycosis without harming the nail matrix cells.

Official Title
-----------------
Non Ablative Radiofrequency in the Treatment of Onychomycosis, a Pilot Study

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Device: Non ablative radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Onychomycosis patients Exclusion Criteria: Patients with excessive manual work

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non ablative radiofrequency<br>Device | Device: Non ablative radiofrequency<br>* Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onychomycosis severity index | Clinical assessment | 3 months |
Anesthetizing the Tympanic Membrane in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.

Official Title
-----------------
Performance and Reliability of the Acclarent Iontophoresis System for Anesthetizing the Tympanic Membrane in Healthy Volunteers

Conditions
-----------------
Evaluate Performance and Reliability of Iontophoresis System

Intervention / Treatment
-----------------
* Device: Acclarent Iontophoresis System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >=18 years of age Both male and female subjects are eligible. Exclusion Criteria: Pregnant or lactating females Subjects with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution. Markedly atrophic TM Perforated TM Sclerotic TM Otitis externa Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) Damaged or denuded skin in the auditory canal Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iontophoresis-treated<br>Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM. | Device: Acclarent Iontophoresis System<br>* Administration of local anesthesia using the Acclarent Iontophoresis System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers | X days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse effects associated with the System and the Iontophoresis procedure | The investigator will rate any adverse event that occurs during the procedure for level of severity and relationship to the study device. | X days | 
| Tolerability of the iontophoresis system | Subject tolerability of the iontophoresis procedure will be assessed using a pain scale | X days |
Ketoconazole Administration: How it is Affected by the Body and Broken Down and How it Acts on the Body When Used With Velcade

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate how ketoconazole (Nizoral) affects the pharmacokinetics (how the study drug is affected by the body and broken down) and pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study drug Velcade (bortezomib).

Official Title
-----------------
Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: bortezomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18 years of age or older, with a diagnosis of advanced solid tumor for which no curative or other treatment of higher priority is available Karnofsky Performance Status (KPS) equal to or greater than 70% Normal liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less than 2 x upper limit of normal [ULN]) Total bilirubin equal to or less than 1.5 x ULN Calculated creatinine clearance equal to or greater than 50 mL/min Normal serum calcium Exclusion Criteria: Patients with significant cardiac disease Equal to or greater than Grade 2 neuropathy Active hepatitis HIV infection Secondary malignancy Transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment Patients taking concomitant medications having inhibitory or inducing activity for CYP 3A4

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bortezomib|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
-----------------
pharmacokinetic, pharmacodynamics, VELCADE, Ketoconazole, CYP 3A4, Solid Tumor, Advanced Solid Tumors
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers

Study Overview
=================
Brief Summary
-----------------
This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. Patients participating in the study may receive an active drug (MRE0094), inactive drug (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the United States. What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study. Participation in the study can be up to 4½ months.

Conditions
-----------------
Foot Ulcer, Diabetic, Diabetes Complications

Intervention / Treatment
-----------------
* Drug: MRE0094


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants included in the study must: Have type 1 or type 2 diabetes mellitus. Have problems with the nerves in their feet. Have an ulcer on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study. Be able to apply study drug to their ulcer, or have a caregiver do it. Be able to visit the doctor regularly during the 4½ month study. Exclusion Criteria: Participants may not participate in the study if: Their ulcer is caused by bad blood flow to their foot. Their ulcer is infected. They cannot wear a special boot during the study to take pressure off the ulcer. They have certain other diseases, or are using certain types of drugs.

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MRE0094|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to closure and percent reduction in surface area of the target ulcer. |  |  | 
| Incidence, intensity, and seriousness of adverse events. Changes in irritation scores. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toe ulcer, heel ulcer, foot ulcer, diabetic feet, diabetic foot, complications of diabetes
Magic Shave Powder Gold's Affects on the Occurrence of Pseudofolliculitis Barbae

Study Overview
=================
Brief Summary
-----------------
Comparing the amount of papules, macules, pustules, and irritation caused by pseudofolluculitis barbae in subjects using depilatory cream versus traditional shaving methods.

Detailed Description
-----------------
Comparing an experimental group that will remove facial hair with magic shave powder gold, and a control group that will continue using traditional shaving methods. Both the subject and a physician will make observations to determine the efficacy of depilatory creams in reducing pseudofolliculits barbae.

Official Title
-----------------
Depilatory Cream's Affect on the Occurrence of Pseudofolliculitis Barbae

Conditions
-----------------
Pseudofolliculitis Barbae

Intervention / Treatment
-----------------
* Drug: Magic Shave Powder Gold
* Device: Traditional Shaving Methods


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male PFB patient Exclusion Criteria: Failed sensitivity testing

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparing an experimental to control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magic Shave Powder Gold<br>This group will receive magic shaving powder gold and instructions on how to apply it. They will keep a log for their facial hair removal | Drug: Magic Shave Powder Gold<br>* Depilatory Cream for facial hair removal<br>* Other names: Experimental;|
| Other: Traditional Methods<br>This group will continue using traditional razors with the standard of care directions to shave. They will keep a log of their facial hair removal | Device: Traditional Shaving Methods<br>* Continued facial hair removal using traditional razors<br>* Other names: Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment | Difference in the investigator assessment of lesions and irritation at baseline and 12 weeks, measured by investigator. The scale title is Investigator Global Assessment, the minimum value is 0, the maximum is 5. Higher scores mean worse outcome. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment | Difference in the investigator assessment of disease symptoms at baseline and 12 weeks, measured by patient. The scale title is Patient Global Assessment, the minimum value is 0, the maximum is 5. Higher scores mean worse outcome. | 12 weeks |
Risk Stratification in Acutely Admitted Medical Patients

Study Overview
=================
Brief Summary
-----------------
The study has three main parts. To see if we can develop a riskstratification tool that can be used to asses the risk for acutely admitted medical patients for inhospital death, admission to the ICU and death within 30 days of release. To test existing tool as in 1. To clarify if it is most reasonable to let the admitting doctor order blood test by clinical judgment or be using a predefined list of tests.

Official Title
-----------------
Risk Stratification in Acutely Admitted Medical Patients

Conditions
-----------------
Hematologic Tests

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient acutely admitted to the medical department of Ribe County Hospital Exclusion Criteria: Age below 15 years Unwilling to participate

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| By protocol<br>Where the test are predefined | |
| By degression<br>The group where the doctor decided which test are to be taken. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of test taken in each group |  | Five months |
Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility

Study Overview
=================
Brief Summary
-----------------
C. dubliniensis has been identified as pathogen in Oropharyngeal Candidiasis(OPC)particularly among HIV patients. Azole therapy is a cornerstone in OPC, but resistance within C. dubliniensis isolates to diflucan is common.This is a prospective collection of biological specimens from oropharyngeal cavity with the purpose of determining the prevalence of C. dubliniensis in HIV/AIDS patients at the Duval County Department of Health Comprehensive care Center. It is hereto proposed an estimation of azole-resistance in these isolates.

Detailed Description
-----------------
This is a study to try to establish the prevalence of C. dubliniensis as a causative organism of OPC in HIV and/or AIDS patients. We will aim to establish the resistance pattern for azoles but also for Flucytosine and amphotericin of these isolates. This study will serve as a support to previously published articles that have suggested intrinsic azole-resistance within this particular species of candida and we will try to postulate its possible correlation with clinical failure.

Official Title
-----------------
Incidence of Oral Candidiasis, Prevalence of Candida Dubliniensis in HIV Patients and In-vitro Azole Susceptibility. (I.C.O.N.I.C.)

Conditions
-----------------
Candidiasis, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient 18 years old or older with a documented diagnosis of HIV infection with or without AIDS-defining illnesses at the time of assessment, who is presenting with clinical symptoms and physical findings compatible with oropharyngeal candidiasis (as defined by the IDSA Guidelines for the Treatment and Management of HIV and HIV- related complications. Exclusion Criteria: Any prior diagnosis or established treatment for oropharyngeal, mucocutaneous or esophageal candidiasis documented in the patient's chart or any proven diagnosis based on reviews of physically available medical records and or history provided by patients that can be subject to later confirmation pertaining to the use of parenteral antifungals within 6 months prior to enrollment (azoles, echinocandins, amphotericin B, Flucytosine, etc).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Incidence of oropharyngeal candidiasis in our HIV population; estimation of the prevalence of candida dubliniensis and pattern of azole resistance to direct future treatment |  | April 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
candida, dubliniensis, candidiasis, HIV, AIDS, azole resistance.
Zenith® TXD Post-market Surveillance in Japan

Study Overview
=================
Brief Summary
-----------------
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval

Official Title
-----------------
Zenith TXD Dissection Stent Graft System Usage Results Surveillance in Japan for Treating Acute Complicated Stanford Type B Aortic Dissection

Conditions
-----------------
Aortic Dissection

Intervention / Treatment
-----------------
* Device: Zenith® TXD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with thoracic aortic dissection, including attempted cases Patients with acute Stanford type B aortic dissection, including attempted cases Exclusion Criteria: Stanford type A aortic dissection and/or chronic type B aortic dissection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aortic Dissection<br>Treating patients with acute complicated Stanford Type B aortic dissection with the Zenith® TXD | Device: Zenith® TXD<br>* Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse events | Major adverse events will include death, aortic rupture, conversion to open surgical repair, spinal cord ischemia, retrograde progression of dissection, myocardial infarction, renal failure requiring dialysis, intestinal ischemia, stroke, paraplegia, and > 72 hours artificial respiratory assistance. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stanford type B aortic dissection, Malperfusion, Rupture, Acute disease, Endovascular procedures