Up-to-date List of Orajel Medical Research Studies
What Research is Being Done?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.
Summed Pain Intensity Difference; Pain Intensity Difference; Comparison of pain scores from AOM-SOS and FLACC pain measurement scales in patients 2 months to 4 years old; Comparison of pain scores from VAS and FPS-R pain measurement scales in patients 5 years to 12 years old; Physician Global Evaluation; Evaluate dosing intervals with pain measurements assessed up to 120 minutes; Report the onset of perceptible and meaningful pain relief using patient reports and stopwatch assessments; Assess the safety and tolerability of benzocaine
Drug: XF-73 in 4% Klucel® gel; Drug: XF-73 in 2% Klucel® gel; Other: Placebo in 4% Klucel® gel
The local (nasal and nasal passage) and systemic safety and tolerability of XF-73 following nasal administration in healthy male and female subjects via adverse events, physical exams, nasal exams, vital signs, clinical lab tests and electrocardiograms.; The efficacy of the modified formulation of XF-73 and of the previous formulation on nasal load of S. aureus after daily treatment with XF-73 for five days as compared to placebo (in Part 2 of the study only).; The pharmacokinetics (PK) of XF-73 following nasal administration of two concentrations of a modified formulation (in both parts of the study) and a single concentration of a previously investigated formulation (in Part 2 of the study).
The change of patients'CDAI.; patients' endoscopic score(Rutgeerts score).; The change of haematological inflammation marker(CRP,ESR); The change of patients'IBDQ.; The change of blood routine examination and blood biochemistry.
Drug: Antipyrine-benzocaine otic solution; Other: Mineral oil
Efficacy of CREWS01 (topical auricular anesthesia of the vagus nerve) to decrease usage of rescue inhalers in moderate to severe asthmatic adults Change in usage of rescue inhalers in moderate to severe asthmatic adults in four weeks; Improvement of spirometry scores in moderate to severe asthmatic adults
Changes in Hemoglobin A1c Level Across Study Visits; Changes in Maximal Oxygen Consumption Across Study Visits; Changes in Self-Reported Physical Activity Level Across Study Visits; Changes in Body Weight Across Study Visits; Changes in Body Mass Index Across Study Visits; Changes in Waist Circumference Across Study Visits; Changes in Blood Pressure Across Study Visits; Changes in Heart Rate Across Study Visits; Changes in Dietary Intake Across Study Visits; Changes in Self-Reported Quality of Life Across Study Visits; Changes in Exercise Perception Across Study Visits; Changes in Patient Satisfaction During Intervention Period
difference in PASI at week 24 between obese psoriatic patients who underwent hypocaloric diet compared to those in free diet after obtaining a PASI reduction >75 following methotrexate.; patients' opinion about their body weight and it's relation with psoriasis
Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS); Major depressive episode: Primary Care Evaluation of Mental Disorders (PRIME-MD); Depression severity: Personal Health Questionnaire-9 (PHQ-9); Anxiety severity: Generalized Anxiety Disorder Assessment (GAD-7); Insomnia severity: Insomnia Severity Index (ISI); Somatic symptoms: The Bradford Somatic Inventory (BSI); Presenteeism: World Health Organization Heath and Work Performance Questionnaire (HPQ); Burnout: Maslach Burnout Inventory (MBI); Quality of Life: EuroQol (EQ-5D)
Drug: Four consecutive days on treatment and 3 days off
Capacity to maintain a therapeutic success with 4 days on treatment followed 3 days off treatment; Virological success; The time of virological failure occurrence; The blips; The low viral loads (between 20 - 50 cp/mL); Detected signal on viral quantification; Mutations resistance; Evaluation CD4, CD8 and CD4/CD8 ratios; HIV proviral DNA; Clinical events related to HIV infection; Adverse events; Interruption or modification of the therapeutic strategy; Renal parameters; Inflammation and immune activation; Antiretrovirals Pharmacokinetic; Antiretrovirals pharmacokinetic; Quality of life; Adherence; Hepatitis parameters; Glucidolipidics parameters
Dietary Supplement: Micronutrients and antioxidants; Dietary Supplement: Multivitamins and minerals
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART; Non-AIDS related adverse events; Tolerance of and adherence to study medication; Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart); Time from baseline to emergence of documented CDC-defined AIDS-defining illness; Time from baseline to start of ART; Serial quarterly lymphocyte measures (ALC, CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8); Serial quarterly HIV RNA plasma viral load; Serum chemistries: Glucose, BUN, creatinine, total protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin,; Serum micronutrient levels: carotene (quarterly), vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD six monthly); Quality of Life measures
LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES
Primary aim for Low Risk Neuroblastoma; Primary aim for Intermediate Risk Neuroblastoma; Primary Aim for Neonatal Suprarenal Masses; To maintain a 2 year EFS of at least 90% and an OS of at least 95% in L2 patients with LTS without SCA (study group 2); To maintain the 2 year EFS of 85% and an OS of at least 98% in Ms patients without SCA (study groups 4 and 5); To improve the 2 year EFS to at least 90% and maintain the OS of close to 100% in L2 patients with SCA (Study Group 3) and improve the 2 year EFS to over 70% in Ms patients with SCA (study group 6); To evaluate adherence to the protocol recommendations regarding LTS; To reduce surgical morbidity by promoting strict adherence to Image Defined-Risk Factors (IDRFs) to determine surgical resectability; To define the long term follow-up and natural history of the Stage L2 non-resected masses that have remained IDRF positive at the end of treatment (study groups 1-3).; To confirm in a larger patient cohort the excellent OS of 95% in stage M neuroblastoma without MYCN amplification, less than 12 months of age, when treated with moderate therapy (study group 10).; Maintain the results of 3yr-EFS of 90% and 3yr-OS of 100% in stage L2 patients over the age of 18 months, with differentiating neuroblastoma or differentiating ganglioneuroblastoma nodular, despite a treatment reduction (group7); To improve the 3 year EFS to at least 50% and the 3 year OS to 80% in INSS stage I patients with MYCN amplified neuroblastoma by the addition of adjuvant treatment (study group 9).; To evaluate the impact of the tumour genomic profile on patient outcome, in order to consider its role in the treatment stratification of these intermediate risk patients (all study groups).; To manage infants with suprarenal masses discovered ante or neonatally with a uniform approach in Europe in a multicentre setting.; To maintain an excellent overall survival with a non-operative therapeutic approach (serial monitoring, surgery if warranted) in infants with a localised suprarenal mass discovered ante or neonatally.; To determine the 3-year surgery-free survival in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).; To find out the natural history of perinatal suprarenal masses, according to the definitions set up for the study.; To study the kinetics of regression in those suspected suprarenal neuroblastomas in infants with suprarenal masses discovered ante or neonatally and managed conservatively (non initial surgery).; To collect tissue from those suprarenal masses excised in order to perform standard and investigational pathological and biological studies (INPC, MYCN, 1p, 11).; To collect frozen plasma from all patients included in the study in order to perform research.
Behavioral: Intervention group; Behavioral: Usual care
Effective Breast Feeding (EBF); Type of breastfeeding, duration of EBF, reasons for breastfeeding withdrawal, intervention satisfaction (SERVQUAL).
These studies may lead to new treatments and are adding insight into Orajel etiology and treatment.
A major focus of Orajel research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.