linjc16/ctgov huggingface dataset:
Neural Correlates of Stress Reduction

Study Overview
=================
Brief Summary
-----------------
This study will identify neural mechanisms associated with changes in emotion regulation following participation in stress reduction programs.

Official Title
-----------------
Structural and Functional Mechanisms of Stress Reduction

Conditions
-----------------
Stress, Psychological Stress, Life Stress, Emotional Stress, Social Stress

Intervention / Treatment
-----------------
* Behavioral: Stress Reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-50 years of age Right-handed Stressed Exclusion Criteria: Lifetime history of schizophrenia or psychosis Psychiatric illness History of seizure or significant head trauma Use of psychotropic medications Metallic implants or devices contraindicating magnetic resonance imaging Claustrophobia Pregnancy

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so. | Behavioral: Stress Reduction<br>* We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.<br>|
| Active Comparator: Group 2<br>Both groups will receive stress reduction materials. We expect both groups to achieve similar amounts of stress reduction, but to use different brain regions to do so. | Behavioral: Stress Reduction<br>* We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gray matter structure | Study participants will undergo an MRI scan before and after attending an 8-week stress reduction program. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion regulation | Study participants will do an emotion regulation task while they are in the MRI scanner. We will assess brain activity and skin conductance during the task. Changes in these measures will be assessed before and after enrollment in the stress reduction program | 8-weeks |
The Effect of Anesthesia Type on RIRS

Study Overview
=================
Brief Summary
-----------------
Retrograde intrarenal surgery (RIRS) with flexible ureteroscopy is based on video monitoring of urinary tract during operation. Therefore, shaking vision on monitor can bother surgeons and make them tired. This can lead in tissue injury from lasing. The purpose of this study is to investigate the stability of monitoring of surgical field which is assessed by surgeon.

Detailed Description
-----------------
RIRS with flexible ureteroscopy is usually performed under general anesthesia, spinal anesthesia. Anesthesia type is decided in the basis of medical condition of a patient and patient's preference. This study is a prospective observational study. During operation after induction of anesthesia, surgeons will be asked how visual stability of surgical field on monitor is (scale from 0 to 10). According to anesthesia type (general anesthesia, spinal anesthesia), 34 patients will be enrolled and investigated in each group. Investigators will compare the scale for visual stability of surgical field during RIRS.

Official Title
-----------------
The Effect of Anesthesia Type on the Surgical Field in Retrograde Intrarenal Surgery With Flexible Ureteroscopy in Renal Stone Patients

Conditions
-----------------
Renal Stone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring RIRS because of renal stone. Exclusion Criteria: disagreement for the trial.

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 |
| --- | --- |
| General anesthesia group<br>Patients in general anesthesia group are scheduled to undergo RIRS under general anesthesia. | |
| Spinal anesthesia group<br>Patients in spinal anesthesia group are scheduled to undergo RIRS under spinal anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for stability of monitoring | VAS (from 1 to 10) for stability in monitoring of surgical field, which is assessed by surgeons | intraoperative |
Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.

Official Title
-----------------
A Double-blind, Parallel, Active Comparator Controlled, Randomized Trial; Comparison of the Efficacy and Safety in Children With Perennial Allergic Rhinitis of Cetirizine Tablets Versus Ketotifen Dry Syrup

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: Ketotifen
* Drug: Cetirizine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion; severity of nasal symptoms was moderate to severe during the observation period; criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge. Exclusion Criteria: history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine; history of drug hypersensitivity; history of convulsive disorder; vasomotor rhinitis or eosinophilic rhinitis; asthma requiring treatment with adrenocortical hormones; concomitant diseases which could impede the efficacy evaluation of the study drug; subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage; pollen allergy; malignant neoplasm.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 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

| Intervention/Treatment |
| --- |
|Drug: Ketotifen|Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks|
|Drug: Cetirizine|Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments |  | TSS: 2 weeks - Safety: 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating |  | T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cetirizine, Zyrtec
Age Dependency of Biological Reaction on Wear Particles

Study Overview
=================
Brief Summary
-----------------
Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival. The main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.

Official Title
-----------------
Age Dependency of Biological Reaction on Wear Particles

Conditions
-----------------
Wear, Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Other: incubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having received a total hip arthroplasty 4 weeks before blood sample for this study Exclusion Criteria: no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| <40<br>patients younger than 40 years | Other: incubation<br>* standardized wear particles are co-incubated with isolated patient cells (monocytes)<br>|
| 40-60<br>patients younger than 60 years and not older than 40 years | Other: incubation<br>* standardized wear particles are co-incubated with isolated patient cells (monocytes)<br>|
| 60-80<br>patients younger than 80 years and not older than 80 years | Other: incubation<br>* standardized wear particles are co-incubated with isolated patient cells (monocytes)<br>|
| >80<br>patients older than 80 years | Other: incubation<br>* standardized wear particles are co-incubated with isolated patient cells (monocytes)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biological reaction | TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro | one hour |
Hati Salama (Secure Voucher)

Study Overview
=================
Brief Summary
-----------------
The use of long-lasting insecticide treated nets (LLINs) is shown to reduce malaria prevalence. The Tanzania Net Voucher Scheme has been an active component of bed net distribution to pregnant women in Tanzania since 2004. The transition from paper vouchers to electronic vouchers in this program has increased efficiency and the ability to track and distribute nets since 2007. Although the program has been successful, to date, electronic voucher redemption varies widely across the country and it has not been clearly established as to what barriers exist for women who receive electronic vouchers in the program. This cluster-randomized trial was designed to examine perceived barriers to electronic voucher redemption among pregnant women and to evaluate if educational and personalized text messages around electronic voucher redemption and bed net usage will increase electronic voucher redemption when directed at pregnant women who receive electronic vouchers in the currently existing program.

Official Title
-----------------
Expanding the Successful E-voucher System to Improve Malaria Prevention and Fight New Global Health Threats Through Innovative Health Partnerships and Mobile Phone Technology in Tanzania

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Behavioral: Behaviour change communication via text message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women capable of providing informed consent

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

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Use of behaviour change communication via text messages to pregnant women receiving an electronic voucher for long lasting insecticide treated nets redemption through antenatal clinics. | Behavioral: Behaviour change communication via text message<br> <br> |
| No Intervention: Control<br>Control group receives no behaviour change communication via text message, but receives an electronic voucher for long lasting insecticide treated nets redemption through antenatal clinics. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased uptake of long-lasting insecticide treated nets from retailers using an electronic voucher through text messaging. | The outcome measure will be assessed by LLIN evoucher redemption. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mHealth, Text message
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.

Official Title
-----------------
A 12-Week Study to Evaluate the Efficacy of Darifenacin to Increase the Warning Time in Patients With Overactive Bladder.

Conditions
-----------------
Overactive Bladder Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Three symptoms of OAB (urge incontinence, frequency and urgency) for at least six months prior to Visit 2. Patients capable of independent toileting and able of independently completing the patient diary. Exclusion Criteria: Patients in whom the use of anticholinergic drugs was contraindicated Evidence of severe liver disease Patients with other clinically significant urinary or gynecological conditions Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin 15 mg tablets once daily<br>* Other names: Enablex;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo tablets once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in warning time at week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in warning time at weeks 2 & 6. |  |  | 
| Change in frequency of urge incontinence episodes. |  |  | 
| Change in frequency of micturitions. |  |  | 
| Change in mean volume per void. |  |  | 
| Change in frequency of urgency. |  |  | 
| Safety and tolerability. |  |  | 
| Quality of life. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, incontinence, antimuscarinic, warning time, darifenacin
A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Study Overview
=================
Brief Summary
-----------------
Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.

Detailed Description
-----------------
The aim of this study is to determine whether dalfampridine can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment. The objective of this double masked crossover study is to determine whether visual function can be improved in numerous parameters. This includes high contrast visual acuity, low contrast visual acuity, visual field, visual quality of life (VFQ-39), electrophysiology, multi focal electro retinography (mERG), visual evoked potential (VEP), and structure, spectral domain optical coherence tomography (OCT). Based on the promising results of the use of dalfampridine in Multiple Sclerosis (MS) and in stroke, we hypothesize that the patients with chronic stable deficits after nonarteritic ischemic optic neuropathy (NAION) will have improved visual function with the administration of dalfampridine.

Official Title
-----------------
Dalfampridine Treatment for Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Conditions
-----------------
Non Arteritic Ischemic Optic Neuropathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NAION 6 months prior to enrollment visual acuity of 20/40 or worse Exclusion Criteria: Current use of Dalfampridine (Ampyra) Pregnancy History of seizures Renal Failure Not able to perform testing

Ages Eligible for Study
-----------------
Minimum Age: 40 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: dalfampridine (ampyra)<br>Dalfampridine (ampyra) 10mgs twice a day (b.i.d.)for two weeks | Drug: dalfampridine<br>* dalfampridine 10 mgs or placebo twice a day for two weeks, wash out period of two weeks, dalfampridine 10mgs or placebo twice a day for two weeks<br>* Other names: Ampyra;|
| Placebo Comparator: Placebo<br>placebo (sugar Pill) twice a day (b.i.d.)for two weeks | Drug: Placebo<br>* placebo (sugar pill) twice a day for two weeks<br>* Other names: Sugar pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve visual function |  | two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ampyra, NAION, Dalfampridine
Description of the Appearance of Brown Fat in Scanner

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate aspects of brown fat in scanner with injection via the PET-CT study.

Detailed Description
-----------------
Brown fat is metabolically active adipose tissue. It can be responsible in PET-CT of a fixation of 18-FDG and a look of pseudo-infiltration of fat. These aspects can be sources of false positives. The objective here is to gain a better knowledge of the scanner in areas of brown fat.

Official Title
-----------------
Description of the Appearance of Brown Fat in Scanner

Conditions
-----------------
Description of Brown Fat

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients since June 2014, who underwent a thoraco-abdominopelvic PET-CT examination with 18F-FDG in the University Hospital of Brest, in a clinical setting which warranted. Major Patients No opposition formalized Exclusion Criteria: Refusal of participation

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 |
| --- | --- | --- |
| Density value | measured by CT and expressed in Hounsfield Units | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Uptake Values (SUV) adipose tissue white and brown. | SUV maximum and average | 1 year |
CHildhood ASthma and Environment Research Study - CHASER Study

Study Overview
=================
Brief Summary
-----------------
CHildhood ASthma and Environment Research study - CHASER study is an observational longitudinal study in outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy. The first phase - transversal study will identify determinants of pediatric asthma control The second phase - longitudinal study, in patients with persistent asthma, will be focused on: predictors for asthma exacerbations and loss of control real life adherence to asthma therapy guidelines phenotypic characterization through the collection of saliva samples assessment of alterations and inflammatory changes in the nasal mucosa through nasal brushing evaluation of the presence of 8-isoprostane, nicotine, cotinine and bisphenol-A through urine analysis. Chaser Project is expected to improve the knowledge of pediatric asthma in patients with different level of control, identifying predictors for asthma exacerbations and loss of control.

Official Title
-----------------
CHildhood ASthma and Environment Research Study - CHASER Study

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 5-16 years asthma not asthma Exclusion Criteria: chest deformity active smoking

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 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 |
| --- | --- | --- |
| Asthma |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures from saliva samples |  | 5 years | 
| Measures from nasal brushing |  | 5 years | 
| Measures from urine samples |  | 5 years |