linjc16/ctgov huggingface dataset:
A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).

Study Overview
=================
Brief Summary
-----------------
Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.

Official Title
-----------------
A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women

Conditions
-----------------
Skin Androgenization

Intervention / Treatment
-----------------
* Drug: testosterone gel
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 3 years postmenopausal Subject is in good general health Subject is willing to avoid excess alcohol or strenuous physical activity during the study Exclusion Criteria: Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks Subject is a regular user of any illicit drugs Subject drinks excessive amounts of coffee, tea or cola Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months Subject has a history of cancer Subject has acne

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2.5 mg testosterone gel | Drug: testosterone gel<br>* 300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks<br>* Other names: AndroGel;|
| Experimental: 2<br>300 ug testosterone gel | Drug: testosterone gel<br>* 300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks<br>* Other names: AndroGel;|
| Placebo Comparator: 3<br>placebo gel | Drug: Comparator: placebo<br>* transdermal placebo gel for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum free testosterone concentrations following multiple doses of AndroGel |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean percent change from baseline in sebum excretion |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers of Skin Androgenization
Impact of the Profession on Parenthood

Study Overview
=================
Brief Summary
-----------------
Professional constraints can have major causes on personal and couple life. In particular, some professions with major professional constraints that can be particularly impacted, such as doctors and healthcare workers. The main objective was to demonstrate the impact of work on the desire and the fact to have children

Detailed Description
-----------------
This is an observational study by questionnaire via an internet link. The self-questionnaire will assess parenthood, socio-demographic parameters, and the perception of the profession.

Official Title
-----------------
Impact of the Profession on Parenthood

Conditions
-----------------
Parenthood Status

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All volunteers Workers or retirees Exclusion Criteria: none

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

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 |
| --- | --- | --- |
| parenthood | The desire to have a child and the parenting management will be assessed by questionnaires | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic characteristics | Age, gender, qualification, personal work status, ethnicity, life and occupational events will be assessed by questionnaires | Day 1 | 
| occupation perception | the perception about occupation will be assessed by questionnaires | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parenthood, Work, child
Actigraphic Measurement of a Neurosurgical Procedure

Study Overview
=================
Brief Summary
-----------------
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

Detailed Description
-----------------
Actigraphic measurements, repeated verbal fluency and multi-symptom operationally defined observations will be recorded for an 11 to 12 day baseline period and continued following neurosurgical tumor resection until a repeat MRI is completed three months after the procedure.

Official Title
-----------------
Analysis of Post Surgical Response in A Fifty-Six Year Old Female With An Incidental Large Left Anterior Cranial Fossa Meningioma

Conditions
-----------------
Sleep Disorders, Circadian Rhythm, Pain, Rehabilitation, Mood Lability

Intervention / Treatment
-----------------
* Procedure: Re-section of a large left anterior cranial fossa meningioma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of incidental meningioma Single subject preparing to receive neurosurgical intervention Exclusion Criteria: Inability to wear actigraphy device

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actigraphic Neurosurgical Outcomes<br>Actigraphic measurements that will be obtained by attaching the actigraphic watch device to the individual's non-dominant wrist and operationally defined repeated observational measurements. All measurements will continue through a baseline period and continue through the identified post surgical period. Actigraphic measurements will occur every 30 seconds with brief periods of non-measurement during the actual neurosurgical procedure and periods when the actigraphic device has reached storage capacity (approximately every 22 days) when data is retrieved and the device prepared resume measurements. | Procedure: Re-section of a large left anterior cranial fossa meningioma<br>* Neurosurgical re-section of an incidental large left anterior cranial fossa meningioma<br>* Other names: Actigraphy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and Post Actigraphic and Systematic Observation Scale measurements |  | March 15, 2009-June 20, 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurosurgical outcome, Actigraphy, Treatment Response Measurement
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks

Study Overview
=================
Brief Summary
-----------------
Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.

Detailed Description
-----------------
Non-interventional (observational) study (NIS), non-controlled, prospective cohort study.

Official Title
-----------------
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate (Picato) in a Period of 8 Weeks.

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Ingenol Mebutate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with Picato® is indicated and the treatment is intended by physicians. Exclusion Criteria: Preceding use of Picato® on the area planned for treatment Any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks Melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment Open wounds on the area planned for treatment Contraindications according to prescribing information

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 |
| --- | --- |
| all eligible patients<br>Treatment with Picato according to Summary of Product Characteristics (SmPC) | Drug: Ingenol Mebutate<br>* No intervention: observation of routine use of Picato®<br>* Other names: Picato®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actinic keratosis | Documentation of the course of actinic keratoses and skin findings during ambulant routine use of Picato® | 8 weeks | 
| Skindex-16 | Patient' s quality of life during ambulant routine use of Picato® | 8 weeks | 
| Dosage of Picato® | Prescribed and applied dosages and adherence during ambulant routine use of Picato® | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Actinic Keratosis
Transversus Thoracic Muscle Plane Block for Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Poststernotomy pain is a complication of cardiac surgery. Poorly controlled pain is associated with myocardial ischemia, cardiac arrhythmias, hypercoagulability, pulmonary complications, and increased rates of delirium and wound infection. The transverse thoracic muscle plane (TTMP) block is a novel plane block that provide pain for sternotomy. The aim of this study was to evaluate the analgesic effect of ultrasound guided TTMP block in patients undergoing open heart surgery.

Official Title
-----------------
Ultrasound Guided Transversus Thoracic Muscle Plane Block for Open Heart Surgery: Randomized Controlled Double Blind Study

Conditions
-----------------
Pain, Acute, Pain, Chest

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound guided transverse thoracic muscle plane block<br> | Drug: Bupivacaine<br>* Ultrasound guided 20 ml % 0.250 bupivacaine injection to transverse thoracic muscle plane bilaterally<br>|
| Sham Comparator: ultrasound guided sham block<br> | Drug: Saline<br>* Ultrasound guided 20 ml % 0.9 saline injection to transverse thoracic muscle plane bilaterally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | First 24 hours total fentanyl consumption with patient controlled analgesia | first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) | postextubation 0-24 hours |
Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Our aim is to examine the influence of blood pressure and glycemic control together with N-acetylcystein utilization on the endothelia function of hypertensive diabetic patient.The study population will include 50 diabetic patient with uncontrolled hypertention that will be recruited from the Hypertension Clinic of Soroka University Medical Center.

Conditions
-----------------
Hypertension, Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Drug: N-acetylcystein(drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with uncontrolled hypertension that will be recruited from the Hypertension Clinic of Soroka University Medical Center Exclusion Criteria: Pregnancy,secondary hypertention,malignancy or other serious illness

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

| Intervention/Treatment |
| --- |
|Drug: N-acetylcystein(drug)|p.O t.Siran 200mg x1 during one weak|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function |  | half of year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure and glycemic control |  | half of year |
Neuraxial and Neurolytic Analgesia for Intractable Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect longitudinal data on outcomes of neuraxial or neurolytic procedures in patients with intractable cancer and chronic noncancer pain so that we may contribute to the growing evidence for or against these therapies and to provide data for ongoing quality improvement activities.

Official Title
-----------------
Neuraxial and Neurolytic Analgesia for Intractable Pain

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treated for intractable pain by the UW Interventional Pain Treatment program inpatient or outpatient Exclusion Criteria: less than 18 years of age

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 |
| --- | --- | --- |
| Prospective review of pain | The purpose of this study was to collect longitudinal data on outcomes of neuraxial or neurolytic procedures in patients with intractable cancer and chronic noncancer pain so that we may contribute to the growing evidence for or against these therapies and to provide data for ongoing quality improvement activities. | six years |
Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate the use of the holographic display of 3D images acquired during ultrasound based cardiac procedures and to assess the clinical use of the HOLOSCOPE-i, in providing 3D spatial understanding to the clinician performing the procedure. Patients scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure will be enrolled to this study. In addition to the standard of practice imaging using ultrasound, patients anatomical structures will be evaluated using a 3D holographic system. The patients will complete their participation in the study, at the end of the procedure. No follow-up is required and patients will continue their routine medical care following the procedure.

Official Title
-----------------
Three-dimensional (3D) Holographic Display for Ultrasound-Guided Structural Heart Disease Procedures

Conditions
-----------------
Structural Cardiac Defects

Intervention / Treatment
-----------------
* Device: 3D Holographic Display


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over the age of 18 Patients are scheduled to undergo an elective procedure in the Cardiac Catheterization Laboratory which use 3D echocardiography (ECHO) as part of the procedure. Exclusion Criteria: Denial of informed consent Any contraindications to three-dimensional echocardiographic imaging.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 3D Holographic Display|3D holographic visualization of the anatomy during the planned interventional procedure. The HOLOSCOPE-i will be used in addition to and will not replace conventional displays that are currently being used during the procedure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOLOSCOPE-i is of clinical use for ultrasound based cardiac procedures | Qualitative assessment using a Likert scale | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOLOSCOPE-i provides an intuitive understanding of the spatial relationship of the anatomy | Qualitative assessment using a Likert scale | During procedure | 
| HOLOSCOPE-i provides an intuitive understanding of the spatial relationship between the tool and the anatomy | Qualitative assessment using a Likert scale | During procedure | 
| Satisfaction with the use of the HOLOSCOPE-i under intra-procedural conditions | Qualitative assessment using a Likert scale | During procedure |
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The presented randomized-controled study aim to assess the use of internet-based mindfulness intervention via mobile application for 30 days in patients with Major Depressive Disorder (MDD)

Detailed Description
-----------------
Mindfulness-based interventions (MBI) proved to be effective in relapse prevention in MDD. Next, MBI in form of free mobile applications can be an effective augmentation of the treatment as usual (TAU) and can fill a gap in the ambulatory care. Given this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via mobile app on the symptom severity and stress levels, compared to TAU.

Official Title
-----------------
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder

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

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based cognitive therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Depression, current ill Exclusion Criteria: acute alcohol- and drug dependency, schizophrenia or psychotic disorder, severe somatic illnes, not having smartphone or not willing to use mobile application

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Daily use of mindfulness-based mobile application for 30 days. | Behavioral: Mindfulness-based cognitive therapy<br>* Mobile application, mindfulness-based therapy<br>|
| No Intervention: Control group<br>Treatment as usual | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline self reported Depression Severity | Beck Depression Inventory | 30 days | 
| Change from Baseline Depression Severity | Hamilton Depression Rating Scale | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline heart rate | Change in resting heart rate | 30 days | 
| Change from baseline blood pressure | Change in systolic blood pressure | 30 days | 
| Change from baseline respiratory rate | Change in resting respiratory rate | 30 days | 
| Change from baseline tobacco consumption | Change in daily tobacco consumption | 30 days | 
| Change from baseline alcohol consumption | Change in weekly alcohol consumption | 30 days | 
| Change in consumption of anxiolytics | Change in daily use of anxiolytic drugs | 30 days |