linjc16/ctgov huggingface dataset:
Vagal Tone and Neonatal Abstinence Syndrome

Study Overview
=================
Brief Summary
-----------------
Symptoms of Neonatal Abstinence Syndrome (NAS) can be attributed largely to dysfunction of the autonomic nervous system in opiate exposed neonates. Vagal tone is a readily available measure of autonomic nervous system functioning. NAS is a widely variable disorder with poorly understood pathophysiology; while all opiate exposed infants will exhibit some signs and symptoms of NAS, only approximately ½ have severe enough symptoms to require pharmacologic therapy. This research seeks to determine the relationship between infant vagal tone and NAS severity. The determination of a link between newborn vagal tone and NAS severity could result in the prediction of infants at risk for severe NAS and provide these infants and mothers with intensified services and early treatment, thereby shortening the course of NAS in the infant.

Detailed Description
-----------------
Consecutively born methadone exposed infants had hert period and cardiac vagal tone measurements extracted via standard EKGs on days 1 and 3 of life. The infant's NAS course was assessed serially.

Official Title
-----------------
Vagal Tone and Neonatal Abstinence Syndrome

Conditions
-----------------
Neonatal Abstinence Syndrome, Vagal Tone

Intervention / Treatment
-----------------
* Device: Vagal tone assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infant (>= 37 weeks by 1st or second trimester sonogram), In utero opiate exposure (either heroin or methadone) requiring a minimum of three day infant hospitalization after birth Delivery to a client active in drug abuse treatment Exclusion Criteria: Significant medical complications in the infant Circumcision within 24 hours of the proposed EKG/vagal tone measurement (circumcision has been found to affect vagal tone) Infant hospitalization in the Neonatal Intensive Care Unit (NICU) Psychiatric impairment of the mother such that informed consent is not possible

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vagal tone assessment|An EKG will be obtained using a Physio-control EKG monitor (R wave Electronics of Florida) in standard application, with three chest leads. The EKG data is inputted into a vagal tone monitor (Delta Biometrix, Bethesda MD) which computes vagal tone from the EKG signal. This data is then transferred to a disk which is analyzed off-line.|

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
-----------------
Neonatal abstinence syndrome, Methadone, Vagal tone
Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

Study Overview
=================
Brief Summary
-----------------
This study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.

Official Title
-----------------
A 7-Day Multicenter Randomized Double-Blind, Double-Dummy Parallel Group Trial to Assess the Safety and Efficacy of 400 mg Lumiracoxib Once Daily Versus 500 mg Naproxen Twice Daily in Patients With Acute Musculoskeletal Pain Due to Uncomplicated Soft Tissue Injury

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Drug: Lumiracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with acute musculoskeletal pain following an uncomplicated soft tissue injury (within the last 72 hours) which is expected to be self-limiting, requiring short-term treatment with a NSAID. Patients' acute musculoskeletal pain at baseline must be ≥ 50 mm on a 0 - 100 mm on a Visual Analogue Scale. Patients may have taken analgesic therapy following injury. However, the baseline pain intensity assessment should be taken: (i) 4 hours after the last dose of ≤ 400 mg ibuprofen, ≤ 1000 mg paracetamol, ≤ 600 mg aspirin or ≤ 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications (ii) or 8 hours after the last dose of > 400 mg ibuprofen or ≤ 50 mg diclofenac Exclusion Criteria Patients whose pain is due to an acute exacerbation of a chronic condition e.g. osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus. Patients who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than aspirin, ibuprofen, diclofenac, as described above). 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in sum of pain intensity difference scores over first 5 days of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in sum of pain intensity difference scores over 7 days of treatment; Improvement in how pts feel about their pain; Comparable perceived pain relief; Comparable treatment satisfaction |  |  | 
| Safety and efficacy as compared to naproxen. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Musculoskeletal pain, cyclooxygenase-2 inhibitors, lumiracoxib, naproxen
Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.

Official Title
-----------------
A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: LDE225


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma) blood work criteria Exclusion Criteria: patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases positive HIV, hepatitis B or C impaired intestinal function impaired heart function pregnant or breast-feeding women Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LDE225<br> | Drug: LDE225<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine maximum tolerated dose of single agent LDE225 |  | 28 day cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterize safety and tolerability |  | 28 day cycles | 
| characterize pharmacokinetics (PK) of single and repeated doses of LDE225 |  | 28 day cycles | 
| assess preliminary anti-tumor activity |  | every other 28-day cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced tumors, hedgehog, smoothened inhibitor
Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

Study Overview
=================
Brief Summary
-----------------
The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.

Official Title
-----------------
Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Other: biomarker levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 years refractory or advanced cardiogenic shock prior to institution of VA-ECMO Exclusion Criteria: History of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (GFR) less than 60 mL per min Cognitive impairment Pregnant women patient or surrogate is not fluent in English Long-term immunosuppression

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

| Intervention/Treatment |
| --- |
|Other: biomarker levels|The level of the biomarker hyaluronic acid will be measured|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal biomarker levels |  | through VA-ECMO decannulation, an average of 3 weeks | 
| need for continuous renal replacement therapy at hospital discharge (Yes/No) | The need for continuous renal replacement therapy at hospital discharge will be assessed using hospital medical records | measured at hospital discharge, an average of 2-3 months following initial hospital admission |
A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Study Overview
=================
Brief Summary
-----------------
A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.

Official Title
-----------------
A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: BLI801 laxative - low dose
* Drug: BLI801 laxative - high dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects at least 18 years of age Constipated, defined by ROME definition: Otherwise in good health, as determined by physical exam and medical history Exclusion Criteria: Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments Subjects who are allergic to any BLI801 component Subjects currently taking narcotic analgesics or other medications known to cause constipation Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days Subjects with an active history of drug or alcohol abuse

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI801 laxative - low dose<br>BLI801 laxative - oral solution | Drug: BLI801 laxative - low dose<br>* BLI801 laxative - oral solution<br>|
| Experimental: BLI801 laxative - high dose<br>BLI801 laxative - oral solution | Drug: BLI801 laxative - high dose<br>* BLI801 laxative - oral solution<br>* Other names: BLI801;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success | percent of patients experiencing a response in 3 out of 4 weeks of treatment | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum chemistry |  | 4 weeks |
A Study to Evaluate fMRI of Active DBS Stimulation in Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ANT) deep brain stimulation (DBS).

Detailed Description
-----------------
Researchers are testing how changing the settings on deep brain stimulation device (DBS) can help reduce the number and severity of seizures. Functional imaging will be used to study the mechanisms of ANT DBS to optimize the device settings to improve the degree of seizure reduction.

Official Title
-----------------
fMRI of Active DBS Stimulation in Epilepsy

Conditions
-----------------
Refractory Epilepsy

Intervention / Treatment
-----------------
* Diagnostic Test: Functional magnetic resonance imaging (fMRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who have previously undergone anterior thalamic nucleus deep brain stimulation (DBS) for refractory epilepsy. Exclusion Criteria: - Contraindication to MRI; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anterior Nucleus of the Thalamus (ANT) Deep Brain Stimulation (DBS)<br>Subjects that have undergone DBS placement for treatment of refractory epilepsy will undergo a fMRI scan. During the fMRI, the subject will undergo alternating short periods of their DBS in the on and off state with high- and low frequency settings to measure the brain activation changes induced by the DBS. | Diagnostic Test: Functional magnetic resonance imaging (fMRI)<br>* Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document brain activation networks with ANT stimulation | Use resting state fMRI to map brain network activation with high and low frequency of ANT stimulation. | Results would be available immediately following processing of the imaging data after each scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Brain Stimulation
Evaluation of the Impact of a Sugar-Sweetened Beverage Tax in Chile

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate formally the short term impacts of the tax policy applied to Sugar-Sweetened Beverages (SSBs) in Chile. The Impuesto Adicional a las Bebidas Analcohólicas (IABA, or additional tax on soft drinks) in Chile was enacted in October 2014, affecting any non-alcoholic beverages to which colorants, flavourings or sweeteners have been added. For beverages above an added sugar concentration of at least 6.25 grams per 100ml (or equivalent proportion), the tax was increased from 13% to 18%, while for those below this threshold the tax was decreased to 10%, producing an 8% tax difference between these beverage groups. This impact evaluation analysis of the Chilean sugar-sweetened beverage (SSB) tax will estimate the impact of increasing the tax as well as decreasing the tax on soft drinks. The study will use household level grocery purchasing data for Chile. The purchasing records are available from October 2011 to September 2015 (three years before; and one year after the implementation of the tax in October 2014). The investigators will use a series of quasi-experimental approaches to evaluate the causal impact of the SSB tax policy on consumers' behaviour as well as on industry responses in the form of pricing and price promotion decisions.

Official Title
-----------------
Empirical Evaluation of the Short Term Impact of a Sugar-Sweetened Beverage Tax in Chile

Conditions
-----------------
Chronic Disease, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Household in Chile that agreed to participate in the purchasing survey and provided data to a satisfactory degree for the first 2 months. Exclusion Criteria: Households that are unwilling to participate in the survey. Households that change physical address. Households with poor compliance to the survey.
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of sugar-sweetened beverage purchased |  | October 2011 - September 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumer shopping patterns - Frequency | Frequency of Purchasing | October 2011 - September 2015 | 
| Consumer shopping patterns - Volume | Volume of Purchases | October 2011 - September 2015 | 
| Market price of sugar-sweetened beverages |  | October 2011 - September 2015 | 
| Body mass index of household members |  | October 2011 - September 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Taxes, Beverages/economics, Carbonated Beverages/economics, Diet, Food and Nutrition/economics, Economics, Energy Intake, Risk Factors
Intra Articular Botox Injection in Treatment of Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

Detailed Description
-----------------
Compared the short and long term effects of sonography guided intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

Official Title
-----------------
Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis

Conditions
-----------------
Osteoarthritis Knees Both

Intervention / Treatment
-----------------
* Drug: Botox Injectable Product
* Device: Radiofrequancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoarthritis Exclusion Criteria: coagulopathy Organ failure

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: Botox injection<br> | Drug: Botox Injectable Product<br>* Intra articular Botox injection<br>|
| Active Comparator: Genicular Radio frequency<br> | Device: Radiofrequancy<br>* Genicular nerves radiofrequancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain visual analog scale | 0-10 Visual analog scale( less than 3 no pain 3-5 in pain, more than 5 sever pain | 6 months |
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.

Detailed Description
-----------------
Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.

Official Title
-----------------
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: pioglitazone
* Drug: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 1 diabetes mellitus diagnosed within 4 months Age > 6 years of age Ability to swallow capsule Signed informed consent / assent Exclusion Criteria: Other illnesses

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pioglitazone<br> | Drug: pioglitazone<br>* Pioglitazone daily; dose varies with size<br>* Other names: Actos;Drug: Placebo control<br>* Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus<br>* Other names: Actos;|
| Placebo Comparator: Placebo control<br> | Drug: pioglitazone<br>* Pioglitazone daily; dose varies with size<br>* Other names: Actos;Drug: Placebo control<br>* Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus<br>* Other names: Actos;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-peptide response to a Sustacal meal |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin requirement |  | 6 months | 
| Hemoglobin A1c |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 diabetes, Insulin dependent diabetes, Juvenile onset diabetes, pioglitazone