linjc16/ctgov huggingface dataset:
Vocal Feature Analysis Algorithm for COVID-19 Detection

Study Overview
=================
Brief Summary
-----------------
This is an observational, prospective, non-randomized, non-significant risk study collecting voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of specimens obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices through an app on their mobile phone. Patients and health care providers will be blinded to the swab test results during Phase 2 of the study.

Detailed Description
-----------------
The primary objective of this observational study is to determine if the Vocal Feature Analysis (VFA) Algorithm developed by Soniphi can screen for the COVID-19 condition from voice recordings. Patients eligible for the study are those being tested for COVID-19 based on molecular diagnostic testing of specimens obtained by nasal or nasopharyngeal swab. No clinical decisions will be based on the recordings. The results of the algorithm analysis will not be made available to the subjects or their healthcare providers during or after the study.

Official Title
-----------------
Testing of Soniphi Vocal Feature Analysis Algorithm for COVID-19

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

Intervention / Treatment
-----------------
* Device: Device used to record voice for screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged > 18 years Provide a valid electronic informed consent form Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and those providing an evaluable sample. Stated willingness to provide evidence of their lab test results Pregnant or lactating women may participate Exclusion Criteria: Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords. Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgery Prior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cords Treatment with another investigational drug or device within 30 days prior to signing Consent Form

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 |
| --- | --- |
| Control<br>Do not test positive for COVID | Device: Device used to record voice for screening<br>* voice recording<br>|
| COVID-19 Positive<br>Test positive for Covid using swab test. | Device: Device used to record voice for screening<br>* voice recording<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | compare Sensitivity and Specificity to standard swab test | 6 months |
INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon + optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s. c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: enfuvirtide [Fuzeon]
* Drug: Optimized background ARV therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; HIV-1 infection, with virologic failure; on same stable HAART for >4 weeks, with viral load >1000 RNA copies/mL; Fuzeon-naive. Exclusion Criteria: coinfection with HIV-2; active opportunistic infection in 4 weeks prior to screening; cirrhosis or severe liver failure; severe renal disease.

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 |
| --- | --- |
| Experimental: 1<br> | Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid<br>Drug: Optimized background ARV therapy<br>* As prescribed<br>|
| Active Comparator: 2<br> | Drug: Optimized background ARV therapy<br>* As prescribed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with plasma viral load <50 copies/mL |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions. |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment experienced
Performance Evaluation of System EOS Imaging in Pelvimetry Versus Pelvi-scanner

Study Overview
=================
Brief Summary
-----------------
The purpose of this study and demonstrate the reliability of EOS imaging system in the measurement of internal diameters of obstetrical pelvis versus Goldstandard current that is the pelviscanner.

Conditions
-----------------
Radiation, Obstetric Labor Complications, Pregnancy Complications

Intervention / Treatment
-----------------
* Radiation: EOS and CT Exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pelviscanner indication in women Exclusion Criteria: In the disqualification of another study or under the national register of volunteers.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EOS and CT Exam<br>EOS and CT Examen for pregnant women in the 8th month of pregnancy | Radiation: EOS and CT Exam<br>* EOS and CT Examen for pregnant women in the 8th month of pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement reliability index Magnin with EOS cab relative to the CT measurements |  | one months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EOS imagery
Neural Mechanisms Underlying Astigmatism

Study Overview
=================
Brief Summary
-----------------
This study is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients.

Detailed Description
-----------------
The presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. However, the neural mechanisms underlying the astigmatism remains unknown. The current study recruited three groups (patients with with-the-rule astigmatism and amblyopia, patients with with-the-rule astigmatism but without amblyopia, normal controls) of subjects and patients receive perceptual learning training (orientation discrimination task) which lasts for around 15 days. This main aim is to compare the contrast sensitivity function and neural response to gratings before and after the orientation discrimination task in the astigmatism or amblyopia patients. Patients with astigmatism or amblyopia were included in this study. All participants underwent an ophthalmic examination that included slit-lamp biomicroscopy, visual acuity, quick CSF under full optical correction, 9-SF life quality questionnaire and fundus examination.

Official Title
-----------------
The Research of the Neural Mechanisms Underlying Astigmatism

Conditions
-----------------
Astigmatism

Intervention / Treatment
-----------------
* Behavioral: perceptual training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high astigmatism Exclusion Criteria: other types of disease (especially optical diseases) that may affect study

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: perceptual training<br>Orientation discrimination task, which is a cognitive task. Patients were trained for 1 hour per day, 15 days in total. | Behavioral: perceptual training<br>* orientation discrimination task<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the contrast sensitivity function tested by quick CSF | The quick CSF (contrast sensitivity function) measures contrast threshold by fitting raw data and calculating the Cutoff sensitivity frequency. | eight months | 
| The change of contrast threshold tested by sweep visually evoked potential (VEP) | The contrast threshold was calculated by analyzing EEG(Electroencephalogram) data recorded with sweep visually evoked potential (VEP) paradigm. | eight months |
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Drug: Amino acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birth weight 400 to 1250 grams 24 0/7 to 30 6/7 weeks gestational age Exclusion Criteria: chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth infants >18 hours of age infants in extremis who are unlikely to survive past 72 hours

Ages Eligible for Study
-----------------
Maximum Age: 18 Hours

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard amino acids<br>Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day | Drug: Amino acids<br> <br> * Other names: Premasol;|
| Experimental: High amino acids<br>Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth | Drug: Amino acids<br> <br> * Other names: Premasol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Weight<10th Percentile for Age |  | 36 weeks post-conceptual age | 
| Number of Participants With Length <10th Percentile for Age |  | 36 weeks post-conceptual age | 
| Number of Participants With Head Circumference <10th Percentile for Age |  | 36 weeks post-conceptual age | 
| Cognitive Development Score | Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome. | 18-22 months corrected gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Bicarbonate |  | Day of life 1, 2, 3, 5 and 7 | 
| Serum Creatinine |  | Day of life 1, 2, 3, 5 and 7 | 
| Serum Blood Urea Nitrogen |  | Day of life 1, 2, 3, 5 and 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amino acids, Protein
Periodontal Care and Glycemic Control in Diabetes

Study Overview
=================
Brief Summary
-----------------
Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.

Detailed Description
-----------------
Background: Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control. Objectives: This project will determine the efficacy of a program of periodontal screening and therapy in improving the level of glycemic control in poorly controlled diabetics. Methods: Status: Subject accrual is complete. Data collection is ongoing.

Official Title
-----------------
Periodontal Care and Glycemic Control in Diabetes

Conditions
-----------------
Diabetes Mellitus, Poor Glycemic Control, Peridontal Disease

Intervention / Treatment
-----------------
* Drug: Doxycycline HCI 10mg po for 2 weeks
* Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have diabetes mellitus, and HbAlc >9, >8 teeth, and CPITN scores of 3 or 4 in, at least 2 sextants of the mouth, indicating moderate to high peridontal treatment need. Exclusion Criteria:
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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Drug: Doxycycline HCI 10mg po for 2 weeks<br> <br> Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intranasal Insulin for Weight Management During Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.

Conditions
-----------------
Tobacco Abstinence Syndrome

Intervention / Treatment
-----------------
* Drug: Intranasal Insulin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: smokers (>10 cig/day) for the past 1 year normosmic olfactory function Exclusion Criteria: previous/current use of insulin current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder current pregnancy (or lactation) lifetime history of endocrine disease excessive alcohol use (>25 standard units of alcohol/week) current use of illicit drugs current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent local infections, inflammation, structural abnormalities, or other nasal pathology current use of any medications administered intranasally, including intranasal steroids

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intranasal Insulin First<br>Intranasal Insulin First, Placebo Second | Drug: Intranasal Insulin<br> <br> |
| Placebo Comparator: Placebo First<br>Placebo First, Intranasal Insulin Second | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount Eaten in Taste Test |  | 90 minutes |
Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser

Study Overview
=================
Brief Summary
-----------------
Acne can be treated with a mid-infrared laser. We demonstrated safety and efficacy using lower energy settings in order to make the treatments less painful

Detailed Description
-----------------
Numerous light based therapies are currently being used for the treatment of acne. Non-ablative mid-infrared lasers have the advantage of decreasing inflammatory acne and improving acne scars. Specifically, the 1450 nm laser has been shown to be quite effective. However, it is associated with considerable pain at higher fluences despite topical anesthetics, especially when treating inflammatory acne. The goal of this study was to determine the possibility of using low fluence settings to treat moderate to severe acne at a more tolerable pain level without compromising treatment effectiveness.

Official Title
-----------------
Comparison of Stacked-Pulses Vs. Double-Pass Treatments of Facial Acne With a 1450 Nm Laser

Conditions
-----------------
Acne Scars, Acne

Intervention / Treatment
-----------------
* Device: 1450nm diode laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acne lesion count of at least 10 inflammatory papules on each side of the face and a severity grade consistent with color photographs in the Allen & Smith grading scale of greater than or equal to grade 3 and no worse than grade 5 Exclusion Criteria: Exclusion criteria included the use of oral retinoids or systemic corticosteroids within the past 6 months and the use of all prescription topical or systemic anti-acne medications 4 weeks prior to the initiation of the study

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 1450nm diode laser|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
-----------------
diode, laser, acne, acne scar
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO

Study Overview
=================
Brief Summary
-----------------
Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with glioma

Official Title
-----------------
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO

Conditions
-----------------
Brain Tumor, Virtual Reality

Intervention / Treatment
-----------------
* Diagnostic Test: VIRTUAL REALITY application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for glioma surgery Karnofsky > 70 Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br> | Diagnostic Test: VIRTUAL REALITY application<br>* application on virtual reality headset<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PERFORMANCE OF the VR APPLICATION compared to classic cognitive tests batery for the detection of cognitive deficit |  | from surgery to 3 months after surgery |