linjc16/ctgov huggingface dataset:
The Effect of Shelf Nutrition Labels on Purchases

Study Overview
=================
Brief Summary
-----------------
NuVal® shelf nutrition labels rate the nutritional quality of foods on a scale of 1 (worst) to 100 (best). In 2014, NuVal updated their nutrient profiling system which changed the NuVal score on many foods. The investigators took advantage of this natural experiment to assess the extent to which a change in the NuVal score at a grocery chain influenced yogurt purchases, a category with a wide range of more and less healthy alternatives. The investigators supplemented the retail scanner data with a survey of consumers in stores using NuVal labels to obtain their experience with the labels and the extent to which they state it influences their purchases.

Official Title
-----------------
Identifying the Effect of Shelf Nutrition Labels on Consumer Purchases, Results of a Natural Experiment and Consumer Survey

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: US adults regularly shopping at one of two retail chains using NuVal Exclusion Criteria: -

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ResearchNow NuVal shoppers<br>a convenience sample of 665 shoppers at two NuVal chains. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet quality as measured by the NuVal scores of yogurt purchased | The investigators measured diet quality using weekly yogurt sales data supplied by a US grocery chain. Using an econometric model of yogurt demand, the investigators associated changes in yogurt sales volume for each product before and after the NuVal score change with the direction and magnitude of the score change. | From 12/30/12 to 8/22/15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge and stated use of NuVal labels by participants of an online survey | The investigators conducted an online survey of 665 adult shoppers of two grocery chains that adopted NuVal. The survey elicited participants' awareness of the label, knowledge of NuVal, and stated use of NuVal and other nutrition labels. | June 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shelf nutrition label, NuVal
Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries

Study Overview
=================
Brief Summary
-----------------
Bispectral index(BIS) is commonly used to monitor the depth of anesthesia. The electroencephalographic signal is collected and analyzed by the device, resulting a number related to the awareness of the patient. Electromyography is also recorded. The aim of the study is recording and analyzing the data of BIS and try to find it's relation to intraoperative neuromuscular blockade.

Official Title
-----------------
Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries

Conditions
-----------------
Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients

Intervention / Treatment
-----------------
* Device: Bispectral index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class between 1 and 3 Patients scheduled for chest surgery Exclusion Criteria: Neuromuscular diseases Mental and psychiatric disturbance ASA class over 4 Drug abuse Aboriginals

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| BIS monitor group<br>Patients under monitoring of BIS | Device: Bispectral index<br>* The BIS monitor will be attached to patients' forehead before anesthetized and kept until the end of the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishing the predicting model of intraoperative electromyographics of BIS monitor and train-of-four of neuromuscular transmission monitor | We will collect EMG activity of bispectral index and train-of-four/count of neuromuscular trasmission monitor in patients undergoing pulmonary surgeries. Total intravenous anesthesia will be given to all included patients, and data will be collected since the induction of anesthesia until extubation of endotracheal tube.By statistical methods, we expect to establish the model predicting intraoperative neuromuscular blockade by EEG activity of BIS monitor. | six months |
Simulation Based Training in Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to create simulation-based tests with credible pass/fail-standards for two different fidelities of colonoscopy models virtual reality simulator physical model simulator To create pass/ fail standards for certification

Detailed Description
-----------------
Twenty-five physicians (10 consultants with endoscopic experience and 15 fellows in the first year of fellowship without endoscopic experience) will be tested twice on each of the two different simulator models. Metrics with discriminatory ability will be identified for both modalities. Reliability will be determined A pass/ fail standard will be determined and the concequences explored.

Official Title
-----------------
Simulation-based Training for Colonoscopy: Establishing Criteria for Competency

Conditions
-----------------
Group Identification

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the two groups Experienced endoscopists : Having performed >350 colonoscopy procedures Novice endoscopists: First or second year of fellowship in gastroenterology Having performed less than 3 colonoscopies Exclusion Criteria: For the two groups Experienced endoscopists: Prior simulator training Novice endoscopists: Prior simulator training

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 64 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 |
| --- | --- |
| Experienced in Colonoscopy<br>two tests on two different modalities of colonoscopy simulators | |
| Novices in colonoscopy<br>Two tests on each of trw colonoscopy simulators | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metrics with discriminatory ability measuring colonoscopy competence | Each participant perform two tests on each model within the same day. | tests were carried out in one day per participant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, assessment, certification,, simulation,, standard setting
Resistance and/or Endurance Training, What is Most Effective in Prevention of Cardiovascular Diseases?

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to evaluate the effects of aerobic interval training versus strength training or a combination of these regimes on factors comprising the metabolic syndrome in order to find the most effective exercise regime for patients with metabolic syndrome.

Detailed Description
-----------------
In the Western world, approximately 25% of young to middle-aged adults have metabolic syndrome. There seem to be a strong age-dependence in the prevalence of the metabolic syndrome, but the incidence rises rapidly within adolescents and middle-aged groups and follows the development of obesity in the general population. Metabolic syndrome confers an increased risk of coronary heart disease, cardiovascular disease, and premature death; therefore, effective and affordable strategies to combat the syndrome would be of great individual and social importance. Despite the general agreement that moderate-intensity physical activity for a minimum of 30 min five days per week or vigorous-intensity aerobic physical activity for a minimum of 20 min three days a week promote and maintain health, the optimal training regime to treat metabolic syndrome and its associated cardiovascular abnormalities remains uncertain.

Official Title
-----------------
Strength Training Versus Aerobic Interval Training to Modify Risk Factors of the Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: aerobic exercise
* Behavioral: strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having metabolic syndrome according to international diabetes foundations definition (IDF). Exclusion Criteria: Unstable angina pectoris Uncompensated heart failure Myocardial infarction during the past 4 weeks Complex ventricular arrhythmias Kidney failure

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aerobic exercise<br> | Behavioral: aerobic exercise<br>* carried out 3 times per week for 12 weeks<br>|
| Experimental: strength training<br> | Behavioral: strength training<br>* carried out 3 times per week for 12 weeks<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proinflammatory markers | circulating interleukin-18 and interleukin-6 | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise therapy
Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to establish the safest doses for the combination of a farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated dose, dose limiting toxicity and the activity of this combination will be assessed. This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777 is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene, while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by the ras oncogene. Animal studies suggest that the combination may be synergistic. Another advantage is that R115777 can be taken by mouth.

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: R115777 (farnesyl transferase inhibitor)
* Drug: Topotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced solid tumors with previous treatment or beyond standard therapy of significant clinical benefit Therapy with no more than 3 prior chemotherapy regimens Radiotherapy to less than 25% of bone marrow volume (no pelvic radiation) Adequate organ function Recovery from the effects of prior chemotherapy and radiation therapy, with at least a 4 week interval. All prior toxicities should have resolved to baseline prior to entry into the study. Good performance status Anticipate life expectancy of at least 6 months Not pregnant or lactating. Sexually active men and women of childbearing age must use adequate contraception. Be able to give signed, written informed consent. No gastrointestinal condition that could affect the absorption of the drug No active infection requiring systemic medical therapy one week prior to chemotherapy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: R115777 (farnesyl transferase inhibitor)|nan|
|Drug: Topotecan|nan|

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
-----------------
solid tumor
A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease

Study Overview
=================
Brief Summary
-----------------
This is an observational study to be conducted at approximately 25 sites in the United States. Approximately 25 subjects with severe obstructive CF lung disease (FVC <40% predicted) will be enrolled.

Official Title
-----------------
A Study to Determine the Variability of a 6-Minute Walk Test in Cystic Fibrosis Subjects With Advanced Lung Disease

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide written informed consent Males or females who will be >=14 years old at Visit 3 A proven diagnosis of CF as evidenced by a positive sweat test (sweat sodium or chloride >60 mEq/L by quantitative pilocarpine iontophoresis), or genotype and clinical symptoms consistent with the diagnosis of CF Able to perform reproducible spirometry maneuvers at Visit 1 in accordance with the American Thoracic Society (coefficient of variation for three FEV1 maneuvers <=0.2) FVC <40% predicted for height, age and sex at Visit 1 On a stable regimen of chest physiotherapy (CPT) begun at least 7 days prior to Visit 1 Able to complete the 6-minute walk test at Visit 1 Exclusion Criteria: Use of an investigational drug or device within 28 days prior to Visit 1 Experiencing an episode of severe acute respiratory failure, as determined by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmozyme
Medtronic MiniMed Implantable Insulin Pump

Study Overview
=================
Brief Summary
-----------------
This research is being done to find out whether subjects previously treated with the implantable insulin pump (IIP) therapy, and now taking insulin by injection, will benefit from re-implantation of IIP. The investigators will see if IIP causes more stable control of blood sugar, with fewer highs and lows. People with type 1 diabetes previously implanted with the MiniMed Implantable Pump (MIP) model 2000 at Johns Hopkins may join this study.

Detailed Description
-----------------
If the participant joins the study and chooses to have a new pump implanted, the study is expected to last 12-15 months for each participant, and each participant will continue to be followed, with 3-monthly refills and research visits for as long as the pump lasts, until the participant chooses to withdraw, until the FDA approves the pump for regular care, or until the company stops supporting the pump. During the first 12-15 months of the study, there will be an estimated 13 clinic visits and one hospital stay for 2-3 days. The data collection visits will take about 30 minutes, and a continuous glucose monitor will be started. The participants will have a brief visit 3-4 days later to drop off the monitor. After this phase of the research, the participants will still be cared for with the implanted pump, having visits for refills and tests every 3 months. This long-term follow up will last until the participants choose to withdraw, the pump malfunctions, the FDA approves the pump for regular care, or the company no longer supports the pump. If the participants are no longer taking part in the study, the investigators will have the pump removed from their body.

Official Title
-----------------
Reimplantation of Subjects With Implantable Insulin Pump Therapy

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: Aventis U-400 Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with type 1 diabetes previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins may join this study. Exclusion Criteria: Anyone not previously implanted with the MiniMed Implantable Pump model 2000 at Johns Hopkins.
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: Aventis U-400 Insulin<br> | Device: Aventis U-400 Insulin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Control as Assessed by Mean Glucose Levels |  | End of study, approximately 5 years |
Puncture Breast Abscess

Study Overview
=================
Brief Summary
-----------------
Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess. The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures. The aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.

Official Title
-----------------
Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures

Conditions
-----------------
Breast Abscess

Intervention / Treatment
-----------------
* Behavioral: Phone call to the patient


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nursing mothers Patients referred for breast abscesses during lactation Having an abscess confirmed ultrasoundly and indicating a puncture Women punctured of an abscess of the breast abscess in the center of Medical Imaging Duroc Not opposing the use of them given and to answer the questionnaire on the immediate and medium-term future by telephone Women aged > 18 years old Women understanding French Affiliated to Social Security Exclusion Criteria: No

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Phone call to the patient|Phone call to the patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation of breastfeeding | Phone call to the patient | 1 week to 6 months after the puncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etiology of the abscess | Medical record and phone call to the patient | 1 week to 6 months after the puncture | 
| Adequacy of medical care with the protocol of the Parisian Perinatal Health Network | Medical record and phone call to the patient | 1 week to 6 months after the puncture | 
| Relationship between puncture breastfeeding continuation | Medical record and phone call to the patient | 1 week to 6 months after the puncture | 
| Relationship between surgery and weaning | Medical record and phone call to the patient | 1 week to 6 months after the puncture | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast feeding, breast abscess, ultrasound-guide, puncture, health
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of congestive heart failure (CHF) in patients from the clinical trial ECOG-5103 (E5103). OUTLINE: Previously collected germline DNA samples are analyzed via whole exome sequencing.

Official Title
-----------------
Exploratory Next Generation Sequencing to Identify Causative Variants for Therapy-Induced Congestive Heart Failure From Breast Cancer Study E5103 Germline DNA Samples

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: European American patients with DNA available European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab African American cases (based on a drop in left ventricular ejection fraction [LVEF] < 50 or a drop from baseline > 20 points) and African American controls
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (whole exome sequencing)<br>Previously collected germline DNA samples are analyzed via whole exome sequencing. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of rare coding variants of large effect that predict the risk of CHF | Assessed by burden analysis. | Baseline |