louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01636765: Study of Inter- and Intra-rater Reliability of the Clinician Erythema Assessment Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythema
Rosacea
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with facial erythema related to rosacea

Brief summary: This is a study to evaluate inter- and intra-rater reliability of the Clinician Erythema Assessment Scale. There is no treatment (intervention) associated with this study.


Eligibility criteria: Inclusion Criteria:

* Rosacea

Exclusion Criteria:

* Unwilling to remove all facial make-up

Primary outcomes:
measure: Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale
timeFrame: Day 1
measure: Intra-rater Reliability of the CEA Scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01908465: Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial
Official title: Peripheral Histamine 1 Receptor Blockade in IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome (IBS)
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose:

To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.

Design:

Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).


Eligibility criteria: Inclusion Criteria:

* Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form
* age 18-65 years

Exclusion Criteria:

* IBS subtype with constipation
* medication: antidepressants or H1-receptor antagonists
* pregnancy, breast feeding
* co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases

Primary outcomes:
measure: Effect of treatment on global symptom relief (of IBS complaints)
timeFrame: after 12 weeks treatment
Secondary outcomes:
measure: Effect of treatment on stool consistency and frequency and other common IBS associated complaints (flatulence, urgency,...)
timeFrame: fter 12 weeks treatment
Other outcomes:
measure: Effect of treatment on quality of life
timeFrame: after 12 weeks treatment
measure: Effect of treatment on inflammatory mediators/metabolites in urine
timeFrame: after 12 weeks
Locations:
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Genk
country: Belgium
facility: ZOL (Ziekenhuis Oost-Limburg)
state: Limburg
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Zottegem
country: Belgium
facility: AZ Sint-Elizabeth Zottegem
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Lucas Brugge
state: West-Vlaanderen
city: Arnhem
country: Netherlands
facility: Rijnstate
state: Gelderland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Limburg
city: Maastricht
country: Netherlands
facility: AZ Maastricht
state: Limburg
city: Amsterdam
country: Netherlands
facility: Sint Lucas Andreas Ziekenhuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
state: Noord-Holland
city: Blaricum
country: Netherlands
facility: Tergooiziekenuizen Blaricum/Hilversum
state: Noord-Holland
Study officials:
affiliation: Catholic University Leuven and Universitary Hospitals Leuven
name: Guy Boeckxstaens, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01166165: Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension
Official title: Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Vitamin D Deficiency
Keywords: Hypertension
blood pressure
vitamin d
winter
cholecalciferol
arterial stiffness
renin
angiotensin
aldosterone
calcium
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2010-07-20
Enrollment: 136
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: High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.


Eligibility criteria: Inclusion Criteria:

* Well-regulated arterial hypertension
* Office blood pressure \> 120/70 mmHg

Exclusion Criteria:

* Pregnancy or nursing
* Cancer
* Alcohol abuse
* Continuous glucocorticoid or NSAID treatment
* 24-hour blood pressure \> 150/95 mmHg
* Hypercalcemia

Primary outcomes:
measure: 24-hour systolic blood pressure
timeFrame: 20 weeks
Secondary outcomes:
measure: Plasma renin concentration
timeFrame: 20 weeks
measure: Plasma concentration of angiotensin II
timeFrame: 20 weeks
measure: Plasma concentration of aldosterone
timeFrame: 20 weeks
measure: Plasma concentration of c-reactive protein
timeFrame: 20 weeks
measure: Urine albumin creatinine ratio
timeFrame: 20 weeks
measure: Urine calcium creatinine ratio
timeFrame: 20 weeks
measure: Plasma concentration of 25-hydroxycholecalciferol
timeFrame: 5 weeks
measure: Serum concentration of FGF-23
timeFrame: 20 weeks
measure: Augmentation index and central blood pressure
timeFrame: 20 weeks
measure: Pulse wave velocity
timeFrame: 20 weeks
measure: Heart rate variability
timeFrame: 20 weeks
measure: Plasma concentration of ionized calcium
timeFrame: 5 weeks
measure: Plasma concentration of phosphate
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research
Study officials:
affiliation: Departments of Medical Research, Holstebro Hospital
name: Thomas Larsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen T, Mose FH, Bech JN, Hansen AB, Pedersen EB. Effect of cholecalciferol supplementation during winter months in patients with hypertension: a randomized, placebo-controlled trial. Am J Hypertens. 2012 Nov;25(11):1215-22. doi: 10.1038/ajh.2012.111. Epub 2012 Aug 2.
Clinical trial NCT00854165: Lung Transplantation in Respiratory Failure Patients
Official title: Extracorporeal Membrane Oxygenation Support for Bilateral Sequential Lung Transplantation in Respiratory Failure Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Keywords: lung transplantation
respiratory failure
ECMO
Lung transplants in respiratory failure patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between July 2006 and July 2008, we performed bilateral sequential lung transplantation under venoarterious ECMO support in 10 respiratory failure patients with various lung diseases. This study wanted to report the preoperative condition, postoperative complications, and short-term outcome after lung transplantation.

Brief summary: Survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. The objectives of this study were to describe the short-term outcomes of bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO) support in a consecutive series of patients who depended on noninvasive and invasive ventilation support preoperatively .

Detailed description: The one-year survival rate and postoperative pulmonary functional results will be reported in this study.

Eligibility criteria: Inclusion Criteria:

* respiratory patients depended on ventilator supports prior to lung transplant

Exclusion Criteria:

* non-cardaveric lung transplant

Primary outcomes:
measure: 6 months and one year survival after lung transplatn.
timeFrame: 6 months and one year posttransplant
Secondary outcomes:
measure: Pulmonary function results, at baseline and posttransplant 1, 3, and 6 months.
timeFrame: baseline, post-op 1,3, and 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Surgery, National Taiwan University Hospital
Study officials:
affiliation: Department of Surgery, National Taiwan University Hospital
name: Yung-Chie Lee, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Surgery, National Taiwan University Hospital
name: Hsao-Hsun Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01437865: Gadofosveset for Axillary Staging in Breast Cancer Patients
Official title: Non-invasive Nodal Staging in Breast Cancer With MRI Lymphography Using Gadofosveset; a Pilot-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: MRI
lymph node metastases
breast cancer
gadofosveset
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this pilot-study is to examine the accuracy of gadofosveset enhanced MRI compared to current nodal staging methods.

The accuracy of MRL will be determined on the basis of a node-to-node matching of imaged nodes to the definitive histopathology. The pathologic examination of the SNLB or ALND will be regarded as the golden standard for nodal involvement.


Eligibility criteria: Inclusion Criteria:

1. Patient with histopathologically confirmed invasive breast cancer about to undergo nodal staging.
2. Tumor must be a T2 according the TNM 6-classification.
3. The ultrasound of the axilla must be suspect for nodal metastases.
4. Willing and able to undergo all study procedures
5. Has personally provided written informed consent.

Exclusion Criteria:

1. Age \<18
2. History of prior chemotherapy
3. History of prior radiotherapy of the surrounding areas of the axilla.
4. Pregnancy
5. Contra indications for MRI such as pacemaker, aneurysm clips or severe claustrophobia.
6. Allergy to any of the ingredients of Gadofosveset (Vasovist® /Ablavar®)
7. Being unable to give informed consent in person
8. Acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2).
9. Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.

Primary outcomes:
measure: The accuracy (sensitivity, specificity, NPV and PPV) of the MRI in predicting the involvement of metastases
timeFrame: Participants will be followed from the moment of first out-hospital clinic vistit untill final breast surgery, an expected average of 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC) AZM
Study officials:
affiliation: Maastricht University Medical Center
name: R. Beets - Tan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454765: Generation of Haploid Stem Cells From Human Germ Cells
Official title: Generation of Haploid Stem Cells From Human Germ Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Induced Pluripotent Stem Cells
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male volunteers

Brief summary: Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex and therefore limits genetic research approaches in biomedical models. To overcome this problem experimental generation of haploid stem cells has been done in animals. The investigators aim at generating haploid stem cells from human germ cells that are a useful tool in genetic research and screening.

Detailed description: Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex and therefore limits genetic research approaches in biomedical models. To overcome this problem experimental generation of haploid stem cells has been done in animal models. haploid cells are easier for genetic manipulations, such as knock-in and knock-out of genes, and therefore should make a better experimental model. The investigators aim at generating haploid stem cells from human haploid germ cells.

Eligibility criteria: Inclusion Criteria:

1. males over the age of 18 and under 50
2. no known chronic illness
3. not taking any chronic drugs

Exclusion Criteria:

1. females
2. males under 18 or over 50
3. any known chronic illness
4. taking chronic medications

Primary outcomes:
measure: Patients donated samples
timeFrame: June 2011-November 2013
Secondary outcomes:
measure: No secomdary outcome
timeFrame: June 2011 - November 2013
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
city: Rehovot
country: Israel
facility: Weizmann institute of science
Study officials:
affiliation: Rambam Health Care Campus
name: Itay Maza, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563665: Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy
Official title: A Prospective Study on Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: CKD With Hepatitis C
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with Hepatitis C infection attending nephrology and Hepatology OPD (Out Patient Department) or getting outpatient dialysis at the dialysis unit of Institute of Liver and Biliary Sciences.

Brief summary: All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.


Eligibility criteria: Inclusion Criteria:

1. Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
2. Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

1. Age less than 18 years
2. Confirmed pregnancy
3. HCV-HIV Co infection
4. HBV-HCV co infection

Primary outcomes:
measure: Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy.
timeFrame: 1 year
Secondary outcomes:
measure: number of adverse Events in both groups
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Suman Lata Nayak, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289665: The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
Official title: The Effect of Lubricating Gel on Patient Comfort During Speculum Insertion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Examination, Gynecological
Examination, Pelvic
Examination, Vaginal
Keywords: lubricating
gel
speculum
Pain, Pelvic
Examination, Gynecological
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if lubricating gel affects patients' perception of discomfort during speculum insertion, as compared to water.

Detailed description: The outcome measure is patient discomfort as measured by a visual analogue scale.

Eligibility criteria: Inclusion Criteria:

* Women undergoing vaginal speculum examination between the ages of 18 and 50.

Exclusion Criteria:

* Pregnancy.
* Non-English speaking.
* Using hormone therapy.
* Active vulvar or vaginal lesion, infection or complaint.
* Undergoing vaginal or vulvar procedure or biopsy.
* History of chronic pelvic pain, interstitial cystitis or vulvar vestibulitis.
* History of prior vulvar or vaginal surgical procedures.

Primary outcomes:
measure: Patient Discomfort During Speculum Insertion as Measured by a Visual Analog Scale.
timeFrame: Immediate.
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Department of Obstetrics and Gynecology, Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: David A Hill, MD
role: STUDY_CHAIR
References:
citation: Hill DA, Lamvu G. Effect of lubricating gel on patient comfort during vaginal speculum examination: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):227-31. doi: 10.1097/AOG.0b013e3182426275.
Clinical trial NCT05558865: Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
Official title: Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Disorder
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Schleswig-Holstein
name: University Hospital Freiburg
First posted: 2022-09-28
Enrollment: 290
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: The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual \[CAU\]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic insomnia
* impaired quality of sleep (Insomnia Severity Index Score ≥ 10)

Exclusion Criteria:

* none

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 3 months after randomization
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 6 months after randomization
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months and 6 months after randomization
measure: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: 3 months and 6 months after randomization
measure: Work and Social Assessment Scale (WSAS)
timeFrame: 3 months and 6 months after randomization
measure: Responder Rate on Insomnia Severity Index
timeFrame: 3 months after randomization
measure: Remission Rate on Insomnia Severity Index
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy
name: Robert Göder, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01965665: Advancing the Standard of Care for Pin Site Care
Official title: Advancing the Standard of Care for Pin Site Care: Prospective Single Center Study Using Medihoney HCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Open Reduction External Fixation
Keywords: Diabetes
Surgical Intervention
Honey
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively evaluate the effect of Active Leptospermum honey utilizing the MediHoney HCS dressing, on the occurrence of PIN site infections, and also to see if the use of MediHoney HCS reduces the frequency of dressing changes compared to published reports of routine standard pin site care.

Detailed description: Up to 20 Diabetic Mellitus patients undergoing Open Reduction External Fixation (OREF) for foot and/or ankle fusions, fracture repair, or osteotomy will be enrolled to receive weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials. No procedures, tests or interventions will be performed exclusively for research purposes or more frequently than the standard of care. Upon completion of the study, pin sites sepsis rates will be compared to published reports for standard pin site care.

Eligibility criteria: Inclusion Criteria:

* A signed and dated informed consent has been obtained from the subject.
* Subject is able and willing to comply with study procedures.
* Subject is 18 years of age or older.
* Type I or II Diabetes
* Albumin \>2.5
* A1C\<12 or average fasting levels \<200
* ABI \> .6 or biphasic pedal vessels by Doppler
* Charcot arthropathy of lower extremity

  * Foot/ankle deformity
  * Foot/ankle fracture
* Subject will undergo an Open Reduction with External Fixation (OREF).

Exclusion Criteria:

* A1C \> 12
* ABI \< .6 or monophasic pedal pulses on Doppler
* Recent (\<2 months) or ongoing bone infection based on radiograph or scan
* Cellulitis of lower extremity within the last 2 months based on clinical exam and/or laboratory markers
* Honey or honey based allergy

Primary outcomes:
measure: Total Number of Pin Sites
timeFrame: Day of surgical intervention approximately 3hrs.
measure: Number of Patients With Pin Site Infection
timeFrame: weekly from baseline until frame removal, up to 16 weeks
measure: Change in Sepsis Rate
timeFrame: weekly from baseline until frame removal, up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center/Duke South Clinics/3J
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Kerzner, DPM
role: PRINCIPAL_INVESTIGATOR
References: