louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00694148: Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
Official title: NT 201 is a Botulinum Toxin Type A Preparation Free of Complexing Proteins. Injected Into the Muscle, NT 201 Causes a Reversible Local Relaxation of the Injected Muscle. Botulinum Toxin Type A is Widely Used for Aesthetic Treatment of Mimic Wrinkles. This Study Will Investigate the Safety and Efficacy of NT 201 in the Treatment of Glabellar Frown Lines.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Treatment of glabellar frown lines
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.


Eligibility criteria: Inclusion Criteria:

* moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
* Stable medical condition
* Age: between 18 and 65 years (inclusively)

Exclusion Criteria:

* Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
* Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
* Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
* Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
* Any other planned cosmetic procedure in the upper third part of the face during the trial period
* Inability to substantially lessen glabellar frown lines even by physically spreading them apart
* Marked facial asymmetry or ptosis of eyelid and/or eyebrow
* History of facial nerve palsy
* Any infection in the area of the injection sites

Primary outcomes:
measure: Investigator's assessment
timeFrame: 4 weeks after initial injection session
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Soden
country: Germany
facility: Dr. Matthias Imhof, Medico Palais Bad Soden
state: Hessen
Study officials:
affiliation: Ästhetische Dermatologie, Medico Palais Bad Soden
name: Matthias Imhof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imhof M, Kuhne U. A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. J Clin Aesthet Dermatol. 2011 Oct;4(10):28-34.
Clinical trial NCT03255148: Influence of Oxytocin on Resting State Neurophysiological Measures
Official title: Influence of Oxytocin on Resting State Neurophysiological Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oxytocin
Keywords: resting state
EEG
skin conductance
heart rate
oxytocin
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2017-08-21
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.

Detailed description: Oxytocin is known to influence several neurophysiological measures, such as heart rate, EEG and skin conductance during specific tasks (e.g., emotion recognition, fear learning and extinction). However, not much is known about the influence of oxytocin on those measures during rest. Therefore, in this randomized, placebo controlled, double blinded study, the investigators will investigate the influence of oxytocin during a resting period of 5 minutes. Heart rate, skin conductance, respiration and EEG will be measured before and after oxytocin or placebo administration. The investigators expect that oxytocin will increase the heart rate variability and decrease the skin conductance levels. Exploratory, the investigators will conduct a cross-frequency analysis of band power and asses the relationship between distinct indexes of sympathetic / parasympathetic balance.

Please note that this study is part of a larger study in which the investigators also asses the influence of oxytocin on neurophysiological responses elicited by direct gaze

Eligibility criteria: Inclusion Criteria:

* right-handed
* male
* age between 18 and 35
* Normal or adjusted-to-normal vision (with lenses only)
* Dutch as mother tongue

Exclusion Criteria:

* not right-handed
* female
* age below 18 or above 35
* Need to wear glasses
* Dutch not as mother tongue

Primary outcomes:
measure: Change in heart rate variability after oxytocin administration
timeFrame: Assessment over 5 minutes, before and after oxytocin or placebo administration
Secondary outcomes:
measure: Change in skin conductance level after oxytocin administration
timeFrame: Assessment over 5 minutes, before and after oxytocin or placebo administration
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: KU Leuven
name: Kaat Alaerts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02515448: A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ventilator-associated Pneumonia
Keywords: VAP
Critical care
Pharmacokinetics
Gentamicin
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection associated with the highest morbidity and mortality.

Respiratory infection with resistant organism are increasing in prevalence. Because of lack of alternatives, amino glycoside, old antibiotics family, can be used for several infection.

Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for respiratory infections. Gentamicin,which is effective against numerous multi drug resistant Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option for nebulisation.

The investigators assume that nebulisation of gentamicin allows to obtain a higher lung concentration while assuring a systematic toxicity much lesser than a parenteral administration.


Eligibility criteria: Inclusion Criteria:

* to be in critical care unit
* to be mechanically ventilated
* to have a ventilator-associated pneumonia requiring a treatment by gentamicin
* to be affiliated to a national insurance scheme
* to have given an informed consent (patient or close person)

Exclusion Criteria:

* to be obese (BMI \> 40 kg/m²)
* to have been treated by gentamicin for 7 days
* to be allergic to aminoglycoside
* to have a severe respiratory failure (PaO2 / FiO2 \< 150)
* to have a renal failure (Cl creat \< 60 ml/min/1.73m²)
* to be under reinforced protection measure

Primary outcomes:
measure: "Peak Plasma Concentration (Cmax)"
timeFrame: 3 days
Secondary outcomes:
measure: PaO2/FiO2 ratio deterioration above 20%.
timeFrame: 3 days
Other outcomes:
Locations:
city: Poitiers
country: France
facility: BOISSON Matthieu
city: Tours
country: France
facility: Dequin P-F
Study officials:
References:
Clinical trial NCT04210648: Effectiveness and Security Testing of a Mobile App for Self-Managing Emotion Dysregulation
Official title: Effectiveness and Security Testing of a Mobile App for Self-Managing Emotion Dysregulation in a Non-Clinical Population With Borderline Traits: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Dysregulation
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
Collaborators: name: University Ramon Llull
First posted: 2019-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness and security of a mobile App (beta version) for people with borderline traits recruited from a non-clinical population of college students in Barcelona (Spain). The main primary outcome will be the severity of the emotional dysregulation. Forty participants will use the mobile app over 6 months. This group while be compared at post-treatment and at 3-month follow-up with other 40 participants (control group) with any intervention.


Eligibility criteria: Inclusion Criteria:

* Borderline traits
* Aged between 18 to 65 years
* College students

Exclusion Criteria:

* None

Primary outcomes:
measure: Emotion dysregulation severity
timeFrame: 9-month
measure: smartphone addiction
timeFrame: 9-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01301248: Cisplatin Chemoradiation With or Without Cetuximab for Locoregionally Advanced Squamous Cell Carcinomas (SCC) of the Head and Neck
Official title: Phase II Safety and Toxicity Study of Cisplatin With or Without Cetuximab and Concomitant Radiotherapy for Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Neoplasms
AJCC Stage III/IV
Keywords: locally advanced,
unresectable,
head and neck squamous cell carcinoma,
stage III/IV
Lead sponsor: Theagenio Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2011-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment

Detailed description: Conventional radiotherapy (65-70 Gy, 1.8 Gy per day) concurrently with weekly cisplatin (40mg/m2) (group A, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group B, n=25) is applied (in a 1:1 randomization ratio). Groups will be matched age, sex, PS, and disease site.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed HNSCC of oral cavity, larynx, oropharynx or
* hypopharynx; age of 18 years or more
* adequate liver (SGOT, SGPT, ALP ≤ 3x normal)
* kidneys (creatinine clearance ≥ 60ml/min
* heart (no arrythmias, no heart failure) and
* bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function
* ECOG performance status 0 or 1 and
* stage III or IVa to b with measurable lesions
* written informed consent

Exclusion Criteria:

* prior radiotherapy
* chemotherapy
* concurrent active malignancies
* pregnancy
* breast-feeding

Primary outcomes:
measure: Determine safety and toxicity of combination
timeFrame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
Secondary outcomes:
measure: Overall survival time
timeFrame: Time from first administration of trial treatment to death or last date known to be alive, anticipated average time frame 24 months
measure: Progression-free survival time
timeFrame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
measure: Response
timeFrame: Time from first administration of trial treatment to disease progression, death or last tumor assessment, anticipated average time frame 12 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Theagenio Cancer Hospital
Study officials:
affiliation: Theagenio Cancer Hospital
name: Charalambos Andreadis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05995548: Mechanisms Involved in the Developement of Sports Addiction Among Military Personnel
Official title: Mechanisms Involved in the Developement of Sports Addiction Among Military Personnel
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Addiction
Keywords: Sports addiction
Military
Comprehension model
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of sport addicts military subjects.

Brief summary: Sport addiction (or exercise addiction) has been recognized as a pathology by the World Health Organization since 2011. However, it is still relatively under-researched. It is one of the so-called behavioral addictions and has long-term negative consequences for physical, psychological and social health, such as : isolation ; frequent injuries; co-addiction with or as a result of sports'.

The study is aimed in particular at military physicians and will target a population where sport is an integral part of the job and where sporting performance is valued: military personnel.

The aim of this study is to explain and try to understand this pathology through the experiences of those who suffer from it. Therefore, investigators have chosen to conduct a qualitative study inspired by the embedded theory. Semi-structured individual interviews will be conducted using an interview guide. This guide, consisting of 5 or 6 open-ended questions, will help to set the general direction of the interview without preventing the participant from deviating. The interview guide may evolve as the interviews progress, enriched by any new ideas or themes that emerge.


Eligibility criteria: Inclusion Criteria:

* Serving or reservist military personnel
* Perceive themselves as "addicted to sport" and say so

Exclusion Criteria:

* Minor
* Incapable major
* Patient unaware of diagnosis
* Pregnant woman
* Legionnaire not rectified

Primary outcomes:
measure: Explanatory model
timeFrame: Through study completion (30 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Hyères
country: France
facility: CMA09
Study officials:
References:
Clinical trial NCT06076148: Virtual Reality and Technologies for Elderly
Official title: Aging Well by Being Connected - Phase 1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging Well
Keywords: Aging well
Virtual reality
Immersive technology
Older adults
Physical activity
Cognitive activity
Social behaviour
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Conseil de recherches en sciences naturelles et en génie du Canada
name: SEC Fonds Immobilier Groupe Maurice
name: Fédération Québécoise des Loisirs en Institution
name: Fédération de l'Age D'Or du Québec
First posted: 2023-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will test both multiplayer and individual games. Order of testing is reversed in between arms.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this clinical trial is to understand the determinants and opportunities for acceptance of immersive technologies to support physical, cognitive, and social health and the possibilities for "aging well" among the new generation of older adults. The main questions it aims to answer are:

* What are the needs and expectations in terms of immersive activities and intervention methods according to age?
* Do different game modes influence the needs and expectations in immersive activities of this population? 50 participants will be asked to complete a preliminary questionnaire about their activity habits and preferences. They will then be invited to participate in individual or multiplayer virtual reality game trials, a post-trial discussion about their experience and a questionnaire completion.


Eligibility criteria: Inclusion Criteria:

* Be 50 years old or older

Exclusion Criteria:

* Having functional limitations
* Having cognitive impairments
* Being at risk of epilepsy
* Not being autonomus
* Having a pacemaker

Primary outcomes:
measure: Perception of immersive technologies experience
timeFrame: Immediately after the intervention
measure: Integration of virtual reality
timeFrame: Immediately after the intervention
measure: Acceptability of immersive technologies
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Change in interest in immersive activities
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: TOPMED
Study officials:
References:
Clinical trial NCT05045248: Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
Official title: Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myasthenia Gravis
Ocular Myasthenia Gravis
Keywords: myasthenia gravis
ocular myasthenia
apraclonidine
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.

Detailed description: The rationale behind using Apraclonidine is that it acts on Muller's muscle which is a sympathetic-innervated muscle. As such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement.

Exclusion Criteria:

* Patients receiving mono-amino-oxidase inhibitors.
* Patients with history of hypertension, cardiac, or cerebrovascular disease.
* Women with confirmed pregnancy.

Primary outcomes:
measure: Change in palpebral fissure height (PF)
timeFrame: Before administration, at 1, 5, 30, and 60 minutes after administration
measure: Change in marginal reflex distance-1 (MRD1)
timeFrame: Before administration, at 1, 5, 30, and 60 minutes after administration
measure: Change in marginal reflex distance-2 (MRD2)
timeFrame: Before administration, at 1, 5, 30, and 60 minutes after administration
measure: Change in levator function (LF)
timeFrame: Before administration, at 1, 5, 30, and 60 minutes after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Johnny Salameh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01787448: RIPT of Ibuprofen Topical Gel
Official title: Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: repeat insult patch test
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.


Eligibility criteria: Inclusion Criteria:

Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder

Exclusion Criteria:

Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study

Primary outcomes:
measure: Dermal sensitization potential
timeFrame: 24-72 hours after last patch removal
Secondary outcomes:
measure: Cumulative Irritancy
timeFrame: 48-72 hours after each patch application
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: During study through 28 days after last product application
Other outcomes:
Locations:
city: Carlstadt
country: United States
facility: Pfizer Investigational Site
state: New Jersey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: