linjc16/ctgov huggingface dataset:
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria

Study Overview
=================
Brief Summary
-----------------
To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.

Detailed Description
-----------------
The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation. The study is an observational study of the first implementation in clinical routine in Austria.

Official Title
-----------------
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria

Conditions
-----------------
Deafness

Intervention / Treatment
-----------------
* Procedure: HEARO Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant. Exclusion Criteria: Age under 18 years Pregnant women Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani Vulnerable or mentally retarded candidates Invalid or withdrawn informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: HEARO Procedure|robotic access to the middle and inner ear in cochlear implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of cochlear access | Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary) | at implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrode array insertion outcomes | Percentage of patients with full electrode insertion (all contacts inside the cochlea) as assessed by postoperative DVT Imaging | at implantation | 
| Safety of cochlear access | Number of patients with facial nerve paralysis after cochlear implantation as assessed by the House-Brackmann scale. | at implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cochlear implantation, robotic surgery, automated inner ear access, automated middle ear access
Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

Study Overview
=================
Brief Summary
-----------------
Patients who meet inclusion criteria will be randomized into treatment vs control group. Treatment groups will undergo Hyperbaric Oxygen Therapy (HBOT) and compared to the control group.

Detailed Description
-----------------
After enrollment, patients will be randomized into treatment vs control group. Both populations will receive the same inpatient medical treatment. All patients in the treatment group will undergo hyperbaric oxygen therapy under the same treatment protocol. After completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.

Official Title
-----------------
Hyperbaric Oxygen Therapy (HBOT) as a Treatment for COVID-19 (COVID-19) Infection

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

Intervention / Treatment
-----------------
* Device: Hyperbaric Oxygen Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult inpatients >18 years old Positive PCR COVID-19 testing CT evidence of interstitial opacity Oxygen saturation <90% on room air pO2 = 55-70. Exclusion Criteria: Increased oxygen requirements Hemodynamic instability (MAP<65) Bradycardia (HR<50) History of seizure disorder Pneumothorax GFR<30 Hemodialysis Refractory anxiety/claustrophobia Current pregnancy Uncorrectable hypoglycemia

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
Interventional Model Description: This study will utilize a single-center sequential two-parallel-group (HBOT/Standard care) randomized controlled design with 2 looks to allow for early stop due to clear benefit/harm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HBOT treatment group<br>Patients will receive hyperbaric oxygen therapy | Device: Hyperbaric Oxygen Therapy<br>* Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.<br>|
| No Intervention: Standard of Care group<br>Patients will not receive hyperbaric oxygen therapy and will receive the current standardized treatment protocol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease incidence of intubation by 30% or greater | Compare rates of intubation between treatment and control groups | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease renal injury | Measure Glomerular Filtration Rate (GFR) and compare between treatment and control groups | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid-19
Demographics and Outcomes of COVID 19 in Pregnancy at a Community Based Hospital

Study Overview
=================
Brief Summary
-----------------
Demographics of pregnant COVID persons under investigation and those who were positive from March-May 2020. Looking at demographics including age, socio-economic status and pregnancy outcomes in these groups.

Official Title
-----------------
Demographics and Outcomes of Pregnant COVID 19 Positive Women in a Community Health System

Conditions
-----------------
Corona Virus Infection

Intervention / Treatment
-----------------
* Other: COVID positive via testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently pregnant, considered PUI or know COVID positive patient during pregnancy, and documentation of COVID symptoms within AHS. Exclusion Criteria: Not pregnant, No documentation of COVID-19 symptoms within AHS.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| COVID positive patients<br> | Other: COVID positive via testing<br>* Following pregnancy outcomes whether they are COVID positive or negative<br>|
| COVID negative patients<br> | Other: COVID positive via testing<br>* Following pregnancy outcomes whether they are COVID positive or negative<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Outcome | increased risk of preterm birth, preeclampsia, etc. | through study completion, approximately 1 year |
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.

Detailed Description
-----------------
This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs. The NCT numbers for the above mentioned studies are: NCT00603798 - for Studies GW01-0703 and GW01-0705 NCT00605176 for Studies GW01-0702 and GW01-0704

Official Title
-----------------
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705

Conditions
-----------------
Actinic Keratoses

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are willing and able to give informed consent; Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements. Exclusion Criteria: None. All subjects who meet the inclusion criteria above may participate.

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 |
| --- | --- | --- |
| Number of Participants With Recurrence of AK Lesions | The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area. | Up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Actinic keratoses, Dermatologic disease
Use of the Nasal Cannula During COVID-19

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to determine the incidence of the use of the low flow nasal cannula in suspected or confirmed cases with Covid-19

Detailed Description
-----------------
An anonymous questionnaire will be sent to a group of anesthesiologists via email which will allow to collect information about the use, or not, of the low flow nasal cannula, the type of procedure where it is used, and the type of personal protection weared.

Official Title
-----------------
Incidence and Implications With the Use of Nasal Cannulas During COVID-19

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: only for physicians Exclusion Criteria: not physicians
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physician using los flow nasal cannula during COVID 19 pandemia | We'll send by email a link with an online quiz to a Group of physicians with questions related to the use of nasal cannula during their routine practice. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physician getting sick during Covid 19 pandemic | We'll send by email a link with an online quiz to a group of physicians with questions related to the use of nasal cannula during their routine practice, and one of the questions is about if the physician was getting sick during the Covid pandemic. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low flow nasal cannula, Anesthesia, Sedation, Regional Anesthesia
Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The majority of bridge graft fistula with polytetrafluoroethylene (PTFE) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. Aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. Many drugs have been used to reduce intimal hyperplasia in animal models. Until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. Recently a major breakthrough was done by GORE when introducing the new heparin bonded PTFE graft by covalent attachment. This trial is planed to assess and compare between the GORE-TEX® PROPATEN vascular graft versus unmodified ePTFE grafts the patency and complication.

Official Title
-----------------
Evaluation of Heparin Bonded Vascular Graft Versus Standard Graft in Prosthetic Arteriovenous Access for Hemodialysis

Conditions
-----------------
Hemodialysis Fistula Thrombosis

Intervention / Treatment
-----------------
* Procedure: Prosthetic AV graft implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial Investigators will attempt to enroll a male:female ratio of patients representative of their current patient population Exclusion Criteria: Anticoagulation therapy

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: propaten graft<br> | Procedure: Prosthetic AV graft implantation<br>* Surgical arteriovenous fistula creation with standard or propaten graft<br>|
| Active Comparator: Standard graft<br> | Procedure: Prosthetic AV graft implantation<br>* Surgical arteriovenous fistula creation with standard or propaten graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of AV fistula |  | Study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Failure, End Stage, Blood Vessel Grafting, Hemodialysis, Surgical Arteriovenous Shunt
Study Accelerometer Signals to Measure Daily Activities (SASMDA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.

Official Title
-----------------
Study Accelerometer Signals to Measure Daily Activities: a Pilot Study

Conditions
-----------------
Urinary Disorders

Intervention / Treatment
-----------------
* Device: LIS302DL accelerometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: man patients fitted with artificial urinary sphincter patients affiliated to social security or similar regime Exclusion Criteria: patient do not speak french patient unable to express his consent patient hospitalize without consent patient under legal protection patient deprived of liberty

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

Sexes Eligible for Study
-----------------
Male

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

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

| Intervention/Treatment |
| --- |
|Device: LIS302DL accelerometer|Recording for 24 hours accelerations related to daily physical activity of the patient.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data. | Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of satisfaction with the use of the medical device, assessed by the patients | Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility. | 6 months |
Pain Reduce Following Refractive Surgery

Study Overview
=================
Brief Summary
-----------------
applying a material over the exposed stromal bed following refractive surgery to prevent local abrasion and significantly reduce pain

Detailed Description
-----------------
Assessed for pain at 1, 2 and 4 hours and 1, 3 and 5 days. Comparison to non study eye will be performed.

Official Title
-----------------
Mitigating Pain Following Refractive Surgery

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Bandage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent bilateral PRK for myopic correction. Age 18-60. Patient complains of significant pain. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits Exclusion Criteria: Any other anterior segment abnormality other than that associated with PRK. Any abnormalities associated with the eye lids. Prior laser treatment of the retina. Any ophthalmic surgery performed within three (3) months prior to study excluding PRK. Diagnosis of glaucoma. Active diabetic retinopathy. Clinically significant inflammation or infection within six (6) months prior to study. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device. Specifically known intolerance or hypersensitivity to contact lenses. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>bilateral post refractive surgery subject | Other: Bandage<br>* one application for one week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
refractive surgery
BRCA1/2 Flu Vaccine

Study Overview
=================
Brief Summary
-----------------
To evaluate immune function in BRCA1/2 mutation carriers without cancer, specifically to determine whether immune function in healthy individuals with germline loss of function BRCA1/2 mutations, impacts overall immune health and fitness.

Official Title
-----------------
Influenza Vaccine Study in BRCA1 or BRCA2 Carriers

Conditions
-----------------
BRCA1 Mutation, BRCA2 Mutation

Intervention / Treatment
-----------------
* Biological: Seasonal influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Over age 25 BRCA1 or BRCA2 pathogenic or likely pathogenic mutation No personal cancer history apart from non melanoma skin cancer, localized thyroid cancer, in situ cancers of any type Participants must sign the informed consent form Exclusion Criteria: Are allergic to influenza vaccination Have received influenza vaccination within the past 6 months Require prednisone, methotrexate, or other immunosuppressing medications Have HIV infection Have a history of solid organ tumor or bone marrow transplant Require combination immunotherapy; Are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Seasonal influenza vaccine|To evaluate immune function in BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate immune function in female BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination | Analysis of the primary objective will depend on determination of the strain-specific neutralizing antibody titer change from day 0 to the last study visit, performed as the standard assay as described by the World Health Organization (WHO). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory analysis- phenotypic evaluation of B cell | Phenotypic evaluation of B and T cell responses to vaccine at each timepoint. Phenotypic analysis involves flow cytometry on peripheral blood mononuclear cells (PBMC) from all subjects (10 mL blood per subject). | 2 years | 
| Exploratory analysis - transcriptional evaluation | Transcriptional evaluation of B and T cell responses to vaccine on day 7-10 timepoint. Transcriptional analyses including quantitative real-time PCR (RT-qPCR) and RNA sequencing (RNAseq) may be performed on a subset of the study subjects on the day 7-10 time point. | 2 years |