linjc16/ctgov huggingface dataset:
Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. This study is to further understand how psoriasis lesions happens. An understanding of key mediators that lead to psoriasis might aid in the discovery of more effective treatments for this skin disorder. This is not an intervention study. The study is looking to obtain currently untreated plaque psoriasis biopsies and also biopsies from non psoriasis patients. Psoriasis and medical history will be collected then skin biopsies will be obtained from the subjects.

Official Title
-----------------
Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Other: No intervention - Psoriasis Subject
* Other: No intervention - Control Subject


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and Male adult subjects age 18 to 50 with plaque psoriasis that is currently untreated (no topical agents for 2 weeks, no systemic agents for 1 month) or controls w/o psoriasis and no family history of psoriasis. Must be able to give informed consent All skin types on Fitzpatrick Scale (Type I-VI) Able to provide medical history and list of medications for psoriasis and control subjects Exclusion Criteria: Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus) Tanning bed use within last 2 months Photodynamic Therapy or UVB treatments in past 2 months Female Subjects: pregnant or nursing History of abnormal scarring (i.e., keloids) Family history of psoriasis in first-degree relatives for control subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis<br>Subjects diagnosed with psoriasis. | Other: No intervention - Psoriasis Subject<br>* Not currently treated plaque psoriasis patients<br>|
| Control<br>Subjects who do not have psoriasis. | Other: No intervention - Control Subject<br>* Control subjects without plaque psoriasis and no family history of psoriasis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal P63 signaling levels | Determining if untreated psoriasis skin has abnormal p63 signaling | Day 0 |
Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations

Study Overview
=================
Brief Summary
-----------------
Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. In this observational cohort study, the investigators wish to explore if the prevalence of neuromas are higher in patients with pain after peripheral nerve injury and amputation, than in patients with the same conditions but without pain.

Official Title
-----------------
Identification of Neuromas by High Resolution Ultrasound in Patients With Peripheral Nerve Injury and Amputations

Conditions
-----------------
Neuropathic Pain, Neuroma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with peripheral nerve injury 3 months prior to participation Subjects with amputation 3 months or more prior to participation Exclusion Criteria: Severe somatic or psychiatric diseases Other peripheral neuropathy Lack of ability to cooperate to the clinical examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Prevalence of neuromas in patients with pain and without pain after peripheral nerve injury or amputation. | Neuromas identified by ultrasound. | 3 hours |
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.

Detailed Description
-----------------
The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with 5-time daily topical administration.

Official Title
-----------------
An Open Label, Multi-Centre, Phase III, Subject Initiated Safety Study of ME-609 in Treatment of Recurrent Herpes Simplex Labialis in Adolescents

Conditions
-----------------
Herpes Labialis

Intervention / Treatment
-----------------
* Drug: ME-609


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General good health History of recurrent herpes labialis with at two recurrences during the last twelve months Exclusion Criteria: Treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion Significant skin condition that occur in the area of herpes recurrences Nursing or/and pregnancy Immunosupressed state due to underlying disease (e.g. HIV infection or concomitant treatment (e.g. cancer chemotherapy)

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ME-609 | Drug: ME-609<br>* Topical treatment 5 times daily for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event |  | 3 weeks after last dose |
Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy

Study Overview
=================
Brief Summary
-----------------
several studies have investigated healing effect of phenytoin.In this study we investigate healing effect of phenytoin mucoadhesive paste comparing to the usual mucoadhesive paste after oral biopsy.

Official Title
-----------------
Phase 1 Study of Phenytoin Mucoadhesive Paste for Wound Healing After Oral Biopsy

Conditions
-----------------
Wound Healing, Pain

Intervention / Treatment
-----------------
* Drug: Phenytoin paste
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergone oral biopsy Exclusion Criteria: systemic disease
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 |
| --- | --- |
| Active Comparator: phenytoin paste<br>this group receives phenytoin paste after oral biopsy | Drug: Phenytoin paste<br> <br> |
| Placebo Comparator: usual mucoadhesive paste<br>this group receives the usual mucoadhesive paste without phenytoin after oral biopsy | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing biopsy wound | patient recieves phenytoin mucoadhesive paste after oral biopsy and the diameter of inflammatory halo is determined in 1,3,5and the 7th days.pain measurment is also assesed by VAS score | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory halo, VAS
Stress and Immunity Breast Cancer Project

Study Overview
=================
Brief Summary
-----------------
An investigative study of the effectiveness of the BioBehavioral Intervention on Stage II/III breast cancer patients. A total of 231 patients were split between an assessment-only control group and an experimental group receiving the Intervention and assessment. The goal of the Intervention is to use psychological, behavioral, and biologic methods with the primary goal of reducing cancer recurrence.

Official Title
-----------------
Psychological/Immunity Studies With Women With Cancer Previously

Conditions
-----------------
Breast Cancer Stage II, Breast Cancer Stage III

Intervention / Treatment
-----------------
* Behavioral: BioBehavioral Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage II or III breast cancer diagnosis prior to adjuvant therapy Exclusion Criteria: -

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Assessment-only<br> | |
| Experimental: Intervention<br> | Behavioral: BioBehavioral Intervention<br>* Psychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (neuroendocrine and immune) factors, and pathways by which health outcomes (e.g. disease endpoints-recurrence, disease free interval) might be affected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence event | Diagnosis of pathologically confirmed breast cancer recurrence | Ten years | 
| Recurrence time | Time from the day of initial stage II or III breast cancer diagnosis to day of pathology confirmed breast cancer recurrence | Ten years |
Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic

Study Overview
=================
Brief Summary
-----------------
The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-SA01, for patients with serious or immediately life-threatening Staphylococcus aureus infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation. To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing expandedaccess@ampliphibio.com with Expanded Access Request in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition. Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.

Official Title
-----------------
Expanded Access Program for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic, for the Treatment of Serious Infections Caused by Staphylococcus Aureus.

Intervention / Treatment
-----------------
* Biological: AB-SA01


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: AB-SA01|AB-SA01 is an investigational bacteriophage therapeutic for treatment of Staphylococcus aureus infections|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf

Study Overview
=================
Brief Summary
-----------------
To study the results of a modified Cutler-Beard technique , using a contralateral tarsoconjunctival graft, in patients who underwent excision of large malignant tumors of the upper eyelid

Detailed Description
-----------------
A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described. Functional, cosmetic outcomes and postoperative complications were evaluated.

Official Title
-----------------
Reconstruction of Upper Eyelid Defects Secondary to Malignant Tumors With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graft

Conditions
-----------------
Reconstructive Surgical Procedure

Intervention / Treatment
-----------------
* Procedure: 'Cutler-Beard modified with graft'


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper eyelid defect after tumor resection Exclusion Criteria: previous surgery

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Retrospective review of charts of the patients enrolled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cutler-Beard modified with graft<br>Reconstruction of Upper Eyelid With a Newly Modified Cutler-Beard Technique With Tarsoconjunctival Graf | Procedure: 'Cutler-Beard modified with graft'<br>* A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.<br>* Other names: Modified Cutler-Beard technique with tarsoconjunctival graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyelid retraction | Upper eyelid retraction in mm | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retraction of the donor lower eyelid | Lower eyelid retraction in mm | 42 months | 
| Lagophthalmos | Excessive aperture of the eyelids, in mm | 42 months | 
| Lid margin stability | in mm | 42 months | 
| Eyelid status | Number of complications, being 0 the best result | 42 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cutler-Beard, tarsoconjunctival graft, upper eyelid
Examine the Possible Association of Hepatic CYP3A Activity and the Susceptibility to Femur Head Necrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Detailed Description
-----------------
Femur head necrosis is one of the major side effects of corticosteroid therapy. Since corticosteroids are metabolized by hepatic cytochrome P-450 (CYP) 3A, a low endogenous activity of this enzyme may contribute to the pathogenesis of ONFH. The purpose of the present study was to examine the possible association of hepatic CYP3A activity and the susceptibility to femur head necrosis in patients treated with corticosteroids.

Conditions
-----------------
Femur Head Necrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of avascular necrosis of the femur Exclusion Criteria: Old age (> 70 years) Severe hepatic or renal dysfunction Heart disease Current use of known CYP3A-inducing or -inhibiting drugs Morbid obesity

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femur Head Necrosis, CYP3A
Novel Non-Invasive Monitoring Parameter in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study Non-Invasive Performance evaluation of monitoring algorithm.

Detailed Description
-----------------
Assess equivalency, performance, and accuracy of a new monitoring algorithm in Healthy Volunteers.

Official Title
-----------------
Novel Cardio-Respiratory Parameter in Healthy Volunteers

Conditions
-----------------
No Conditions, Focus is Respiratory Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 or older Subject is willing and able to provide written consent Exclusion Criteria: Severe contact allergies to standard adhesive materials Subjects with abnormalities that may prevent proper application of the device Women who are pregnant or lactating Subjects with significant Arrhythmias

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Healthy volunteers ASA Class 1 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device. | Mean and standard deviations of respiration rates collected from healthy volunteers were compared between Covidien Respiration Rate Software, Transthoracic Impedance and Overscored End-Tidal Carbon Dioxide Waveforms. Each volunteer served as its own control. | Participants were monitorerd on average of 30 minute period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence. | The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject. The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software | Participants were monitored on average of 30 minute periods | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory Rate
A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

Study Overview
=================
Brief Summary
-----------------
To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias To compare healing related complications, post-operative pain, and scarring between the two procedures.

Detailed Description
-----------------
First line of treatment for vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VAIN) is not well defined. Laser vaporization and ultrasonic surgical aspiration are both accepted surgical modalities used in the treatment of vulvar and vaginal dysplasias, however no prospective study has been done to compare the two procedures. The specific aims of this research study include: To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias in a prospective, multi-institutional, randomized clinical trial. To compare healing related complications, post-operative pain, and scarring between the two procedures.

Official Title
-----------------
Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias

Conditions
-----------------
Vulvar Dysplasia, Vaginal Dysplasia

Intervention / Treatment
-----------------
* Procedure: CO2 laser surgery
* Procedure: ultrasonic surgical aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician Pre-operative biopsies to confirm presence of dysplasia / condyloma. Patients with dysplasias of grade 3 / CIS will be included at the discretion of the treating surgeon and will have had invasion confidently excluded by clinical exam and biopsy. Exclusion Criteria: Patients under the age of eighteen or who are pregnant will be excluded

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: CO2 laser surgery|nan|
|Procedure: ultrasonic surgical aspiration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 
| side effects |  |  | 
| complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasonic surgical aspiration, CO2 laser surgery, vulvar dysplasia, vaginal dysplasia, recurrence