louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01182688: Prospective Review of Procalcitonin After Cardiac Surgery
Official title: Prospective Review of Procalcitonin After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Procalcitonin
Coronary Artery Bypass Grafting
Keywords: utilization of Procalcitonin in the cardiac setting
Lead sponsor: Tampa Bay Heart Foundation
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients having Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases

Brief summary: This study is designed to demonstrate the value of Procalcitonin (PCT) in assisting the rapid diagnosis of post- operative infection that includes elevation of Procalcitonin above and beyond the changes seen with the acute and inflammatory response induced by cardio-pulmonary bypass.

Procalcitonin is an innovative and highly specific biomarker for clinically relevant severe bacterial infections and sepsis. PCT supports early diagnosis and clinical decision making.This is a prospective single center study designed to assess the normal change in PCT levels following major surgery and the utilization of PCT regarding the diagnosis of infection and the response to treatment, following major cardiac surgery

Detailed description: Inclusion Criteria:

Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases

Exclusion Criteria:

Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever \> 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation

Eligibility criteria: Inclusion Criteria:

Elective CABG + / - Aortic / Mitral valve patients Off pump and on pump cases

Exclusion Criteria:

Exclusion Criteria:

Check any box that applies:

Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever \> 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\\ Intra aortic balloon pump pre - op No CABG patients with CRYO MAZE, or Ablation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
Study officials:
References:
Clinical trial NCT00156988: The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
Official title: The Effect of Two Versus Ten Days Application of Flammacerium in Partial Thickness Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Burns
Keywords: burns
partial thickness
cerium flamazine
randomised clinical trial
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
Collaborators: name: Dutch Burns Foundation
First posted: 2005-09-12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the proposed study is to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.

Detailed description: Cerium is suggested to halt the cytokine cascade ensuing burn injury by binding the 'burn toxin' and, when used in combination with silver-sulfadiazine, may enhance its antibacterial effect. Since 1984, the combination of cerium and silver sulfadiazine, flammacerium, has been used in our centre. Current practice is to treat acute, non-facial, burns with daily cleaning and (re-)application of flammacerium for a total of ten days. However, prolonged application of cerium is thought to be unnecessary - it is effective in the early stages after injury- and prolonged application of silver sulfadiazine has a negative effect on wound healing. The objective of the proposed study is therefore, to assess whether the application of flammacerium for 2 days is as good as, or even better than, the application of flammacerium for 10 days regarding woundhealing in partial thickness burns.

Eligibility criteria: Inclusion Criteria:

* patients having partial thickness burns with TBSA of \< 10%

Exclusion Criteria:

* patients not seen within 24 hours postburn
* patients with only facial burns
* patients with electrical or chemical burns
* patients or their parents/caregivers with mental or cognitive deficits that may interfere with providing informed consent

Primary outcomes:
measure: number of days required for wound healing, judged clinically and assessed as both number of days till 95% and 100% re-epithelialisation by planimetry at the time the decision regarding surgery is made (8-10 pb) and as wounds are considered healed
Secondary outcomes:
measure: Wound colonisation, assessed by swabs taken at 0 or 3 days pb, 7 days pb and subsequently every 7 days until wounds are healed or treated surgically, and on indication
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Burns Centre, Martini Hospital
Study officials:
affiliation: Association Dutch Burns Centres
name: Marianne K Nieuwenhuis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04981288: Lipids and Energy Study: Optimizing the Analysis of Lipids and Energy Metabolism in Blood Samples
Official title: Lipids and Energy Study: Optimizing the Analysis of Lipids and Energy Metabolism in Blood Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population chosen for the study is adults 18 years of age or older and strive to represent the ethnic diversity of the greater Columbus, OH region

Brief summary: The proposed research is a feasibility pilot trial designed to optimize the remote collection dried blood spots (DBS) from a finger stick and the analysis of fatty acid from the DBS and to optimize the analysis of mitochondria activity (or energy metabolism) from peripheral blood mononuclear cells (PBMC) or white blood cell samples. Participants in this study will provide a blood sample from venous blood draw and finger sticks. One finger stick collection will be completed remotely using a DBS kit that is sent through the mail while the other finger stick collection will be completed at the research site. These samples will be use to optimize the method for measuring fatty acids and mitochondria function as well as measure other lipids, insulin, glucose and markers of inflammation using established protocols. Demographic, dietary, sleep, and physical activity information will be measured using questionnaires, while height and weight will be measured to calculate body mass index (BMI).

Detailed description: The primary objectives of the study are

* To optimize remote blood collection and laboratory analysis of polyunsaturated fatty acids (PUFAs) in dried blood spot (DBS) samples
* To optimize the analysis of mitochondria function in fresh and frozen peripheral blood mononuclear cells (PBMC)

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Nonsmoking

Exclusion Criteria:

* Diabetes

Primary outcomes:
measure: Optimize mitochondria function measurements in fresh and frozen blood
timeFrame: 1 Day
measure: Optimize remote blood collection and laboratory analysis of in dried blood spot samples
timeFrame: 2 Days
Secondary outcomes:
measure: Assess the relationship of mitochondria function in and cardiolipin in peripheral blood mononuclear cells
timeFrame: 1 Day
measure: Assess the relationship of mitochondria function and fatty acid metabolites
timeFrame: 1 Day
measure: Assess the relationship of mitochondria function and markers of inflammation
timeFrame: 1 Day
measure: Assess the relationship of mitochondria function in peripheral blood mononuclear cells and markers of glycemia
timeFrame: 1 Day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Human Nutrition Laboratory
state: Ohio
Study officials:
References:
Clinical trial NCT01774188: the Impact of EECP on Intraocular Pressure
Official title: Study of the Impact of Enhanced Extracorporeal Counterpulsation Treatment on Intraocular Pressure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraocular Pressure
Keywords: Enhanced Extracorporeal Counterpulsation
intraocular pressure
Pen type tonometer
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Select 40 cases of patients who had counter pulsation treatment at Enhanced External Counter Pulsation (EECP) Specialist in First Affiliated Hospital of Sun Yat-sen University .

Brief summary: EECP therapy may affect the intraocular pressure while improving the ischemia systemic organ blood perfusion the same time. The present study investigated the impact of Enhanced Extracorporeal Counterpulsation treatment on the intraocular pressure.

Detailed description: Select 40 cases of patients (80eyes) who had counter pulsation treatment at Enhanced External Counter Pulsation (EECP) Specialist in First Affiliated Hospital of Sun Yat-sen University during Apr 2012 - Mar 2013. Separated the patients into 2 groups according to having glaucoma history or not.The cases whose eyes have erythralgia and who have received corneal surgery or intraocular surgery in recent one month are excluded.

Eligibility criteria: Inclusion Criteria:

* counter Enhanced External Counter Pulsation treatment

Exclusion Criteria:

* whose eyes have erythralgia
* who have received corneal surgery or intraocular surgery in recent one month
* Hemorrhagic disease
* Atrial fibrillation
* Aortic regurgitation
* thrombophlebitis or infection lesions
* severe hypertensive

Primary outcomes:
measure: intraocular pressure
timeFrame: 7 weeks
Secondary outcomes:
measure: ophthalmic and retina artery blood flow rate
timeFrame: 7 weeks
Other outcomes:
measure: Blood Pressure
timeFrame: 7 weeks
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat- sen University
state: Guangdong
Study officials:
References:
citation: Klein BE, Klein R, Knudtson MD. Intraocular pressure and systemic blood pressure: longitudinal perspective: the Beaver Dam Eye Study. Br J Ophthalmol. 2005 Mar;89(3):284-7. doi: 10.1136/bjo.2004.048710.
citation: Liu L, Zhou S, Wu G, Zheng Z, Jin Y, Yang S, Zhan C, Fang D, Qian X. [Effects of external counterpulsation on the pulsatility of blood pressure in human subjects]. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2002 Sep;19(3):467-70. Chinese.
citation: Werner D, Michalk F, Harazny J, Hugo C, Daniel WG, Michelson G. Accelerated reperfusion of poorly perfused retinal areas in central retinal artery occlusion and branch retinal artery occlusion after a short treatment with enhanced external counterpulsation. Retina. 2004 Aug;24(4):541-7. doi: 10.1097/00006982-200408000-00006.
Clinical trial NCT04430088: Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Vivozon, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-12
Enrollment: 300
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 purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.


Eligibility criteria: Inclusion Criteria:

* Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential.
* Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal fixation (Austin bunionectomy) without collateral procedures.
* Subjects must have the ability to provide written informed consent.
* Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff.

Key Exclusion Criteria:

* Subjects undergoing emergency or unplanned surgery.
* Subjects who had any previous bunionectomy procedure on either foot.
* Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery.
* Female subjects who are pregnant or breastfeeding.
* Diagnosis of chronic pain and ongoing or frequent use of pain medications.

Primary outcomes:
measure: Time-weighted Sum of Pain Intensity Difference (SPID) from baseline over 12 hours after the start of study drug infusion (i.e., post-dose)
timeFrame: 0-12 hours post-dose
Secondary outcomes:
measure: Time to onset of perceptible pain relief using the double stopwatch method
timeFrame: 0-12 hours post-dose
measure: Total number of rescue medication request between 0-12 hours post-dose
timeFrame: 0-12 hours post-dose
measure: Proportion of patients with >40% improvement in pain from baseline to 6 hours post-dose
timeFrame: 0-6 hours post-dose
measure: Proportion of patients who take prescription opioid after discharge
timeFrame: 2 weeks after discharge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Clinical Trial Site
state: Arizona
city: Anaheim
country: United States
facility: California Clinical Trial Site
state: California
city: San Antonio
country: United States
facility: Texas Clinical Trial Site
state: Texas
Study officials:
References:
Clinical trial NCT00023088: Screening Study for the Department of Rehabilitation Medicine
Official title: Rehabilitation Medicine Screening Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Convalescence
Healthy
Keywords: Rehabilitation
Functional Level
Activity of Daily Living
Mobility
Normal Volunteer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-08-23
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The primary function of the Department of Rehabilitation Medicine (RMD) is to diagnose and treat patients at the NIH who have problems in locomotion, activities of daily living, occupational roles, communication, swallowing, or problems with chronic pain. The major goal of this department s to help patients achieve maximal function so that they can resume their daily living activities as normal as possible.

In order for the department to accomplish it's goal it requires the involvement of medical staff and the use of a variety of tests and instruments. Before a new test, evaluation technique, or piece of physical equipment can be considered for use in the treatment of patients it must be carefully studied.

Researchers must make sure the test, technique, or instrument is safe, sensitive, accurate, specific, and reproducible. Therefore all of these tests, techniques, and instruments must first undergo a trial period. Normal volunteers and patients from the RMD and outside of the RMD may be selected to participate in the trial period.

This study provides a framework for researchers in the Department of Rehabilitation Medicine (RMD) to develop new tests, techniques, technology, and equipment.

Detailed description: This protocol provides a framework for clinicians in the Department of Rehabilitation Medicine (RMD) to develop and pilot new tests, techniques, technology, or equipment to remain state-of-the-art.

Eligibility criteria: * INCLUSION CRITERIA:

In- and outpatients referred to the Rehabilitation Medicine Department.

Normal volunteers of either sex.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
References:
Clinical trial NCT01879488: Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Neurosurgery
Keywords: Aerosol
Lung deposition
Mechanical ventilation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition.

The aim of this study is to analyse the effect of ventilation mode (barometric versus volumetric) on deposition by planar scintigraphy during mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Invasive mechanical ventilation
* Healthy lungs

Exclusion Criteria:

* Change of ventilation mode during nebulization

Primary outcomes:
measure: Pulmonary deposition
timeFrame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Secondary outcomes:
measure: Penetration index
timeFrame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
measure: Mechanical ventilation settings
timeFrame: During nebulisation time, an expected average of 15 minutes
measure: Lung function
timeFrame: Preoperative assessment, the day before inclusion
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc
name: Pierre-François Laterre
role: STUDY_CHAIR
References:
citation: Dugernier J, Reychler G, Wittebole X, Roeseler J, Depoortere V, Sottiaux T, Michotte JB, Vanbever R, Dugernier T, Goffette P, Docquier MA, Raftopoulos C, Hantson P, Jamar F, Laterre PF. Aerosol delivery with two ventilation modes during mechanical ventilation: a randomized study. Ann Intensive Care. 2016 Dec;6(1):73. doi: 10.1186/s13613-016-0169-x. Epub 2016 Jul 22.
Clinical trial NCT00419588: Growth of Airways and Lung Tissues in Premature and Healthy Infants
Official title: Growth of Airways and Lung Parenchyma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature, Diseases
Bronchopulmonary Dysplasia
Asthma
Keywords: infant, premature
Bronchopulmonary dysplasia
asthma
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 184
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are recruiting premature infants from Riley Hospial for Children, Methodist Hospital and IU NICu's. We also recruit from the Infant Lung Disease clinic at Riley Hospital for Children. Healhy full term infant are recruited through advertisements.

Brief summary: The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.

Detailed description: SPECIFIC AIM # 1: Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.

SPECIFIC AIM # 2: Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.

We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways at a corrected-age of 1-year. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.

Eligibility criteria: Inclusion Criteria:

* Group 1
* full term greater than 37 weeks
* Group 3
* infants born premature between 23-35 weeks of age to be tested between the ages of two to twenty four months corrected.

Exclusion Criteria:

* heart disease
* severe developmental delays

Primary outcomes:
measure: Pulmonary function Test
timeFrame: day of testing
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Robert S. Tepper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: