linjc16/ctgov huggingface dataset:
Diesel Exhaust Particles and Leukotriene Production

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the effects of allergens and/or diesel exhaust particles in the nose to learn more about allergic responses in individuals with cat allergic rhinitis.

Official Title
-----------------
Diesel Exhaust Particles and Leukotriene Production

Conditions
-----------------
Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 years old. Positive prick (epicutaneous) skin test to standardized cat with a wheal equal to or greater than 3 mm and with a surrounding flare. Ability to give informed consent. Exclusion Criteria: Pregnancy or breast-feeding. (Pregnancy and the period during breast feeding can affect nasal congestion and be a confounder in this regard.) Systemic corticosteroid use within the previous three months or anytime during the challenge protocol. Topical nasal corticosteroid use within the past month or anytime during the challenge protocol. Systemic antihistamines or decongestant use within past two weeks or anytime during the trial. Chronic sinusitis or chronic non-allergic rhinitis. Use of reserpine. Cigarette smoking within the past year or during the challenge protocol Use of topical nasal antihistamines, chromoglycolates (chromolyn, Cromlon®), decongestants or non-steroidal anti-inflammatory agents (NSIADS) within the preceding week or anytime during the challenge protocol. Present or treatment within the past 10 years with allergy immunotherapy (injections). Present or past treatment with anti-IgE therapy. Any unusual exposure to air pollutants (e.g., working as a diesel mechanic) that, in the opinion of the investigators, might compromise the individual's ability to participate in the study. Living arrangement where the subject has a cat dwelling within the subject's habitation. Any serious heart, lung, neurological or kidney disease that in the opinion of the investigators would impair the individual's ability to participate in the study. Use of asthma-required medications.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cat Allergic Rhinitis<br>Individuals with cat allergic rhinitis, yet without routine cat exposure | |

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
-----------------
Cat Allergic Rhinitis
Team-Based Delivery of Care in Outpatient Settings

Study Overview
=================
Brief Summary
-----------------
Through this research we intend to evaluate whether a team-based care delivery approach using daily huddles is effective in improving caregiver and patient outcomes in primary care setting. This approach is expected to not only lead to effective primary care delivery outcomes, but also result in greater team morale, reduced burnout, and a higher rate of innovation.

Official Title
-----------------
Team-Based Delivery of Care in Outpatient Settings: An Experimental Investigation

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Other: Retreat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 year old adult member of Mayo care team in the Midwest Exclusion Criteria: -Unable to provide consent

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retreat<br>A full day off-site training session | Other: Retreat<br>* Full day off-site training session<br>|
| No Intervention: Control<br>Care teams normal process | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in team cohesion | Survey with 5 point likert scale | Change from baseline to 6 months |
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design

Official Title
-----------------
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: alverine citrate and simeticone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female ambulatory patients, aged 18-75 years with IBS as defined by Rome III criteria Exclusion Criteria: Functional bowel disorder other than IBS, Underlying cause for symptomatology, which excludes IBS diagnosis, Gastro-intestinal cancer or significant gastro-intestinal surgical background, Any acute/uncontrolled systemic pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: alverine citrate and simeticone<br> <br> * Other names: Meteospasmyl®;|
| Placebo Comparator: B<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject self assessment of abdominal pain/discomfort |  | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS life impact, overall treatment assessment, concomitant factors |  | Baseline and 4 weeks |
Deductive Reasoning and Math Learning Difficulty

Study Overview
=================
Brief Summary
-----------------
Most studies to date that have examined the factors underlying math achievement in children have focused on basic numerical knowledge. Yet, math skills are clearly not limited to basic numerical knowledge and recent behavioral studies suggest a relationship between math and deductive reasoning skills. The goal of this study is to determine the neural mediators of this relationship using functional magnetic resonance imaging. The investigators will ask children from 8 to 14 to complete a standardized math achievement test, and measure their brain activity while they process deductive arguments. The investigators will then correlate brain activity during reasoning to individual math skills to identify the brain regions in which activity during reasoning is modulated by math skill.

Official Title
-----------------
Deductive Reasoning and Math Learning Difficulty: an fMRI Study in Children

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

Intervention / Treatment
-----------------
* Other: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Girl or boy between 8 and 14 Right-handed Affiliated to the French social security Whose parents gave informed consent Exclusion Criteria: Neurological disorders Psychiatric disorders Birth complications requiring admission into neonatal intensive care unit Medication affecting central nervous system processing Significant hearing impairment Uncorrected visual impairment Non-native French speaker Contraindications for MRI

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain activity during reasoning and measure of math skill<br>Brain activity during reasoning and measure of math skill | Other: fMRI<br>* All participants are scanned while evaluating deductive reasoning problems. Their math skill is also assessed.<br>* Other names: fMRI scanning;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between brain activity during deductive reasoning and math skill 18 to 24 months later | Brain activity measured using fMRI and math skill measured using a standardized test 18 to 24 months after scanning | 18 to 24 months after scanning |
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Drug: ES135


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of either sex and 15-65 years of age. Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale. Subjects have adequate heart, lung, kidney and liver function. Subjects are able to give voluntary and dated informed consent prior to enrollment. Exclusion Criteria Penetration SCI Brain damage or multiple injuries History of congenital or acquired abnormalities in the spinal cavity History of congenital or acquired immunodeficiency disorders History of malignancies or positive results Current serious/uncontrollable infections or others serious diseases Pregnant or lactating women Allergy to ES135 or any of its excipients Unable to obtain informed consent from subject

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ES135<br> | Drug: ES135<br>* ES135 will be administered via intrathecal<br>|
| Placebo Comparator: Placebo<br> | Drug: ES135<br>* ES135 will be administered via intrathecal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord, spinal cord injury
Diabetes and Psychological Profile

Study Overview
=================
Brief Summary
-----------------
This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.

Official Title
-----------------
Prospective Study on the Influence of Psychosocial Variables (Stress, Type A Behaviour Pattern, Quality of Life of the Diabetic) on Glycemic Balance in Patients With Type 1 and 2 Diabetes.

Conditions
-----------------
Type 1 or 2 Diabetes

Intervention / Treatment
-----------------
* Other: psychological and social self-administered questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have been given information about the research patients with National Health Insurance diabetic patients (type 1 or 2) patients > 18 ans Exclusion Criteria: Adult patients under guardianship or intellectually dependent patients without National Health Insurance

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 |
| --- | --- |
| Diabetic patients<br> | Other: psychological and social self-administered questionnaires<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire |  | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on the scales |  | At 1 year |
Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation

Study Overview
=================
Brief Summary
-----------------
Use of amniotic membrane(AMT) and platelet rich plasma (PRP) clot for closure of central corneal perforation

Detailed Description
-----------------
Use of amniotic membrane and platelet rich plasma clot for closure of central corneal perforation either post infective or posttraumatic

Official Title
-----------------
Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation

Conditions
-----------------
Corneal Perforation

Intervention / Treatment
-----------------
* Procedure: Platelet rich plasma clot implantation
* Procedure: Wound closure with amniotic membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: central corneal perforation Exclusion Criteria: active infection posterior segment pathology non seeing eye
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 |
| --- | --- |
| Other: Corneal perforation patients<br>Patients who had/impeding corneal perforation due to melting of the cornea after infection with a corneal pathogen (bacterial or viral), with no previous surgical intervention. Patients will undergo: Platelet rich plasma clot implantation Wound closure with amniotic membrane | Procedure: Platelet rich plasma clot implantation<br>* Implantation of a platelet rich plasma clot, which is created from the plasma of the patients, and refrigerated to be inserted under the sealing amniotic membrane<br>Procedure: Wound closure with amniotic membrane<br>* Closure of the corneal perforation with a synthetic amniotic membrane with a 2 mm safety margin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of the corneal wound | sealing of the edges corneal gap, with formation of scar tissue | 3 months |
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma

Study Overview
=================
Brief Summary
-----------------
To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.

Official Title
-----------------
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma

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

Intervention / Treatment
-----------------
* Drug: Simvastatin
* Drug: B1-6-12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild-to-moderate persistent asthmatics FEV1 = OR > 50% of predicted Exclusion Criteria: Previous history of renal disease or serum creatinine is more than 2 mg/dl. Previous history of liver disease. Pregnancy or lactation. Are already receiving or are known to be allergic to statins or to have developed myositis. Have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry. Being treated with immunosuppressive agents. Unwilling to cooperate the study.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simvastatin<br> | Drug: Simvastatin<br>* 10 mg once daily for 8 weeks<br>* Other names: Zocor;|
| Placebo Comparator: B1-6-12<br> | Drug: Simvastatin<br>* 10 mg once daily for 8 weeks<br>* Other names: Zocor;Drug: B1-6-12<br>* 1 tablet once daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum eosinophils | To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum and on lung function (FEV1) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phosphorylated p38 MAPK in sputum cells | To determine the additional effects of simvastatin in combination with inhaled corticosteroids on the expression of phosphorylated p38 MAPK and phosphorylated activating transcription factor (ATF)2 in induced sputum cells from asthmatic patients. To confirm the above in vivo results in the in vitro model using monocyte-derived dendritic cells. To determine the effects of simvastatin and/or corticosteroids on Th2 cytokine production by peripheral blood CD4+ T-lymphocytes in vitro. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moderate persistent asthma, Inhaled corticosteroids
Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical response rates of doripenem versus a comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal infections.

Detailed Description
-----------------
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of intravenous doripenem versus a comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. The primary endpoint is the clinical response rate measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections

Conditions
-----------------
Bacterial Infections and Mycoses, Appendicitis, Cholecystitis, Pancreatitis, Peritonitis

Intervention / Treatment
-----------------
* Drug: Doripenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a requirement for surgical intervention within 24 hours of study entry Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections. Exclusion Criteria: Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control Any rapidly-progressing disease or immediately life-threatening illness.

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: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate measured at late follow-up visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate measured at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory tests results) conducted throughout the study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritonitis, Complicated Intra-Abdominal Infections, Appendicitis, Cholecystitis