louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01446341: Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
Official title: A Pilot Study Towards a Randomized Clinical Trial of Cast Immobilization Versus Functional Therapy for Acute, Severe Lateral Ankle Sprains
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Sprain
Keywords: Ankle sprain
Functional rehabilitation
Immobilization
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Workers' Compensation Board of BC
First posted: 2011-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acute, severe lateral ankle sprains are estimated to comprise between 3-5% of emergency department visits and are the most common musculoskeletal injury in the physically active population. Although the current accepted treatment of ankle sprains is to encourage early mobilization with functional rehabilitation, there is little high-quality evidence directing this clinical practice.

This pilot study is to:

* provide quantitative data for estimation of mean outcome scores and standard deviations to allow subsequent sample size calculations
* evaluate the feasibility of the proposed study design
* assess patient enrollment issues specific to randomization into an active rehabilitation program compared to below knee immobilization.


Eligibility criteria: Inclusion Criteria:

* age over 18
* meet clinical criteria for unilateral grade II-III ankle sprains (inability to weight bear)

Exclusion Criteria:

* bony injury on x-ray or computed tomography
* contraindications to recurrent icing
* high risk of deep-vein thrombosis
* injury greater than 3 days old
* ongoing recovery from previous acute ankle sprain
* age greater than 60
* non-English speaking patients, those patients unable to provide informed consent or patients with insufficient contact information for follow-up

Primary outcomes:
measure: Change from baseline Foot and Ankle Outcome Score (FAOS)measured at 1 and 3 months.
timeFrame: Measured at 0, 1, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia - Vancouver Coastal Health Research Institute
name: Nicholas Rose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421941: Enteral Feeding Study of Formula Containing Fish Oil in Critical Care Setting
Official title: Use of a High-protein Enteral Formula Containing Prebiotics and Fish Oil in Critical Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trauma
Tube Feeding
Keywords: enteral feeding
critical care
fish oil
surgical
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical applicability of an enteral tube feeding formula containing fish oil and prebiotics in a critical care population.

Detailed description: In terms of nutrition support in the acute care setting, it is generally accepted that

1. earlier is better
2. enteral is superior to parenteral
3. the quality of nutrients appears more important than quantity
4. select populations will show additional benefit from specific nutrient supplementation.

The current study is designed to evaluate the tolerance of an enteral formula in trauma and surgery patients, as demonstrated by achieving and maintaining enteral feeding goal, gastrointestinal tolerance and inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* 18 - 70 years old
* New ICU admit
* Enteral tube feeding anticipated for at least 7 days
* Informed consent

Exclusion Criteria:

* Enteral tube feeding immediately prior to admit
* Parenteral feeding
* Medical condition that preclude receiving tube feeding or formula
* Determined by PI to be inappropriate
* Participating in another clinical trial

Primary outcomes:
measure: Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day
Secondary outcomes:
measure: Gastrointestinal tolerance
measure: Time to advance to full feed
measure: Inflammatory markers
measure: Infection
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Robert Martindale, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03153241: Subglottic Secretion Culture in Predicting Tracheal Microbial Flora
Official title: Value of Subglottic Secretion Culture in Predicting Microbial Flora of Tracheal Secretions in Intubated Patients. a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 100
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: ICU patients under invasive mechanica ventilations for at least 48 hours

Brief summary: Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been recommended as a preventive strategy to avoid microaspiration and VAP. In this context, whereas considerable literature exists on the use subglottic secretion drainage (SSD) in patients at risk for developing VAP, there is a lack of data on the bacterial growth in the subglottic fluid above the cuff.

The primary objective of the study will be to assess the value of subglottic secretion culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point will be to estimate the predictive value of subglottic secretion culture in identifying bacterial pathogens in the sub-population of patients who will develop VAP.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

* age \<18 years
* absence of informed consent
* pregnancy
* documented treatment-limitation orders in the patient's chart

Primary outcomes:
measure: Number of patients with the same pathogens in both subglottic secretions and endotracheal aspirates
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazioen Policlinico Universitario A. Gemelli IRCCS
Study officials:
References:
citation: Bello G, Bisanti A, Giammatteo V, Montini L, Eleuteri D, Fiori B, La Sorda M, Spanu T, Grieco DL, Pennisi MA, De Pascale G, Antonelli M. Microbiologic surveillance through subglottic secretion cultures during invasive mechanical ventilation: a prospective observational study. J Crit Care. 2020 Oct;59:42-48. doi: 10.1016/j.jcrc.2020.05.013. Epub 2020 May 26.
Clinical trial NCT04324541: Health & Aging Brain Study: Health Disparities TAU Project
Official title: Health & Aging Brain Study: Health Disparities TAU Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Aging in Mexican Americans
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexican Americans that participated in the Health \& Aging Brain Study Amyloid Project

Brief summary: By doing this study we are trying to learn more about brain aging in Mexican Americans.

Participants will be asked to complete a screening visit to determine if it is safe to undergo a PET scan.

If eligible, participants will undergo a medical procedure that takes a picture of their brain. This procedure is called a PET scan of the brain.


Eligibility criteria: Inclusion Criteria:

* Participation in the Health \& Aging Brain Study: Health Disparities Amyloid Project

Exclusion Criteria:

* Not a participant in the Health \& Aging Brain Study: Health Disparites Amyloid Project
* Medical condition that precludes safe use of PET tracer

Primary outcomes:
measure: Tau Accumulation Measured by PET Imaging
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center Institute for Translational Research
state: Texas
Study officials:
References:
Clinical trial NCT00408941: EEG and Auditory Evoked Potentials During Local Anesthesia
Official title: EEG and Auditory Evoked Potentials During Local Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Keywords: EEG
AEP
Artefacts
Propofol
Local Anaesthesia
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.

Detailed description: Spontaneous or evoked electrical brain activity is increasingly used to monitor general anesthesia. During alertness, surgery and anesthesia the quality of AEP recordings may be reduced by artefacts. This poses the question to what extent AEP are sensitive for muscular artefacts. High frequency artefacts can have its seeds in muscles and in technical instruments in the operating room. Therefore, the study will take place under the terms of laboratory.

The present study was designed to measure the influence of muscular artefacts on AEP under propofol sedation with or without local anesthesia in the area of the electrodes.

If artefacts influence AEP, which are used to measure anesthesia, it is particularly interesting with regard to clinical application. AEP as a measure of "anesthetic depth" may not only reflect brain, but also muscular and high frequency activity. Therefore, while using muscle relaxants, the AEP of an awake patient may indicate deep anesthesia, because muscle signals are absent.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion Criteria:

* drugs that effect the central nervous system
* neurological or psychiatric deceases
* contraindications against use of propofol or local anesthesia

Primary outcomes:
measure: differences of AEP during sedation with and without local anaesthesia
Secondary outcomes:
measure: fraction of high frequency artefacts
measure: time to LOC
measure: differences AEP awake with and without local anaesthesia
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar der Technischen Universität München
name: Eberhard Kochs, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00614341: Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
Official title: A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Peripheral Neuropathy
Keywords: diabetes mellitus
neuropathy
distal symmetric polyneuropathy
pulsed electric fild
Lead sponsor: MedRelief
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.

The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.

Detailed description: A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.

Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).

Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.

Eligibility criteria: Inclusion Criteria:

* currently diagnosed with diabetes mellitus
* confirmed diagnosis of diabetic peripheral neuropathy
* age 18 years to 75 years
* both males and females are eligible for study participation
* HgA1c level under 9
* Physician confirmed stable glycemic control for 3 months prior to enrollment
* baseline pain level over previous month of 5
* willing to sign IRB approved consent and follow study visit requirements
* if female of childbearing age willing to undergo urine pregnancy test

Exclusion Criteria:

-

Primary outcomes:
measure: Pain reduction in diabetic patients with chronic diabetic neuropathy
timeFrame: Day 21
Secondary outcomes:
measure: Improvement in sensation and overall foot condition
timeFrame: Day 21
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Nephrology and Rheumatology Associates
state: Georgia
Study officials:
affiliation: Nephrology and Rheumatology Associates
name: Amy M Sprague, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05859841: Effect of Music Listening on Stress in Acute Stroke
Official title: Effect of Music Listening at Acute Stage of Stroke on the Recovery and Quality of Life: Block-randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Stroke
Keywords: Stroke
Music
stress
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Helsinki
First posted: 2023-05-16
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 15 pt listen to music, 15 receives standard treatment, care and rehabilitation
Primary purpose: TREATMENT

Brief summary: Investigation on changes in the neurochemical stress parameters in acute stroke. 30 patients are recruited in the stroke unit, blood samples are collected at fixed intervals during the first two days. Patients are randomized to music listening and control.Neuropsychological testing is performed in the acute phase and 6 months post-stroke.

Detailed description: Outcome measures: NIHSS, stress hormone levels, questionnaires on mood and quality of life.

Eligibility criteria: Inclusion Criteria:

* Hemispheric infarction
* Neurologically stable

Exclusion Criteria:

* Previous neurological disease affecting the outcome
* Previous psychiatric disease affecting the outcome
* Substance abuse

Primary outcomes:
measure: Depression, Anxiety and Stress Scale
timeFrame: 1 day post-stroke
measure: National Institute of Health Stroke Scale
timeFrame: 1 day post-stroke
measure: Visual Analogue Mood Scale
timeFrame: 2 days post stroke
measure: Serum cortisol
timeFrame: 2 days post-stroke
measure: Serum C-reactive protein
timeFrame: 2 days post-stroke
measure: Montreal Cognitive Assessment
timeFrame: 3 days post-stroke
measure: Blood pressure
timeFrame: 3 days post-stroke
measure: Pulse rate
timeFrame: 3 days post-stroke
measure: Depression, Anxiety and Stress Scale
timeFrame: 6 months post-stroke
measure: National Institute of Health Stroke Scale
timeFrame: 6 months post-stroke
measure: Visual Analogue Mood Scale
timeFrame: 6 months post-stroke
measure: Montreal Cognition Assessment
timeFrame: 6 moths post-stroke
measure: Stroke and Aphasia Quality of Life scale
timeFrame: 6 months post-stroke
measure: Center for Epidemiological Studies Depression score
timeFrame: 6 months post-stroke
measure: Working Memory Questionnaire
timeFrame: 6 months post-stroke
measure: Stroke Impact Scale
timeFrame: 6 months post-stroke
Secondary outcomes:
measure: Leisure Activity Questionnaire
timeFrame: 6 months post-stroke
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Chief of Research
name: Susanna Tuomaala
role: STUDY_CHAIR
References:
Clinical trial NCT01341041: Chlorine Dioxide Versus Saline for Wound Irrigation
Official title: Wound Irrigation: Comparison of Normal Saline With Chlorous Acid Chlorine Dioxide Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Wound - in Medical Care
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 201
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: This research is being done because the investigators are trying to examine the safety and effectiveness of this wound cleaning liquid, CACD (chlorine dioxide). The investigators are trying to see if this liquid has the ability to decrease infection rates and decrease the scarring effects from the healing process. In animal studies, CACD has been shown to decrease scar formation and decrease the risk of wound infections. CACD is also used for the treatment of burns to decrease infection rates and improve wound healing. CACD is not FDA approved for this specific use, but it is FDA and USDA approved for reducing bacterial contamination on meat and food products for human consumption. In addition, an investigational drug (IND) application has been submitted to the FDA for this study. The FDA has approved the use of this solution for this study.


Eligibility criteria: Inclusion Criteria:

* 18-100 years old
* simple laceration requiring irrigation \& sutures
* patient has method of contact
* patient is willing to return to ED in 3-4 mths

Exclusion Criteria:

* immunocompromised
* consult required for repair
* diabetic
* require antibiotics

Primary outcomes:
measure: cosmesis
timeFrame: 72 hrs post-ED visit
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT03655041: 24-Wk β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males
Official title: 24-Weeks of β-Alanine Ingestion on Muscle Taurine and Clinical Blood Parameters in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Nutritional Physiological Phenomena
Keywords: Physiological Phenomena
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Although β-alanine (BA) has been shown to be an effective ergogenic aid, little information exists on the safety of chronic supplementation despite potential concerns. The aim of this study was to investigate the effects of chronic BA supplementation on muscle taurine content, blood clinical markers and sensory side-effects during 24 weeks of BA supplementation.


Eligibility criteria: Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* Smokers
* Chronic disease
* Prior or current use of steroids
* Use of creatine in the last 6 months
* Use of beta-alanine in the last 6 months

Primary outcomes:
measure: Muscle taurine content in mmol/kg
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Aspartate transaminase; alanine aminotransferase; alkaline phosphatase; lactate dehydrogenase and creatine kinase in U/L
timeFrame: Up to 24 weeks
measure: Albumin; globulin; creatinine in mg/dL
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: PRINCIPAL_INVESTIGATOR
References: