louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02870595: The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia
Official title: The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Analgesia
Lead sponsor: Christus Spohn Memorial Medical Center
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.

Detailed description: Research Question/Hypothesis

The investigators hypothesize that patients who receive 1% lidocaine injections for digit blocks of the finger will experience less pain when the injection is accompanied by the use of a micro-vibratory stimulator (MVS) compared with patients who receive injections without the MVS.

Objectives

The primary objective of this study is to compare the pain rating scale from an exposure group (digit block injection with the aid MVS) and the control group (traditional injection).

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between the ages of 18 and 65 who are willing and able to consent and who require the use of local anesthetic digit block to both sides of a finger for the treatment of wounds, injuries, infections, or laceration of the fingers.

Exclusion Criteria:

* Allergy to any type of local anesthetic.
* Inability to Consent.
* Inability to complete a numeric pain scale.
* Clinical appearance or clinical evidence of intoxication.
* Significant compromising conditions such as major trauma and severe respiratory distress.

Primary outcomes:
measure: Pain associated with injection of lidocaine
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02450214: Intraoperative Ketamine and Magnesium Therapy for Control of Postoperative Pain After a Liposuction and Lipoabdominoplasty
Official title: Efficacy of Ketamine and Magnesium Association in the Postoperative Pain After Liposuction and Lipoabdominoplasty: Prospective, Randomized and Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Ketamine
Magnesium
Analgesia
Liposuction
Lipoabdominoplasty
Preemptive analgesia
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 63
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: PREVENTION

Brief summary: Lipoabdominoplasty and liposuction are one of the most common plastic surgeries. The management of postoperative pain is complex. Non Steroidal Anti Inflammatory Drugs (NSAIDs) are insufficient, while opioids are avoided by their adverse effects and regional techniques are hampered by a premature discharge. In this context, the investigators seek an intraoperative multimodal analgesic technique blocking NMDA receptors with ketamine plus magnesium to significantly decrease postoperative pain.


Eligibility criteria: Inclusion Criteria:

* Female and male
* 18 years or older
* Liposuction and lipoabdominoplasty
* ASA 1 and 2
* BMI 21-28 Kg/m2
* Full secondary education

Exclusion Criteria:

* Patients with surgeries added to the main proceedings
* Scheduled to tuck in Flor de Lis or Body Lift
* History of use of analgesic drugs 48 hours before surgery
* Peripheral central neurological diseases
* Known allergy will be excluded to medication in use in this study (ketamine, magnesium, clindamycin and penicillin or other)

Primary outcomes:
measure: Opioids consumption
timeFrame: 12 h after surgery
measure: Postoperative Pain (Postoperative Pain and Disability Scale)
timeFrame: 2, 7, 14, 21, 45 and 90 days after surgery
Secondary outcomes:
measure: Early postoperative pain (Visual analogue pain scale)
timeFrame: 0, 2, 4, 6, 12 and 24 h after surgery
measure: Early postoperative pain (Time to first request for supplemental analgesia)
timeFrame: 1 day
measure: Disability (Time delay in returning to work)
timeFrame: 90 days
measure: Postoperative Chronic Pain (McGill scale)
timeFrame: Day after surgery, 7, 30 and 90 days after surgery
Other outcomes:
measure: Drug Side Effect
timeFrame: First day after surgery
measure: Other Variables
timeFrame: First day
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico de la Universidad de Chile
state: RM
Study officials:
References:
Clinical trial NCT06286514: Food at Home Study
Official title: Food at Home Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Diet, Healthy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over 18 who speak either English or Spanish at home and who are responsible for the majority of the cooking or grocery shopping for their family. There will be 150 participants in the paper validation phase (75 who speak English at home and 75 who speak Spanish at home) and 200 participants in the validation of the electronic Home Food Inventory (eHFI) (100 who speak Spanish at home and 100 who speak English at home)

Brief summary: The study objective is to develop an accessible home food environment assessment toolkit that includes valid and reliable paper and electronic tools targeting foods known to impact diet-related health that can be user-administered across literacy levels in English and Spanish.


Eligibility criteria: Inclusion Criteria:

* Speak Spanish or English at home
* 18 or older
* primary grocery shopper or meal preparer

Exclusion Criteria:

* Any person younger than 18
* lacks the capacity to consent
* does not purchase the majority of the groceries for the home

Primary outcomes:
measure: Usability of HFI core
timeFrame: 1 month
measure: Acceptability of HFI core
timeFrame: 1 month
measure: Concurrent criterion validity of HFI core
timeFrame: 1 month
measure: Concurrent criterion validity of HFI core
timeFrame: 1 month
measure: Convergent construct validity of HFI core
timeFrame: 1 month
measure: Convergent construct validity of HFI core
timeFrame: 1 month
measure: Test-retest reliability of HFI core
timeFrame: 1 month
measure: Usability of eHFI
timeFrame: 1 month
measure: Acceptability of eHFI
timeFrame: 1 month
measure: Concurrent criterion validity of eHFI
timeFrame: 1 month
measure: Concurrent criterion validity of eHFI
timeFrame: 1 month
measure: Convergent construct validity of eHFI
timeFrame: 1 month
measure: Convergent construct validity of eHFI
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jayne Fulkerson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03438214: Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients
Official title: Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gram-Positive Bacterial Infections
Nephrotoxicity
Sepsis
Keywords: Vancomycin infusion
critical ill patients
MRSA
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled multicenter clinical trial. The purpose of this study is to compare the continuous infusion of vancomycin with intermittent infusion regarding the effectiveness to reach the target serum level and the relationship between infusion type and nephrotoxicity in critically ill patients.

Detailed description: The vancomycin is a glycopeptide antimicrobial which has been used for 50 years against gram-positive microorganisms and remains effective against multiresistant bacteria as the methicillin resistant Staphylococcus aureus (MRSA), the main microorganism causing nosocomial infections. Around the world, the continuous infusion of vancomycin has been studied and associated with less rate of nephrotoxicity. This is a randomized, controlled multicenter clinical trial that will compare continuous infusion with the intermittent vancomycin infusion, the relationship between infusion type with rate of nephrotoxicity and the time to target therapeutic serum in critically ill patients at the intensive care units of the Cancer Institute of the State of Sao Paulo (ICESP) and the Heart Institute (Incor).

Eligibility criteria: Inclusion Criteria:

* Critically ill patients
* Treatment with vancomycin
* Preserved renal function.

Exclusion Criteria:

* Cystic fibrosis
* Chronic renal failure
* Acute renal failure
* Having received vancomycin in the last 24 hours
* Vancomycin hypersensibility

Primary outcomes:
measure: Acute renal failure
timeFrame: 30 days after randomization
Secondary outcomes:
measure: Acute renal failure
timeFrame: 30 days after randomization
measure: Hypersensibility reactions with vancomycin
timeFrame: 30 days after randomization
measure: Length of ICU stay
timeFrame: 30 days after randomization
measure: Time of treatment with the antimicrobial
timeFrame: 30 days after randomization
measure: Length of hospitalization
timeFrame: 30 days after randomization
measure: Mortality rate
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculty of Medicine University os São Paulo
state: SP
Study officials:
affiliation: University os São Paulo
name: Juliano P Almeida, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University os São Paulo
name: Estela M de Oliveira, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03399214: Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects
Official title: A Phase Ib Study to Evaluate Safety and Efficacy Profiles of IOP Injection for Magnetic Resonance Imaging (MRI) Contrast Agent in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Magnetic Resonance Imaging
Lead sponsor: MegaPro Biomedical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-16
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.

Detailed description: Find the max. signal change after IOP administration

Eligibility criteria: Inclusion Criteria:

1. Male, age ≥ 20 \~40 years, BMI=18\~27.
2. The biochemistry test results, complete blood count (CBC) test results, urinalysis test results, coagulation time test results must within normal range or considered clinically normal by the clinical investigator at screening.
3. Male subjects must take reliable contraceptive method(s) during and after the study for a period of 14 days.
4. No screening of drug or alcohol abuse within one year prior to study enrollment.
5. Subjects are willing to comply with the protocol and sign informed consent form.

Exclusion Criteria:

1. Subjects have serious allergic history or known allergy to MRI contrast agent.
2. Subjects with HBV, HCV, HIV.
3. Imaging and/or functional abnormalities of liver and/or spleen.
4. Subjects have alcohol or caffeine consumption within 48 hours prior to the administration of study contrast agent.
5. Subjects have electronically, magnetically and mechanically activated implanted devices.
6. Subjects have participated in other investigational trials or receive any contrast agents within 28 days prior to study enrollment.
7. Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption and elimination of investigational contrast agent.
8. Subjects have taken any food 6 hours prior to administration.

Primary outcomes:
measure: The Change of MRI SI (%) in vessels, liver, and spleen
timeFrame: Day1: within 60 mins after IOP administration
Secondary outcomes:
measure: The changes from baseline in hematology data
timeFrame: within 14 days
measure: The incidence of all treatment-related adverse events (TRAE)
timeFrame: within 14 days
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: rclee@vghtpe.gov.tw
name: Rheun-Chuan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04589195: Measuring Mindfulness Application
Official title: Measurement of an Application - Based Delivery of Mindfulness Training Program Content
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: Mindfulness Training
Cognitive Training
Psychological Health
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness.


Eligibility criteria: Inclusion Criteria:

1. Individuals who are between 18 and 64 years of age.
2. Individuals who are fluent English speakers.
3. Individuals who have access to either an Apple or Android smart phone and a desktop or laptop computer, are able to adequately and independently use both devices, and have Internet connection.
4. Individuals who are willing and able to consent to participate in the study.
5. Individuals who are in the South Florida ROTC program.

Exclusion Criteria:

1.Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.

Primary outcomes:
measure: Change in Positive Affect
timeFrame: Baseline to Week 5
measure: Change in Negative Affect
timeFrame: Baseline to Week 5
measure: Change in Perceived Stress
timeFrame: Baseline to Week 5
Secondary outcomes:
measure: Change in Sustained Attention Response Task (SART) scores
timeFrame: Baseline to Week 5
measure: Change in Cognitive Failures
timeFrame: Baseline to Week 5
Other outcomes:
measure: Change in Psychological Health
timeFrame: Baseline to Week 5
measure: Change in Mindfulness
timeFrame: Baseline to Week 5
measure: Change in Decentering
timeFrame: Baseline to Week 5
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amishi Jha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04483895: Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates
Official title: Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method.


Eligibility criteria: Inclusion Criteria:

* • Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant.

  * Delivery room intubations were not included as infants are not routinely weighed prior to resuscitation at our hospital. However, infants intubated in the delivery room who were subsequently intubated in the NICU were eligible for inclusion in our study.

Exclusion Criteria:

- 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.

4. Neonates those whose parents declined consent were excluded from the study.

Primary outcomes:
measure: the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.
timeFrame: 28 days
Secondary outcomes:
measure: the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.
timeFrame: 28 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: medicine -Ain Shams University
Study officials:
References:
Clinical trial NCT03001895: Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
Official title: Correlation Between SUV on 18F-DCFPyL PET/CT and Gleason Score in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed manifold on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabeled tracer molecules. 18F-DCFPyL is a tracer for prostate cancer PET imaging which binds to PSMA. The strength of functional imaging methods is in distinguishing tissues according to metabolism rather than structure. Studies have shown that PET/CT imaging with 18F-DCFPyL can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low.

The objective of this study is to evaluate if the patient-wide SUVmax on 18F-DCFPyL PET/CT in locoregional and metastatic prostate cancer correlates with histopathologic Gleason score at initial biopsy. It is hypothesized that SUVmax will correlate positively with Gleason score. This is of interest because non-invasive risk stratification may be possible in the future.


Eligibility criteria: Inclusion Criteria:

* Resident of Canada
* Male sex
* Age 18 years or older
* Previous diagnosis of prostate cancer with Gleason Score available
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Under referring physician's care
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation

Exclusion Criteria:

* Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
* Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients with unmanageable claustrophobia

Primary outcomes:
measure: SUVmax on 18F-DCFPyL PET/CT
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT02262195: Dysfunctional Hemoglobin
Official title: Dysfunctional Hemoglobin Pulse Co-ox
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elevated Levels of Carboxyhemoglobin and Methemoglobin
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2014-10-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Adult volunteers

Brief summary: The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.


Eligibility criteria: Inclusion Criteria:

* Subjects does not have significant medical problems
* Subject is willing to provide written informed consent
* Subject is between 18 and 45 years of age

Exclusion Criteria:

* Has a BMI greater than 31
* Has had any relevant injury at the sensor location site
* Has deformities or abnormalities that may prevent proper application of the device under test
* Has a known respiratory condition
* Is currently a smoker
* Has a known heart or cardiovascular condition
* Is currently pregnant
* Is female and actively trying to get pregnant
* Has a clotting disorder
* Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia)
* The subject has a COHb greater than 3% or MetHb greater than 2%
* Has taken blood thinners or medication with aspirin within the last 24 hours
* Has unacceptable collateral circulation from the ulnar artery
* Has donated more than 300 mL of blood within one month prior to start of study
* Is unwilling or unable to provide written informed consent to participate in the study
* Is unwilling or unable to comply with the study procedures
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing

Primary outcomes:
measure: Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
timeFrame: 4 hours
measure: Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry
timeFrame: 4 hours
Secondary outcomes:
measure: Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin
timeFrame: 4 hours
measure: Determine oxygen saturation accuracy in conditions of elevated methemoglobin
timeFrame: 4 hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of San Francisco
name: Phillip E Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: