linjc16/ctgov huggingface dataset:
A DirEct to PatieNt Study in Chronic Pain

Study Overview
=================
Brief Summary
-----------------
To compile real-world, direct from patient clinical outcomes and objective metrics in patients who have received or plan to receive a commercially approved interventional medical device therapy/procedure for chronic pain in routine clinical practice.

Official Title
-----------------
A DirEct to PatieNt Study in Chronic Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Patient is planning to receive or has received a commercially approved interventional medical device therapy/procedure to treat chronic pain, ascertained from self-reporting Age ≥ 22 years at time of eligibility screening, ascertained by self-reported age at time of eligibility screening Proficient in written and spoken English, defined by self-reporting of comfort reading, writing and speaking English Key Exclusion Criteria: Requires a legal representative to sign the ICF ascertained from self-reporting

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Medical Device Therapy/Procedure for Chronic Pain<br> | Device: Commercially Approved Interventional Medical Device/Therapy for Chronic Pain<br>* Commercially Approved Interventional Medical Device/Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain post procedure | Change in patient-reported pain on a scale of 0 - 10 where 0 is no pain and 10 is maximum pain | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Pain
Study of Methotrexate Given to Juvenile Idiopathic Arthritis Patients Based on Pharmacogenomics and Pharmacometrics

Study Overview
=================
Brief Summary
-----------------
This study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

Detailed Description
-----------------
In order to find out The critical reasons for individual variances in MTX of JIA pediatric patients and quantize the influence of these factors, based on early research, this study will integrate Pharmacogenomics and Pharmacometrics, to explore an effective concentration of MTXPGn for JIA pediatric patients, and set up a Population Pharmacokinetics model to provide reference for individual administration on JIA pediatric patients.

Official Title
-----------------
Individual Study of Methotrexate Based on Pharmacogenomics and Pharmacometrics

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Other: therapeutic drug monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with Juvenile Idiopathic Arthritis 7.5-10mg/m2 per week per dose of methotrexate all patients have been treated with methotrexate at least for 3 months Exclusion Criteria: co-treated other drugs which can interact with methotrexate

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- |
| good efficacy<br>using therapeutic drug monitoring to adjust the dose of methotrexate. patients can reach effective outcome. | Other: therapeutic drug monitoring<br>* dose of methotrexate can be adjusted by therapeutic drug monitoring.<br>|
| poor efficacy<br>patients can not reach effective outcome. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism | genotype are collected from hospital system. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration as measured by liquid chromatography mass spectrometry | concentration of methotrexate are collected from hospital system | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrexate, Juvenile Idiopathic Arthritis
Evaluating the Foot Touch Framework Model

Study Overview
=================
Brief Summary
-----------------
A Foot Touch framework model has been developed to express the ground reaction force waveforms observed for walking and running. The purpose of this research is to collect ground reaction force data during walking and running that can be used to evaluate and verify the Foot Touch framework.

Official Title
-----------------
Evaluating the Foot Touch Framework Model in Running

Conditions
-----------------
Barefoot Running

Intervention / Treatment
-----------------
* Other: Four speeds
* Other: Foot Strike Pattern


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult men and women Capable of independently walking and running at various speeds for a minimum of 30 minutes No history of significant injuries in the past six months Ability to walk and run without shoes/footwear Ability to perform one- and two-footed hops up and down from 5 cm and 10 cm heights Ability to provide informed consent Exclusion Criteria: Confounding chronic injury or musculoskeletal problem Pregnancy Symptomatic cardiovascular disease or chronic obstructive pulmonary disease Not able to read and understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Runners<br>All participants will be required to run unshod for a combination of four prescribed speeds (walking and up to 9 mph) and three different foot strike patterns (rearfoot, midfoot, and forefoot) on level ground. | Other: Four speeds<br>* Four speeds ranging from a set walking speed up to 9 mph<br>Other: Foot Strike Pattern<br>* Foot strike sequences (rearfoot strike, midfoot strike, forefoot strike)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MatScan Forces | Ground reaction forces for distinct anatomical regions of the foot (Calcaneal, Tarsal, Metatarsal, Phalangeal) measured by the MatScan system | Assessed on day 1 (data collection day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ground reaction force | Ground reaction force measured by the force plate during walking, running, and hopping tasks | Assessed on day 1 (data collection day) | 
| Ankle joint angle | Ankle joint angle measured by motion analysis system during walking, running, and hopping tasks | Assessed on day 1 (data collection day) | 
| Knee joint angle | Knee joint angle measured by motion analysis system during walking, running, and hopping tasks | Assessed on day 1 (data collection day) | 
| Hip joint angle | Hip joint angle measured by motion analysis system during walking, running, and hopping tasks | Assessed on day 1 (data collection day) |
Pharmacogenetics and Cardiovascular Events

Study Overview
=================
Brief Summary
-----------------
To assess interactions between selected cardiovascular medications and genes in the incidence of heart attack, stroke, and atrial fibrillation, an irregular heartbeat.

Detailed Description
-----------------
BACKGROUND: This complex study will collect additional genetic data for 3 ongoing case-control observational studies of drug-gene interactions in myocardial infarction, stroke, and new-onset atrial fibrillation. This study will add single nucleotide polymorphism (SNP) discovery for 16 of 36 candidate genes involving the renin-angiotensin system, sodium transport, adrenergic receptors, and G-proteins, and allow analysis of haplotype data. The study was initiated in response to RFA HL-03-001, Ancillary Studies in Pharmacogenetics. DESIGN NARRATIVE: The primary aim of this study is to assess interactions between selected cardiovascular medications and the major candidate-gene variants or haplotypes on the incidence of myocardial infarction (MI), stroke and atrial fibrillation (AF). The candidate-gene sets-selected on the basis of biology, pharmacology, and information from genome-wide scans-include: (1) 10 genes in the renin-angiotensin system; (2) 10 genes involved in renal sodium transport; (3) 8 genes encoding alpha and beta adrenergic receptors; (4) 8 other genes, including G-proteins, estrogen receptors, and the alpha-1C subunit of the L-type calcium channel. The products of these genes represent the sites of action for many cardiovascular drugs: angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, all classes of diuretics, alpha blockers, beta-blockers, central alpha agonists, calcium antagonists, and estrogens. Both hypothesis-testing and hypothesis-generating analyses are planned. For selected single nucleotide polymorphisms (SNPs) studied in vitro or in small clinical populations, several specific drug-gene interactions are plausible, and these associations will be evaluated in an hypothesis-testing manner. The study used data from previously funded case-control studies which are expected to produce 1053 MI cases, 565 stroke cases and 800 atrial fibrillation cases and 3249 matching controls from the enrollees of Group Health Cooperative. These patients will already have had chart abstractions, pharmacy database searches, telephone interviews and phlebotomy with specimen storage.

Conditions
-----------------
Cardiovascular Diseases, Atrial Fibrillation, Cerebrovascular Accident, Heart Diseases, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria
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 |
| --- | --- | --- |
Nutritional Management of Children With Chronic Diarrhea

Study Overview
=================
Brief Summary
-----------------
The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.

Official Title
-----------------
Clinical Management of Children With Chronic Diarrhea

Conditions
-----------------
Growth and Tolerance Infant Study

Intervention / Treatment
-----------------
* Other: Experimental Infant Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than or equal to 9 months of age at enrollment Candidates for an elemental formula Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula Parents agree to feed infant with experimental formula for least 50% of total calories during study period Exclusion Criteria: - Any non-approved concomitant study

Ages Eligible for Study
-----------------
Maximum Age: 9 Months

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: Experimental Infant Formula<br>Complete peptide amino acid-based infant formula | Other: Experimental Infant Formula<br>* Infant formula to be fed ad libitum<br>* Other names: EleCare;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician determined target outcome | Outcome dependent on individual subject assessment and may include decreased stool number, decreased vomiting, decreased gas, weight gain, increased caloric intake, increased protein intake, increased serum albumin concentration, increased hemoglobin concentration, better acceptance of supplemental formula. | Study Day (SD)1-84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Assessment | Parent completed record of infant dietary intake. | Study day (SD) 2-4, 5-7, 25-27 and 81-83 | 
| Gastro-Intestinal Tolerance | Parent reported record of incidence of regurgitation. | Study Day (SD) 2-4, 5-7, 25-27, 81-83 | 
| Stool characteristics | Parent completed diary of stool consistency, frequency/volume. | Study Day (SD) 2-4, 5-7, 25-27 and 81-83 | 
| Blood Chemistry | Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase | Study Day (SD) 1 and 84 | 
| Anthropometrics | Weight and length | Study Day (SD) 1, 28 and 84 |
Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods (ECG and MEG)

Study Overview
=================
Brief Summary
-----------------
Optically Pumped 4He Magnetometers operability for cerebral and cardiac magnetic fields measurement.

Detailed Description
-----------------
Optically Pumped 4He Magnetometers vs reference sensors electrocardiogram (ECG) or SQUIDs data acquisitions

Official Title
-----------------
Optically Pumped 4He Magnetometers Performances Compared With Medical Reference Methods : Electrocardiography (ECG) and Magnetoencephalography (MEG)

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

Intervention / Treatment
-----------------
* Device: MINIMAG / MEG
* Device: MINIMAG / ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more or equal than 18 years old patient affiliated to social security or similarly regime informed consent form signed without cardiac, neurologic, psychiatric or metabolic medical history. Exclusion Criteria: Pregnant women and lactating mothers Ward of court or under guardianship Adult unable to express their consent Person deprived of freedom by judicial or administrative decision Person hospitalized without their consent Person under legal protection Person with any implant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MINIMAG / MEG<br>Cerebral magnetic fields | Device: MINIMAG / MEG<br> <br> |
| Experimental: MINIMAG / ECG<br>Cardiac magnetic fields | Device: MINIMAG / ECG<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse EventsMagnetic brain or cardiac activity | Measure of Safety and Tolerability | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain or cardiac magnetic activity (Cerebral or cardiac magnetic fields record) | Cerebral or cardiac magnetic fields record | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins. The purpose of this study is to compare the effects of the milk proteins casein, Whey Isolate, Whey Hydrolysate, and Alphalact-Albumin on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.

Official Title
-----------------
Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes

Conditions
-----------------
Postprandial Lipemia, Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Casein
* Dietary Supplement: Whey Isolate
* Dietary Supplement: Whey Hydrolysate
* Dietary Supplement: Alphalact-Albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Exclusion Criteria: Liver-, Kidney- and/or Heart Disease Serious Hypertension (160/110 mmHg)

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Casein<br> | Dietary Supplement: Casein<br> <br> |
| Active Comparator: Whey Isolate<br> | Dietary Supplement: Whey Isolate<br> <br> |
| Active Comparator: Whey Hydrolysate<br> | Dietary Supplement: Whey Hydrolysate<br> <br> |
| Active Comparator: Alphalact-Albumin<br> | Dietary Supplement: Alphalact-Albumin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride levels |  | 0h- 2h- 4h- 6h- 7h- 8h postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incretin levels |  | 0h- 0.5h- 1h- 2h- 4h- 6h- 8h postprandial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Casein, Whey, postprandial, Triglyceride, Free fatty acids, Retinyl palmitate, Incretins, Type 2 Diabetes
An Analysis of Treatment Timelines for Lung Cancer Patients Across System Evolutions

Study Overview
=================
Brief Summary
-----------------
This study is a single center, minimal risk, physician initiated retrospective chart review. An analysis of treatment timelines for patients diagnosed with lung cancer within the St. Elizabeth system from January 2013 until study completion. The study investigator and designee(s) will review patient electronic medical records, extracting data related to the symptom presentation, diagnosis, and treatment of new diagnoses of lung cancer. Collected data will focus on dates of encounters, diagnostic imaging/procedures, and treatments, with data analysis evaluating time between care encounters and potential delays in care. The data will be further stratified based on system-wide changes implemented to improve efficiency, patient outcomes, and patient experience.

Official Title
-----------------
An Analysis of Treatment Timelines for Lung Cancer Patients Across System Evolutions

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient seen within the St. Elizabeth system >=18 years of age New diagnosis of histologically or cytologically documented primary lung cancer diagnosed January 2013 or later Exclusion Criteria: Patients with metastatic lung disease of other primary Other malignancies at investigator's discretion Patient received treatment at a facility outside of St. Elizabeth where records are not available through EPIC Patient currently undergoing treatment for new diagnosis of lung cancer

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 |
| --- | --- | --- |
| Time from presentation to treatment | Time from initial patient presentation with symptoms or incidental finding to first day of treatment, measured in days. | from initial patient presentation with symptoms or incidental finding to first day of treatment, up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional time between imaging and physician referrals |  | From identification of concerning nodule to specialist appointment, up to 3 years |