linjc16/ctgov huggingface dataset:
Microperimetry in Macular Edema

Study Overview
=================
Brief Summary
-----------------
In uveitic patients with fluorescein angiographically proven macular edema, a fundus related microperimetry is performed and results are correlated with foveal thickness as measured with optical coherence tomography (OCT).

Official Title
-----------------
Place of Fundus-related Microperimetry in Uveitic Macular Edema

Conditions
-----------------
Uveitis, Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with noninfectious uveitis, macular edema Exclusion Criteria: Pregnancy, fluorescein allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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>Patients with noninfectious uveitis and macular edema | |

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
-----------------
microperimetry, macular edema, uveitis, Retinal sensitivity as measured with fundus related microperimetry
A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.

Official Title
-----------------
FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

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

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine Those who have at least one erosion on X-ray of hands, wrists or feet Exclusion Criteria: Those who have been treated with any biologic drugs or leflunomide Those who meet Class 4 with the Steinbrocker functional classification

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tacrolimus<br>* oral<br>* Other names: FK506;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic progression of structural joint damage |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and symptoms of rheumatoid arthritis |  | 52 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Rheumatoid Arthritis, Tacrolimus anhydrous
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Response in Advanced or Metastatic Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average. Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments. The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.

Official Title
-----------------
A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)

Conditions
-----------------
Advanced Melanoma, Metastatic Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years of age. Patient must be able to give own signed informed consent. Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin. Patients that are planned to receive either: Adjuvant treatment 1st line treatment for metastatic disease 2nd line treatment for metastatic disease Patients with prior adjuvant treatment are allowed. Patients receiving planned standard treatment of one or more of the following: Chemotherapy regimens containing DTIC, TMZ and/or cisplatin Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies) BRAF and/or MEK inhibitors Patients were FFPE and fresh frozen tissue is available (both mandatory). Exclusion Criteria: -

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 |
| --- | --- |
| Study<br>Patients who have fresh frozen and FFPE tissue taken prior to treatment | |
| Control<br>Fresh frozen tissue and FFPE tissue is available | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of SYS-ACT | Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment | 2 years | 
| Progression free survival | Progression free survival (PFS) and overall survival will be assessed for each patient for up to 2 years. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced melanoma, metastatic melanoma, fresh frozen tissue, FFPE tissue
Effect of Induction Method in Post Operative Agitation

Study Overview
=================
Brief Summary
-----------------
To compare the effect of two different induction method; mask ventilation and intravenous cannulation on emergence agitation on pediatric adenotonsillectomy

Detailed Description
-----------------
Many things cause emergence agitation after operations on pediatric population. This research aims determine which method, mask ventilation or intravenous cannulatin is more effective on emergence agitation

Official Title
-----------------
the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy

Conditions
-----------------
Emergence Agitation

Intervention / Treatment
-----------------
* Device: mask ventilation
* Device: intravenous cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric adenotonsillectomy Exclusion Criteria: patients with neurological, hepatic, renal disorders and using any drugs

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mask ventilation<br>induction is made with mask ventilation | Device: mask ventilation<br>* before intravenous induction, mask application is made. then intravenous cannulation and induction<br>* Other names: induction method with mask ventilation;Device: intravenous cannulation<br>* induction is applied by using intravenous cannulation<br>* Other names: induction method with intravenous cannulation;|
| Experimental: intravenous induction<br>induction is made with intravenous cannulation | Device: intravenous cannulation<br>* induction is applied by using intravenous cannulation<br>* Other names: induction method with intravenous cannulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess changing in pediatric agitation/ emergence delirium scale(PAED) scores | to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit. | postoperative first hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC (face, legs,activity, cry, consolobility) | to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit | postoperative first hour |
Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess in general population NSAID and gastroprotective agent utilization and compliance in elderly people.

Official Title
-----------------
Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: French people > 65 years old, part of Kantar Health Access Santé panel

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NSAID Treatment Compliance |  | At the end of month 1 | 
| Gastroprotective agent compliance (Girerd Questionnaire) |  | At the end of month 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Compliance, France, Self-administered questionnaire to patients
ZAP, US. Zomig for Appropriate for Primary Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™ (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in treating migraine over a period of 6 months

Official Title
-----------------
A Multicenter, Open-Label Study Using the MIDAS Questionnaire to Assess the Effect of Using the HCPC Guidelines for Migraine Management in Primary Care, Including the Use of Zomig-ZMT (Zolmitriptan) Orally Disintegrating Tablets 5.0mg and Zomig Nasal Spray 5.0mg as Indicated.

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Zolmitriptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an established diagnose of migraine as with an age at onset of less than 50 years Have experienced an average of at least 1 migraine headache per month in the previous three months Be able to differentiate between migraine and non-migraine headaches Exclusion Criteria: Use of any triptan within the last 12 months or use of MAO-A inhibitors, methysergide or methylergonovine in the 2 weeks before entering the study. History of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache History, symptoms, or significant risk factors for ischaemic heart or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways or arrhythmias or uncontrolled hypertension.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zolmitriptan|5mg Nasal Spray|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Migraine Disability Assessment questionnaire (MIDAS) score |  | Twice within 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore patients assessment of value of zolmitriptan |  | Maximum of 3 times between 1 - 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain, MIDAS, HCPC
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.

Official Title
-----------------
An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Diazepam Nasal Spray [Valtoco]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a clinical diagnosis of epilepsy and, in the opinion of the Investigator, may need benzodiazepine intervention for seizure control. Subjects having either partial or generalized epilepsy with motor seizures or seizures with clear alteration of awareness, for which rescue medications have been used at least once in the last 3 months or in the opinion of the investigator, may need a benzodiazepine intervention for seizure control 1-2 times every 3 months on average. Exclusion Criteria: Subjects whose body weight are < 6 kg or > 33 kg. Subject is undergoing intracranial electroencephalogram (EEG) monitoring. In the opinion of the investigator, a history of clinically significant medical history that would jeopardize the safety of the subject or impact the validity of the study results (such as significant gastrointestinal, renal, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration. Subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening. Participation in a clinical trial within 30 days prior to the first dose of study drug. Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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: Valtoco In Pediatric Subjects with Epilepsy<br>5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight. | Drug: Diazepam Nasal Spray [Valtoco]<br>* 5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age |  | 0-6 hours |
Creatine Supplementation and Cognition

Study Overview
=================
Brief Summary
-----------------
Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women.

Conditions
-----------------
Cognition, Aging

Intervention / Treatment
-----------------
* Dietary Supplement: creatine supplementation
* Other: Placebo (Dextrose)
* Other: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women older than 60 years old Exclusion Criteria: cardiovascular diseases or muscular disturbances precluding exercise training drugs affecting the cognition

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo control<br>this only receives placebo (dextrose) | Other: Placebo (Dextrose)<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>|
| Experimental: placebo and exercise<br>this is trained and receives placebo | Other: Placebo (Dextrose)<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>Other: Resistance training<br>* resistance training twice a week for 24 weeks<br>|
| Experimental: creatine supplementation<br>this is non-exercise trained and receives creatine supplementation | Dietary Supplement: creatine supplementation<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>|
| Experimental: Creatine and Exercise<br>this is exercised trained and receives creatine supplementation | Dietary Supplement: creatine supplementation<br>* 20g/d for 7 days followed by 5g/d for 23 weeks<br>Other: Resistance training<br>* resistance training twice a week for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive function |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical capacity | muscle strength and function | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition, supplementation creatine, resistance training, aging
To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.

Official Title
-----------------
Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
* Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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 |
| --- | --- |
| Experimental: 1<br>Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories) | Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)<br> <br> |
| Experimental: 2<br>Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.) | Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 19 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antihistamine
Magnetic Resonance Imaging and Spectroscopy of the Prostate

Study Overview
=================
Brief Summary
-----------------
Past studies have shown that MRI is useful for staging prostate cancer. This study will use magnetic resonance spectroscopic imaging (MRSI) to obtain more information. MRSIs with MRIs help doctors locate prostate cancer and determine the extent of tumor before deciding on treatment. This study looks at structural and chemical properties of prostates in prostate cancer patients before and after treatment.

Official Title
-----------------
Magnetic Resonance Imaging and Spectroscopy of the Prostate

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

Intervention / Treatment
-----------------
* Other: MRI and MRSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate cancer patients willing to undergo a MRI and MRSI exam Exclusion Criteria: patients with prostate cancer and bone or lymph node metastasis patients who can not have an MRI exam

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 |
| --- | --- |
| 1 - MRSI / MRI<br> | Other: MRI and MRSI<br>* Compare treatment impact when using MRI and MRSI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine added value in combining MRSI and MRI in prostate cancer treatment |  | 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRSI, MRI, Prostate Cancer