linjc16/ctgov huggingface dataset:
Non Interventional Clinical Investigation of Ectoin Ear Spray in Skin Treatment of Outer Ear Canal Irritations

Study Overview
=================
Brief Summary
-----------------
In this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with Ectoin Ear Spray compared to Normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.

Official Title
-----------------
Non Interventional Study (NIS): Clinical Investigation for Evaluation of the Safety and Efficacy of Ectoin Ear Spray and Normison Ear Spray in Skin Treatment of Outer Ear Canal Irritations: A Mulitcenter Non Interventional Study

Conditions
-----------------
Pruritus, Dermatitis, Otitis Externa

Intervention / Treatment
-----------------
* Device: ear spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: according to instructions for use Exclusion Criteria: otitis media, acute otitis media acute otitis externa earache perforation of the ear-drum (membrana tympani) infections at the ear systemic corticosteroid treatment or local at the ear

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 |
| --- | --- |
| Ectoin Ear Spray<br>treatment according to instruction for use | Device: ear spray<br> <br> |
| Normison ear spray<br>treatment according to instruction for use | Device: ear spray<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus at outer ear canal | assessment of the symptoms on visual analogous scale | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of pruritus | assessment of the symptom on Visual Analog Score on values between 0 and 10 | 14 days | 
| Dermatitis | assessment of the symptoms of scaly dermatitis on Visual Analog Score on values between 0 and 10 | 14 days | 
| burning issue on skin | assessment of the symptom on Visual Analog Score on values between 0 and 10 | 14 days | 
| Tolerability | assessment on Visual Analog Score on values between 0 and 10 | 14 days | 
| Efficacy | assessment on Visual Analog Score on values between 0 and 10 | 14 days | 
| Change in number of adverse events | incidence of adverse events and correlation to therapy | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dermatitis and irritations at the outer ear canal, prevention of subacute otitis externa
Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
To test the effect of post operative complications on the health related quality of life (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer (NSCLC). The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery) using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be assessed using the same questionnaires to determine the difference between patients with low/no post operative complications to those with high grade post-operative complications. Post operative complications will be assess while the patients in the hospital on a daily basis using the Clavien classification system for surgical complications.

Conditions
-----------------
Operable Early Stage NSCLC by the VATS Approach

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (more than 18 years) early stage NSCLC speak English No hearing/Speaking difficulties Able to walk without assistance Surgery via the VATS approach Exclusion Criteria: Less than 18 years old Metastatic disease to the lung Benign Lung disease Advanced NSCLC Small Cell Lung Cancer Non English speakers Walking/Hearing/Speaking difficulties

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 |
| --- | --- |
| low complications<br>Patients who had VATS lung resection for NSCLC, and have no or low grade (grade 1 and 2) post operative complications based on the Clavien classification system. | |
| High complications<br>Patients who had VATS lung resection for NSCLC, and have no or high grade (grade 3 and 4) post operative complications based on the Clavien classification system. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of life | Health Related Quality of Life will be assessed using the SF-36, EQ-5D and QLQ30/13 questionnaires. | Change in health related quality of life at 2 weeks. Change of Health Related Quality of Life at 4 weeks. Change in Health Related Quality of Life at 8 weeks. Change in Health Related Quality of Life at 12 weeks. |
Suicide Risk Assessment by Digital Means

Study Overview
=================
Brief Summary
-----------------
This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. It should be noted that this is a pilot study, only for a wider study involving a larger number of patients. The system developed for the benefit of this study is based on a smartphone application installed on a standard Smartphone device that will be found in the ED or by the examiner. The system collects data from five channels one by one (the information collected from each channel is collected separately). The data recorded from the various channels is saved on the tablet device. Then, the information transferred to the database using a cable. A statistical analysis of the data from the various channels is carried out in order to assess suicidal behavior. After the statistical analysis, correlations will be examining between the results of the measurements and the results of the accepted questionnaires for the assessment of suicidality, which will be performed simultaneously. Note that the duration of participation is the duration of the measurements, ie a single session that lasts up to two hours The duration of the participants in the study is determined by the time of the measurements, ie a single session lasting up to two hours.

Official Title
-----------------
Suicide Risk Assessment by Digital Means

Conditions
-----------------
Suicide

Intervention / Treatment
-----------------
* Other: safe mood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient who is examined in the psychiatric ward at the Sheba Medical Center Proper ability to give informed consent Exclusion Criteria: A patient who is not independent and without an active therapist / guardian involved in the treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: safe mood|A tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between collected digital data and suicidality rating score | Correlations between collected digital data and suicidality rating score. | 1.5 years |
Pediatric Health Promotion Program

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.

Official Title
-----------------
Pediatric Health Promotion Program

Conditions
-----------------
Tobacco Use

Intervention / Treatment
-----------------
* Behavioral: Provider Advice, Framed Messaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Well-child visit Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients. | Behavioral: Provider Advice, Framed Messaging<br>* The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco Use |  | 1 Month |
A Prevalence Study of Obstructive Sleep Apnea in Subjects With Chest Pain, Positive Exercise Treadmill Test and Normal Coronary Angiogram

Study Overview
=================
Brief Summary
-----------------
Cardiac syndrome X consists of a triad of chest pain, abnormal exercise stress testing and normal coronary angiogram, and is hypothesized to be related to endothelial dysfunction. Endothelial dysfunction is also reported to be linked to obstructive sleep apnea. While chest pain can be one of potential presenting symptoms of obstructive sleep apnea, the investigators hypothesize that obstructive sleep apnea is common in subjects with cardiac syndrome X.

Conditions
-----------------
Obstructive Sleep Apnea, Cardiac Syndrome X, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Other: no intervention is involved in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≧18 years, < 70 years Symptom of chest pain occurring at least once in the preceding year Positive exercise treadmill test Negative coronary angiogram Mentally fit to give informed consent Exclusion Criteria: Mentally incapacitated persons Congestive heart failure Other potential causes of orthopnea (severe chronic obstructive pulmonary disease, persistent asthma)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| cardiac syndrome X<br>subjects fulfilling the clinical triad of cardiac syndrome X | Other: no intervention is involved in this study<br>* no intervention is involved in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea hypopnea index | assess apnea hypopnea index by overnight polysomnography, by a single admission to sleep laboratory | measure at a single time point when the subjects are admitted for overnight polysomnography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function | assess endothelial function by EndoPAT 2000 (an non-invasive device) and peripheral blood endothelial progenitor cells | measured at a single time point when the subjects are admitted for overnight polysomnography |
Somatosensory Processing in Depression

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to investigate neuronal differences (EEG/evoked potentials; functional MRI) between patients with major depression and healthy controls concerning brain activity after acute pain as well as changes of pain related brain activity during treatment with escitalopram.

Official Title
-----------------
Influence of Escitalopram on Somatosensory Processing in Patients With Major Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: simultaneous EEG/fMRI
* Device: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychiatric in or outpatients with acute depressive episode Indication for pharmacological treatment Exclusion Criteria: Acute suicidal tendency Neurological or severe somatic disorders Women during pregnancy or lactation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment as usual<br>simultaneous EEG/fMRI | Procedure: simultaneous EEG/fMRI<br>* fMRI/EEG recordings<br>Device: fMRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in evoked potentials/functional MRI from baseline to week 4 |  | two assessments, at baseline and week 4 |
Comparative Study of the Effect of Dysport and Botox

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effect of Dysport and Botox on forehead wrinkles and EMG activity.

Official Title
-----------------
A Comparative Randomized Double-Blinded Study of the Effect of Dysport and Botox on Forehead Wrinkles and EMG Activity

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Drug: botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 30 and 70 years moderate to severe hyperfunctional forehead wrinkles at maximum contraction and at rest Exclusion Criteria: application of botulinum toxin products for a period of 12 months prior to the study any significant health disturbances facial nerve palsy, and any facial conditions that could confound safety or efficacy results pregnancy and breast-feeding neuromuscular diseases drugs interfering with neuromuscular function (e.g. aminoglycosides)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: botulinum toxin type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG Muscular Activity at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks |  |  | 
| Frown Wrinkle Severity (photographs and questionnaire) at baseline and 0.5, 1, 2, 4, 8 and 10 weeks after injection, followed by weekly examinations for a total observation period of 20 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side Effects upon completion of the study (20 weeks after injection) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Botox®, botulinum toxin type A, Dysport®, hyperfunctional forehead lines, randomized controlled trial, double-blinded trial, electromyogram (EMG)
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (ICH).

Official Title
-----------------
Multi-center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) for Preventing Early Hematoma Growth in Acute Intracerebral Hemorrhage (ICH)

Conditions
-----------------
Acquired Bleeding Disorder, Intracerebral Haemorrhage

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spontaneous ICH diagnosed by CT (Computerized Tomography) scanning within 3 hours of onset Signed informed consent form, or an exception from standard informed consent requirements Exclusion Criteria: Time of onset of symptoms of ICH unknown or more than 3 hours prior to CT Patients with secondary ICH related to infarction, hemophilia or other coagulopathy, tumor, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, AVM (Arteriovenous Malformation) or severe trauma Surgical haematoma evacuation planned or performed within 24 hours of onset

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: activated recombinant human factor VII<br> | Drug: activated recombinant human factor VII<br>* Subjects will be randomised to receive a single intravenous dose of either 5, 20, 40 and 80 mcg/kg body weight. Administered within the first 4 hours after the insult<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a treatment-related serious adverse event (SAE) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  |  | 
| Change in ICH volume as measured by CT head scans |  |  |
Individual Patient Expanded Access for Human Acellular Vessel (HAV)

Study Overview
=================
Brief Summary
-----------------
Individual patient expanded access requests may be considered for patients who have no other treatment options and are not eligible for an HAV clinical study

Detailed Description
-----------------
Procedure for Requesting Expanded Access: The treating physician requesting expanded access must contact Humacyte directly with the basis for the request. Please include your contact information so that Humacyte may follow up with you directly. General Criteria: We will evaluate and respond to each expanded-access request that we receive on a case-by-case basis. Humacyte will consider the nature of the request, the patient's health, the available medical and scientific information about the investigational product, the balance of risk and potential benefit to the patient, the availability of investigational product, and the potential regulatory impact. Anticipated Timing: If you contact Humacyte as described above, Humacyte anticipates that we will acknowledge receipt within ten (10) business days or less.

Conditions
-----------------
Vascular Diseases, Vascular System Injuries, End Stage Renal Disease on Dialysis

Intervention / Treatment
-----------------
* Biological: Human Acellular Vessel (HAV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Human Acellular Vessel (HAV)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Relationship of Interstitial Cystitis to Vulvodynia

Study Overview
=================
Brief Summary
-----------------
This study is important in urologic nursing since many patients have interstitial cystitis (IC), a condition of frequency, urgency and pain affecting more than 1 million women in the United States. The vulva may actually be the site of some of the reported pain in women with IC, not the urethra or bladder. IC and vulvodynia can impact one's sexual functioning and diminish one's quality of life. The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC).

Official Title
-----------------
Part A: STUDY OF THE RELATIONSHIP OF INTERSTITIAL CYSTITIS TO VULVODYNIA

Conditions
-----------------
Interstitial Cystitis

Intervention / Treatment
-----------------
* Other: Physical Examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females who are 18 years of age and older. Diagnosis of interstitial cystitis

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survey<br>Patients with interstitial cystitis | Other: Physical Examination<br>* Patients will be invited to be evaluated in the Urology Research office at a future date.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC). |  | Prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic pain, Vulvar pain