linjc16/ctgov huggingface dataset:
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Mesalamine is commonly used to induce and maintain remission in patients with Inflammatory Bowel Disease (IBD). Behavioral and psycho-social barriers to mesalamine adherence exist in patients with IBD. These factors can be identified using qualitative testing in order to develop a validated instrument to measure the adherence profile of an individual patient, and design appropriate behavioral interventions to reduce non-adherence. Objectives: To test a novel interview instrument that determines the medication adherence profile of patients with IBD prescribed mesalamine by correlating with objective measures of adherence

Detailed Description
-----------------
Specific Aims: To test a novel interview instrument to classify patients into adherence profiles To validate this instrument with quantitative scores of mesalamine adherence and objective testing. Study Design Rationale: Qualitative research design and prospective validation

Official Title
-----------------
Adherence to Mesalamine Profile for Patients With Inflammatory Bowel Disease

Conditions
-----------------
Ulcerative Colitis, Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (age >18) Diagnosis of IBD (confirmed by endoscopy and histology) > 3 months In clinical remission (based on Simple Colitis Activity Index score <2.5) On mesalamine compound for maintenance of remission Stable mesalamine dose for 1 month Exclusion Criteria: Not receiving primary GI care at BIDMC

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mesalmine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between Adherence to Mesalamine Profile scores and medication adherence as measured by pharmacy refill data | Participant's adherence behaviour will be measured using a behavioral profile questionnaire, and both the total score, and each individual sub-score, correlated with medication adherence as measured using pharmacy refill rates | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Adherence (Moriskey Medication Adherence Scale (MMAS) 8 score >6) | Validated measure of reported medication adherence | 12 months | 
| Spot Urinary 5-ASA | Urine salicylic acid and 5-ASA levels will be measured in participants | 12 months | 
| Short Inflammatory Bowel Disease Questionnaire | Validated measure of Quality-of-Life for patients with IBD | 12 months | 
| Pharmacy Refill Rates | Mesalamine refill rates will be captured from patiernts' pharmacies | 12 months |
Lipitor Trial To Study The Effect Of Torcetrpib/Atorvastatin To Atorvastatin Alone.

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at various lipids in the blood of people with Fredrickson Type IIa and Type IIb mixed dyslipidemias

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
A Phase 3, Double-Blind, Randomized, Multisite Trial Of The Efficacy, Safety, And Tolerability Of The Fixed Combination Torcetrapib/Atorvastatin Administered Orally, Once Daily For 12 Months, Compared To Atorvastatin Alone, Titrated Based On NCEP ATP-III LDL-C Goals In Subjects With Fredrickson Types IIa And IIb Dyslipidemias

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Statin eligible per NCEP ATP-III guidelines At least 18 years of age Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant Intolerance to statin therapy Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipid parameters (HDL, LDL) at various timepoints over 12 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in levels of lipids and other biomarkers. |  |  |
Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier

Study Overview
=================
Brief Summary
-----------------
Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital

Official Title
-----------------
Retrospective Study on the Management of Pediatric Anaphylaxis and Clinical Signs of Allergy in the Pediatric Emergency Department of Montpellier University Hospital

Conditions
-----------------
Anaphylaxis, Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients evaluated at the Montpellier University Hospital, Allergy Unit ; Children consulting for suspected allergy from 2016 to 2020 Exclusion criteria: - Patients under legal protection, under guardianship or under curatorship;

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 99 Years

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 |
| --- | --- | --- |
| Evaluation of the management of pediatric anaphylaxis of allergy | Evaluation of the management of pediatric anaphylaxis of allergy in the pediatric emergency department of Montpellier University Hospital. | day 1 | 
| Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital. | Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of an appropriate use of epinephrine | Evaluation of an appropriate use of epinephrine | day 1 | 
| Evaluation of an appropriate use of a possible follow-up of patients after the episode | Evaluation of an appropriate use of a possible follow-up of patients after the episode | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Emergency, Epinephrine
A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices

Study Overview
=================
Brief Summary
-----------------
An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)

Detailed Description
-----------------
Study Type: observational, investigator led Study Design: observational model: cohort (retrospective) Population: 150 people over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK Data collection: daily PA measures, demographic details, co-morbidity status, physical frailty assessment, functional status, quality of life (QOL) and NEHA data Consent: for participation in the study, physical frailty assessment, additional collection of retrospective CIED data, and access to electronic patient records Data sources: CIED downloads, self-report questionnaire, physical measurements (height, weight, hand grip strength, gait speed), electronic hospital records, HES (hospital episode statistics) data Results analysis: data will be analysed to investigate: daily PA variability; the association between PA and NEHAs, and the impact of frailty on PA patterns

Official Title
-----------------
A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices

Conditions
-----------------
Physical Activity, Aging, Cardiac Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60+ years Functioning CIED in situ for at least 6 months Medtronic manufactured device compatible with CareLink® Cardiac Compass application (platform which measures and stores physiological parameters) Lives in the Greater Manchester area Able and willing to given written, informed consent to enter the study Exclusion Criteria: Faulty or incompatible device Immobile (unable to walk in upright position) Active participant in a clinical trial which does not allow concurrent recruitment into this study People unable to consent in the English language (including the understanding of study literature which is published in English only)

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Study cohort<br>People over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-elective hospitalisation episodes | All cause | Retrospective, previous 400 days |
First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts

Study Overview
=================
Brief Summary
-----------------
This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects with cutaneous warts.

Official Title
-----------------
A Phase I/IIa Open-label First-in-Human Study to Assess Safety and Pharmacokinetics and Explore Biomarker Effects of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Subjects With Cutaneous Warts

Conditions
-----------------
Cutaneous Warts

Intervention / Treatment
-----------------
* Drug: CLS003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. Body mass index (BMI) between 18 and 30kg/m2, inclusive Fitzpatrick skin type I-II-III-IV At least 4 cutaneous warts on the hands, separated by at least 1cm of skin Exclusion Criteria: For women, a positive pregnancy test and/or nursing at screening A positive test for drugs of abuse at screening History of alcohol or illicit drug abuse Positive test results for Hepatitis B, Hepatitis C or HIV Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment Have received cryotherapy in the treatment area within 60 days prior to enrollment Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLS003<br> | Drug: CLS003<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of CLS003 |  | 7 days | 
| Number of participants with adverse events |  | 7 days | 
| Peak Plasma Concentration (Cmax) of CLS003 |  | 7 days | 
| Time to reach Cmax (Tmax) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLS003, safety, pharmacokinetics (PK), pharmacodynamics (PD)
Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections

Study Overview
=================
Brief Summary
-----------------
Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI. The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.

Official Title
-----------------
Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections

Conditions
-----------------
Bone and Joint Infection, Staphylococcus

Intervention / Treatment
-----------------
* Other: Patients having had an osteo-articular infection with Stahylococcus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had an osteo-articular infection with Staphylococci Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients having had an osteo-articular infection with Stahylococcus<br>Patients having had an osteo-articular infection with Stahylococcus managed at the Croix Rousse hospital | Other: Patients having had an osteo-articular infection with Stahylococcus<br>* Immunostaining targeting staphylococci and components will be performed on tissue samples collected from patients with osteo-articular infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of intracellular staphylococci | to explore if intracellular staphylococci can be observed on samples of patient having an osteo-articular infection with staphylococci | 2 months | 
| rate of localisation of intracellular staphylococci | to explore where in what type of celles they can be observed on samples of patient having an osteo-articular infection with staphylococci | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone and Joint Infection, Staphylococcus, intracellulare
A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health

Study Overview
=================
Brief Summary
-----------------
The aim of this analysis was to compare gingivitis- and plaque-reduction efficacy from randomized controlled trials (RCTs) up to six months long evaluating oscillating-rotating, sonic, and manual toothbrushes

Official Title
-----------------
A Meta-analysis Comparing Electric and Manual Toothbrushes on Plaque Removal and Gingival Health

Conditions
-----------------
Gingivitis, Dental Plaque

Intervention / Treatment
-----------------
* Device: Oscillating-rotating electric toothbrush
* Device: Sonic electric toothbrush
* Device: Manual toothbrush


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects were excluded from this study for the following reasons; pregnancy, rampant caries, severe periodontitis, at discretionary of the Principal Investigator.

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 |
| --- | --- |
| Oscillating-Rotating electric toothbrush<br>Twice daily brushing | Device: Oscillating-rotating electric toothbrush<br>* Oscillating-rotating electric toothbrush used twice daily<br>|
| Sonic electric toothbrush<br>Twice daily brushing | Device: Sonic electric toothbrush<br>* Sonic electric toothbrush used twice daily<br>|
| Manual toothbrush<br>Twice daily brushing | Device: Manual toothbrush<br>* Manual toothbrush used twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Bleeding Sites | Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Gingival Bleeding Index (GBI), Papillary bleeding index or Mazza gingival index). | Up to 6 months (26 weeks) | 
| Dental Plaque Scores | Change from baseline as measured by mean plaque score reduction from baseline (via Turesky's Modification of Quigley-Hein index, or Rustogi Modified Navy Plaque Index). | Up to 6 months (26 weeks) |
Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Study Overview
=================
Brief Summary
-----------------
Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied. The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.

Official Title
-----------------
Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Conditions
-----------------
Brain Injury, Constipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ABI: Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission) or Stroke or Anoxic brain injury Ability to swallow the capsules used to assess GITT Ability to give meaningful informed consent to participate in the study Exclusion Criteria: Major abdominal disorders Severe acute comorbidity Known cancer Pregnancy Known autonomic neuropathy Other known neurological disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- |
| ABI Patients<br>Patients with acquired brain injury. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal transit time (GITT) [in days] |  | During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between heart rate variability (HRV) and GITT | Linear regression with GITT as dependent variable, and high frequency power sepectral density analysis of the heart rate (HF) as the independent variable. | During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury. |