louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03279575: Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage
Official title: Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1:1 allocation
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the efficacy of two behavioral interventions at recalibrating physician heuristics.

Detailed description: Treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. Accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. Nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. Most of this under-triage occurs because of physician decisions (rather than first-responder decisions). Existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. These strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). Heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. The investigators have developed two separate behavioral interventions to recalibrate physician heuristics in trauma triage, and will compare the effect of these interventions, an educational program, and no intervention on physician performance on a virtual simulation.

Eligibility criteria: Inclusion Criteria:

* Emergency medicine physicians who work at a non-trauma center.
* Emergency medicine physicians who work at a Level III/IV trauma center.

Exclusion Criteria:

* Emergency medicine physicians who work only at a Level I/II trauma center.
* Emergency medicine physicians who do not practice in the US.

Primary outcomes:
measure: Incidence rate of successful triage
timeFrame: One month after completion of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: Mohan D, Fischhoff B, Angus DC, Rosengart MR, Wallace DJ, Yealy DM, Farris C, Chang CH, Kerti S, Barnato AE. Serious games may improve physician heuristics in trauma triage. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9204-9209. doi: 10.1073/pnas.1805450115. Epub 2018 Aug 27.
Clinical trial NCT00465075: Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women
Official title: An Open-Label, Single-Dose, 3-Period, Crossover Study To Determine The Effect Of A High-Fat Meal On The Relative Bioavailability And Pharmacokinetics Of A Single Dose Of Bazedoxifene Acetate/Conjugated Estrogens (Premarin© New Process) Administered Orally To Healthy, Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective is to determine the effect of a high-fat meal on the bioavailability and PK of a single, oral dose of BZA/CE (PNP) 20mg/0.625 strength tablet, assessing both the BZA and CE components.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by the investigator on the basis of history, physical examinations, clinical laboratory test results, vital signs, and 12-lead ECGs.

Primary outcomes:
measure: PK parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04058275: "Immunomodulation in GWI (Phlebotomy)"
Official title: "Immunomodulation in GWI (Phlebotomy)"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gulf War Illness
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Nova Southeastern University
First posted: 2019-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Deployed veterans

Brief summary: Gulf War Illness and deployed veterans of the 1990-1991 Persian Gulf War are invited to have a brief history and physical examination to determine their health status, complete questionnaires, then donate about 83 ml of blood. There is no follow-up

Detailed description: Gulf War Illness and deployed veterans of the 1990-1991 Persian Gulf War are invited to have a brief history and physical examination to determine their health status, complete questionnaires, then donate about 83 ml of blood. There is no follow-up.

Eligibility criteria: Inclusion Criteria:

* Kansas Criteria for GWI
* CDC criteria for CMI

Exclusion Criteria:

* Chronic medical or psychiatric disorder that may be responsible for symptoms of GWI

Primary outcomes:
measure: Gene expression in peripheral blood mononuclear cells
timeFrame: After study recruitment, phleobotomy and mRNA quantification for all participants has been completed in June 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: James N Baraniuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01857375: A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe
Official title: A Study of Improved Efficacy, Safety and Compliance to Administer Insulin in Pen vs. Vial and Syringe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes - insulin administration
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2013-05-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults newly begun on insulin therapy during their hospital stay.

Brief summary: This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay.

Detailed description: This research is to determine the use of insulin pens compared to syringe and vial therapy in adults newly begun on insulin therapy during their hospital stay. Patients will have no prior experience using insulin or other self-administered injectable medicine. The study will examine which method of administering insulin reduces dosing errors, causes a lower incidence of low blood sugars, increases adherence to therapy and with which method patients are more satisfied.

Eligibility criteria: Inclusion Criteria:

* Adult in hospital and diagnosed with diabetes; must have no prior experience using insulin or other self-administered injectable medicine. they must be able to prepare an injection and to self administer the insulin using either a pen device or syringe and vial. They must be willing to monitor their blood sugar three times per day and keep a diary of their sugar measurements and insulin doses.

Exclusion Criteria:

* Previously treated with injectable medicine

Primary outcomes:
measure: Insulin Dosing Accuracy (in units)
timeFrame: Approximately one year
Secondary outcomes:
measure: Reduce the Risk of hypoglycemia (assessed by patient diary)
timeFrame: 3 months
measure: Adherence to prescribed dose of insulin (assess patient diaries and observation of used pens/vials)
timeFrame: 3 months
measure: Patient satisfaction with method of insulin administration measured by questionnaire.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: SIUH
name: Jeffrey Rothman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01607775: In-house Produced PMMA- Versus PEEK-cages
Official title: Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cervical Disc Degeneration
Cervical Stenosis
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.


Eligibility criteria: Inclusion Criteria:

* virgin spines
* no emergency operation
* age above 18
* sufficient knowledge of the German language
* indication for anterior cervical discectomy and fusion
* absence of concomitant spinal disease

Exclusion Criteria:

* prior cervical surgery
* indications other than ACDF
* concomitant neoplastic, metabolic, severe general or infectious disease

Primary outcomes:
measure: Clinical outcome (NDI)
timeFrame: 12 months postoperative
Secondary outcomes:
measure: Clinical outcome (VAS-neck), Subsidence
timeFrame: 12 months postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00228475: A Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women
Official title: An Open Single Centre Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women on Maintenance Treatment w/Pulmicort ® Turbuhaler ® at the Dose Levels 200/400 µg Bid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 8
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on their normal maintenance treatment with budesonide (Pulmicort Turbuhaler), and to estimate the exposure of budesonide to infants.


Eligibility criteria: Inclusion Criteria:

* Be willing and able to comply with study procedures and provide informed consent.
* Be breast-feeding women, aged 18 to 45 years inclusive, and having infants aged 1 to 6 months.
* Be asthmatics that have been on maintenance treatment with Pulmicort Turbuhaler 200 or 400 µg bid for at least 3 months prior to visit

Exclusion Criteria:

* Clinically relevant abnormalities in physical examination, laboratory assessments, blood pressure or pulse as judged by the investigator.
* Clinically relevant disease and/or abnormalities, which in the opinion of the investigator, may either put the patient or infant at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study.
* A suspected/manifested infection of HIV, hepatitis B or C or other infection according to WHO Risk classification 2-4

Primary outcomes:
measure: The concentration of budesonide in breast milk from asthmatic women
measure: on maintenance treatment with Pulmicort Turbuhaler
Secondary outcomes:
measure: Level of budesonide to the infant from breast milk concentrations
Other outcomes:
Locations:
city: Uppsala
country: Sweden
Study officials:
affiliation: AstraZeneca
name: AstraZeneca RITA Clinical Department
role: STUDY_DIRECTOR
References:
Clinical trial NCT01963559: Cutaneous Microcirculation and Diabetic Foot
Official title: Cutaneous Microcirculation and Diabetic Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Proned Patients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.


Eligibility criteria: Inclusion Criteria:

* Adult Men and Women
* Presence of diabetes
* Signed acknowledgement form

Exclusion Criteria:

* No signed acknowledgement form
* patients under 18 year-old

Primary outcomes:
measure: Cutaneous blood flow
timeFrame: Within 3 months after inclusion
Secondary outcomes:
measure: Effect of neuropathy on PIV impairment
timeFrame: Within 3 months after inclusion
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT03349359: Impact of CMV Status on HIV Viral Load Decay
Official title: Impact of Cytomegalovirus (CMV) Status Prior Antiretroviral Therapy on HIV Viral Load Decay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients followed at the Department of Infectious Diseases, Croix-Rousse Hospital, Groupement Hospitalier Nord, Hospices Civils de Lyon, Lyon, France between June 2005 and July 2016 starting an antiretroviral treatment and with available CMV serology at treatment initiation.

Brief summary: Background: Cytomegalovirus (CMV) infection is usually observed among patients with HIV infection. No study to date has investigated the impact of CMV infection on HIV viral load decay during antiretroviral therapy.

Methods: 345 consecutive HIV patients coinfected (N=300) or not (N=45) with CMV were enrolled. Clinical, biological and virological data were collected from HIV antiretroviral therapy initiation to the day of HIV viral load undetectability if any.


Eligibility criteria: Inclusion Criteria:

* HIV patients starting an antiretroviral therapy
* CMV serology available at antiretroviral therapy initiation
* HIV viral load assessed at each follow-up visit after treatment initiation

Exclusion Criteria:

* HIV antiretroviral treatment initiation before June 2005

Primary outcomes:
measure: HIV viral load undetectability
timeFrame: From date of HIV therapy initiation until the date of HIV viral load undetectability (12 weeks in average after treatment initiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00241059: Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
Official title: A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal transplantation, maintenance patients, tolerability, EC-MPS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.


Eligibility criteria: Inclusion Criteria:

* All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion Criteria:

* Other protocol-defined inclusion / exclusion criteria may apply

Primary outcomes:
measure: Safety parameters and graft function in maintenance renal transplant recipients.
Secondary outcomes:
measure: Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02781259: Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Official title: Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Neoplasms
Keywords: Sentinel Lymph Node Biopsy
Fluorescence
Breast Neoplasms
Indocyanine Green
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.

Detailed description: Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. The operator can track the lymphatic pathway without skin incision in real time. By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. This is why we can identify the lymphatic metastasis pathway of breast cancer.

Eligibility criteria: Inclusion Criteria:

* Operable breast cancer patient
* Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection

Exclusion Criteria:

* Breast cancer history
* Occult breast cancer
* Past history of axillary surgery
* Iodine hypersensitivity
* Pregnancy

Primary outcomes:
measure: Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist
timeFrame: within 2 weeks (plus or minus 3 days) after surgery
Secondary outcomes:
measure: Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes
timeFrame: within 2 weeks (plus or minus 3 days) after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: SeokWon Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02896959: How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.
Official title: How Much is Too Much: Assessing Varying Pressure Pump Pressures in Post Operative Pain Control in Shoulder Arthroscopy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Arthroscopy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative surgical pain has been extensively study with regard to anaesthesia pain modalities, however little is published with regards to various arthroscopic shoulder surgical techniques. An intriguing characteristic of shoulder arthroscopy is the various arthroscopic pump pressures used by different surgeons. One could hypothesize that excessive water retention from the arthroscopic pump could causes excessive tissue pressure and swelling resulting in post operative pain. Unfortunately we could not find any literature in the English language regarding varying pressure pump settings on post operative pain control. For that reason we would like to assess how variable pump pressure effect tissue pressure over pre set time points, and how this may relate to post operative pain control.


Eligibility criteria: Inclusion Criteria:

* Patients attending St. Joseph's hospital
* Shoulder pathology amenable to arthroscopic surgery
* Medically suitable for surgical management
* Able to consent for surgery.

Exclusion Criteria:

* Unable to consent
* Active infection
* Active malignancy
* Drug or alcohol misuse
* Work related injury
* Lack of permanent home residence
* Previous surgery to affected shoulder
* Medical contraindiction to surgery
* Pregnant women

Primary outcomes:
measure: Pain - VAS scale
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: