linjc16/ctgov huggingface dataset:
Prolactin Hormone in Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
Oral lichen planus (OLP) is one of the most common mucosal diseases with autoimmune etio-pathogenesis with involvement of various cytokines similar to psoriasis.It generally occurs more commonly in females, in a ratio of 3:2. prolactin (PRL),It is a peptide hormone that has a role in autoimmune related diseases like systemic lupus erythematosus and , rheumatoid Artheritis. The role of PrL in OLP pathogenesis was never investigated.the aim of this study is to investigate the expression of PRL receptors in tissue biopsies of OLP patients.

Official Title
-----------------
Prolactin Hormone in Oral Lichen Planus Tissue Samples

Conditions
-----------------
Oral Lichen Planus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with oral lichen planus systemically healthy Exclusion Criteria: oral lichenoid lesions

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| oral lichen planus group<br>patients with chronic bollus erosive lichen planus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolactin receptors expression in oral mucous membrane | immuno-histochemistry | 24 hours |
Clinical Importance of Filaggrin Gene Mutation for Treatment Outcome in Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Atopic dermatitis is a common disease which affects about one million people in Finland at some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin and a defect in skin barrier function. The filaggrin protein plays a central role in the skin barrier function and studies indicate that about 30% of patients with atopic dermatitis have a mutation in the filaggrin gene. The aim of the study is to investigate whether a mutation in the filaggrin gene affects the clinical treatment outcome in patients with atopic dermatitis. If a mutation predisposes to a worse response to treatment, this could be examined and those patients with the mutation could be given extra treatment support for their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic population is studied in the control group.

Official Title
-----------------
Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?

Conditions
-----------------
Atopic Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (patients with atopic dermatitis): Age at least 18 years Clinical diagnosis of atopic dermatitis Need for follow-up at the Skin and Allergy Hospital Patient gives signed informed consent to participate in this study Patients parents and grandparents are of Finnish origin Inclusion Criteria (Controls): No history of atopy or skin disease Age at least 18 years

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 atopic dermatitis<br> | |
| Non-atopic controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Filaggrin mutation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment |  | 12 months | 
| Serum IgE |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic dermatitis, Filaggrin
A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.

Official Title
-----------------
A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement

Conditions
-----------------
Age-Related Macular Degeneration (AMD)

Intervention / Treatment
-----------------
* Drug: pegaptanib sodium (Macugen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subfoveal CNV secondary to AMD At least 1 but not more than 3 prior treatments for AMD Exclusion Criteria: Subfoveal scar or subfoveal atrophy Significant media opacities, including cataract, which might interfere with visual acuity

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Drug: pegaptanib sodium (Macugen)|nan|

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
-----------------
Age-Related Macular Degeneration (AMD), pegaptanib sodium, subfoveal CNV, macugen
Does Telephone Follow-up Improve Patients Satisfaction

Study Overview
=================
Brief Summary
-----------------
Several studies have shown the importance of Telephone follow-up in reducing hospital readmissions for heart failure. Therefore, we aimed in this cohort to investigate whether telephone follow-up with patients discharged from the general internal department improves patients' satisfaction, increases compliance to treatment and reduces adverse effects. Patients are recruited from the department of general internal medicine who gave informed consent and could communicate. Patients are interviewed by during hospital stay, one and three months later. This group will be compared with patients that are not interviewd by phone aftert hospital discharge.

Official Title
-----------------
Does Telephone Follow-up After Discharge Improve Patients Satisfaction and Decrease Hospitalization

Conditions
-----------------
Congestive Heart Failure, Angina Pectoris, Pneumonia, Urinary Tract Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to sign informed consent and communicate by phone in Hebrew, Arabic, Russian or English - Exclusion Criteria:Non of the above -

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
-----------------
telephone,, internal medicine,, readmission,, patients' satisfaction
Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVE: I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.

Conditions
-----------------
Sporotrichosis

Intervention / Treatment
-----------------
* Drug: fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presumptive evidence of sporotrichosis Culture-proven sporotrichosis determined on study Relapsing disease following antifungal therapy eligible if culture positive for Sporothrix schenckii prior to entry No life-threatening disease No central nervous system sporotrichosis --Prior/Concurrent Therapy-- No concurrent drugs known to react with fluconazole No more than 3 days of systemic antifungals for current sporotrichosis episode --Patient Characteristics-- Hepatic: Liver function tests no greater than 5 times normal Other: No HIV infection No pregnant or nursing women

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluconazole|nan|

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
-----------------
fungal infection, rare disease, sporotrichosis
Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up

Study Overview
=================
Brief Summary
-----------------
This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer. This study is also being done to relate treatment outcome to measurement of substances in the blood such as prostate-specific antigen (PSA) and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated.

Official Title
-----------------
Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent explained and signed prior to any study related procedures. Age ≥18 years Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better, or Karnofsky performance of 60% or better. Histologically confirmed adenocarcinoma of the prostate within 10 years of study entry. Willingness to return to Mayo Clinic Rochester for follow-up or participate in mail-in PSA processing. Must be disease-free from a previous diagnosis of cancer for a period of time = 5 years excluding cutaneous malignancies of squamous cell or basal cell carcinoma. Exclusion Criteria: Life expectancy < 5 years. Inability to return to Mayo Rochester for follow-up appointments, sera, and urine collection per protocol. Previous or a concurrent diagnosis of cancers other than basal cell or invasive squamous cell carcinoma of skin within the past 5 years.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-risk radical prostatectomy patients<br> | |
| Primary external beam radiotherapy patients<br> | |
| Primary prostate brachytherapy patients<br> | |
| Hormone refractory prostate cancer patients<br> | |
| Active Surveillance<br> | |
| Prostate biopsy patients<br> | |

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
-----------------
Prostate Cancer
Perioperative Inflammation and Breast Cancer Outcome

Study Overview
=================
Brief Summary
-----------------
It is increasingly recognized the NSAIDS (nonsteroidal antiinflammatory drug) might prevent the several cancers. In breast cancer, the role of NSAIDS (nonsteroidal antiinflammatory drug) has been suggested.However, there was no consistent results. surgery is main cause of inflammation for cancer patients. Therefore, we want to know the association between prevention of perioperative inflammation with NSAIDS and breast cancer outcomes.

Official Title
-----------------
Suppression of Inflammation by Using NSAIDs During Peri-operative Period Can Affect the Prognosis of Breast Cancer.

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: NSAIDS (ketorolac and ibuprofen)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients who took the surgery Exclusion Criteria: underlying medical disease (major heart disease, lung disease, coagulopathy) major psychologic disease (major depression, schizophrenia, manic disorder) pregnancy rheumatic disease patients

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>no medication or acetaminophen | |
| Experimental: NSAIDS (ketorolac intravenous, ibuprofen)<br>ketorolac IV (just before surgery) and ibuprofen for 1 weeks | Drug: NSAIDS (ketorolac and ibuprofen)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-Inflammatory Agents, Non-Steroidal, Inflammation, Perioperative Period
In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.

Detailed Description
-----------------
The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

Official Title
-----------------
In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Other: SYSTANE® Gel Drop lubricant eye gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have history of dry eye as determined by: Questionnaire Tear Film Break Up Time less than or equal to 10 seconds Schirmer's score of less than or equal to 5 mm Corneal staining greater than or equal to 3 in either eye, and Positive for conjunctival staining (greater than or equal to 1) Exclusion Criteria: Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

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: SYSTANE® Gel Drops Lubricant eye gel<br>SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period. | Other: SYSTANE® Gel Drop lubricant eye gel<br>* SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.<br>* Other names: Systane Gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel. | The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel. | baseline and 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, Epithelial changes
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.

Study Overview
=================
Brief Summary
-----------------
Participants with hearing loss and Tinnitus will wear hearing aids with amplification-only or with an added sound, and have their tinnitus level evaluated before and after intervention.

Detailed Description
-----------------
2 groups of adults with hearing loss and chronic bothersome tinnitus and no experience with amplification will participate in a cross over intervention study with 2 conditions of 4 weeks each: 1. fit with hearing aid (HA) amplification-only, and 2. fit with HA amplification with an added sound, returning to their original unaided condition after undergoing the intervention phase.

Official Title
-----------------
Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.

Conditions
-----------------
Hearing Loss, Sensorineural, Tinnitus

Intervention / Treatment
-----------------
* Device: hearing aid amplification
* Device: hearing aid amplification with an added sound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hearing loss candidate for hearing aid amplification Bothersome chronic tinnitus (3 months+) Exclusion Criteria: age less than 18 years normal hearing tinnitus presence for less than 3 months tinnitus not bothersome enough to warrant intervention non hearing aid candidates

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amplification-only<br>Hearing aid will be fit to prescribed participant hearing loss. | Device: hearing aid amplification<br>* Hearing aid will be fit to prescribed participant hearing loss.<br>|
| Active Comparator: Amplification with added sound<br>Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated on the hearing aid. | Device: hearing aid amplification with an added sound<br>* Hearing aid will be fit to prescribed participant hearing loss and an added sound will be activated.<br>|
| No Intervention: No intervention<br>Participants will return to their original unaided state. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index evaluation (TFI) | Tinnitus Functional Index (TFI) questionnaire results, ranging from 0 to 100, with higher numbers indicating more severe (worse) Tinnitus interference in the person's quality of life. | TFI collected before intervention to serve as a baseline. TFI change from baseline will be assessed after each study condition, which will last 4 weeks/each. Up to 1 year of study completion, a follow-up TFI will be done for comparison reasons. |
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA

Study Overview
=================
Brief Summary
-----------------
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA

Official Title
-----------------
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA

Conditions
-----------------
Rectal Neoplasms

Intervention / Treatment
-----------------
* Drug: Chemotherapy, radiation therapy & surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with localized rectal CA
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

| Intervention/Treatment |
| --- |
|Drug: Chemotherapy, radiation therapy & surgery|radiation and chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA