linjc16/ctgov huggingface dataset:
Stamp-in-Safety Playground Safety Project

Study Overview
=================
Brief Summary
-----------------
Playground injuries are common at childcare centers. Adequate adult supervision is an important component to reducing playground injuries in preschool children. The investigators studied the Stamp-in-Safety Program, an intervention to improve adult supervision and reduce children's risky playground behaviors.

Detailed Description
-----------------
Using a non-equivalent control group design, we evaluated the Stamp-in-Safety program which increases the quality of adult supervision and rewards children for safe play. In an urban childcare center, 71 children, ages 3-5 years, and 15 teachers participated in the study. The primary outcome measures were teacher verbalizations (warnings, explanations, redirects), teacher location (core, outskirts, or fringe of playground), risk taking behaviors by children (using equipment appropriately), and number of injuries on the playground.

Official Title
-----------------
Stamp-in-Safety Playground Safety Project

Conditions
-----------------
Injury Prevention

Intervention / Treatment
-----------------
* Behavioral: Stamp-in-Safety Curriculum
* Behavioral: Stamp-in-Safety curriculum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: teachers at childcare center students at childcare center Exclusion Criteria: not affiliated with childcare center

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: teachers taught curriculum<br>Teachers taught Stamp-in-Safety curriculum | Behavioral: Stamp-in-Safety Curriculum<br>* 30 minute curriculum on playground safety<br>Behavioral: Stamp-in-Safety curriculum<br>* 30 minute lesson on playground supervision<br>|
| Experimental: teachers do not learn curriculum<br>Teachers are not taught Stamp-in-Safety curriculum | Behavioral: Stamp-in-Safety Curriculum<br>* 30 minute curriculum on playground safety<br>Behavioral: Stamp-in-Safety curriculum<br>* 30 minute lesson on playground supervision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve adult supervision on playgrounds |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease preschool children's risky behaviors on playgrounds |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
playground, injury prevention
Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease

Official Title
-----------------
A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: denufosol tetrasodium (INS37217) Inhalation Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have confirmed diagnosis of cystic fibrosis have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height be able to reproducibly perform spirometry maneuvers be clinically stable for at least 4 weeks prior to screening Exclusion Criteria: have abnormal renal or liver function have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease have had a lung transplant

Ages Eligible for Study
-----------------
Minimum Age: 10 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: denufosol tetrasodium (INS37217) Inhalation Solution|Denufosol 60 mg is administered as an inhalation solution one time during the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mucociliary clearance from baseline |  | 30, 60, and 90 minutes post aerosol inhalation |
Human Lipoprotein Pathophysiology - Subproject: Genetics of Familial Combined Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
To conduct focused studies of lipoprotein physiology and pathophysiology in genetically characterized patients with the objectives of understanding disease mechanisms, developing better treatments, and identifying and preventing early vascular disease.

Detailed Description
-----------------
BACKGROUND: Premature vascular disease in young hyperlipidemic subjects remains a major unsolved health problem in terms of pathogenesis and treatment. Research advances have led to new markers for genetic analysis, new methods for studying lipoprotein metabolism and atherosclerotic disease progression and regression, and reference values for diagnosing hyperlipidemia. DESIGN NARRATIVE: Attention is focused on the molecular, genetic and pathophysiological basis of the inherited dyslipoproteinemias associated with premature coronary artery disease with particular reference to familial combined hyperlipidemia, familial moderate hypercholesterolemia, familial elevation of Lp(a) and the carrier state for homocysteinemia. Coordinated studies of characterization of the pathophysiological state, the identification of possible molecular biological defects and the evaluation of these results in families by statistical genetic techniques are performed in each disorder. The role of protein mediated intravascular modification of lipoproteins and the role of oxidation of lipoproteins in each disorder will lead to characterization of these genetic lipoprotein abnormalities. The study is a subproject within a program project grant. The subproject on the genetics of familial combined hyperlipidemia (FCHL) was renewed in 1999 through 2010 to continue mapping the apoB elevating gene l(BEL) level using a genomic search in pedigrees with familial combined hyperlipidemia. The major focus of the genetic analyses are the 15 FCHL families under the BEL segregation analysis model in a power analysis. These families also show the most evidence for segregation at an apoB elevating gene locus. Genotyping for a 10 centimorgan genomic scan has been completed for these families.

Official Title
-----------------
Human Lipoprotein Pathophysiology - Subproject: Genetics of Familial Combined Hyperlipidemia

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Hyperlipidemia, Familial Combined

Participation Criteria
=================
Eligibility Criteria
-----------------
All participants related to a patient with familial combined hyperlipidemia

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 |
| --- | --- | --- |
| No outcome measures for this research | Analysis of Familial Data | 1980-2003 |
Evaluating ABX-EGF Extended Therapy in Subjects With MetastaticColorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.

Official Title
-----------------
A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: ABX-EGF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subject previously randomized to BSC in protocol 20020408 and subsequently determined to have progressive disease - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Myocardial infarction in time interval between completing 20020408 and enrollment in study - History or evidence of interstitial pneumonitis or pulmonary fibrosis - Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics during the time interval between completing 20020408 protocol and enrollment in this study - Use of systemic chemotherapy or radiotherapy during the time interval between completing 20020408 protocol and enrollment in this study

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABX-EGF|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse events |  |  | 
| Changes in Lab values |  |  | 
| Incidence of HAHA formation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Colorectal Cancer, Colon, Colorectal, Rectal Cancer, EGFr, Metastatic, Cancer, ABX-EGF, Panitumumab, Clinical Trial, Immunex, Abgenix, Amgen
Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.

Official Title
-----------------
Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia

Conditions
-----------------
Anesthesia, Regional

Intervention / Treatment
-----------------
* Drug: Levobupivacaine
* Drug: NaCl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class 1 to 3 Need for shoulder surgery Exclusion Criteria: Mental retardation allergy for local anesthetics a medical reason as a contra-indication for NSAID use Diabetes mellitus peripheral neuropathy chronic analgetic use chronic pain patients

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>NaCl 0.9% 3ml perineural stellate ganglion injection | Drug: NaCl 0.9%<br>* Inject 3ml of NaCl 0.9% into the stellate ganglion area<br>|
| Active Comparator: Stellate ganglion block<br>Levobupivacaine 3ml perineural stellate ganglion injection | Drug: Levobupivacaine<br>* Inject 3ml of levobupavacaine into the stellate ganglion area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesia | The duration of analgesia assessed with quantitative sensory testing | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for rescue analgesia | The timing of the need for rescue analgesia as requested by the patient | 24 hours | 
| Duration of motor block | The duration of a motor block | 24 hours |
Single-dose AME Study With [14C]AR882 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.

Official Title
-----------------
A Phase 1, Absorption, Metabolism, and Excretion Study of [14C]AR882 Orally Administered to Healthy Adult Male Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: [14C]AR882


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2 Must have a minimum of 1 bowel movement every 2 days Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs Exclusion Criteria: Inadequate venous access or unsuitable veins for repeated venipuncture Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mass Balance<br> | Drug: [14C]AR882<br>* Single dose of [14C]AR882<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity (TRA) in urine |  | Days 1-14 | 
| TRA in feces |  | Days 1-14 | 
| TRA concentration equivalents in plasma |  | Days 1-14 | 
| TRA concentration equivalents in whole blood |  | Days 1-14 | 
| Area under the curve (AUC) for plasma [14C]-AR882 | Profile from plasma in terms of AUC following a single dose of [14C]-AR882 | 7 Days | 
| Time to maximum plasma concentration (Tmax) for [14C]-AR882 | Profile from plasma in terms of Tmax following a single dose of [14C]-AR882 | 7 Days | 
| Maximum plasma concentration (Cmax) for [14C]-AR882 | Profile from plasma in terms of Cmax following a single dose of [14C]-AR882 | 7 Days | 
| Apparent terminal half-life (t1/2) for [14C]-AR882 | Profile from plasma in terms of t1/2 following a single dose of [14C]-AR882 | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs [14C]-AR882 |  | Days 1-14 |
Cortisol Measurement During Intravenous Access With a Medical Clown

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.

Official Title
-----------------
Level of Cortisol in Stress Response During Intravenous Access in the Pediatric Emergency Department With a Medical Clown: a Randomized Prospective Pilot Study

Conditions
-----------------
Stress, Physiological

Intervention / Treatment
-----------------
* Behavioral: Clown


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients needing venous blood sampling or insertion of an intravenous canula Normal development according to parents Exclusion Criteria: Critically ill children (e.g. shock, respiratory distress or failure) Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections) Known adrenal or pituitary disease Children who have received glucocorticoids during the preceeding six weeks

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No clown<br>Routine venipuncture without distraction | |
| Active Comparator: Clown<br>A medical clown is present in the procedure room during venipuncture | Behavioral: Clown<br>* Comparison of routine venipuncture with a distraction technique by a medical clown<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Cortisol level |  | During intravenous cannulation or blood sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs (heart rate, respiratory rate, blood pressure) |  | During intravenous cannulation or blood sampling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical clown, Pediatric emergency medicine
Long Term Therapy With Imatinib: Development of Late Side Effects and Compliance to Treatment

Study Overview
=================
Brief Summary
-----------------
Imatinib has revolutionised the treatment of chronic myeloid leukaemia (CML). The first clinical trials were conducted in 1998 in patients with advanced disease, and by 2002 imatinib was established as the standard therapy for all patients including those recently diagnosed. In spite of overwhelming evidence about its efficacy we still need to gain more knowledge about issues related to long term treatment with imatinib such as why some patients respond better than others, the development of side effects and the quality of life.

Detailed Description
-----------------
We plan to follow prospectively a cohort of CML patients in order to study their compliance to therapy,pharmacological levels of imatinib and the prevalence of side effects. We expect to be able to correlate the actual dose received, the pharmacological levels of drug in blood, with the change in the level of residual disease (measured by Q-PCR) at various time points. We also want to gain insight into the relationship between compliance to therapy and specific side effects and between compliance and duration of treatment. We will also assess the adherence to imatinib therapy after increases in the drug dose that are part of standard treatment.

Official Title
-----------------
Compliance to Long Term Imatinib Therapy in Newly Diagnosed Patients With Chronic Myeloid Leukaemia.

Conditions
-----------------
Chronic Myeloid Leukemia, Newly Diagnosed

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CML who have been treated with imatinib (Glivec®) within 6 months of diagnosis as first line therapy. Initial therapy with hydroxyurea is permitted. Exclusion Criteria: Unable to give consent. Unable to communicate with the medical and nursing staff

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 |
| --- | --- |
| 1<br>Patients with CML who have been treated with Imatinib (Glivec) within 6 months of diagnosis as first line therapy. Initial therapy with Hydroxyurea is permitted | Drug: Imatinib<br>* Conventional therapy with imatinib<br>|

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
-----------------
Chronic Myeloid Leukemia, Long term Imatinib therapy compliance, Newly diagnosed, Late side effects