louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05290103: Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy
Official title: Promoting Early Adolescent Non-smoking With a Game Intervention Supporting Self-efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Efficacy
Smoking
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 781
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This intervention study evaluates the effectiveness of a digital game intervention supporting smoking refusal self-efficacy among early adolescents (10-13 y). The participants are randomly allocated to two groups: the experimental group that receives the digital game intervention, and the control group that receives no intervention.


Eligibility criteria: Inclusion Criteria:

* Goes to school at 4th, 5th, or 6th grade
* Sufficient skills in Finnish or Swedish

Exclusion Criteria:

-

Primary outcomes:
measure: Change in smoking refusal self-efficacy
timeFrame: At baseline, at 2 weeks, and at 3 months
Secondary outcomes:
measure: Change in sources of refusal self-efficacy related to tobacco use
timeFrame: At baseline, at 2 weeks, and at 3 months
measure: Change in motivation to decline tobacco use in the future
timeFrame: At baseline, at 2 weeks, and at 3 months
Other outcomes:
Locations:
city: Nine Cities
country: Finland
facility: Primary schools (n=15)
Study officials:
References:
Clinical trial NCT01655303: Rate Control in Atrial Fibrillation
Official title: Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rapid Ventricular Response Atrial Fibrillation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 90
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: Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments.

This study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are compared in patients with a stable hemodynamic status.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years old
* Stability in hemodynamic

Exclusion Criteria:

* Systolic blood pressure less than 90 mm Hg
* Altered mental status attributable to rapid ventricular response atrial fibrillation
* Acute pulmonary edema attributable to rapid ventricular response atrial fibrillation
* Chest pain attributable to rapid ventricular response atrial fibrillation
* Allergy to Propranolol or Metoprolol or Verapamil or Diltiazem
* History of asthma

Primary outcomes:
measure: Rate less than 100 per minute
timeFrame: In 1 hour
Secondary outcomes:
measure: Drugs adverse effects
timeFrame: 2 hours
measure: Unstability in hemodynamic
timeFrame: 2 hours
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rasoul-e-Akram Hospital
Study officials:
References:
Clinical trial NCT01924403: Perfusion Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty
Official title: Assessment of Wound Closure Techniques in Primary Total Knee Arthroplasty Using SPY Intra-operative Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: TKA
Wound Closure
Wound Perfusion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess which of the three most common methods of wound closure in primary total knee arthroplasty (staples, interrupted vertical mattress, or running subcuticular suture) provide the best wound vascular perfusion. This can be achieve by using SPY intra-operative vascular angiography, which is commonly used in clinical practice to assess perfusion of wound closure at the clinic. By understanding the differences in perfusion afforded by different closure techniques, surgeons will then be able to select the technique that optimizes this parameter so as to avoid complications such as tissue necrosis, wound dehiscence, or infection.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Primary diagnosis of osteoarthritis
* Surgical indication for index total knee arthroplasty

Exclusion Criteria:

* Previous surgery about the knee
* Systemic corticosteroid use
* Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis

Primary outcomes:
measure: Perfusion of Wound Closure
timeFrame: Surgical Point of Care
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert Trousdale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wyles CC, Jacobson SR, Houdek MT, Larson DR, Taunton MJ, Sim FH, Sierra RJ, Trousdale RT. The Chitranjan Ranawat Award: Running Subcuticular Closure Enables the Most Robust Perfusion After TKA: A Randomized Clinical Trial. Clin Orthop Relat Res. 2016 Jan;474(1):47-56. doi: 10.1007/s11999-015-4209-x.
Clinical trial NCT05921890: To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.
Official title: To Evaluate the Safety and Tolerability of GS3-007a Oral Solution in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subject
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.

Detailed description: To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects

Eligibility criteria: Inclusion Criteria:

* Healthy adult subjects aged 18-45 years (including boundary values), male or female;
* Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;

Exclusion Criteria:

* (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation;
* (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment;
* ALT and AST exceed the upper limit of the normal range;

Primary outcomes:
measure: TEAEs
timeFrame: 35 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
state: Sichuan
Study officials:
References:
Clinical trial NCT03652090: Primary Nasal Cell Culture as a Tool for Personalized Therapy in Cystic Fibrosis
Official title: Evaluation of the Primary Human Nasal Epithelial Cell Culture Model in the Context of Personalized Therapy in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: biomarker
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: ABCF2
First posted: 2018-08-29
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Cystic Fibrosis with 2 mutations in CFTR

* healthy heterozygotes with 1 mutation in CFTR
* healthy subjects with no familial history of Cystic Fibrosis and no symptoms compatibel with Cystic Fibrosis

Brief summary: characterization of CFTR function and expression in nasal primary cells collected from patients with cystic fibrosis in comparison to their parents, healthy heterozygotes and healthy controls

Detailed description: 3 groups of subjects are enrolled CF subjects according to their genotypes (aiming to enroll patients carrying 2 CF causing mutations with no CFTR expression/function, and patients carrying at least 1 mutation with residual function, such R117H) Parents or siblings of the CF subjects, as healthy hétérozygotes healthy controls All these subjects experience nasal brushings. From these nasal brushings,nasal cells are expanded, and cultured in air liquid interface to obtain polarized epithelium. This epithelium is then studied in Ussing chamber experiments to characterize the level of cAMP dependant Chloride transport and Sodium reabsorption. Apical expression of CFTR is assessed by immunofluorescence.

Results will allow to define the variability of CFTR function and expression criteria in subjects with the same genotype. Such data are crucial for interpretation of the effect of CFTR modulators.

Eligibility criteria: Inclusion Criteria:

* patients with Cystic Fibrosis with 2 mutations in CFTR
* healthy heterozygotes with 1 mutation in CFTR
* healthy subjects with no familial history of Cystic Fibrosis and no symptoms suggesting Cystic Fibrosis

Exclusion Criteria:

* smoking

Primary outcomes:
measure: variation in the short-circuit-current (Isc) after Forskolin (Forskolin)/IBMx and VX-770 (∆IscFsk/IBMx+VX-770)
timeFrame: 1 day
Secondary outcomes:
measure: percentage of cells displaying apical staining
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05260190: Manual Dexterity Modifications After Application of tSMS Over the Primary Motor Cortex (M1)
Official title: Hand Grip Strength and Manual Dexterity Modifications After Application of Transcranial Static Magnetic Field Stimulation (tSMS) Over the Primary Motor Cortex (M1) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Neurologic Disorder
Manual Dexterity
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Transcranial static magnetic field stimulation (tSMS) is a novel brain stimulation technique that has been shown to be safe and effective in modifying biological parameters when applied to the cerebral cortex. Its application decreases cortical excitability, regardless of the polarity of the magnetic field, reducing the amplitude of motor evoked potentials (MEP). tSMS is presented as a potentially useful tool in the management of the interhemispheric inhibition, a condition present in neurological pathologies such as stroke or multiple sclerosis. Despite having demonstrated neurophysiological effects in previous studies, the effects of tSMS application on force production and manual dexterity, have not yet been clearly established.

The present study aims to evaluate changes in force production, manual dexterity, and fatigue after unilateral application of a tSMS session on the primary motor cortex (M1). It is hypothesized that the application of tSMS will momentarily decrease the parameters of strength and manual dexterity in the upper limb contralateral to the stimulated cortex, without changes in the strength and dexterity of the unstimulated hemibody. These parameters may show an increase in the unstimulated hemibody. If the hypothesis is confirmed, it could be considered a valid treatment for health conditions presenting interhemispheric inhibition.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years.
* Absence of cognitive impairment.
* Adequate understanding of verbal and written information, sufficient to complete the tests.

Exclusion Criteria:

* Presence of metallic implants (e.g., neurostimulator, pacemaker, cochlear implant, or metallic elements in the head or around the eyes).
* Diagnosis of epilepsy or being under treatment with antiepileptic drugs.
* Diagnosis of unstable cardiovascular disease.
* Diagnosis of any disease or condition that may interfere with this study.
* Use of drugs that may influence with neuromuscular function (muscle relaxants or some analgesics...).

Primary outcomes:
measure: Finger Tapping Test (FTT)
timeFrame: 5 minutes
measure: Nine-Hole Peg Test (9HPT)
timeFrame: 5 minutes
Secondary outcomes:
measure: Hand grip strength
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References:
Clinical trial NCT03969290: Clinical Performance of Two Daily Disposable Contact Lenses - Study 1
Official title: Clinical Performance of Two Daily Disposable Contact Lenses - Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Contact lens
Vision correction
Visual acuity
Daily disposable contact lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Contralateral
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate end of day (EOD) visual acuity (VA) at distance when wearing Precision1™ contact lenses compared to Acuvue® Moist contact lenses.

Detailed description: The expected duration of subject participation in the study is 1-8 days, with 3 scheduled visits (Screening, Dispense, Exit).

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign an approved Informed Consent form
* Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day
* Best corrected VA of logMAR 0.10 or better in each eye
* Willing to discontinue artificial tears and rewetting drops during the study
* Able to wear contact lenses within the protocol-specified sphere power range
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator
* History of ocular or intraocular surgery, including refractive surgery, and/or irregular cornea
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment
* Previous 3 years or current wearers of Acuvue Moist or DAILIES TOTAL1® contact lenses
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: End of day (EOD) visual acuity at distance
timeFrame: Day 1, after 8 hours of wear
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References:
Clinical trial NCT05940090: Correlation of Dermatologist Made Biopsy Decision With AI Assisted Total Body Photography Detection of Outlier Lesions
Official title: Correlation of Dermatologist Made Biopsy Decisions With Artificial Intelligence (AI) Assisted Total Body Photography Detection of Outlier Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Lesion
Lead sponsor: Halcyon Dermatology
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females participants in overall good health ages 18 to 85 who have skin lesions

Brief summary: This research study will determine how a smart phone application (app) for total body photography outlier analysis compares to a dermatologist's decision to biopsy skin lesions.

Detailed description: Informed written consent will be obtained by all study subjects. Each participant will be asked to generate a unique identifier, so their demographic data, medical intake, and study assessments can be stored without any patient identifiers. The unique identifier is the participant's 2-digit day of birth, first 3 initials of their mother's maiden name, and the 4 digits of their birth year. All clinical data will be entered into a de- identified database.

Demographic information including age, gender, ethnicity, collected via medical intake survey at the initial visit. Data from the survey will be associated only with the patient's unique identifiers.

Eligibility criteria: Inclusion Criteria:

* Males and females participants in overall good health ages 18 to 85 who have skin lesions

Exclusion Criteria:

* Those who are under 18 or over 85

Primary outcomes:
measure: Dermatologist made biopsy decision compared to AI outlier lesions
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Halcyon Dermatology
state: California
Study officials:
References:
Clinical trial NCT00946790: To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Official title: Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunosuppression
Rheumatism
Keywords: Immunosuppressant and Antirheumatic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 72
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 171 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PharmaKinetics Laboratories Inc.
name: Gerald Gantt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02683590: STernectOmy Repair Efficiency of a Ceramic Implant
Official title: STernectOmy Repair Efficiency of a Ceramic Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bones, Tumors
Keywords: Sternectomie
Ceramic Implant
Bones Tumors
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: For the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. The use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection.

Main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.


Eligibility criteria: Inclusion Criteria:

* Patient major
* Having a replacement indicating the sternum (or a part of the sternum)
* With an expected life of over one year, estimated by the principal investigator
* Written consent of the patient

Exclusion Criteria:

* People under safeguard justice,
* Patient under guardianship,
* Patient pregnant or breastfeeding,
* Topic attending another search including a period of exclusion still going to run-in
* Contraindication to general anesthesia
* Of alumina allergy antecedent
* Recent infectious disease unsupported
* BMI\> 40

Primary outcomes:
measure: vital capacity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges Hospital
city: Nice
country: France
facility: Saint George clinic
city: Reims
country: France
facility: Reims university hospital
Study officials:
References:
Clinical trial NCT05958290: Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
Official title: Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Implantable Electronic Device Infection
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this non-randomized prospective study is to test whether 6-weeks antibiotic treatment can cure an cardiac implantable electronic device (CIED) infection in patients where device extraction is not feasible.

The main question it aims to answer:

• Is 6-weeks medical therapy effective in curing definite CIED infection with device retention?

Participants will discontinue the antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total. After discontinuation of antibiotics, patients are closely observed for bacterial relapse.

For patients who are not interested in participation and who do not have exclusion criteria, we will ask for consent into a registry as we wish to compare patients undergoing discontinuation of antibiotics with patients undergoing standard treatment.


Eligibility criteria: Inclusion Criteria:

* Definite CIED infection by the EHRA criteria
* Deemed non-eligible for CIED extraction

Exclusion Criteria:

* Unavailable for follow-up (e.g., tourist)

Primary outcomes:
measure: Composite endpoint of death or relapse bacteremia
timeFrame: 12 months
Secondary outcomes:
measure: Death
timeFrame: 12 months
measure: Readmission for any cause
timeFrame: 12 months
measure: Device extraction
timeFrame: 12 months
measure: Change in quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Region Hovedstaden
Study officials:
References: