louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03057405: Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction
Official title: Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction in Post-traumatic and Post-ablative Defects. Evaluation of the Potential of a Fully Integrated Brainlab Iplan System.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Fractures
Keywords: intra-operative navigation
3D virtual planning
intra-operative cone beam computed tomography (CBCT)
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016

Brief summary: Background Correction of post traumatic and post-ablative orbita defects remains a challenge for the maxillofacial surgeon. The purpose of such intervention is the restoration of both function and aesthetics by anatomical reconstruction of the bony orbitawalls, with attention to the orbitavolume. Unfortunately, the results of such interventions today are still somewhat unpredictable.

The aim of this study is to determine whether 3D virtual planning combined with intra-operative navigation can increase the predictability of the outcome in function and aesthetics.

Study design Retrospective study. Demographic data, diagnostic and surgical parameters will be collected of all patients undergoing orbital surgery between 01/01/2012 and 31/12/2016 at the department. Pre- en postoperative orbit volume will be determined based on CT-analysis in Brainlab software, and compared to the non-defected orbit.


Eligibility criteria: inclusion criteria

* patients of all genders
* patients of all ages
* patients undergoing surgery for orbit fractures between 01/01/2012 until 31/12/2016

Primary outcomes:
measure: accuracy of orbital volume reconstruction, as measured in Brainlab
timeFrame: immediate postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: head of department
name: Johan Abeloos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03456505: Dissecting De-automatization
Official title: Dissecting De-automatization: The Effect of Mindfulness Training on Unconscious Habit Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study will assess the effects of mindfulness meditation training on an eye blink conditioning (EBC) task in a sample of novice meditators. This methodology will allow investigation of whether mindfulness interrupts classical conditioning through the process of de-automatization. Implicit learning rates, as reflective of unconscious habit formation and measured by the frequency of conditioned responses during the EBC, will be a main outcome of interest. The proposed study will also assess the effects of mindfulness meditation training on an emotion regulation (ER) task, with a specific focus on reappraisal of negative images and savoring of positive images.


Eligibility criteria: Inclusion Criteria:

1. Age 18-60,
2. willingness to participate in study interventions and assessments.

Exclusion Criteria:

1. Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention, or a history of meditation practice,
2. Learning disability, significant memory problems or significant attentional disruptions as determined by self-report,
3. History of head injury resulting in loss of consciousness.

Primary outcomes:
measure: Conditioned Eyeblink Frequency
timeFrame: 9 minutes
Secondary outcomes:
measure: Positive Emotion Regulation Task
timeFrame: 5 minutes
measure: Negative Emotion Regulation Task
timeFrame: 5 minutes
measure: Self-Transcendence (NADA-State)
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT04961905: Pharmacokinetic Characteristics and Safety After Administration of NVP-2002
Official title: A Phase I Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and Safety After Administration of NVP-2002 and Co-administration of NVP-2002-R1 and NVP-2002-R2 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2 in healthy adult volunteers.

Detailed description: Phase 1 to evaluate the pharmacokinetic characteristics and safety after administration of NVP-2002 and co-administration of NVP-2002-R1 and NVP-2002-R2. Which is designed as ramdomized, oral, single dose, 2×2 crossover.

Eligibility criteria: Inclusion Criteria:

* healthy adult subjects who signed informed consent
* Body Mass Index(BMI)=18.5\~29.9kg/㎡

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
* Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin

Primary outcomes:
measure: Pharmacokinetics of plasma: Cmax
timeFrame: 0hours - 72hours
measure: Pharmacokinetics of plasma: AUCt
timeFrame: 0hours - 72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk national university hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Min-Gul Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04757805: Accuracy of Manual Palpation vs Ultrasound for Spinal Anesthesia
Official title: Assessment of the Accuracy of the Manual Palpation of Surface Landmarks Versus Ultrasound for Identification of the Correct Intervertebral Space for Spinal Anesthesia in Children Less Than 1 Year of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Infant Conditions
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 50
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Although the current standard for lumbar puncture and spinal anesthesia is the use of manual palpation of surface landmarks to identify the correct interspace, performance of the procedure at too high of a level may increase the incidence of adverse effects. The current study will evaluate the efficacy of ultrasound in identifying the correct intervertebral space for lumbar puncture thereby improving the safety of the procedure.


Eligibility criteria: Inclusion Criteria:

* Patients less than 1 year of age scheduled for spinal anesthesia for elective lower abdominal, urologic, or lower extremity surgery at Nationwide Children's Hospital

Exclusion Criteria:

* Parents unwilling for their children to undergo spinal anesthesia for surgery.
* Children with known spinal anomalies including sacral dimple.
* Children with coagulation abnormalities or receiving anticoagulation which precludes the use of spinal anesthesia.
* Children with superficial or deep infections over the spine which precludes the use of spinal anesthesia.

Primary outcomes:
measure: Intended Interspace
timeFrame: Immediately prior to spinal anesthesia
measure: Actual Interspace of Provider's Mark
timeFrame: Immediately prior to spinal anesthesia
Secondary outcomes:
measure: Level of Conus Medullaris - Sitting
timeFrame: Immediately prior to spinal anesthesia
measure: Time to Mark
timeFrame: Immediately prior to spinal anesthesia
measure: Time to Conduct Ultrasound
timeFrame: Immediately prior to spinal anesthesia
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02814305: Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
Official title: Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorders
Tooth Extraction Status Nos
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.

Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.

Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.


Eligibility criteria: Inclusion Criteria:

* Non-institutionalized

Exclusion Criteria:

* pregnancy
* a history of opioid analgesic misuse/abuse
* ongoing participation in other clinical research
* or daily use of opioid analgesics in the week prior to surgery

Primary outcomes:
measure: Unused opioids
timeFrame: 21 days after surgery
Secondary outcomes:
measure: Intent to dispose of opioids
timeFrame: Any time during the 21-day data collection period or during the follow-up interview on (or shortly after) postoperative day 21
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03910205: Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
Official title: Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: interleukin-18
gingival crevicular fluid
tumor necrosis factor alpha
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 88
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 88 Children with diabetes mellitus and systemically healty children with and without gingivitis.

Brief summary: This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.

Detailed description: Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.

Eligibility criteria: Inclusion Criteria:

* Children diagnosed as type 1 diabetes mellitus
* Age between 7 and 14 years

Exclusion Criteria:

* Having another systemic problem except type 1 diabetes mellitus
* Children carrying orthodontic appliances

Primary outcomes:
measure: Interleukin-18 level
timeFrame: Baseline
Secondary outcomes:
measure: Tnf-alpha level
timeFrame: Baseline
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Sultan KELES
Study officials:
affiliation: Dr.
name: Sultan KELES, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03048305: Prospective Study for Molecular Biomarkers of Normal Nasopharyngeal Tissue
Official title: Prospective Study for Molecular Biomarkers of Normal Nasopharyngeal Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guilin Medical University, China
name: First People's Hospital of Foshan
First posted: 2017-02-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected of nasopharyngeal carcinoma but excluded by biopsy

Brief summary: The investigators collect nasopharyngeal epithelium samples from healthy individuals and analyze for biomarkers compared with tumor tissues from another clinical research project. The goal of this study is to identify molecular biomarkers for prediction of nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients suspected of nasopharyngeal carcinoma but excluded by biopsy

Exclusion Criteria:

* Diagnosed as nasopharyngeal carcinoma during the follow-up period

Primary outcomes:
measure: the positive rate of risk signature in healthy individuals
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT00991705: A Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Official title: An Open-label, Two-treatment, Two-period, Two-sequence, Crossover Study to Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Keywords: Fimasartan, Atorvastatin
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-10-08
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetics of fimasartan.


Eligibility criteria: Inclusion Criteria:

* age: 20 - 45 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and atorvastatin
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD
role: STUDY_CHAIR
References:
citation: Shin KH, Kim TE, Kim SE, Lee MG, Song IS, Yoon SH, Cho JY, Jang IJ, Shin SG, Yu KS. The effect of the newly developed angiotensin receptor II antagonist fimasartan on the pharmacokinetics of atorvastatin in relation to OATP1B1 in healthy male volunteers. J Cardiovasc Pharmacol. 2011 Nov;58(5):492-9. doi: 10.1097/FJC.0b013e31822b9092.
Clinical trial NCT06354205: Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels
Official title: Comparison of Salivary Procalcitonin (PCT) Levels and Serum PCT Levels in Infants Under 1 Year of Age Suspected of Systemic Bacterial Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Infections
Children, Only
Procalcitonin
Saliva
Keywords: procalcitonin
saliva
children
infection
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-04-09
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Recently, it has been seen that investigations from saliva samples could be an alternative to those from blood samples. Saliva collection is a simple, non-invasive, cost-effective, and relatively easy method, making it potentially suitable as a new diagnostic tool in pediatric patients. In the current literature, elevated levels of saliva CRP, TNF-α, IL-6, and IFN-γ have been reported in inflammatory conditions. However, while there are animal studies suggesting the use of saliva PCT levels for focal diseases such as gingival inflammation and periodontitis and as a potential tool for non-invasive detection of sepsis, there is no human study regarding its use in systemic infections.

The aim of this study is to evaluate the correlation between serum PCT levels and saliva PCT levels in children suspected of SBE and to determine the diagnostic value of saliva PCT.


Eligibility criteria: Inclusion Criteria:

* Being under one year of age
* Having serum Procalcitonin (PCT) requested due to suspicion of systemic infection

Exclusion Criteria:

* Being over one year of age
* Having a chronic illness that could cause elevation in inflammatory biomarkers
* Taking any medication (such as antibiotics, immunomodulatory, or immunosuppressive drugs, etc.) that could affect inflammatory biomarkers
* Diagnosis of gingivostomatitis

Primary outcomes:
measure: Correlation
timeFrame: One year
Secondary outcomes:
measure: Diagnose
timeFrame: One year
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University School of Medicine
Study officials:
References:
Clinical trial NCT03723005: A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
Official title: A Light Emitting Diode (LED) Mattress for Phototherapy of Jaundiced Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemia, Neonatal
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: NeoLight, LLC.
First posted: 2018-10-29
Enrollment: 41
Sex: ALL
Minimum age (years): 28
Maximum age (years): 8
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants (not gender or racial/ethnically based) equal or greater than 28 weeks GA and great than 6 hrs of age until hospital discharge.

Brief summary: The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices.

Detailed description: The new investigational and FDA-approved device is named "SkyLife" and is a mattress, which uses blue LEDs as the light source similar to those used in the currently-used overhead blue LED panel devices. It is believed that this device will not only avoid many of the side effects when fluorescent tube lights are used, since it delivers safer, non-ultraviolet light; but may also be more effective than currently-used blankets or mattresses, which use blue halogen lamps or fluorescent tubes as light sources. The light is emitted under the baby. This study will discover if this device should be used in place of the currently-used devices.

Eligibility criteria: Inclusion Criteria:

* Male and female newborns greater of equal to 28 weeks GA
* Parental informed consent
* Enrollment at age greater than 6 hrs of age until neonatal discharge
* Phototherapy routine order

Exclusion Criteria:

* Infant requiring respiratory assistance (such as mechanical ventilation)
* Severe or life-threatening congenital anomalies
* Blood transfusion history

Primary outcomes:
measure: Total Bilirubin (TB) Levels
timeFrame: up to 1 week
measure: Duration of Phototherapy
timeFrame: up to 1 week
Secondary outcomes:
measure: Irradiance Stability of the neoLight Device
timeFrame: 1 year
measure: Infant Temperature Change
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Investigator
name: Ronald J Wong, MD
role: STUDY_DIRECTOR
References: