linjc16/ctgov huggingface dataset:
Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Detailed Description
-----------------
Same as brief summary

Official Title
-----------------
Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression

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

Intervention / Treatment
-----------------
* Biological: Dendritic Cells DCVAC/PCa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18 years and older Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2) Post radical Primary Prostatectomy Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease Exclusion Criteria: Prior androgen deprivation therapy for prostate cancer Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater Other uncontrolled intercurrent illness Treatment with immunotherapy against PCa Clinically significant cardiovascular disease Active autoimmune disease requiring treatment

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

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

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: DCVAC/PCa Arm<br>Dendritic Cells DCVAC/PCa Experimental therapy | Biological: Dendritic Cells DCVAC/PCa<br>* DCVAC/PCa Experimental therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of the second cycle of DCVAC | Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Prostate Specific Antigen (PSA) Doubling Time |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Radical Prostatectomy
Open Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1

Study Overview
=================
Brief Summary
-----------------
This is an open trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.

Official Title
-----------------
Effectiveness of a Telehealth Group for Improving Peer Relationships for Adolescents With Neurofibromatosis Type 1

Conditions
-----------------
Social Skills, Neurofibromatosis 1

Intervention / Treatment
-----------------
* Behavioral: PEERS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician diagnosis of neurofibromatosis type 1 Age 12-17 Main language spoken in the home is English Reliable internet access Current functional impairment in peer relationships Teen is interested and motivated to participate Exclusion Criteria: Main language spoken in the home is not English Cognitive or developmental delays that affect reading comprehension or understanding of treatment material Significant behavioral concerns Other comorbid medical conditions Major surgery in past 6 months Prior social skills group treatment within past 6 months Prior participation in PEERS

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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: Treatment Group<br>Participation in 16 week telehealth administration of the PEERS protocol for teens (parallel teen and parent/caregiver groups) | Behavioral: PEERS<br>* 16 week telehealth intervention; parallel teen and parent/caregiver groups; 90 minutes each week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Skills Improvement System - SEL (SSIS-SEL; Gresham & Elliot, 2017) | Parental report of social skills (SSIS-SEL Total Score; Mean 100, SD 15; Higher scores mean stronger social functioning | within four weeks of PEERS completion | 
| Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010) | Questionnaire completed by teen participants; measures knowledge of the PEERS intervention concepts (raw total score; higher score means stronger functioning) | within four weeks of PEERS completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale (SRS; Constantino, 2005) | Questionnaire completed by caregivers on social function and autism symptoms (SRS Total Score; Mean 50, SD 10; higher scores mean greater difficulties | within four weeks of PEERS completion |
Study to Evaluate the Efficacy of Adalimumab in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints

Study Overview
=================
Brief Summary
-----------------
Patients will be randomized into two groups (1/1) during one year: 40 mg adalimumab subcutaneously (sc) every other week placebo The effect on x-rays and clinical parameters will be evaluated.

Official Title
-----------------
TNF-Blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints: Randomized, Double Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of Adalimumab 40 mg SC Every Other Week in Patients With Erosive Osteoarthritis of the Interphalangeal Finger Joints

Conditions
-----------------
Erosive Osteo-Arthritis

Intervention / Treatment
-----------------
* Drug: Adalimumab (40 mg sc every other week)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clear erosive image on x-ray of at least one interphalangeal finger joint

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug - adalimimab sc | Drug: Adalimumab (40 mg sc every other week)<br>* Adalimumab (40 mg sc every other week)<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of x-rays |  |  | 
| Evaluation of clinical parameters (pain, daily functioning, etc.) |  |  |
Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve fusion (bony healing) techniques and improve patient recovery by identifying cells in your body that make bone. Patients with spine problems often need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together in order to hold the bones steady allowing them to heal together (fusion). If the vertebrae (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a slower recovery and may require revision (another) surgery. By using a small portion of the graft taken during surgery the investigators hope to define the cells that make bone most efficiently. This will help reduce the need for revision surgeries and improve patient recovery.

Detailed Description
-----------------
This study requests using your additional bone tissue (the extra tissue not needed after your back surgery is complete). This tissue will be measured for total volume (amount), labeled with your age, gender, date and time the tissue was removed (date and time of surgery), and taken to a lab for analysis. You will not be billed for the collection of your additional tissue or the lab analysis. All routine procedures (surgery and all follow-up care relating to your back surgery) will still be paid for by you or your insurance. Once your extra tissue sample has been collected, measured, labeled, and sent to the lab for testing, no further participation is required from you in this research study. The investigators will use your sample in our research to enhance bone healing.

Official Title
-----------------
Defining the Osteogenic Potential of Mesenchymal Stem Cells and Their Progenitors During Spinal Decompression and Posterolateral Lumbar Fusion

Conditions
-----------------
Pseudarthrosis After Fusion or Arthrodesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients electing to undergo spinal decompression with an instrumented posterolateral fusion Exclusion Criteria: Patients not undergoing spinal decompression with an instrumented posterolateral fusion

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 |
| --- | --- |
| Spinal decompression<br>Spinal decompression with an instrumented posterolateral fusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteogenic Potential of Mesenchymal Stem Cells |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fusion, Spine, Decompression, Pseudarthrosis, bone harvest, Instrumented posterolateral fusion
Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation

Study Overview
=================
Brief Summary
-----------------
The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI).

Official Title
-----------------
Can Non-Contrast Magnetic Resonance Angiography Accurately Define Arterial Access and Aortic Root Anatomy in Patients Referred for Transcatheter Aortic Valve Implantation?

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging Exclusion Criteria: Inability or unwillingness to consent Inability to complete magnetic resonance imaging (MRI) study Contraindication to MRI Participation in another research study Non-diagnostic computed tomography scan
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 |
| --- | --- | --- |
| Minimal luminal size for aorta and ileofemoral arteries | Compare luminal diameter for each segment of the ileofemoral arteries and aorta between MRI and CT | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graded image quality | Compare graded image quality for ileofemoral arteries, aorta, and aortic annulus between MRI and CT | 3 hours | 
| Annular size | Compare annular diameter, area, and perimeter between MRI and CT | 3 hours |
Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma

Study Overview
=================
Brief Summary
-----------------
Spectrailis optical coherence tomography has come with a new posterior pole asymmetry analysis for glaucoma diagnosis. The aim of the investigators study was to assess its applicability in diagnosing early glaucoma patients.

Official Title
-----------------
Diagnostic Ability of Posterior Pole Asymmetry Analysis Parameters (PPAA) of Spectralis Optical Coherence Tomography (OCT) in Detecting Early Glaucoma

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years Best corrected visual acuity 20/40 or better Refractive error within ±5D sphere and ±3D cylinder Willingness to participate in the study Exclusion Criteria: Media opacities preventing imaging Intraocular surgery within the last 6 months Any retinal or neurological disease other than glaucoma that could confound the results of visual field examination and OCT.

Ages Eligible for Study
-----------------
Minimum Age: 49 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 |
| --- | --- |
| Early glaucoma<br>The study group consisted of consecutive unilateral glaucoma patients, categorized as early stage by Hodapp-Anderson-Parrish classification. | |
| Normal subjects<br>Normal control subjects had a normal ocular examination, Intraocular pressure (IOP) <22 mmHg, no past history of high IOP, no family history of glaucoma, normal optic disc morphology and visual field in both eyes. One eye of control subject was randomly selected. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve for all the diagnostic parameters of optical coherence tomography | This was a cross sectional study with one time measurement of the diagnostic parameters of the optical coherence tomography. | up to 32 weeks |
Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour Application

Study Overview
=================
Brief Summary
-----------------
Topical ophthalmic antibiotics are common prescribed just prior to eye surgery to lower the risk of infection. Previous studies have suggested that antibiotics containing a preservative (Zymar) kill bacteria much quicker than those without a preservative (Vigamox). The purpose of this research is to compare how quickly to the two commonly prescribed antibiotics eliminate bacteria from the eye surface.

Official Title
-----------------
Prospective Randomized Comparison of Zymar(Gatifloxacin) and Vigamox (Moxifloxacin) in Killing Conjunctival Bacterial Flora Following a One-hour

Conditions
-----------------
Conjunctical Flora

Intervention / Treatment
-----------------
* Drug: gatifloxacin, moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age- older than 50 years of age Diagnosis- Cataract or had cataract surgery Exclusion Criteria: Systemic or topical antibiotic treatment within 30 days Use of systemic or topical steroids Active ocular infection Ocular surgery in the past 6 months Allergy to fluoroquinolones

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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gatifloxacin, moxifloxacin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic killing of conjunctival bacterial flora 1 hour after application |  |  |
Autologous Fibroblast Grafts in Facial Skin Regeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.

Detailed Description
-----------------
- Analytical prospective autocontrolled study

Official Title
-----------------
Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm

Conditions
-----------------
Skin Aging

Intervention / Treatment
-----------------
* Procedure: autologous fibroblasts grafts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, aged between 50 to 70 years with facial wrinkles (rhytides), Fitzpatrick III skin type, and Who had reached menopause at least 3 years before entering the study were eligible for participation. Exclusion Criteria: Women with uncontrolled comorbid conditions, Smokers, Alcohol and corticosteroid users, Who had undergone chemical peeling or skin filling in the face or neck at least 12 months prior to the study, Who had a keloid scar, Who scored below 18 on the Mini-Mental State Examination, Who had any psychiatric disorder or those undergoing orthodontic treatment were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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: autologous fibroblast grafts<br>autologous fibroblast grafts | Procedure: autologous fibroblasts grafts<br>* Autologous cultured fibroblasts will be grafted in facial skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regeneration of facial ectoderm | To evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses. | one year after the grafting of autologous fibroblasts. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin aging, fibroblasts, transplantation, autologous
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in adults and lithium is also FDA approved in children; quetiapine is commonly used in children with mania, but is not FDA approved for this indication in this age group.

Official Title
-----------------
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: lithium
* Drug: quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - First-episode manic bipolar patients (N=100; 15-20 patients/year): Patients meet DSM-IV criteria for type I bipolar disorder, manic or mixed. Patients have an index Young Mania Rating Scale (YMRS)70 total score >20. Patients have <3 months of lifetime anti-manic or anti-depressant medication exposure, including no active psychotropic medication in the one weeks prior to the index admission. Importantly, patients will NOT be taken off medications for this study; this criterion is to exclude subjects receiving active treatment at the time of admission to support the 'first-episode' criterion. Patients have no more than two prior episodes of major depression. Patients are between 12 and 35 years old; subjects < 18 yrs old have a Tanner greater than or equal to 4 Exclusion criteria: All subjects will be excluded from participation for the following reasons. Any chemical use disorder within 3 months. Any medical or neurological disorder that could influence fMRI and MRS results. A history of mental retardation or an estimated IQ total score <85. An MRI scan is contraindicated in the subject. The patient cannot attend follow-up visits. A positive urine pregnancy test (in women).

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 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>Study subjects receiving lithium | Drug: lithium<br>* standard clinical care<br>|
| 2<br>Study subjects receiving quetiapine | Drug: quetiapine<br>* standard clinical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain structure, function and chemistry in people with bipolar disorder who are being treated with either quetiapine or lithium. |  | 8 weeks |