louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04594577: Clinical Validation of the Fluispotter System for Serial Sampling of Venous Dried Blood Spots
Official title: The Clinical Validation of Fluispotter®, a Novel Automated Body-worn System for Serial Sampling of Venous Dried Blood Spots
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Sampling Procedure
Healthy
Lead sponsor: Fluisense ApS
Sponsor class: INDUSTRY
Collaborators: name: Dantrials Aps
First posted: 2020-10-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective, single-centre, non-comparative, non-randomized, open label, clinical investigation of the clinical performance and safety of Fluispotter. The main aim is to validate the clinical performance and safety of the body-worn Fluispotter system used for automated extraction, collection and storage of 20 dried venous dried blood spot samples of 10 µl over the course of 20 hours.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age ≥ 18
* Able to understand verbal and written instructions in Danish
* Able and willing to sign and date the informed written consent form and letter of authority

Exclusion Criteria:

* Currently participating in a clinical trial evaluating drugs or medical devices
* Known history of coagulation disorders
* Currently taking regular medication (contraceptives, hormonal replacement therapy and antihistamines exempted)
* Regular smoking or use of nicotine products
* Pregnancy
* Haematocrit \< 38% (male); \< 33% (female)
* Haematocrit \> 52% (male); \> 48% (female)
* C-reactive protein (CRP) \> 10 mg/dL
* Body Mass Index (BMI) \> 30
* Known allergies or hypersensitivity to flushing solution constituents
* Other factors which in the opinion of the investigator would interfere with the ability to provide informed consent, comply with study procedures/instructions, or possibly confound the interpretation of the study results or put the subject at undue risk

Primary outcomes:
measure: Number of samplings
timeFrame: 20 hours
Secondary outcomes:
measure: Clinical safety, safety reporting
timeFrame: 8 ± 2 days
measure: Clinical safety, systemic effects
timeFrame: 24 hours
measure: Technical performance
timeFrame: 20 hours
measure: Procedure
timeFrame: Approximately 60 minutes and 24 hours
measure: Usability: User experience based on questionnaire
timeFrame: 24 hours
measure: Usability: Subject experience based on questionnaire
timeFrame: 24 hours and 8 ± 2 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: DanTrials ApS
Study officials:
affiliation: Dantrials Aps
name: Jesper Sonne, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547077: Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure
Official title: Use of 2-octylcyanoacrylate (Dermabond) Versus 5-0 Fast Absorbing Gut During Cutaneous Wound Closure: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Closure Techniques
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut.

Detailed description: The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of linear cutaneous surgery wounds improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigators will use a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted linear closure of 3 cm of longer.
* Willing to return for follow-up visits

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Pregnant Women
* Wounds with predicted closure length less than 3 cm

Primary outcomes:
measure: Assessment of Scar on the Patient and Observer Scar Assessment Scale
timeFrame: 3 months
Secondary outcomes:
measure: Measurement of Scar Width
timeFrame: 3 months
measure: Assessment of Complications
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhuang AR, Beroukhim K, Armstrong AW, Sivamani RK, Eisen DB. Comparison of 2-Octylcyanoacrylate Versus 5-0 Fast-Absorbing Gut During Linear Wound Closures and the Effect on Wound Cosmesis. Dermatol Surg. 2020 May;46(5):628-634. doi: 10.1097/DSS.0000000000002076.
Clinical trial NCT05547477: Continuous EMG Measurements in Children With Asthma During Sleep
Official title: Continuous EMG Measurements in Children With Asthma During Sleep
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma in Children
Electromyography
Sleep-Disordered Breathing
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to include 20 paediatric patients with paediatrician diagnosed asthma of bronchial hyperresponsiveness, admitted to the paediatric ward of Medisch Spectrum Twente.

Brief summary: The objective of this study is to investigate whether electromyography of the diaphragm during sleep in asthmatic children can be used to objectively monitor asthma control.


Eligibility criteria: Inclusion Criteria:

* Paediatrician diagnosed asthma or bronchial hyperresponsiveness
* Aged 4 till 18
* Admitted to the paediatric ward of Medisch Spectrum Twente

Exclusion Criteria:

* Admittance to the ICU
* Patient has ICD or pacemaker
* Parents and/or patient cannot understand or speak Dutch
* Does not fit in one of the available Hexoskin shirts

Primary outcomes:
measure: Breathing registration in sleep using electromyography
timeFrame: From admittance to the ward, up to 12 hours
Secondary outcomes:
measure: Prediction of asthma exacerbations
timeFrame: After inclusion of all subjects, up to 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05114577: Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
Official title: Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Addiction
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Society for Health Psychology
First posted: 2021-11-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to examine how to improve sleep in college students in recovery from substance use disorder(s). This study is a pilot test of an experimental program called Recovery Sleepers (RS) to explore its feasibility and how well it works to improve sleep, wellbeing, and cravings.


Eligibility criteria: Inclusion Criteria:

* More than 18 years of age
* Enrolled (full- or part-time) at a college or university
* Have struggled with substance addiction in the past
* More than 3 months of self-reported continuous abstinence from alcohol and all illegal drugs
* Have an Internet-enabled device with audio capabilities.

Exclusion Criteria:

* Younger than 18 years of age
* Not enrolled at VCU
* Have not struggled with substance addiction in the past
* Have not had at least 3 months of self-reported continuous abstinence from alcohol and all
* illegal drugs
* In active treatment for a sleep disorder (seen a health provider specifically regarding sleep within the last 6 months)
* Unable to communicate in English both orally and in writing
* Do not have an Internet-enabled device with audio capabilities.

Primary outcomes:
measure: Satisfaction with treatment
timeFrame: 6 weeks
measure: Study participant retention
timeFrame: 6 weeks
measure: Study material completion
timeFrame: 6 weeks
measure: Study group attendance
timeFrame: 6 weeks
measure: Recruitment success
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Natalie Dautovich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04906577: Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
Official title: Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Birth
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the CHU of Nice lead to a separation between mother and child, with a reduction in sensory interactions.

The immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother.

The hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. In the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.


Eligibility criteria: Inclusion Criteria:

* Immediate postpartum mothers of newborns with a term of \< 33 weeks (32 weeks + 6 days)
* primiparous mothers
* Mothers with vaginal delivery, without oxytocin infusion after delivery
* Mothers planning to breastfeed, with no maternal contraindication to breastfeeding

Exclusion Criteria:

* Substance abuse: active smoking at the time of delivery, alcohol, drugs
* Use of medication: antidepressants or psychotropic drugs or centrally acting anti-emetics
* Active depression or history of depression (under medical care with medical follow-up) in the year preceding the birth, on questioning
* Chromosomal abnormality or congenital malformation of pre- or post-natal diagnosis in the newborn
* Language barrier not allowing proper explanation of the protocol and responses to questionnaires

Primary outcomes:
measure: Change in ocytocine levels
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Florence CASAGRANDE, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06700577: Multidrug Resistance in Newly Diagnosed TB Patient
Official title: Prevalence of Multidrug Resistant Tuberculosis by Xpert MTB/RIF Ultra and Xpert XDR Assay Among Newly Diagnosed Cases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tuberculosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All newly diagnosed TB patient above 18 years who not recieved antituberculus drug before

Brief summary: Tuberculosis (TB) is one of the major public health threats, competing with the human immunodeficiency virus (HIV) as the cause of death due to infectious diseases worldwide.

Multi drug-resistant Mycobacterium tuberculosis (MDR-TB) is one of the leading causes of death in the world.

The resource constraints make it difficult to diagnose and monitor the cases of MDR-TB.

GeneXpert is a recognized tool used to diagnose the patients of pulmonary tuberculosis in clinical settings across the globe MDR Multidrug-resistant tuberculosis (MDR-TB), caused by Mycobacterium tuberculosis that is resistant to both isoniazid and rifampicin with or without resistance to other drugs According to current World Health Organization and the International Union Against Tuberculosis and Lung Disease estimates, the median prevalence of MDR-TB has been 1.1% in newly diagnosed patients. The proportion, however, is considerably higher (median prevalence, 7%) in patients who have previously received anti-TB treatment.

XDR tuberculosis is caused by a strain of Mycobacterium tuberculosis resistant to isoniazid and rifampin (which defines MDR tuberculosis) in addition to any fluoroquinolone and at least one of the three following injectable drugs: capreomycin, kanamycin, and amikacin The main causes of the spread of resistant TB are weak medical Systems, amplification of resistance patterns through incorrect treatment, and transmission in communities and facilities. Although patients harboring MDR and XDR strains present a formidable challenge for treatment, cure is often possible with early identification of resistance and use of a properly designed regimen.

Detailed description: To detect the prevalence of MDR T.B. using xpert MTB/RIF ultra and XDR assay in newly diagnosed cases

Eligibility criteria: Inclusion criteria

* newly diagnosed tuberculosis patient
* Diagnosed by direct smear for sputum or body fluid

Exclusion Criteria:

\* previously treated patient

Primary outcomes:
measure: To detect the prevalence of multidrug resistant tuberculosis in newly diagnosed cases by xpert XDR assay.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Seung KJ, Keshavjee S, Rich ML. Multidrug-Resistant Tuberculosis and Extensively Drug-Resistant Tuberculosis. Cold Spring Harb Perspect Med. 2015 Apr 27;5(9):a017863. doi: 10.1101/cshperspect.a017863.
Clinical trial NCT01230177: Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Official title: Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 3
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Brief summary: This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

Detailed description: Implemented as a Special Investigation by Central Registration System

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered etanercept in order to be enrolled in the survey
* Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Exclusion Criteria:

* Patients who have been administered etanercept 50mg once a week
* Patients who have been administered etanercept 25mg once a week

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: 12 weeks
measure: Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
timeFrame: 12 weeks
measure: Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
timeFrame: 12 weeks
Secondary outcomes:
measure: Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Taihaku Sakura Hospital
state: Miyagi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01148277: Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
Official title: Propofol and Remifentanyl Versus Midazolam and Fentanyl for Diagnostic Colonoscopy in Patients With Compensated Cirrhosis Child A-B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Disease
Keywords: Endoscopies
Liver diseases
Propofol
Midazolam and remifentanyl
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2010-06-22
Enrollment: 90
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: This is a prospective, randomized-controlled trial (RCT) comparing the use of Propofol and Remifentanyl and traditional sedation (Midazolam and Fentanyl) for diagnostic colonoscopies in patients with compensated cirrhosis child A-B. The working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications (Hepatic Encephalopathy) in the context of patients with advanced liver disease.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients older than 18 and younger than 75 years with cirrhosis defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B)

Exclusion Criteria:

* Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea.
* HCC

Primary outcomes:
measure: Safety and efficacy of propofol in liver diseases
timeFrame: up to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
Study officials:
References:
Clinical trial NCT00136877: Tonsillectomy in Recurrent Tonsillitis
Official title: Effect of Tonsillectomy on Preventing Recurrent Streptococcal Throat Infections: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tonsillitis
Keywords: recurrent tonsillitis
streptococcus
tonsillectomy
prevention
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2005-08-29
Enrollment: 70
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether tonsillectomy is effective in preventing further streptococcal pharyngitis episodes in patients with recurrent tonsillitis.

Detailed description: Tonsillectomy is widely used worldwide in recurrent streptococcal tonsillitis, but its effect remains unknown.

In this randomized controlled trial, the effect of tonsillectomy (compared to watchful waiting) in preventing further culture proven symptomatic streptococcal pharyngitis episodes is studied. In addition, symptoms after the operation, side effects, and life quality issues are recorded.

Eligibility criteria: Inclusion Criteria:

* At least 3 tonsillitis episodes during the preceding year (at least one verified by culture or antigen testing)

Exclusion Criteria:

* Other serious illness
* Long term antibiotic treatment for other disease
* Documented immunologic disorder
* Pregnancy

Primary outcomes:
measure: microbiologically confirmed streptococcal pharyngitis episodes
Secondary outcomes:
measure: side effects
measure: symptoms
measure: quality of life issues
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Dept of Otolaryngology, University of Oulu, Finland
name: Olli-Pekka Alho, MD
role: STUDY_DIRECTOR
References:
citation: Alho OP, Koivunen P, Penna T, Teppo H, Koskela M, Luotonen J. Tonsillectomy versus watchful waiting in recurrent streptococcal pharyngitis in adults: randomised controlled trial. BMJ. 2007 May 5;334(7600):939. doi: 10.1136/bmj.39140.632604.55. Epub 2007 Mar 8.