linjc16/ctgov huggingface dataset:
Safety and Efficacy of Vilazodone in Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
Safety and Efficacy of Vilazodone in Major Depressive Disorder

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study With Vilazodone in Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Vilazodone
* Drug: Vilazodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18-70 years of age Currently meet the DSM-IV-TR criteria for Major Depressive Disorder The patient's current major depressive episode must be at least 8 weeks and no longer than 18 months in duration Exclusion Criteria: Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control Patients with a history of meeting DSM-IV-TR criteria for: any manic, hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic, or mixed episode; any depressive episode with psychotic or catatonic features; panic disorder with or without agoraphobia; obsessive-compulsive disorder; Schizophrenia, schizoaffective, or other psychotic disorder; bulimia or anorexia nervosa; presence of borderline personality disorder or antisocial personality disorder; h. mental retardation, dementia, amnesia, or other cognitive disorders Patients who are considered a suicide risk

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Dose-matched placebo capsules, oral administration | Drug: Placebo<br>* Matching placebo given orally, once per day<br>|
| Experimental: Vilazodone 20mg<br>Vilazodone tablets, 20 mg per day, oral administration | Drug: Vilazodone<br>* Vilazodone, 20 mg per day, oral administration<br>* Other names: Viibryd;|
| Experimental: Vilazodone 40mg<br>Vilazodone tablets, 40 mg per day, oral administration | Drug: Vilazodone<br>* Vilazodone, 40 mg once per day, oral administration<br>* Other names: Viibryd;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first relapse during the double-blind treatment phase |  | Number of days from the randomization date to the relapse date, up to 28 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder, Depression
Social Influences on Adolescents' Snack Purchases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of peer influences on snack purchases in adolescents. During the session teens will be given a certain amount of money to use to purchase foods and beverages in a hypothetical convenience store setting. The investigators hypothesize that overweight youth will be less responsive to own-price elasticity for high calorie foods and less likely to show cross price elasticity for low calorie foods when the price of the high calorie for nutrient foods increases. The investigators also predict that overweight youth will show more cross price elasticity for low calorie foods when in the presence of peers; whereas lean youth's food purchases and price sensitivity will not be affected by the presence of peers.

Official Title
-----------------
Social Influences on Adolescents' Snack Purchases

Conditions
-----------------
Social Influences, Food Consumption

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls ages 12-14 Youth must have at least a moderate liking of study foods used Youth must be at or above the 15th BMI percentile Exclusion Criteria: Youth should have no dietary restrictions Youth should have no food allergies Youth should have no medical conditions that alter the body's ability to absorb nutrients or that can otherwise influence the participants' response to food

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 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
-----------------
social influences, food purchases, childhood obesity, amount of energy dense food and beverage items purchased, amount of nutrient dense food and beverage items purchased
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study

Study Overview
=================
Brief Summary
-----------------
According to the results Ciloğlu et al., CSC is related to elevated total testosterone levels. Testosterone may play a role in predisposing males to CSC. Thus, we aimed to investigate the possible effect of external testosteron intake over choroidal parameters; such as choroidal thickness, choroidal vascularity index, choroidal stromal ve luminal areas,ect.

Detailed Description
-----------------
In the study, we have two group: First group consists of patients with testosteron deficiency and there are sex and age-matched healthy control subjects in the second group. We will measure the parameters of both groups at baseline. And first month and 3rd month we will remeasure the values of the parameters by enhance depth optical coherence tomography. The results will be compared between the groups.

Official Title
-----------------
Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical

Conditions
-----------------
Effects of the External Testosteron Intake Over the Choroids of the Patients With Androgen Deficiency

Intervention / Treatment
-----------------
* Drug: external testosteron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for androgen deficient group: no other ocular and systemic disease except androgen deficiency. no history of ocular surgery or disease no medicine use for healthy controls :no other ocular and systemic disease. no history of ocular surgery or disease no medicine use, no smoking or any tobocco use Exclusion Criteria:having any ocular and systemic disease. history of ocular surgery or disease,medicine use, smoking or any tobocco use -

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| androgen deficient<br> | Drug: external testosteron<br>* external testosteron<br>|
| healthy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate Effects of External Testosteron Intake on the Choroid: Enhance-depth Imaging Optical Coherence Tomography Study | to obtain the measurements of the choroids | 2019 and 20120 |
A Prospective Randomized Trial on Mycophenolate Mofetil in Risk Penetrating Keratoplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospectively randomized multicentre study was to prove the efficacy and safety of mycophenolate mofetil (MMF) to preventing graft rejection and improvement of clear graft survival following high-risk keratoplasty. The patients of the MMF group receive MMF orally 2x1 g daily for 6 months. Endpoints were immune reaction free and clear graft survival and the occurence of side-effects.

Conditions
-----------------
Corneal Transplantation

Intervention / Treatment
-----------------
* Drug: Mycophenolate Mofetil 2x 1g


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Keratoplasty with increased risk for immunologic graft rejection in the abscence of other risk factors for graft failure. (repeat keratoplasty, steroid-response, limbo-keratoplasty, oversized graft. Exclusion Criteria: Normal risk cases. Herpes-Keratitis. Glaucoma. Limbus stem cell deficiency.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mycophenolate Mofetil 2x 1g|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Axial Mobility Exercises in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the benefit of exercise versus usual care (no exercise) on impairments and functional limitations in patients with Parkinson disease.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. Patients assigned to the Axial Mobility Exercise Program participate 3 times a week for 10 weeks. The program consists of individualized exercises specifically directed toward restoration of axial mobility in the context of functional tasks. Patients assigned to the control group receive standard care (no exercise).

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Stage 2 or 3 Parkinson disease (Hoehn/Yahr scale) Able to ambulate independently Able to function independently in home Moderate rigidity No moderate or severe tremor --Prior/Concurrent Therapy-- Concurrent stable pharmacologic regimen required --Patient Characteristics-- Cardiovascular: No unstable angina Other: No psychiatric or medical contraindication to exercise, e.g., dementia, hip fracture; no other neurologic disorder, e.g., stroke, multiple sclerosis; resides within 30 miles of Duke University

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Educational/Counseling/Training


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise|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
-----------------
Parkinson disease, Neurologic and psychiatric disorders, Rare disease
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Study Overview
=================
Brief Summary
-----------------
The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.

Official Title
-----------------
Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females >= 18 years of age ACR criteria for RA diagnosis for at least 6 months Active RA defined as a DAS 28 >3.2 at study entry Unsatisfactory response, loss of response or intolerance to prior infliximab treatment A negative pregnancy test for females of childbearing potential Exclusion Criteria: Patient who had previous treatment with cyclophosphamide and chlorambucil Treatment within the last 8 weeks with infliximab Prior treatment with more than one DMARD or DMARD combination following infliximab treatment Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease Prior treatment with total lymphoid irradiation

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: adalimumab|40 mg adalimumab every other week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas (Study P04460)

Study Overview
=================
Brief Summary
-----------------
This open-label, randomized, parallel-group clinical study is designed to compare the efficacy and safety of the topical antibiotic, sisomicin cream, with that of another topical antibiotic cream, nadifloxacin cream, in the treatment of Indian patients with primary pyodermas.

Official Title
-----------------
Sisomicin Cream Vs Nadifloxacin Cream in Primary Pyodermas

Conditions
-----------------
Pyoderma

Intervention / Treatment
-----------------
* Drug: sisomicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of either sex and suffering from primary pyodermas requiring topical antibiotic therapy without occlusive dressings. >=6 years of age. Written informed consent. Exclusion Criteria: Patients must not take any other antibiotics. Patients should not be hypersensitive to any of the test drugs. Patients are not to have any other investigational drug within one month of starting this study. Patients cannot be enrolled more than once in the study. Patients must not have any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment. Pregnant women and nursing mothers are to be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 6 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sisomicin|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
-----------------
pyoderma, sisomicin, nadifloxacin
The Role of Intravitreal Glucose in Macular Thinning Following Surgery for Retinal Detachment or Epimacular Membrane

Study Overview
=================
Brief Summary
-----------------
Comparison between intravitreous glucose rate and macular thinning measured by Ocular Coherence Tomography (OCT) at 3 months post vitrectomy for retinal detachment or epimacular membrane. Hypothesis : Association between post-operative macular thickness and intravitreous glucose rate

Detailed Description
-----------------
Comparison between intravitreous glucose rate and macular thinning measured by OCT at 3 months post vitrectomy for retinal detachment or epimacular membrane. The cohort is divided in 2 groups, one with the thinnest macular measurement under 190µm, and the others above 190µm. We are looking for a correlation between increasing glucose rates and decreased macular thickness.

Official Title
-----------------
Impact of Intravitreal Glucose Rate in Macular Thinning Following Retinal Detachment or Epimacular Membrane Surgery

Conditions
-----------------
Vitrectomy, Macular Thinning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who underwent vitrectomy for retinal detachment or epimacular membrane Exclusion Criteria: patient suffering of diabetes, recurrence of retinal detachment, age-related macular degeneration, post surgical macular oedema

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 |
| --- | --- |
| GLUC-MAC-COHORT<br>post vitrectomy for retinal detachment or epimacular membrane patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular thickness measured by OCT |  | 3 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  | 3 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitrectomy,, macular thinning,, retinal detachment,, epimacular membrane,, intravitreal glucose,, OCT
Seroquel XR in Schizophrenia Relapse Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients

Official Title
-----------------
Seroquel XR in Schizophrenia Relapse Prevention

Conditions
-----------------
Schizophrenia Relapse Prevention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month Exclusion Criteria: Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity

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 |
| --- | --- |
| 1<br>Schizophrenic outpatients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients remained relapse free after 6 months of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate of patients |  |  | 
| Quality of Life (QoL ) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seroquel XR, schizophrenia relapse prevention
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Study Overview
=================
Brief Summary
-----------------
The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.

Official Title
-----------------
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: High Resolution Microendoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having a needle biopsy of a breast mass Exclusion Criteria: none

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

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

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Core needle biopsy<br>Patients needing a needle biopsy of a breast mass | Device: High Resolution Microendoscope<br>* Using core biopsy and reduction mammoplasty tissue<br>|
| Placebo Comparator: Reduction mammoplasty<br>Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer | Device: High Resolution Microendoscope<br>* Using core biopsy and reduction mammoplasty tissue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical signatures | The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast | Day of procedure (less than 10 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Breast Biopsy, Reduction mammoplasty