linjc16/ctgov huggingface dataset:
Real-Ear Measurement (REM) and Test Box System Integration Into Fitting Software

Study Overview
=================
Brief Summary
-----------------
Integration of the REM-verification within the fitting workflow will enable the hearing care professional to easily run real ear measurements. The purpose of the two study parts is to prove that an integrated cooperative system, consisting of fitting software and measurement system, matches desired responses for certain stimuli faster, more reliably and more precisely at the ear drums of hearing instrument wearers than current best practice processes.

Conditions
-----------------
Validation Studies

Intervention / Treatment
-----------------
* Device: Real-Ear Measurement system integrated in hearing aid fitting software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clean and healthy ear canal, eardrum and pinna Ability to keep current position (of head and body) during a period of about 5 minutes while seated. Exclusion Criteria: Ear infections Ear wax in the ear Hyperacusis Pacemaker Tremor Disability to keep position.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-Ear Measurement<br>The study arm goes through a comparative test run followed by a comparative hearing aid fitting. | Device: Real-Ear Measurement system integrated in hearing aid fitting software<br>* The subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance (mm) from probe tube to eardrum measurement | Precise of the Probe Tube placement | 1 month | 
| Procedure time (min) of fitting workflow including Real Ear measurement | In addition to the outcome measurement time (in minutes) further outcome measurements can be obtained due to the performed real ear measurement procedure itself. Data that give information pertaining to test reliability (in dB) and precision of hearing aid fitting (in dB). | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective rating of unpleasantness (0 = not unpleasant at all, 10 = very unpleasant) | Pleasantness during the probe tube placement | 1 month | 
| Questionnaire about perceived annoyance | Perceived annoyance of the hearing care professional and the test subject measured with a questionnaire including rating scales for stessful and boring. | 2 month |
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.

Official Title
-----------------
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - Creative Testing Solutions

Conditions
-----------------
Dengue

Intervention / Treatment
-----------------
* Device: Procleix Dengue Virus Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donor must meet all the blood collection sites' standard eligibility requirements. Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
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 |
| --- | --- |
| Dengue Virus<br> | Device: Procleix Dengue Virus Assay<br>* in vitro diagnostic assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. |  | Approximately three years |
Cardiovascular Function in Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.

Detailed Description
-----------------
Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.

Official Title
-----------------
Cardiovascular Function in Leukemia Patients: an Observational Prospective Study

Conditions
-----------------
Leukemia, Myeloid, Acute, Leukemia, Lymphoid, Acute, Cardiotoxicity

Intervention / Treatment
-----------------
* Other: observation only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years of age, New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included). Signed the informed consent form Exclusion Criteria: • Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Acute Leukemia<br>Observation only. Patients newly diagnosed with acute leukemia who are scheduled to start treatment with chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year. | Other: observation only<br>* No intervention, observational study only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular dysfunction | defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cardiovascular Events |  | 1 year | 
| Incidence of Symptomatic Heart Failure |  | 1 year | 
| Incidence of Cardiac Death and all mortality |  | 1 year |
Assessment of Poles' Attitudes Towards Living Kidney Donation

Study Overview
=================
Brief Summary
-----------------
The main goal of the project is to examine the public opinion on living kidney donation and to assess the knowledge of Poles in this field.

Detailed Description
-----------------
Researchers also want to estimate how large percentage of the respondents will declare their willingness to donate a kidney to a stranger and what percentage of respondents would support a possible extension of the existing law on the collection, storage and transplantation of cells, tissues and organs of July 1, 2005 to include donation to a stranger.

Official Title
-----------------
Assessment of Poles' Attitudes Towards Living Kidney Donation

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Other: Attitude assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Polish citizenship Exclusion Criteria: below 18 yers of age not Polish citizen

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Attitude assessment|The study covered a representative group of 1000 people. Own questionnaire and standardized tools sent online via the Statistical Research and Analysis Office, in compliance with the privacy policy and personal data protection of the General Data Protection Regulation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire answers under statistical processing |  | 15.03.2021 |
Management of Septic Non-union of the Tibia Using the Induced Membrane Technique

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to assess clinical and radiological results with the induces membrane technique, described by A. C. Masquelet in 1986, in a series of patients with septic non-union of the tibia

Detailed Description
-----------------
Septic tibial non-union is a therapeutic challenge that may even lead to amputation. Treatment often necessitates several chirurgical steps. It is agreed that resection must extend to several tissues (osteitis zone ans macroscopically pathological soft tissue), with associated non-union site stabilization ans effective antibiotic therapy. In 1986, Pr A. C. Masquelet described a 2-step procedure called the induced membrane technique, to manage bone defects of varying severity. Initial results were encouraging but there have been few large homogeneous series specific to this technique in septic non-union.

Official Title
-----------------
Management of Septic Non-union of the Tibia Using the Induced Membrane Technique

Conditions
-----------------
Septic Tibial Non-union

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria : Patients with septic non-union of the tibia managed using the induced membrane technique between novembrer 2007 and novembre 2014 in Reims University hospital Patients who agree to participate to the study Major patient exclusion criteria : Patient under law protection Minor patient

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 |
| --- | --- |
| Patients with septic non-union of the tibia<br> | Other: Data collection<br>* Data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Bone union | Bone union was defined by 2 continuous cortices on 2 views (radiologic images comprising 2 perpendicular views of the affected segment) | Day 0 |
Research on the Application of Artificial Intelligence Ultrasonic Recognition Technology in Difficult Airway Assessment

Study Overview
=================
Brief Summary
-----------------
Although there is no related research on the evaluation of difficult airways by ultrasound features based on artificial intelligence, the investigators guess that the evaluation of ultrasound features based on artificial intelligence can make further breakthroughs in difficult airway early warning systems. Therefore, this project intends to use AI technology to extract and analyze the ultrasound features of the subjects, evaluate the correlation between the ultrasound features of the subjects and the occurrence of difficult airways, and construct possible diagnostic models to evaluate AI ultrasound feature recognition in the prediction of difficult airways. The effect and application value of this method are expected to be more intelligent and accurate for early warning of difficult airways in clinical anesthesia.

Official Title
-----------------
Research on the Application of Artificial Intelligence Ultrasonic Recognition

Conditions
-----------------
Difficult Airways

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonic test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA classification is 1-3 Patients who intend to undergo tracheal intubation under general anesthesia Age ≥ 18 years old Exclusion Criteria: Patients with speech communication and cooperation barriers; Patients with open head and neck trauma Patients with cervical spine fractures or cervical spine diseases; Emergency surgery; Patients who are allergic to related drugs.

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 |
| --- | --- |
| difficult airway<br>C-L≥3 grade | Diagnostic Test: Ultrasonic test<br>* Ultrasonic test to the patient's head, neck and jaw area.<br>|
| none difficult airway<br>C-L<3 grade | Diagnostic Test: Ultrasonic test<br>* Ultrasonic test to the patient's head, neck and jaw area.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosed as a difficult airway | Cormack-Lehane was used for grading the best glottic view. In grade the entire glottis was visible; in grade 2 a portion of the glottis was visible; in grade 3 only the epiglottis could be seen; and in grade 4 the epiglottis was not visible. A score of 3-4 indicated difficult video laryngoscopy | 0-10minutes after intubation |
Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

Study Overview
=================
Brief Summary
-----------------
Different kinetics markers have been proposed to select embryos with higher implantation rates. The effect of external factors on these markers, such as the stimulation protocol should be analyzed. There are two different types of FSH that are commonly used for in vitro fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if there is a difference in embryo kinetics and morphology as well as oocyte morphological parameters between the two types of FSH and therefore to analyze if such markers can be used despite of the stimulation protocols chosen.

Official Title
-----------------
Embryo Kinetcis From Embryos Deriving From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH

Conditions
-----------------
Embryo Kinetics

Intervention / Treatment
-----------------
* Procedure: Stimulation with human FSH
* Procedure: Stimulation with recombinant FSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Egg donation cycles with more than 8MII in oocyte retrieval day Exclusion Criteria: Male factor Uterine malformations genetic alterations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Human FSH<br>Human FSH | Procedure: Stimulation with human FSH<br>* Human FSH<br>|
| Active Comparator: Recombinant FSH<br>Recombinant FSH | Procedure: Stimulation with recombinant FSH<br>* Recombinant FSH<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of cell cleavage | Analysis of cell cleavage | February 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo and oocyte morphology | Analysis of all oocytes | February 2012 | 
| Outcome rates (implantation, pregnancy and miscarriage rate) | Time requierd to know all the implantation, pregnancy and miscarriage rate | February 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
time-lapse, FSH, kinetics
A Safety and Efficacy Trial of TTHX1114 in People With CED

Study Overview
=================
Brief Summary
-----------------
Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114

Official Title
-----------------
A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection

Conditions
-----------------
Corneal Endothelial Dystrophy

Intervention / Treatment
-----------------
* Drug: TTHX1114


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, 18 years of age or older Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3) Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint Fellow Eye with 20/100 BCVA or better No concurrent ocular or medical condition that would impair the assessment of safety and efficacy Exclusion Criteria: Prior exposure to TTHX1114 Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug) Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study History of: Ocular cancer (including melanoma) Herpetic keratitis Documented and repeated elevated IOP in either eye Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy) Uveitis Use of any concomitant medications that may interfere with the assessment of safety and efficacy Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TTHX1114 weekly x 5<br>TTHX1114 via IC injection weekly x 5 | Drug: TTHX1114<br>* engineered FGF-1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specular Microscopy | Corneal Endothelial Cell Density | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pachymetry | Central Corneal Thickness | Day 28 |
Role of Epicardial Adipose Tissue in Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial fat than patients without CAD, which would suggest that epicardial fat may be more than an innocent bystander and be actively involved in the disease process. Its role as a modulator of vascular response and myocardial function could potentially lead to new areas of cardiac research. We also sight to evaluate whether epicardial fat from patients with CAD releases more adipokines than subcutaneous fat from these patients which could prompt studies into the differential regulation of adipokine secretion in this tissue. Thus for e.g., the use of thiazolidinediones (glitazones), statins, ARBs or other compounds that can specifically modulate adipokine secretion could be explored to determine their benefit in ameliorating the effects attributable to increased epicardial fat.

Official Title
-----------------
Role of Epicardial Adipose Tissue in Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients elegible for elective cardiac surgery are elegible Ability to provide written informed consent in accordance with GCP guidelines and local legislations. > 18 years of age Exclusion Criteria: Control patients will not have clinical signs of CAD and will show normal coronary arteries on angiography. Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, coronary artery disease, epicardial adipose tissue, epicardial fat