linjc16/ctgov huggingface dataset:
The Utility of Levofloxacin-Rifampin in the Therapy of Prosthetic Joint Infection

Study Overview
=================
Brief Summary
-----------------
Prosthetic joint infection is a devastating complication of total joint arthroplasty ultimately leading to the failure of the total joint arthroplasty function and possibly death. Optimal treatment requires the resection of the infected total joint arthroplasty followed by prolonged parenteral antimicrobial therapy. This procedure is followed by reimplantation of a new total joint arthroplasty at a later date. Surgical debridement and retention of the infected total joint arthroplasty offers a more conservative surgical approach and has been proven to be cost-effective in selected groups of patients. Traditional medical therapy for staphylococcal infection would require an initial parenteral antimicrobial followed by chronic oral non-rifampin containing antimicrobial suppression regimen for the life of the total joint arthroplasty. With this strategy the success rate is close to 30%. Recently, several prospective studies of patients with THA, TKA and fracture fixation device infections conducted in Europe showed that the success rate with a 3-6 month course of a quinolone-rifampin combination is effective in 70% to 100% of cases. The proposed study will be a prospective open label observational cohort that will evaluate the outcome of Patients with S. aureus PJI treated with a medical regimen that includes oral levofloxacin- rifampin and debridement and retention of components. This medical regimen was approved for use by the Orthopedic Infectious Diseases focus group, Mayo Clinic, Rochester. 15 patients will be enrolled over a one-year period and followed up to minimum of 1 additional year. The outcome of this group will be compared to a historical group that is treated with traditional therapy.

Official Title
-----------------
Prolonged Oral Levofloxacin-Rifampin for Staphylococcus Aureus Prosthetic Joint Infection (PJI) Treated With Debridement And Retention Of Components: A Prospective Observational Cohort Study. Mayo PJI Study Group (MPSG)*

Conditions
-----------------
Staphylococcal Infection, Staphylococcus Aureus Prosthetic Joint Infection

Participation Criteria
=================
Eligibility Criteria
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A maximum of 15 adult participants with total hip or total knee arthroplasty are approved for enrollment in this protocol at Mayo Clinic Rochester.

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 |
| --- | --- | --- |
Placental Passage and Disposition of Drugs: A Physiology-based Approach

Study Overview
=================
Brief Summary
-----------------
The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life' maternal and fetal PK data, such as data from the PANNA network. PBPK models of drug therapy during pregnancy will provide a powerful tool to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based research in pregnant women in the future, and 3.) guide future development of new molecular entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and potentially toxic effects in utero).

Official Title
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Placental Passage and Disposition of Drugs: A Physiology-based Approach

Conditions
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Pregnancy

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Female Age > 18 Signed informed consent >38 weeks pregnant Exclusion Criteria: Retained placenta HIV infected Known hepatitis C infection Multiple pregnancy Congenital birth defects child Sectio EXIT procedure

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

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

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 |
| --- | --- | --- |
| placental transfer | 1.) An ex-vivo placenta perfusion model will be used to estimate placental passage of drugs | at delivery | 
| histological profiling | Histological and protein profiling experiments will be conducted to investigate factors that may influence the placental passage and disposition of drugs (e.g. the abundance, localization and inter-individual variation of expression of enzymes and transporters). | at delivery | 
| in vitro experiments | Furthermore, in vitro experiments will be conducted to estimate the pharmacodynamic effects of drugs on the placental barrier function itself (e.g. whether exposure to drugs can induce/reduce the expression of enzymes and transporters, as has been reported for several organs, such as the liver, intestine and kidney). | at delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
placenta, placental passage
Adult Outcomes of Children With CAPS

Study Overview
=================
Brief Summary
-----------------
The patients included in this study were followed up in the Internal Medicine and Paediatrics Departments of the Lille CHU, the Paediatric Rheumatology and Immunology Department of the Necker Enfant Malade Hospital in Paris and the Paediatric Rheumatology Department and Internal Medicine of the Bicêtre Hospital in Paris. All patients selected presented one of the 3 CAPS clinical phenotypes (CINCA/NOMID, Muckle-Wells or Cold Urticaria). The mutation and the determination of the variant had to be confirmed by genetic analysis. Patient data were collected from their medical records, retrospectively. Data collected concern childhood period from appearance of symptoms, adulthood period, in the last year and patients' way of life and quality of life upon the assessment. In addition, we collected demographic data related to the patients' lifestyle (intoxications, living arrangements, level of education) and we conducted individual telephone interviews lasting 15 minutes to complete a quality of life questionnaire including the SF36 questionnaire. The study aimed to describe the clinical symptoms of patients in adulthood and to assess quality of life. We also wanted to compare the clinical phenotypes of patients according to their genetic variant.

Official Title
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Clinical Characteristic and Quality of Life Assessment in Adulthood of Patients With Cryopyrin Associated Periodic Syndrome

Conditions
-----------------
Cryopyrin Associated Periodic Syndrome

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Diagnosis of FCAS, Muckle-Wells or NOMID/CINCA; age < 16 years at the apparition of the first symptoms of the disease; age ≥ 16 years old at inclusion follow-up in a CEREMAIA reference or competence center. Exclusion Criteria: Age < 16 years at inclusion; non-consenting patient

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Clinical characteristics of patients with CAPS in adulthood |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the quality of life of patients with CAPS in adulthood |  | Baseline | 
| Compare the clinical status between childhood and adulthood |  | Baseline | 
| Compare the clinical status of patients according to their genetic variant. |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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CAPS Cryopyrin associated periodic syndromes, MWS Muckle-Wells syndrome, CINCA Chronic infantile neurological cutaneous and articular syndrome ;, FCAS Familial cold auto-inflammatory syndrome, Phenotype ; Quality of life, Quality of life
A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile

Study Overview
=================
Brief Summary
-----------------
This study is a parallel translational study of a Randomized Phase III trial Investigating the Role of Oxaliplatin duration (6 Cycles Versus 12 Cycles) in modified FOLFOX-6 Regimen as Adjuvant Therapy for Patients with Stage II/III Colon Cancer (MIDAS trial: protocol NCCCTS-467) . Patients participating in the trial will be provided with the informed consent of this parallel study, and peripheral blood and tumor tissue of those who signed the consent will be collected for germline polymorphism analysis and gene expression profile study .

Official Title
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A Prospective Study of Pharmacogenetic Factors and Gene Expression Profile in Patients Receiving Adjuvant Therapy With FOLFOX-6 After Curative Resection of Colon Cancer

Conditions
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Colon Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Curatively resected, histologically confirmed colon adenocarcinoma (presence of the inferior pole of the tumor above the peritoneal reflection) AJCC/UICC high-risk stage II, stage III colon cancer Stage II patient with high risk of relapse, if they fulfill one or more of the following criteria:(T4 tumors,bowel obstruction or perforation,vascular or lymphatic or perineural invasion) Patients who are participating in the randomized phase II trial of FOLFOX 6 or 12 cycles Patients should sign a written informed consent for this translational study before or during participating in a randomized phase III study investigating the role of oxaliplatin duration (6 cycles versus 12 cycles) in modified FOLFOX-6 regimen as adjuvant therapy for patients with stage II/III colon cancer Exclusion Criteria: Patients who do not agree with sampling of peripheral blood for genetic analysis Patients who are considered not to be suitable for this study at investigator's discretion

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 |
| --- | --- |
| FOLFOX_6<br>Oxaliplatin : 85 mg/m2/day D1 Leucovorin : 200 mg/m2/day D1 5-FU : 400 mg/m2/day D1 5-FU : 2,400 mg/m2/day D1 over 46 hrs Every 2 weeks, first 6 cycles, then Leucovorin : 200 mg/m2/day D1 5-FU : 400 mg/m2/day D1 5-FU : 2,400 mg/m2/day D1 over 46 hrs Every 2 weeks, 6 cycles | |
| FOLFOX_12<br>Oxaliplatin : 85 mg/m2/day D1 Leucovorin : 200 mg/m2/day D1 5-FU : 400 mg/m2/day D1 5-FU : 2,400 mg/m2/day D1 over 46 hrs Every 2 weeks, total of 12 cycles | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | To estimate the interaction between disease-free survival, duration of adjuvant oxaliplatin treatment, and genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1) | 6years |
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Study Overview
=================
Brief Summary
-----------------
To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia. The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria. A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.

Official Title
-----------------
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Conditions
-----------------
Gastrointestinal Neoplasia, Hirschsprung's Disease, Esophageal Obstruction, Gastroparesis, Spastic Esophageal Disorders, Zenker's Diverticulum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will undergo submucosal endoscopy Age >18 years Exclusion Criteria: Age <18 years Pregnancy Coagulopathy (platelets less than 50, INR more than 1.8)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical and clinical success in performing submucosal endoscopy | Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology. | baseline to one year | 
| Adverse Events | as defined by published ASGE criteria | baseline to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Procedure time | During procedure | 
| Submucosal endoscopy technique and device used | Submucosal endoscopy technique and device used | During procedure |
Patient Knowledge of Medication Indication

Study Overview
=================
Brief Summary
-----------------
This is a study to compare patient knowledge about the indications of their medications between two sites. Regions Hospital has a population of patients that receive the medication indication on the label for any new or changed medications at the time of patient discharge. Brigham Women's Health follows a standard policy of discharge medication labels including the name of the medication and instructions for use without any indication of what the medication is intended to treat. Consented patient will receive a phone call where researchers will ask about which medications they are taking and other questions about those medications. The study population will be patients recently discharged from the hospital with 1 or more new or changed medications

Official Title
-----------------
Patient Knowledge of Medication Indication

Conditions
-----------------
Medical Audit

Intervention / Treatment
-----------------
* Other: Medication knowledge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Hospital Medicine (HM) inpatient being discharged to home Patient being discharged with ≥ 1 new or changed medications English speaker Exclusion Criteria Inpatient being discharged to nursing home or TCU facility Patient being discharged with no new or changed medications Non-English speaker

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 |
| --- | --- |
| Medication indication on the label<br>Patients discharged from Regions Hospital (St. Paul, MN) where we have implemented a standard process of printing the indication for all new medications on the prescription bottle. | Other: Medication knowledge<br>* Participants will be asked questions over the phone about their medications<br>|
| No medication indication given<br>Patients discharged from Brigham and Women's Hospital (Boston, MA) where there is no requirement for providing information on medication indications to patients at discharge. | Other: Medication knowledge<br>* Participants will be asked questions over the phone about their medications<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Knowledge Questionnaire | Scripted questionnaire administered on patients knowledge of their medication indications who received new, changed, or continued medications at discharge via phone call. Questions are focused on understand of relationship of the medication and what symptom or disease it is teaching. | up to 5 days |
An Investigation of a New Laryngeal Mask Airway LMA Protector

Study Overview
=================
Brief Summary
-----------------
Evaluation of LMA Protector

Detailed Description
-----------------
This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.

Official Title
-----------------
An Investigation of a New Laryngeal Mask Airway LMA Protector

Conditions
-----------------
Airway Morbidity

Intervention / Treatment
-----------------
* Device: LMA Protector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned elective surgery with indication for LMA use Exclusion Criteria: body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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: LMA Protector<br>Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port) | Device: LMA Protector<br>* Insertion of airway device for airway management during gynaecological procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of insertion attempts | Time of pickup of device to the presence of carbon dioxide trace on | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal Leak Pressure | Closure of expiratory valve of circle anaesthetic breathing system and noting the airway pressure in the breathing system at equilibration with cuff pressure of 60cmH2O or up to maximum of 40cmH2O | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laryngeal Mask Airway
Tecfidera and MRI for Brain Energy in MS

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to test the hypothesis that DMF can improve mitochondrial function in the brain of people with MS. The investigators will assess mitochondrial function in the cerebral grey matter by measuring PCr and ATP by 31P magnetic resonance spectroscopy (MRS) and NAA in NAWM by 1H MRS.

Official Title
-----------------
Modulation of Cerebral Grey Matter High Energy Phosphate Metabolites in Multiple Sclerosis by Dimethyl Fumarate

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Dimethyl fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of MS by 2010 McDonald criteria Relapsing clinical course Ages 18-55 Laboratory values that allow initiation of dimethyl fumarate (Tecfidera) Exclusion Criteria: Systemic disease associated with cerebrovascular disease (e.g. diabetes mellitus, hypertension, hyperlipidemia, coronary heart disease) Treatment with corticosteroids or disease-modifying therapies (interferon beta, glatiramer acetate, natalizumab, fingolimod, teriflunomide) within 30 days of the first baseline MRI scan. Treatment at any time with mitoxantrone, cyclophosphamide, or any other long acting immunosuppressant Prior treatment of greater than 1 month at any time with DMF Inability to tolerate MRI procedures Pregnant/breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dimethyl fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in phosphocreatine (PCr) in cerebral grey matter | PCr levels evaluated by magnetic resonance spectroscopy | baseline and 6 months of treatment with Dimethyl Fumarate (DMF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ATP in normal appearing white matter (NAWM) | ATP levels evaluated by magnetic resonance spectroscopy | baseline and 6 months of treatment with Dimethyl Fumarate |