louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03033628: Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children
Official title: Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using "DentalVibe Comfort System" Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.

Detailed description: The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone.

Intervention:

History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria.

Clinical procedure:

Intervention group:

Clinical examination using mirror and probe to assess inclusion criteria. Before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec.

Demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally.

The cheek will be retracted and the device will be turned on.

1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min.

Control group:

AS that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off.

Assessment:

Objective assessment will be performed by observing the patients behavior using the FLAAC scale during the anesthetic injection and needle insertion.

Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.

Eligibility criteria: Inclusion Criteria:

1. Healthy children aged 6-7 years old.
2. Apparently healthy Children.
3. Cooperative children.
4. Children with carious maxillary bilateral primary molars indicated for extraction.

Exclusion Criteria:

1. Children who are allergic to amide group.
2. Children with Neurologic disorders.
3. Children with mental disability.
4. Presence of periapical or gingival legion.
5. Severe Gingivitis.

Primary outcomes:
measure: pain during injection
timeFrame: within 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Norhan El-dokky, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01692028: Identification of the Region of Vitamin D Responsiveness
Official title: A Novel Approach Localizes the Association of Vitamin D Status With Insulin Resistance to One Region of the 25(OH)D Continuum.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypertension
Keywords: vitamin D
Associational study
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 4116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults living in or near Calgary and associated with the oil and gas industries

Brief summary: Hypothesis: low vitamin D status is associated with increased insulin resistance and increased blood pressure.

Approach: Multiple regression analysis of information extracted from a large database accumulated by a Canadian health foundation, specifically evaluating statistical associations between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure, after adjusting these variables for BMI, age, sex, and waist circumference.

Detailed description: Data obtained from the entry records of 4,116 adult men and women in Calgary,Alberta previously enrolled in the Pure North S'Energy Foundation's health program. Individuals with a clinical diagnosis of diabetes mellitus or a HOMA-IR value above 16 were excluded. Standard statistical analyses carried out. An association between 25(OH)D and the endpoints of interest was first established. The residual values after adjusting HOMA-IR, serum insulin, QUICKI, and blood pressure for BMI, age, sex, and waist circumference were then regressed against serum 25(OH)D using 40-percentile data blocks, stepping upward from the lowest 25(OH)D values by 5 percentile increments through the 7th decile. Regression coefficients are then computed for each data block and each outcome variable. The location (along the 25(OF)D continuum) of the largest and most statistically significant coefficients is noted, and regions of null response noted as well.

Eligibility criteria: Inclusion Criteria:

* Age \> 18

Exclusion Criteria:

* Diabetes
* Elevated HOMA-IR (\>16)

Primary outcomes:
measure: HOMA-IR
timeFrame: Observational/cross-sectional study
Secondary outcomes:
measure: Blood pressure
timeFrame: cross-sectional study
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pure North S'Energy Foundataion
state: Alberta
Study officials:
References:
Clinical trial NCT02495428: Effect of Kinesio Taping in Muscle Fatigue
Official title: Effect of Kinesio Taping in Muscle Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Fatigue
Keywords: Bandage
Treadmill
Lactate Acid
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effect of Kinesio taping on lactic acid in an running anaerobic test.


Eligibility criteria: Inclusion Criteria:

* They should practice physical activity 2-4 days a week.

Exclusion Criteria:

* History of surgery in the lower limbs
* Muscle-tendon injury or trauma in the lower limbs (LL) in the last six months
* cardiovascular and / or respiratorydisease
* Any allergies related to the bandage material.

Primary outcomes:
measure: Change in capillary blood acid lactate
timeFrame: Participants will be measured four times to follow the changes of lactate: Baseline (Pre Exercise), immediately post exercise, 5 minutes post exercise and 15 minutes post exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
References:
Clinical trial NCT03201328: Impact of Binaural Audition on Postural Performance and Orientation
Official title: Prospective, Single Centre Cohort Study on the Impact of Binaural Audition on Postural Performance and Orientation in Healthy Subjects and Patients With Cochlear Implants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Cochlear Implants
Bilateral Cochlear Implants
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective research study talking place at University hospital of Dijon and requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants and 10 patients with bilateral cochlear implants to carry out:

* an audio-vestibular examination,
* a videonystagmoscopic study,
* a posturography study and
* a movement study. The aim of the study is to evaluate the impact of binaural audition on postural performance and orientation.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided written consent
* Patients with health insurance cover
* Age between 18 and 75 years old
* For subjects with implants: unilateral or bilateral cochlear implants for more than one year
* For healthy subjects: absence of known audio-vestibular disorders (deafness, vertigo)

Exclusion Criteria:

* Patients dependent on an aid to move around (cane, wheelchair, crutch, ...)
* Patients under guardianship
* Pregnant women
* Disability interfering with understanding or carrying out instructions
* Associated sensory or motor disorders

Primary outcomes:
measure: Presence of a sensation of rotation due to a turning sound source
timeFrame: Baseline
measure: Modification of posturography parameters in the presence and absence of a de turning sound source
timeFrame: Baseline
measure: Time to cover a distance of 3metres in a straight line and number of steps used
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT00042328: A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
Official title: A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Keywords: Cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2002-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to study the pharmacology (how the body handles this drug) of valacyclovir in children receiving treatment for cancer. This study will last approximately 7 days.

Detailed description: In this study, patients will receive a single dose of oral valacyclovir. Blood samples will be drawn to evaluate the pharmacology (how the body handles the drug). Blood samples (less than one teaspoon each) will be obtained before receiving the drug and at 0.5, 1, 1.5, 2, 5, 6, and 8 hours after receiving the drug. The total amount of blood drawn from patients for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5% of the total blood volume.

We will also have all urine output collected for 8 hours starting at the time patients receive the dose of valacyclovir. A 5cc sample of urine will be collected and analyzed to determine how the body handles the drug at hours 2, 4, 6, and 8.

Eligibility criteria: Inclusion criteria:

* Age: Patients must be \> / = 2 and \< / = 18 years old.
* Life Expectancy: Patients must have a life expectancy of \> 8 weeks
* Subjects must have a diagnosed malignancy, and must currently be receiving consolidation or maintenance chemotherapy
* Hepatic/Renal Function: Patients must have adequate hepatic function (bilirubin \< / = 1.5 mg/dl: SGPT \< 3x normal) and adequate renal function (creatinine \< / = 1 mg/dl: BUN \< 20 )
* Medication Tolerance: Patients must be able to swallow pills or tolerate a suspension of the medication
* Fluid Tolerance: Children must be able to retain liquids at the time of enrollment
* Informed Consent: Written informed consent will be obtained from all patients and/or their parents prior to enrollment
* Pregnancy: Women of childbearing age must have a negative serum pregnancy test at the time of study entry

Exclusion criteria:

* More than one prior chemotherapy regimen.
* Patients with uncontrolled infections.
* Subjects with known history of adverse reaction to acyclovir in the past.
* Patients with concurrent infections requiring treatment with valacyclovir or acyclovir.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Susan Blaney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06032728: Multimodal Recurrence Scoring System for Stratifying Stage III Clear Cell Renal Cell Carcinoma of Receiving Adjuvant Treatment
Official title: A Multi-site, Open, Perspective Study of Prognostic Value and Benefit From Adjuvant Targeted Therapy of Stage III Clear Cell Renal Cell Carcinoma Based on Multimodal Recurrence Scoring System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: target therapy
tyrosine kinase inhibitors (TKIs)
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 488
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: Whether patients with stage III clear cell renal cell carcinoma (ccRCC) should receive adjuvant targeted therapy or not is still on debate. The investigators invented a multimodal recurrence scoring system that was successfully categorise patients with stage III clear cell renal cell carcinoma into high-risk and low-risk groups with Hazard Ratio (HR) of 6.21. Here the investigators randomly assign assay-defined high risk patients of locally advanced ccRCC into adjuvant targeted therapy group and observation group. Disease free survival and overall survival are the end points of observation.


Eligibility criteria: Inclusion Criteria:

* The informed consent has been obtained from the patient.
* With confirmed diagnosis of stage III clear cell renal cell carcinoma
* With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
* The patient receive no anti-cancer treatment before primary surgery.
* The patient receive radical operation for renal cancer with negative margin.

Exclusion Criteria:

* Patients who have previously received neoadjuvant therapy
* With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
* With bad compliance or contraindication to enrollment.
* Pregnant woman or lactating woman.
* With contraindication to receive adjuvant targeted therapy.

Primary outcomes:
measure: Disease free survival
timeFrame: From the date of registration to up to 10 years
Secondary outcomes:
measure: Overall survival
timeFrame: From the date of registration to up to 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03751228: A Taste Assessment of BMS-986165 in Healthy Participants
Official title: An Open-Label Taste Assessment of BMS-986165 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 9
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the taste characteristics of BMS-986165 formulations, alone and mixed, in order to develop a pediatric oral form of BMS-986165.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* WOCBP must agree to follow instructions for method(s) of contraception for 5 half-lives of BMS-986165 (2 days) plus 30 days (duration of ovulatory cycle) for a total of 32 days after each tasting day.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception 5 half-lives of the study drug (2 days) after each tasting day.

Exclusion Criteria:

* A known sensitivity to BMS-986165
* A history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the participant. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Taste properties of BMS-986165 alone & in prototypes to determine Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria
timeFrame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria
timeFrame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria
timeFrame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria
timeFrame: Approximately 2 years
measure: Taste properties of BMS-986165 alone & in prototypes to determine aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria
timeFrame: Approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Senopsys
state: Massachusetts
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03535428: Venous Thrombo-embolic Complication prévention in Pelvic Surgery
Official title: Venous Thrombo-embolic Complication prévention in Pelvic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Pelvic Surgery
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with pelvic surgery indication consulting surgeons

Brief summary: Pelvic fracture surgery are very high thrombotic risk surgery with about 10% to 50% venous thrombo embolic complications and 0.5% to 10% of pulmonary embolism. The ST JOSEPH's Hospital have almost 60 cases per year . Following a fatal pulmonary embolism per operatory the team has set up a venous exploratory protocol before surgery.

This protocol includes a venous doppler ultrasound of lower limbs associated to a abdo pelvic scanner in the 48hours before surgery.

The aim is to evaluate this new protocol efficacy on prevention of thrombo embolic complications in pelvic fracture surgery.


Eligibility criteria: Inclusion Criteria:

* pelvic fracture with surgery indication
* age above 18 years

Exclusion Criteria:

* pelvic fracture without surgery indication

Primary outcomes:
measure: major thrombo-embolic events
timeFrame: Day 10 after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: BONHOMME Stéphanie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GHPSJ
name: RIOUALLON Guillaume, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02902328: Accuracy Evaluation for SIS Software-based Visualization of Anatomical Brain Structures
Official title: Accuracy Evaluation for Software-based Visualization of Anatomical Brain Structures Using Surgical Information Sciences Inc. Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Software Evaluation for Visualizing Anatomical Structures That Are Not Typically Identified on Clinical MR Images
Lead sponsor: Surgical Information Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of 30 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of their brain.

Brief summary: SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.

Detailed description: A cohort of 30 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not easily identified on standard clinical images.

SIS software will be used to visualize selected anatomical features on the clinical image and the results will be compared with the images of the same subject obtained from the 7T MRI.

Eligibility criteria: Inclusion Criteria:

* all subject that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.

Exclusion Criteria:

1. MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, artificial knee or hip, metal plates, pins, screws or wires anywhere in the body, any other metal implants, etc.).
2. Pregnant women.
3. Subject under the age of 18

Primary outcomes:
measure: Validation of the accurate visualization of brain structures based on SIS algorithms
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: