linjc16/ctgov huggingface dataset:
Ultrasound Assessment of BC in the NICU

Study Overview
=================
Brief Summary
-----------------
The overall objective of the proposal is to evaluate the ability of ultrasound to predict and routinely (weekly) monitor changes in the body composition of healthy preterm infants in the neonatal intensive care unit (NICU) in response to nutritional intake. The investigators hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight gain and assess the adequacy of nutritional provision for premature infants in the neonatal intensive care unit. The investigators will address the hypothesis in the following Specific Aims: Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat free mass in healthy, premature infants. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP). Stable isotope dilution techniques will be used in a subset of our population as a secondary source of validation. Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen, quadriceps) until discharge in healthy, premature infants.

Official Title
-----------------
Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit

Conditions
-----------------
Premature Infant

Intervention / Treatment
-----------------
* Device: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, premature infants 25-34+6 weeks gestational age at birth Admitted to the University of Minnesota Masonic Children's Hospital NICU Stable on room air or can be removed from respiratory support for 5 minutes Written or verbal (telephone) informed consent can be secured from a parent within 1 week of admission to the NICU Exclusion Criteria: -Require medical support preventing ADP measurements

Ages Eligible for Study
-----------------
Minimum Age: 25 Weeks
Maximum Age: 34 Weeks

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ultrasound|validation of portable ultrasound to measure body composition|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole-body measurements of body composition | Measurement of whole body fat mass and fat-free mass via air displacement plethysmography and stable isotope dilution. | Up to 6 weeks |
Glycaemic Response to a Liquid Meal Tolerance Test

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether added food ingredient(s) affect glycaemic responses to a liquid meal tolerance test (LMTT).

Official Title
-----------------
Effects of Dehydrated Vegetable Powder on Glycaemic Responses to a Liquid Meal Tolerance Test (LMTT)

Conditions
-----------------
Glycaemic Index, Glycaemic Response

Intervention / Treatment
-----------------
* Other: Control Drink
* Other: Experimental Drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female (not less than 40% Male) Aged 18 - 55 years Non Smokers Have a body mass index between 18.5 to 29.99 kg/m2 Healthy, non-diabetic, no gastric bypass surgery Not allergic to dairy, or soy Have a fasting plasma glucose (finger-stick) <100 mg/dl (<5.5 mmol/L) Willing and able to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Test Drink<br>control drink | Other: Control Drink<br> <br> Other: Experimental Drink<br> <br> |
| Experimental: Experimental Test Drink<br>Experimental Drink | Other: Control Drink<br> <br> Other: Experimental Drink<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic response (incremental area under the curve) of experimental test food using capillary blood |  | 120 minutes |
A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers

Study Overview
=================
Brief Summary
-----------------
Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.

Detailed Description
-----------------
Methodology Validation

Official Title
-----------------
A Randomized, Double-Blind (3rd Party Open), Placebo-Controlled, 2-Way Crossover Study To Determine The Effects Of A Single Inhaled Dose Of 500 MCG Fluticasone Propionate On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Fluticasone Propionate
* Drug: Placebo for Fluticasone Propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Normoresponsive airways - histamine PC20>16mg/mL Able to complete sputum induction successfully Exclusion Criteria: Non (or ex) smokers No LPS challenge in previous 4 weeks

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Fluticasone Propionate<br>* Dry powder for inhalation, Single Dose, 500mcg<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo for Fluticasone Propionate<br>* Dry powder for inhalation, Single Dose, placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum Neutrophil (%) |  | 6 hours post LPS challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta) |  | 6 hours post LPS challenge | 
| Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta) |  | 1, 4 and 6 hours post LPS challenge | 
| Sputum cells (macrophages and total cell count) |  | 6 hours post LPS challenge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the emptying of the colon and increases total colonic transit time.

Official Title
-----------------
An Exploratory Phase I Study in Healthy Volunteers of GI Transit Following Administration of the ß3-Adrenergic Receptor Agonist, Solabegron (Study B3I106248)

Conditions
-----------------
Irritable Bowel Syndrome (IBS)

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Solabegron (GW427353)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with no evidence of current or past history suggestive of gastrointestinal disease or disorder or medical illness that could compromise interpretation of the study. no clinically significant laboratory results collected at the screening visit men: body weight greater than or equal to 50kg (110 lbs) women: body weight greater than or equal to 45kg (100 lbs) BMI between 18.5 - 35 kg/m2 Exclusion Criteria: Females who are nursing or pregnant. history of inflammatory bowel disease history of gastric ulcers within 12 months of signing the informed consent form tobacco users

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Placebo|nan|
|Drug: Solabegron (GW427353)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonic emptying rate by radiolabeled scintigraphy |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: ECG, vital signs, adverse events, clinical lab tests. Diary card collection of stool frequency Stool consistency and ease of passage Blood levels of GW427353 |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), pharmacokinetics, tolerability, gastrointestinal transit
Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children). Specific Aim 2 (Experiment 2): Determine whether children with ASD can learn from addressed and overheard teaching via videoconferencing. The investigators will use a similar procedure to Study 1, except that both overheard and directed teaching will take place on video.

Official Title
-----------------
Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Overheard Speech
* Behavioral: Addressed Speech


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with or without a diagnosis of ASD between 18 to 71 months of age Exclusion Criteria: native language is not English born premature (< 36 weeks) has uncorrected hearing or vision impairments has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD) has a history of photosensitive epileptic seizures

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 71 Months

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Addressed<br>Children participate via video in an interaction with an experimenter who uses the word to be learned. | Behavioral: Addressed Speech<br>* New words are introduced directly to the child by an experimenter.<br>|
| Experimental: Overheard<br>Children watch via video while an experimenter uses the word to be learned in an interaction with another experimenter. | Behavioral: Overheard Speech<br>* New words are introduced with the child as a bystander rather directly taught.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time during which children's eye gaze is directed toward the target object | Children's eye gaze is recorded as they look at images. The proportion of time during which gaze is directed to an image of the targeted word is the dependent measure. | immediately after intervention | 
| Proportion of time during which children's eye gaze is directed toward the target object | Children's eye gaze is recorded as they look at images. The proportion of time during which gaze is directed to an image of the targeted word is the dependent measure. | after 5 minutes |
Clearance of Nasal Staphylococcus Aureus With Triple Antibiotic Ointment

Study Overview
=================
Brief Summary
-----------------
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. This research study is designed to determine the rate of clearance of this bacteria in healthcare workers who are carriers when using triple antibiotic ointment instead of mupirocin ointment.

Official Title
-----------------
Clearance of Nasal Staphylococcus Aureus Colonization With Triple Antibiotic Ointment

Conditions
-----------------
Nasal Carriers of Staphylococcus Aureus

Intervention / Treatment
-----------------
* Drug: Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give informed consent Must have consented prior to registration for the study Exclusion Criteria: active infection concurrent treatment with antibiotics, topical or systemic S. aureus decolonization attempt in prior six months history of HIV chemotherapy or systemic immunosuppressive therapy history of neomycin allergy or sensitivity

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)|2 1/32oz packages will be dispensed. If positive nasal swab for S. aureus, subjects will apply a small amount to anterior nares twice daily for 5 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carrier Rate for Staphylococcus Aureus | Percentage of subjects with baseline culture positive for Staphylococcus aureus (via nasal swab) | Baseline | 
| MSSA Clearance Rate | Percentage of subjects with methicillin-sensitive S. aureus on Baseline culture who achieved clearance with treatment. | 14 days | 
| MRSA Clearance Rate | Percentage of subjects with methicillin-resistant S. aureus on Baseline culture who achieved clearance with treatment. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthcare, staphylococcus aureus, nasal
Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population

Study Overview
=================
Brief Summary
-----------------
Diabetic retinopathy is the major cause of blindness in working age Americans, and screening for it is cost-effective. There are a quarter of a million people in Southeast Michigan with diabetes and pre-diabetes. Only half of patients with diabetes are screened regularly for diabetic retinopathy, and this proportion has been difficult to increase despite various interventions. Previous research focused on HMO patient groups because preventative care was thought to decrease plan costs. In addition, it was administratively feasible to track patient-doctor interactions. This project builds on published research and institutional experience to determine an effective method for increasing the screening rate, in a mobile, non-HMO population. It uses administrative methods and information technology infrastructures, such as large scale electronic medical records and patient demographic databases, to identify existing patients requiring examinations. Patients were telephoned by a trained service representative who offered and scheduled firm examination appointment times. Hypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in non-HMO patient groups by directly contacting patients and scheduling firm appointment times.

Official Title
-----------------
Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Behavioral: phone call contact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were Henry Ford Health System patients, diabetic using the BCBSM payer plan Exclusion Criteria: retina examination in prior year

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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: phone call contact|A sample of subjects who had not completed their annual diabetic screening exams were contacted by phone and offered appointments for eye exams|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in the proportion of diabetic patients who acted as a result of the phone contact, and obtained a retina eye exam. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic retinopathy, screening, annual
A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR)

Study Overview
=================
Brief Summary
-----------------
Use of the Chartis® Assessment System prior to EBV Treatment

Detailed Description
-----------------
This is a multi-center study which will enroll up to 120 patients. Subjects will undergo a Chartis Assessment prior to EBV treatment. The Chartis assessment will determine the presence or absence of collateral ventilation, a potential determining factor in the success of EBV therapy. This study is not randomized; all subjects are eligible to receive EBV Treatment, regardless of Chartis Assessment outcome. Follow-up data will only be collected on those patients that meet the Chartis inclusion criteria.

Official Title
-----------------
A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Device: Chartis System
* Device: Endobronchial Valve (EBV) Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heterogeneous emphysema Able to obtain a Chartis value during Assessment Exclusion Criteria: Any co-existing major medical problems that would not make it possible for the subject to tolerate a bronchoscopic procedure.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chartis System-EBV Treatment<br>Subjects with heterogeneous emphysema, had their collateral ventilation status in the target treatment lobe assessed using the Chartis System (CV- or CV+) and underwent endobronchial lung volume reduction (ELVR) with endobronchial valves (EBV). | Device: Chartis System<br>* The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.<br>Device: Endobronchial Valve (EBV) Treatment<br>* The endobronchial valve is designed to induce target lobe volume reduction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Volume Change |  | 30 Days |