louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01120860: Magnetic Resonance Imaging (MRI) and Decline of Aging Aviator Performance
Official title: MRI and Decline of Aging Aviator Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Cognitive Decline
Keywords: Cognitive Aging
Apolipoproteins E
Magnetic Resonance Imaging
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 67
Sex: ALL
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: active healthy pilots

Brief summary: The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over time in the brain.

Detailed description: We expect that MRI and MRSI techniques will be a useful adjunct in research efforts to understand individual differences in performance of a complex attention-demanding task, such as flying a plane or driving a car. Other predictors of change in performance of a complex task may include simple tests of processing speed and working memory, past training and recent practice of the task, and genetic risk factors for degenerative brain disease. In this project, we will examine whether baseline MR measures are as useful as longitudinal MR measures in predicting amount of change over time in task performance.

This research is part of a long-term effort to achieve earlier identification of individuals at risk of decline and ultimately minimize loss of function.

Eligibility criteria: Inclusion Criteria:

* Subjects will be included if they have participated in the protocol "Age-Related Longitudinal Changes in Aviator Performance" and agree to participate in this protocol.

Exclusion Criteria:

* Subjects will be excluded if they currently have a major neurological disease, unstable/untreated medical disease (such as untreated hypertension).
* In consideration of the magnetic fields in which subjects will be placed for the MR scanning, we will also exclude subjects who are unable to safely and comfortably complete the scanning session. This includes individuals who are wearing any metal prosthesis or who have cardiac pacemakers or any other nonremovable metal objects.
* Subjects reporting a history of severe claustrophobia or poorly controlled back pain will be excluded because it is unlikely they could comfortably remain still in the MRI scanner for the duration of the scan.
* In addition, subjects who do not fit in the apparatus will also be excluded.

Primary outcomes:
measure: flight simulator performance summary score
timeFrame: yearly for up to 6 years
Secondary outcomes:
measure: CogScreen-AE
timeFrame: yearly
measure: Salthouse processing speed measures
timeFrame: yearl
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University
name: Joy Taylor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01373060: A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of ASP1941 in Healthy Male Taiwanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of ASP1941
Keywords: ASP1941
ipragliflozin
plasma glucose
urine glucose
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Taiwan, Inc.
First posted: 2011-06-14
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.

Detailed description: The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.

Eligibility criteria: Inclusion Criteria:

* Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive

Exclusion Criteria:

* Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence
* Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range
* Labo test results deviate from preset normal range
* Receiving treatment, including medication, within 14 days before the study
* Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study
* Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study
* Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day
* Employed by the sponsor, delegated CRO or the study site
* Fasting plasma glucose level of \< 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8%
* Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2

Primary outcomes:
measure: Safety assessed by the incidence of adverse events, vital signs, safety lab tests and 12-lead ECG
timeFrame: up to 72 hours
Secondary outcomes:
measure: Cmax of ASP1941 plasma concentration
timeFrame: up to 72 hours
measure: AUC (Area under the curve) of ASP1941 plasma concentration
timeFrame: up to 72 hours
measure: Changes in plasma glucose
timeFrame: baseline and up to 72 hours
measure: Changes in urine glucose
timeFrame: baseline and up to 72 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT05044260: Sinus Lift Using PTFE Titanium Reinforced Membrane
Official title: Evaluation of Direct Sinus Lift Using Ptfe Titanium Reinfored Membrane Assosiated With Immediate Implant Placement (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Lift
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Various attempts have been implemented using different materials and techniques to augment the maxillary sinus floor enhancing autogenous bone formation to allow proper dental implant positioning. The aim of this study is to evaluate the sinus lift procedure using polytetrafluoroethylene (PTFE) titanium-reinforced membrane to maintain the space formed after Schneiderian membrane elevation followed by immediate implant placement.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders requiring implant placement in posterior maxilla
* Age range: 40-60 years.
* Good oral hygiene
* Healthy maxillary sinus free from pathology
* The minimum crestal bone height is (4-6) mm
* Patients who are willing and fully capable to comply with the study protocol.

Exclusion Criteria:

* Sinus infection
* Tumors or pathologic lesions in sinus
* Severe allergic rhinitis.
* Chronic topical steroid use.
* Radiation therapy.
* Psychologic / mental impairment
* Acute infection (periodontitis or mucosal infection
* Patients on radiotherapy or chemotherapy.
* Alcohol or drug abuse.
* Patient with systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
* Smokers
* Parafuctional habits

Primary outcomes:
measure: Change in implant stability
timeFrame: at baseline and 6 months
measure: Change in bone formation
timeFrame: at baseline and 6 months
measure: Change in bone height
timeFrame: at baseline and 6 months
measure: Change in bone density
timeFrame: at baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02350660: Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Official title: Oral Immunotherapy for Peanut and Mammalian Meat Allergies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot study to assess the effect of oral immunotherapy on specific Immunoglobulin E (IgE) levels and antigen consumption in two distinct food allergies.

Detailed description: In subjects with mammalian meat allergy, the effect of daily oral cow's milk on immune parameters and desensitization will be assessed. Similarly, in subjects with a peanut allergy the effects of low dose peanut flour will be assessed and comparisons between two distinct food allergies.

Eligibility criteria: Inclusion Criteria:

* Presence or absence of specific IgE to alpha-gal or peanut

Exclusion Criteria:

* History of severe anaphylaxis
* allergy to cow's milk protein

Primary outcomes:
measure: The Level of Allergen Consumed Post-oral Immunotherapy
timeFrame: Following 36 months of maintenance oral immunotherapy, participants completed an open challenge at month 37
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Scott Commins, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wisniewski JA, Commins SP, Agrawal R, Hulse KE, Yu MD, Cronin J, Heymann PW, Pomes A, Platts-Mills TA, Workman L, Woodfolk JA. Analysis of cytokine production by peanut-reactive T cells identifies residual Th2 effectors in highly allergic children who received peanut oral immunotherapy. Clin Exp Allergy. 2015 Jul;45(7):1201-13. doi: 10.1111/cea.12537.
Clinical trial NCT04597060: The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
Official title: The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keloid
Keywords: Keloid, thermo-mechanical system
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety and efficacy of Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of Hypertrophic scars and Keloids.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers without underlying disease
* Patient with keloid age more than 6 months and keloid thickness more than 1 mm.

Exclusion Criteria:

* Dermatitis or infection on treatment area
* Suspected cancer on treatment area
* Immunocompromised host
* Pregnancy or lactating woman
* Recieved corticosteroid injection within 2 months

Primary outcomes:
measure: Thickness by caliper (mm) - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
timeFrame: 6 months
measure: Vancouver Scar Scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
timeFrame: 6 months
measure: Antera Elevation Volume - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
timeFrame: 6 months
measure: Patient satisfaction quartile scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
timeFrame: 6 months
measure: Physician evaluation quartile score - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids
timeFrame: 6 months
Secondary outcomes:
measure: Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect
timeFrame: 6 months
measure: Side effect of Triamcinolone acetonide injection
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Siriraj Hospital, Mahidol University
Study officials:
References:
Clinical trial NCT06513260: Effect of Virtual Reality Distraction on Anxiety Control During Impacted Molar Tooth Surgery
Official title: Evaluation of the Effect of Virtual Reality Distraction on Controlling Dental Anxiety During the Surgical Extraction of Impacted Lower Third Molar Teeth
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Anxiety
Impact Molar
Virtual Reality
Keywords: Dental Anxiety
Impact Molar
Virtual Reality
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 50
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: - Healthy volunteers

Brief summary: The goal of this clinical trial is to investigate the effectiveness of virtual reality distraction therapy using virtual reality glasses in reducing dental anxiety during the surgical extraction of impacted lower third molar teeth.The main questions it aims to answer are:

* Is the use of the virtual reality distraction during the procedure effective on perceived pain and anxiety?
* Evaluation of the effectiveness of the virtual reality distraction based on initial anxiety test scores.
* Does the use of the virtual reality headset cause difficulties for the clinician in performing the procedure?

Patients will undergo anxiety tests before surgery.

Pre-operative vital signs will be recorded.

The procedure will be performed either with or without virtual reality glasses, according to the randomly assigned groups.

Post-operative vital signs will be recorded.

At the end of the procedure, all patients will undergo anxiety tests and verbal rating scales.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Being systemically healthy
* Needing surgical extraction treatment of impacted lower third molar (in mesioangular position according to Tetsch and Wagner Classification)
* Having a score of 11 or higher on the dental anxiety scale

Exclusion Criteria:

* History of seizures or convulsive disorders
* Balance disorders such as nystagmus or vertigo
* Use of psychotropic medications
* Undergoing treatment for anxiety
* Patients with psychiatric disorders
* Presence of dermatological lesions, especially around the face and eyes
* Presence of any lesion in the eye that would prevent the use of virtual reality
* Presence of systemic diseases and medication use contraindicating surgical extraction of impacted teeth

Primary outcomes:
measure: Modified Dental Anxiety Scale Scores
timeFrame: Baseline
measure: Heart rate measurements
timeFrame: During the operation
measure: Blood pressure measurements
timeFrame: During the operation
measure: Oxygen saturation measurements
timeFrame: During the operation
Secondary outcomes:
measure: Dentist feedback
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Kutahya University of Health Sciences
name: Eda İzgi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00957060: Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients
Official title: A Multicenter, Open, Randomized, 24 Weeks Study to Evaluate the Superiority of Glimepiride Over Sitagliptin for the Treatment of naïve Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 400
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: TREATMENT

Brief summary: Primary Objective:

To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after 6 months of treatment in patients with monotherapy until the end of the trial.

Secondary Objective:

To evaluate the effect of glimepiride compared to sitagliptin in:

Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c \< 7% and \< 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of patients with rescue therapy; Safety (adverse events and serious adverse events, hypoglycemia, vital signs and laboratory results).


Eligibility criteria: Inclusion criteria:

* Subject naïve to treatment
* HbA1c \> 8.5 up to 11 %
* Lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing

Exclusion criteria:

* Treatment with any oral antidiabetics or insulin
* Known type 1 Diabetes Mellitus
* Pregnant or breast feeding women
* Ketoacidosis history
* History of sensitivity to any of the active substances
* Renal dysfunction : serum creatinine \> or = 1.5 mg/dL in male subjects \> or = 1.4 mg/dL in female subjects
* Liver impairment (ALT, AST \> 3-fold the upper limit of normal range)
* Systemic corticosteroid treatment 3 months prior to study or during the study
* Drug or alcohol abuse history
* Patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months
* Presence of any condition (medical, psychological, social or geographic) current or previously seen that according to Investigators judgment jeopardizes the safety or restricts the participation of the patient during the study
* Neoplasias

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: HbA1c
timeFrame: at baseline, week 12 and week 24
measure: Fasting and postprandial glucose
timeFrame: at baseline, week 2, 4, 12 and 24
Secondary outcomes:
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Sanofi-Aventis Administrative Office
city: Col. Coyoacan
country: Mexico
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Judith Diaz
role: STUDY_DIRECTOR
References:
Clinical trial NCT00404976: Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma
Official title: Biomarkers in Exhaled Breath (Condensate) Indicate Presence, Severity and Control of Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Healthy
Children
Keywords: inflammometry
exhaled breath condensate
fractional exhaled nitric oxide
asthma
children
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2006-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: Background:

Exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful to diagnose and monitor childhood asthma. Their ability to indicate an asthma diagnosis, and to assess asthma severity and control, is largely unknown.

Objective:

To study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and controls. 2) the ability of these biomarkers to indicate asthma severity and control.

Methods:

114 Children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls (10.0±0.4 years). Condensate was collected using a glass condenser


Eligibility criteria: Inclusion Criteria:

* Asthmatic and control children, aged 5 to 16 years
* Children with doctor-diagnosed asthma, known at the department of Paediatric Pulmonology, University Hospital Maastricht

Exclusion Criteria:

* Presence of a disease that might interfere with the results of this study (e.g. recent upper airway infection, heart disease, anatomic abnormalities of the airways and other chronic inflammatory diseases such as Crohns disease and rheumatoid arthritis)
* Mental retardation
* Inability to perform the EBC procedure properly
* Active smoking
* The use of one of the following medication: Papaverin, Sodium nitroprusside, ACE inhibitors, Oxymetazoline, L-arginine, or NOS inhibitors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
Study officials:
affiliation: Maastricht University Medical Center
name: Charlotte M Robroeks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Edward Dompeling, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Quirijn Jöbsis, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02656576: Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy
Official title: Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Keywords: Human Papillomavirus
oropharynx biopsy
tonsillar lesion
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR).


Eligibility criteria: Inclusion Criteria:

* Presents a suspicious lesion of the amygdala region
* Have a biopsy of the oropharynx planned in the operating room.

Exclusion Criteria:

* Pregnant Patient.
* Against anesthetic or surgical indication for endoscopy of the upper aerodigestive tract.

Primary outcomes:
measure: the correlation between the two sampling methods
timeFrame: 1 month
Secondary outcomes:
measure: rate of concordance for the detection of HPV between biopsy and smear
timeFrame: 1 month
measure: the overall agreement
timeFrame: 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: CHU Toulouse
name: Benjamin VAIREL, Doctor
role: PRINCIPAL_INVESTIGATOR
References: