louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00850122: An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Official title: An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sepsis
Prematurity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-02-24
Enrollment: 9
Sex: ALL
Minimum age (years): 48
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants \<121 days of age and \< 28 weeks gestation with suspected sepsis. There will be two cohorts of 6 infants each: 1) \>48 hours of age and ≤28 days and 2) \>28 days of age and \<121 days of age. The study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained over the 2 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.


Eligibility criteria: Inclusion Criteria:

* \< 28 weeks gestation at birth
* \> 48 hours and \<121 days of age at the time of study drug administration
* One of the following:

  * Suspected systemic infection
  * Receiving cefazolin for prophylaxis
  * Receiving cefazolin treatment of a systemic infection

Exclusion Criteria:

* History of anaphylaxis attributed to a β-lactam
* Exposure to cefazolin in the month prior to study
* Serum creatinine \> 1.7 mg/dL

Primary outcomes:
measure: Cefazolin pharmacokinetics including half life, clearance, and volume of distribution
timeFrame: Dose 1 and Dose 4
Secondary outcomes:
measure: Safety
timeFrame: 7 days following last dose of cefazolin
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
References:
Clinical trial NCT01738022: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
Official title: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea
Keywords: Sleep apnea
Pathophysiology
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models. In this study, subjects will breathe gas mixtures of different densities and viscosities for brief periods of time in order to test those models.

Detailed description: Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models.

In this study, subjects will breathe gas mixtures of different densities (helium and sulfur-hexafluoride) or viscosity (neon) for brief periods of time during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP). The investigators will test some models of upper airway collapse by observing if flow while breathing different gas mixtures scales according to the differences in density and viscosity.

Eligibility criteria: Inclusion Criteria:

* Normal subjects or patients with OSA

Exclusion Criteria:

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Allergy to lidocaine or oxymetazoline hydrochloride
* For women: Pregnancy

Primary outcomes:
measure: Difference in peak inspiratory flow
timeFrame: 10 - 15 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David A Wellman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02614222: Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks
Official title: Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nerve Blocks
Keywords: Computer Assisted Instrument Guidance (CAIG)
Peripheral Nerve Block
Clear Guide ONE
Needle path
Needle Guidance
Ultrasound
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: The Cooper Health System
First posted: 2015-11-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.

Detailed description: This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.

Eligibility criteria: Inclusion Criteria:

* Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Patients in whom regional anesthesia is contradicted

Primary outcomes:
measure: Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
timeFrame: Immediately after intervention (within 2 hours)
Secondary outcomes:
measure: Clinician Rating of the Device
timeFrame: Immediately following intervention (within 2 hours)
measure: Number of Attempts
timeFrame: Immediately following intervention (within 2 hours)
measure: Number of Times Needle Needs Repositioning
timeFrame: Immediately following intervention (within 2 hours)
measure: Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire
timeFrame: Post-op day 1
measure: Number of Patients That Needed Rescue Opioids
timeFrame: During hospital stay (maximum 3 days)
measure: Incidence of Postoperative Nausea and Vomiting
timeFrame: During hospital stay (maximum 3 days)
measure: Undesired Muscle Weakness Measured Subjectively
timeFrame: During hospital stay (maximum 3 days)
Other outcomes:
Locations:
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Ronak Desai, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02745522: Can Oxytocin Enhance the Placebo Effect?
Official title: Can Oxytocin Enhance the Placebo Effect?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oxytocin Effect on Memory Performance During Phase 1
Oxytocin Effect on Memory Performance During Phase 2
Oxytocin Effect on Memory Performance During Phase 3
Oxytocin Effect on Memory Performance During Phase 4
Keywords: Placebo effect
Working memory
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 224
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The current study aimed to investigate whether oxytocin (OXT) had effect on placebo effect.

Detailed description: The current study included three phases to investigate oxytocin effect on placebo effect:

1. In a double-blind, between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 66 healthy male subjects using working memory task.
2. In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task.They were informed that oxytocin would increase memory perfomance by a female experimenter.
3. In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 53 healthy male subjects using working memory task. But the subjects were told that oxytocin would decrease the performance by the same female experimenter.
4. In a single-blind(subjects were informed that the treatment was oxytocin), between-subject, placebo controlled design study to investigate the intranasal OXT (24IU) treatment in 52 healthy male subjects using working memory task. The subjects were told that oxytocin would increase the performance by a male experimenter.

Memory performance was included as dependant factor. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety: State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Interpersonal Trust Scale(ITS).

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorder

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.

Primary outcomes:
measure: Memory performance in different phases
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology
state: Sichuan
Study officials:
References:
Clinical trial NCT02904122: Oral Teleconsultation
Official title: Validation Study of Oral Teleconsultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Care
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this study we want to compare a dental diagnose during face to face consultation vs remote consultation with telemedicine device.

Detailed description: Using Soprocare® camera, videos of patients' oral cavity are recorded and analysed remotely. 200 patients have been included: 100 in Montpellier (France) and 100 in Kitakyushu (Japan).

A classical face-to-face oral consultation is realized using ICDAS II classification. Then a student recorded 6 videos of patients' mouth: one video by sector, showing each face of molars and premolars in cario fluorescence mode of Soprocare® and one video of the maxillary and mandibular incisor-canine block in perio mode.

In a third step, a remote dentist analysed videos and made a telediagnosis using the same classification. Dental hygiene and missing teeth are also noted in classical and tele diagnostic.

The direct and the tele diagnostic are compared.

Eligibility criteria: Inclusion Criteria:

* The subject is aged at least 18 years
* The subject must be given free and informed consent
* Topics scheduled consultation from the dental center of Montpellier University Hospital and the Center Kyushu University (Japan).

Exclusion Criteria:

* NA

Primary outcomes:
measure: diagnostic of caries
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01253122: Comparative Bioavailability in Healthy Elderly Volunteers
Official title: Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: TauRx Therapeutics Ltd
Sponsor class: INDUSTRY
Collaborators: name: Quotient Clinical
First posted: 2010-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A randomised four way crossover design in which each subject will receive two dose levels of TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.


Eligibility criteria: Inclusion Criteria:

* Male and female 55 and over
* No clinically important abnormal physical finding
* No clinically significant lab results
* Normal ECG, Normal BP and HR,BMI between 19 and 32
* Weight 50 to 100 kg, Able to communicate
* Provide written informed consent
* Non smokers
* Males to use contraception
* Females to be surgically sterile or post menopausal

Exclusion Criteria:

* Administration of any IMP other than study drug within 12 weeks before entry
* Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
* Surgical or medical condition that might interfere with IMP
* History of drug or alcohol abuse
* Clinically significant allergy requiring treatment
* Loss of greater than 400ml of blood within 12 weeks.
* Serious adverse reaction or hypersensitivity to any drug
* Prescence of Hep B, Hep c or HIV-1 or HIV-2 at screening
* Presence of G6PD at screening
* History of methaemoglobinaemia
* Partner who is pregnant of lactating
* Positive Pregnancy test

Primary outcomes:
measure: Relative bioavailability
Secondary outcomes:
measure: Safety, tolerability and pharmacokinetics
Other outcomes:
Locations:
Study officials:
affiliation: Quotient Clinical
name: Stuart Dr Mair, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03230422: A Comparison of Video Laryngoscopes and the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway.
Official title: A Comparison of the Novel King Vision Pediatric aBlade and the C-MAC Video Laryngoscope to the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway. A Bicentric, Prospective, Randomized Manikin Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Complication of Anesthesia
Keywords: infant, laryngoscopes, pediatrics
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Pediatric both manikin and human studies have suggested that the video laryngoscopy is equally suitable to facilitate intubation compared to the direct laryngoscopy.

Detailed description: The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new born and infants. In this manikin studie we want to compare different types of video laryngoscopes in a simulated normal and difficult infant airway.

Eligibility criteria: Inclusion Criteria:

- anesthesiologists or neonatal/pediatric intensive care medicice specialists with experience in securing pediatric airway

Exclusion Criteria:

- participants without experience in pediatric airway management

Primary outcomes:
measure: Time to ventilation (seconds)
timeFrame: Assessed intraoperatively at time of intubation (seconds)
Secondary outcomes:
measure: First attempt success rate of tracheal intubation (in 40 seconds)
timeFrame: Assessed intraoperatively at time of intubation
measure: Grades of Laryngeal View (Cormack&Lehane Class)
timeFrame: Assessed intraoperatively at time of intubation
measure: Use of ELM
timeFrame: Assessed intraoperatively at time of intubation
measure: Intubation Adjustments & Ease of Use
timeFrame: Assessed intraoperatively following intubation
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Centre Mainz
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Albers B, Bienia S, De Oliveira GS. Randomized equivalence trial of the King Vision aBlade videolaryngoscope with the Miller direct laryngoscope for routine tracheal intubation in children <2 yr of age. Br J Anaesth. 2017 Jun 1;118(6):932-937. doi: 10.1093/bja/aex073.
Clinical trial NCT06589622: Major Failure Rate Assessment of Atraumatic Restorative Techniques Versus Hall Technique in the Management of Decayed Primary Molars in Children Aged 4-6 Years Old
Official title: The Major Failures of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Decayed Primary Molars
Keywords: ART
Hall technique
decayed primary molars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare major failure rate between ART ( excavation of caries with hand instruments and placing glass ionomer restoration without the use of rotary instruments) versus hall technique ( placing a stainless steel crown on the decayed primary molar without prepartion or caries removal)


Eligibility criteria: Inclusion Criteria

* Age: From 4 to 6 years.
* Cooperative children
* Children with no systemic disease, occlusal problems or bad habits.
* Primary molars with vital pulp.
* Class II Caries in primary molars within enamel/dentin.
* Molars in occlusion with the antagonist tooth/teeth.
* Teeth with no developmental anomalies.
* Absence of spontaneous pain and tenderness to percussion.
* Absence of any radiolucency in furcation and/or periradicular regions.
* No pathological and internal/external resorption.

Exclusion criteria:

* Presence of signs and symptoms of necrosis (Fistula, abscess, mobility or furcation involvement).
* Root caries.
* History of Spontaneous pain.

Primary outcomes:
measure: Major failure
timeFrame: 1 year follow up
Secondary outcomes:
measure: Canine overbite
timeFrame: 3 months, 6 months and 1 year follow up
measure: Postoperative pain and discomfort
timeFrame: Immediately postoperative
measure: Child anxiety
timeFrame: Intraoperative
measure: Child behavior
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT03743922: The Effects of Vitamin D2 Supplement During Pregnancy
Official title: The Effects of Vitamin D2 Supplement During Pregnancy on Postpartum Maternal and Fetal Vitamin D Levels: the Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Early
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-11-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effects of vitamin D2 supplement during pregnancy on postpartum maternal and fetal vitamin D levels: the randomized controlled trial

Detailed description: Vitamin D structurally similar to steroids. Made from the skin. And metabolism of the liver, kidneys, vitamin D levels in the bloodstream are two types of vitamin D 2 (Ergocalciferol) and vitamin D 3 (Cholecalciferol) Vitamin D regulates calcium and phosphorus levels in the body. Including the accumulation of minerals in the bone. Vitamin D is important in the formation of bones and teeth and the normal growth of children, affects the reabsorption of amino acids in the kidneys, regulates the amount of calcium and phosphorus in the blood Vitamin D deficiency in pregnant affects the mother and baby example high maternal blood pressure during pregnancy, diabetes during pregnancy, increase birth body weight of baby. low calcium seizures Infants, baby have bones and growth disorders. Currently, no vitamin D supplement is used in pregnant women in Thailand who attend antenatal clinics. The researcher has proposed to study the effects of vitamin D supplement during pregnancy on postpartum maternal and fetal vitamin D levels by using vitamin D 20,000IU / week

Eligibility criteria: Inclusion Criteria:

* Women who have pregnant and ANC at Rajavithi hospital
* Women who have age at least 18 year
* Women who have Thai nationality
* Women who have pregnant of gestational age under 20week

Exclusion Criteria:

* Women who don't plan of delivered at Rajavithi hospital
* Women who have complication of pregnancy
* Woman who delivered before gestational age 37week
* Women who have abnormal kidney function
* Woman who have been used anticonvulsant drug or others form of vitamin d
* Women who have vitamin d allergy

Primary outcomes:
measure: effect of vitamin D 2 supplementation during pregnancy
timeFrame: within 30 minute after delivered
Secondary outcomes:
measure: vitamin D levels in maternal blood during pregnancy
timeFrame: at first time ANC
measure: vitamin D levels in maternal blood after vitamin D supplementation
timeFrame: within 30 minute after delivered
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Patitta Vacharaprechaskul
role: PRINCIPAL_INVESTIGATOR
References: