louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05314816: Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
Official title: Clinical Impact of a Multiplex PCR Blood Culture Identification Panel in Early Identification of Positive Blood Cultures in Pediatric Patients in Guatemala
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteremia
Sepsis
Keywords: bacteremia
sepsis
antimicrobial resistance
BCID2
multiplex PCR
pediatric
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: BioFire Diagnostics, LLC
First posted: 2022-04-06
Enrollment: 479
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in children hospitalized in a low resource setting in Guatemala City.

Detailed description: A retrospective review of positive blood cultures was performed on pediatric patients at a tertiary hospital in Guatemala City. These will serve as retrospective controls. The prospective portion of this study will implement the BioFire FilmArray blood culture identification panel (BCID2). Laboratory technicians will perform BCID2 simultaneously with standard culture after it flags positive on the automated blood culture system. BCID2 will be performed on those blood culture specimens that become positive during normal laboratory daytime working hours. Those specimens that become positive overnight will not have the BCID2 performed and will serve as concurrent controls. Physicians will be notified of panel results for the BCID2 intervention group and standard culture results per current laboratory protocol. This study will compare time to optimal antimicrobial therapy (primary outcome), as well as secondary outcome measures, between the intervention group and the 2 control groups.

Eligibility criteria: Inclusion Criteria:

* Age \<18 years of age
* First positive blood culture during the hospitalization

Exclusion Criteria:

* Non-blood specimens
* Repeat positive blood cultures from the same admission
* Patients who expire prior to positive culture
* Outpatient blood cultures

Primary outcomes:
measure: Time to Optimal Antimicrobial Therapy
timeFrame: 14 days
Secondary outcomes:
measure: Time to Organism Identification
timeFrame: 14 days
measure: Time to Effective Antimicrobial Therapy
timeFrame: 14 days
measure: All-cause Mortality
timeFrame: 30 days
measure: Length of Hospital Stay
timeFrame: 30 days
measure: Intensive Care Unit Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Hospital Roosevelt
Study officials:
affiliation: University of Colorado, Denver
name: Samuel Dominguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03754816: The Combination of PECS II Block and Parasternal Block for Radical Mastectomy
Official title: The Combination of PECS II Block and Parasternal Block Provide Useful Analgesia After Radical Mastectomy With Axillary Dissection and Implant Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: PECS II block, parasternal block, analgesia
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The combination of PECS II and parasternal Block provides analgesia after radical mastectomy

Detailed description: The cambionation of PECS II block and parasternal block

Eligibility criteria: Inclusion Criteria:

* ASA status patients:1,2 and 3
* patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction

Exclusion Criteria:

* patients with allergy to local anesthetics
* ASA status patients: 4
* breast anatomy abnormalities
* neurological diseases
* septic conditions
* coagulopathies
* drug abuse history

Primary outcomes:
measure: Postoperative pain: Numeric Rate Scale
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Intraoperative opiates
timeFrame: From start to the end of surgery
measure: Postoperative opiates
timeFrame: 24 hours after surgery
measure: Side effects
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Coppito
country: Italy
facility: San Salvatore Academic Hospital
state: L'Aquila
Study officials:
affiliation: San Salvatore Academic Hospital of L'Aquila
name: Emiliano Petrucci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01261416: Pharmacokinetics of Levetiracetam (Keppra) in Neonates
Official title: Pharmacokinetics and Safety of IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Epilepsy
Keywords: seizures
epilepsy
neonatal
levetiracetam
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants ≥ 32 weeks gestation and ≤ 30 days of age requiring treatment with levetiracetam for clinical and/or electrographic seizures or seizure prophylaxis.

Brief summary: The primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.


Eligibility criteria: Inclusion Criteria:

* Gestational age ≥ 32 weeks
* Postnatal age ≤ 30 days
* Birth weight ≥ 2000 grams
* Admitted to the NICU at Cincinnati Children's Hospital or Good Samaritan Hospital
* Clinical or electrographic seizures of any etiology
* Seizures or seizure prophylaxis requiring treatment with levetiracetam
* Parental consent obtained

Exclusion Criteria:

* Infants with renal insufficiency indicated by serum creatinine \> 2.0 at any time
* Infants who have previously received levetiracetam
* Parents refuse consent
* Attending physician does not wish the infant to be enrolled in the study
* Infants who are currently receiving an investigational drug

Primary outcomes:
measure: Pharmacokinetic profile
timeFrame: 24 hours after dose
Secondary outcomes:
measure: Change in vital sign baseline
timeFrame: 24 hours
measure: Number of participants with adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephanie Merhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901716: Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation
Official title: Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation: A Randomized Double-blind Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sufentanil
Remifentanil
Fentanyl
Bronchoscopy
Narcotrend
Conscious Sedation
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 60
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: OTHER

Brief summary: The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and physician satisfaction were analized.


Eligibility criteria: Inclusion Criteria:

* ASA grade I-II

Exclusion Criteria:

1. psychological disorders
2. SpO2\<90% in ambient air
3. hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
4. severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
5. unstable haemodynamic status
6. habitual alcohol consumption
7. asthmatic patients

Primary outcomes:
measure: Dosage of midazolam
timeFrame: during the procedure
Secondary outcomes:
measure: severity of cough
timeFrame: during the procedure
measure: patient's subjective tolerance
timeFrame: 30minutes after bronchoscopy
measure: patient's global tolerance assessed by operator
timeFrame: 30minutes after bronchoscopy
measure: rate of oxygen desaturation
timeFrame: during the procedure
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue Li, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02066324: Urine Sample Collection From FOP Patients
Official title: Urine Sample Collection From Patients With Fibrodysplasia Ossificans Progressiva (FOP) for Biomarker Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrodysplasia Ossificans Progressiva
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Fibrodysplasia Ossificans Progressiva.

Brief summary: The purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. Disease related biomarkers in these patients are currently unknown. This study aims to support the development of novel therapy/ies for this disease.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of FOP.
* Physically able to provide first-morning urine sample of at least 30 mL
* Able to communicate well with the investigator, to understand and comply with the requirements of the study
* About half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function

Exclusion Criteria:

* Diagnosis of diabetes
* Diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.)
* Diagnosis of cancer other than nonmelanomatous skin cancer.

Primary outcomes:
measure: Analysis of pre-defined biomarker FGF2
timeFrame: 3 months
measure: Analysis of pre-defined biomarker WEGF
timeFrame: 3 months
measure: Analysis of microRNAs
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01959724: Macular Detachment Associated With Intrachoroidal Cavitation
Official title: Macular Detachment Associated With Intrachoroidal Cavitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Detachment
Macular Retinoschisis
Intrachoroidal Cavitation
Keywords: Macular detachment
Macular retinoschisis
Vitrectomy
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 69
Sex: ALL
Minimum age (years): 10
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of clinical characteristics and surgical outcome for macular detachment associated with peripapillary intrachoroidal cavitation with or without pathologic myopia.


Eligibility criteria: Inclusion Criteria:

* Eyes with macular detachment or macular retinoschisis

Exclusion Criteria:

* Optic pit maculopathy, vitreomacular traction syndrome

Primary outcomes:
measure: Visual acuity
timeFrame: one year
Secondary outcomes:
measure: Optical coherence tomography
timeFrame: one year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139724: Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet
Official title: A Phase III Randomized, Double-Blind, Double Dummy, Multi-Center Study To Compare The Efficacy, Safety And Tolerability Of Tolterodine Extended Release Capsule With Tolterodine Immediate Release Tablet In Subjects With Symptoms Of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 260
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 evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder


Eligibility criteria: Inclusion Criteria:

* Subjects with a diagnosis of overactive bladder.

Exclusion Criteria:

* Subjects with significant stress incontinence as determined by the investigator.
* Subjects with recurrent urinary tract infections defined as treated for UTI; 5 times in the last year.

Primary outcomes:
measure: To evaluate the efficacy of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder
Secondary outcomes:
measure: To evaluate the safety of tolterodine extended release formulation compared with immediate release formulation after 8 weeks of treatment in subjects with symptoms of overactive bladder.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Beijing
country: China
facility: Pfizer Investigational Site
state: Beijing
city: Huangzhou
country: China
facility: Pfizer Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Chongqing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04301024: Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users in Montpellier
Official title: Nitrous Oxyde Misuse Among Teenagers Consulting in an Addictology Center Dedicated to Young Drug Users: an Observational Study Led in Montpellier
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nitrous Oxide
Drug Abuse
Keywords: screening
spotting
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: teenagers and young adults consulting in an addictology center dedicated to young drug abusers in Montpellier

Brief summary: Nitrous oxide gas is used in several application areas : medical as an anesthetic drug ; in food industry as a foaming and a mixing agent ; industrial to speed combustion. It is also misused for its hilarant, euphoric and hallucinogenic effect. For this purpose the gas is transfered in a balloon to be inhaled.

As its effects are briefs, its consumption is often perseived as safe. However, some risks exist and are majorated by the way of use and for some groups of people.

Since 2016, the French observatory of drug and substances addiction (OFDT) describes an increasing misuse of nitrous oxide amoung teenagers and young adults. In november 2019, a french press release alerts on the recent increasing of neurologic side effects related to the misuse of nitrous oxide.

That's why, it seems to be interesting to improve the screening of nitrous oxide abuse, in particular amoung adolescents and young adults.

In our study, the investigators would like to determine the characteristics (social, medical, any drug abuse) of teenagers and young adults who misuse nitrous oxide. Through a questionnaire, the investigators plan to select teenagers and young adults who consult in an addictology center dedicated to young drug consumers in Montpellier. This questionnaire is anonymous. The data will be collected only after obtaining the patient's agreement.

The final goal is to create a tool to help general practitioners in screening young people at risk of nitrous oxyde misuse.


Eligibility criteria: Inclusion criteria:

- teenagers and young adults consulting in an addictology center dedicated to young abusers in Montpellier and who agree with being included in the study

Exclusion criteria:

- to refuse to participate to the study

Primary outcomes:
measure: nitrous oxide misuse
timeFrame: 1 day
Secondary outcomes:
measure: use of other drugs (cannabis, tobacco, alcohol, cocaine, heroine)
timeFrame: 1 day
measure: Assess of the side effect based to answers
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Marion Ambrosino, medical resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05667324: Septorhinoplasty Post-operative Pain Control With SPG Nerve Block
Official title: Post-operative Pain Control With Sphenopalantine Ganglion Nerve Block in Septorhinoplasty Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Deviated Nasal Septum
Keywords: Post-op pain
septorhinoplasty
deviated septum
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Maxillary nerve blocks have been shown to significantly reduce post-operative pain and analgesic intake during the 24-hour period following sinus surgery. This randomized, double-blinded, placebo-controlled study will investigate blocks of the pterygopalatine fossa using a suprazygomatic approach during septorhinoplasty surgery. It is the investigator's hypothesis that this technique will result in decreased post-operative pain and opioid use, and the morbidity associated with it.


Eligibility criteria: Inclusion Criteria:

* Patient presenting for open or endoscopic septorhinoplasty
* Age 18-80
* Normal oral food and water intake before surgery
* ASA physical classification 1-3

Exclusion Criteria:

* Refusal to consent
* Patients without a cellular phone or who are unable to accept text messages
* Allergy to opioid narcotics
* ASA physical classification of 4 or higher
* Patient requires other surgery in addition to septorhinoplasty
* Age \> 80 or \<18
* Any underlying chronic pain condition or ongoing opioid use over the preceding 3 months
* Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
* Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
* Pregnant women

Primary outcomes:
measure: Decrease the opioid requirement post-operatively as assessed by providers.
timeFrame: 7 days +/- 2 days
Secondary outcomes:
measure: Decrease in post-anesthesia care unit observation time.
timeFrame: 60-180 minutes
measure: Efficiency of SMS based survey for post-operative data collection.
timeFrame: 5 days post-operatively +/- 1 day
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health of University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jeffrey D Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00774124: Improving Outcomes in Underserved Women With GDM
Official title: Improving Outcomes in Underserved Women With GDM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Pregnancy
Keywords: GDM, pregnancy, macrosomia
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-10-17
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.

Detailed description: Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.

Eligibility criteria: Inclusion Criteria:

* diagnosis of GDM
* 33 or less weeks gestation

Exclusion Criteria:

* multiple gestations
* history of glucose intolerance outside of pregnancy

Primary outcomes:
measure: maternal blood glucose control
timeFrame: 3 to 9 months
Secondary outcomes:
measure: infant birthweight
timeFrame: at delivery
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Memorial Diabetes Center
state: Florida
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Carol J Homko, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Homko CJ, Santamore WP, Whiteman V, Bower M, Berger P, Geifman-Holtzman O, Bove AA. Use of an internet-based telemedicine system to manage underserved women with gestational diabetes mellitus. Diabetes Technol Ther. 2007 Jun;9(3):297-306. doi: 10.1089/dia.2006.0034.