louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05614687: Art as Healing: A Community-informed Art-based Programme (CiAbP) for Reintegrating Ex-offenders Into Society in Nigeria
Official title: Art as Healing: A Community-informed Art-based Programme (CiAbP) for Reintegrating Ex-offenders Into Society in Nigeria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Depression
Anxiety and Fear
Keywords: Trauma
Anxiety and Fear
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
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: The goal of this pilot experimental study is to test a community-informed art-based programme in improving community members trauma from crime and to aid the reintegration of ex-offenders into society.

The main question it aims to answer are:

• What is the feasibility in terms of recruitment, retention, adherence to the intervention and communities/victims' satisfaction with CiAbP to promote healing and improve the successful reintegration of ex-offenders into society?

Participants will be randomly allocated into two groups. The first group, the intervention group, will receive the Community-informed Art-based programme (CiAbP). The second group will receive government intervention involving media messages from the National Orientation Agency devoid of CiAbP. The CiAbP. sessions will cover relevant aspects of art, such as photo story, story telling, poetry, and drawing in tackling trauma and negative attitudes towards ex-offenders reintegration.

Researchers will compare CiAbP group with the media orientation group to see if there are differences between a change in attitude towards ex-offenders' reintegration at base line, end of intervention and three months follow up.


Eligibility criteria: Inclusion Criteria:

* Community members with previous experience of trauma
* Aged 18+ years and are residents in areas including Lagos/Delta states and its environs.
* Able to give informed consent,
* Speak the English language,
* Able to partake in baseline, pre-, post- and three-month follow-up data collection.

Exclusion Criteria:

* The exclusion criteria are those not meeting the study's inclusion criteria.

Primary outcomes:
measure: Trauma Screening Questionnaire
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
measure: Belief in Redeemability Scale v2
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
measure: Service Satisfaction Scale
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teesside University
name: Tarela Ike, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06301087: Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App
Official title: An Observational Cross-Sectional Study of Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development, Child
Postnatal Depression
Keywords: early detection
neurodevelopmental disorders
postnatal depression
mHealth
real-world study
smartphone
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Kelindi
First posted: 2024-03-08
Enrollment: 55618
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will include the first 50,000 users of the application who consent to the use of their data for this assessment

young parent withe a minimum of 1 child under 10 years matching the criteria and agreeing to participate

Brief summary: The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :

* the median age of possible neurodevelopmental disorders notification of infants
* the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data


Eligibility criteria: Inclusion Criteria:

* Youg parent with a minimum of 1 child under 10 years
* User of the app (downloaded)
* Having given informed consent (in-app)

Exclusion Criteria:

* none

Primary outcomes:
measure: Time to neurodevelopment desorder diagnostic
timeFrame: 20 months
Secondary outcomes:
measure: User's satisfaction
timeFrame: 20 months
measure: Relevance of the neurodevelopmental desorder notification
timeFrame: 20 months
measure: Rate of mothers'postnal depression
timeFrame: 20 months
measure: Time of mothers'postnatal depression
timeFrame: 7 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: ILC
Study officials:
affiliation: Kelindi
name: Fabrice DENIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05190887: What do Patients Expect After Scaphoid Fractures?
Official title: What do Patients Expect After Scaphoid Fractures?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Expectations
Lead sponsor: Kuwait Institute for Medical Specialization
Sponsor class: OTHER_GOV
First posted: 2022-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with scaphoid fracture

Brief summary: This study will assess patients expectations pre-op and assess their views on their outcome at one year follow up

Detailed description: Using Trauma expectation factor and trauma outcome measure questionnaire. At fracture time and at one year post fracture

Analyse according to age, sex, fracture pattern, type of intervention

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of a scaphoid fracture
* Age \> 18
* Consent for one year follow up

Exclusion Criteria:

* Age \<18
* Polytrauma (Multiple systems/ Multiple fractures)
* Ipsilateral fractures of the upper limb that may become distracting or affect rehabilitation
* Delayed presentation with higher risk of non-union or avascular necrosis

Primary outcomes:
measure: Patient expectations after scaphoid fractures
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: AlRazi Orthopedic Hospital
Study officials:
References:
Clinical trial NCT01359787: Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
Official title: Double-blind, Randomized, Vehicle-controlled, Multicenter, Multinational, Parallel-group Study of the Efficacy and Safety of Mapracorat Ointment in Three Concentrations Over Max. 4 Weeks in Subjects With Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of three concentrations of a development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
* Willingness of subject to follow all study procedures
* Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight

Exclusion Criteria:

* Pregnancy and breast-feeding
* Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
* Clinically manifested immunosuppressive disorder or known history of malignant disease
* History of relevant drug and/or food allergies

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: Over all study visits for up to 4 weeks
Secondary outcomes:
measure: Subjects´ assessment of pruritus
timeFrame: At baseline and after 4 weeks of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00011687: Study for Future Families
Official title: US Study of Semen Quality in Partners of Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Fertility
Hormones
Semen
Reproductive Health
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-28
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The Study for Future Families is a multi-center study that is recruiting pregnant women and their partners in four US cities to look for differences between cities in several measures of reproductive health. These measures include how long it took couples to conceive as well as hormone levels and semen quality in the male partners. This study is modeled after a study in four European cities so that,when complete, data on the 300 couples in each of the eight cities can be compared.


Eligibility criteria: Pregnant women and their partners who are literate in English or Spanish and competent to complete a questionnaire whose pregnancy was conceived without medical intervention.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
Clinical trial NCT03060187: Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score
Official title: The "KU Score": Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score; an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include persons presenting to the University of Kansas Hospital to have surgery under standard general anesthesia.

Brief summary: The purpose of this observational study is to evaluate the usefulness of Kansas University airway exam score ("KU score") in predicting difficulty of placement of a breathing tube into the windpipe.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-IV
* Patients scheduled for a surgical or any other diagnostic or therapeutic procedure that requires endotracheal intubation (ETI)

Exclusion Criteria:

* Patients scheduled for an emergent surgery
* Obstetric patients

Primary outcomes:
measure: Correlation between KU score and intubation difficulty scale (IDS) measure
timeFrame: Time between preoperative exam to after intubation, up to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Mirsad Dupanović, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04048187: Quality Control of CE-Certified Phonak Hearing Aids - 2019_23
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2019_23
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2019-08-07
Enrollment: 0
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: Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibiltiy studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interpendency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a pre-validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed description: This study will prove the overall performance and system context of the functionality in the mobile application in combination with hearing devices under real life conditions with experienced hearing aid users. The enduser should be able to adjust their hearing aid settings by App.

The app allows the user to change e.g. the loudness of the hearing aids and to create hearing scenarios by themselves. The users also shall be able to accept a conferecene call, which they will receive from the investigator via App.

This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility criteria: Inclusion Criteria:

* experienced hearing aid users (minimum age: 18 years, moderate to moderate/severe hearing loss)
* modern subjects with an affinity to new technology
* willingness and interest in testing Apps
* owning a compatible smartphone
* Healthy outer ear
* willingness to wear behind the ear hearing aids
* Informed Consent as documented by signature

Exclusion Criteria:

* the audiogramm is not in the fitting range of the intended hearing aid
* limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* participant is not able to describe experiences and hearing impressions

Primary outcomes:
measure: Successful creation of a Custom Sceario (%)
timeFrame: 4 weeks
measure: Successful answering of conference call (%)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
References:
Clinical trial NCT00932087: Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange
Official title: Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Metabolic Syndrome
Keywords: Platelet function
diabetes
metabolic syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 48
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group 1: type 2 diabetics with metabolic syndrome group 2: metabolic syndrome without diabetes group 3: subjects with type 1 diabetes group 4: controls

Brief summary: Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls


Eligibility criteria: Inclusion Criteria:

* statin and fibrate Wash out for one week
* HbA1c\>7% and \<12% (Arms 1 and 3)
* HbA1c\<6% (Arms 2 and 4)
* Metabolic sd according NCEP III (3 out 4 criteria) (Arms 1 and 2)

Exclusion Criteria:

* secondary CV prevention

Primary outcomes:
measure: Level of plasma isoprostane and lipoperoxides
timeFrame: at baseline
Secondary outcomes:
measure: TXA2 and PF4 levels after platelet activation of control platelet exposed to LDL
timeFrame: 2 hours
Other outcomes:
Locations:
city: Lyon Cedex 03
country: France
facility: Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe MOULIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colas R, Sassolas A, Guichardant M, Cugnet-Anceau C, Moret M, Moulin P, Lagarde M, Calzada C. LDL from obese patients with the metabolic syndrome show increased lipid peroxidation and activate platelets. Diabetologia. 2011 Nov;54(11):2931-40. doi: 10.1007/s00125-011-2272-8. Epub 2011 Aug 17.
Clinical trial NCT01181687: Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
Official title: Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: COMFORT behavioral scale
pain assessment scale
child
validity
reliability
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2010-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children admitted to Telemark Hospital (level II hospital) and meeting the inclusion and exclusion criteria specified

Brief summary: The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.

Detailed description: Structured pain assessment is the foundation for the management of pain. Several different pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005), developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the Comfort scale have been tested in several studies, but so far no Norwegian version of the scale has been developed and tested. Neither has the scale been tested in spontaneously breathing children undergoing minor surgery. The aim of this study is to establish incipient psychometric properties of the Norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.

Eligibility criteria: Inclusion Criteria:

* Younger than 3 years old at the time of surgery
* Day care patients admitted for minor elective surgery

Exclusion Criteria:

* Pre-entry use of sedation and/or analgesics
* Neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease

Primary outcomes:
measure: Increase in Comfort behavioral scale score
timeFrame: Within 24 hours after admission to the hospital for surgery
Secondary outcomes:
measure: Convergent validity of the Comfort behavioral scale
timeFrame: Within 24 hours after admission to the hospital for surgery
measure: Inter-rater reliability of the Comfort behavioral scale
timeFrame: Within 24 hours after admission to the hospital for surgery
measure: Reduction in Comfort behavioral scale score (2)
timeFrame: Within 24 hours after admission to the hospital for surgery
measure: Reduction in Comfort behavioral scale score (1)
timeFrame: Within 24 hours after admission to the hospital for surgery
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Telemark Hospital
state: Telemark
Study officials:
affiliation: Karolinska Institutet
name: Leena Jylli, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02204787: Treatment of Negative Symptoms and Schizophrenia
Official title: A Double Blind Sham Controlled Trial of tDCS for Treatment of Negative Symptoms in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Schizophrenia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.


Eligibility criteria: * Inclusion Criteria:

  * Schizophrenia with prominent negative symptoms
* Exclusion Criteria:

  * other psychiatric or neurological diseases
  * specific tDCS limitations

Primary outcomes:
measure: Scale for the Assessment of Negative Symptoms
timeFrame: up to 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: UH Montpellier
name: Jerome ATTAL, MD
role: PRINCIPAL_INVESTIGATOR
References: