louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06836375: Pilot Study for the Application of Low Power External Bioelectronic Devices in the Diagnosis of Bronchial Asthma.
Official title: Estudio Piloto Para la aplicación de Dispositivos bioelectrónicos Externos de Baja Potencia en el diagnóstico de Asma Bronquial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma Bronchiale
Keywords: Asthma
Lead sponsor: Acurable Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-20
Enrollment: 50
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: Patients from or referred to the asthma unit in the hospital Virgen del Rocio in Seville, Spain

Brief summary: The objective of this study is to detect the acoustic signals generated by the respiratory system on asthma patients using an acoustic sensor and retrospectively use these signals to identify the characteristics that differentiate patients with asthma and healthy subjects.

Detailed description: The objective of this project is to detect acoustic signals generated by the respiratory system in patients with asthma using the acoustic sensor; and then, retrospectively, to use these signals to carry out signal processing research, with the aim of trying to identify signal characteristics that can be used to differentiate asthma patients from people who do not have the disease.

The hypothesis, therefore, is that it is possible to target through external smart bioelectronic devices and wireless connectivity (wearables) the initial signals of the pathophysiology of bronchial asthma and differentiate them from the signals of the normal respiratory physiology of a healthy individual.

Similarly, detection of such signals would not only be useful for asthma diagnosis but also for monitoring and early detection of exacerbations before they can be detected by the usual respiratory functional tests.

The patients will first visit the asthma unit where the diagnostic tests will be undertaken. Then the subjects will take the acoustic sensor home with them and wear it during sleep for at least two weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged \>= 18 and \< 65.
* Ability to access applications on mobile device, technical understanding and minimal technological skills
* Subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* Subject does not consent to the study
* Subject does not comply with inclusion criteria
* Subject has a known allergy to medical adhesives

Primary outcomes:
measure: Acoustic respiratory signals
timeFrame: During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
Study officials:
References:
Clinical trial NCT00839475: Investigation of the Uterine Cervix Using CervicalMD
Official title: Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colposcopy
Keywords: colposcopy
Cervical intraepithelial neoplasia
cervical cancer
cervical precancer
Lead sponsor: STI-Medical Systems
Sponsor class: INDUSTRY
First posted: 2009-02-09
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women identified with an abnormal Pap smear

Brief summary: The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination.


Eligibility criteria: Inclusion Criteria:

* Female
* Negative Pregnancy test
* Abnormal Pap smear
* 18 years and older
* Presence of a cervix

Exclusion Criteria:

* Pregnant
* Absence of a cervix
* Less than 18 years old
* Male

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Augusta University
name: Daron G Ferris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270775: Traduction and Validation of the Central Sentitization Inventory Into French
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Heathy Volunteers
Keywords: Questionnaire
Translation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 groups:

Fibromyalgia Patients (group 1) Acute or subacute Ankle Sprain (Group 2) Healthy Volunteers (Group 3)

Brief summary: The study will include a translation of the Central Sensisization Inventory into French and a cultural validation of the French version of the questionnaire (Reliability, discrimination and comparison with other questionnaires).


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Fibromyalgia (Group 1)
* Clinical Diagnosis of a Acute of Subacute Ankle Spain (Group 2)
* Healthy Volunteer (Group 3)

Exclusion Criteria:

* Having any chronic pain (group 1 and group 2)

Primary outcomes:
measure: Reliability of the French version the Central Sensitization Inventory Score
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01146275: A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
Official title: A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Keywords: Patients who participated in pilot study (31GB0601) and performed breast augmentation with previous formulation of Macrolane
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 6
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).

Detailed description: All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments.

The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast.

Eligibility criteria: Inclusion Criteria:

* Participant in 31GB0601

Exclusion Criteria:

* There are no exclusion citeria in this study

Primary outcomes:
measure: To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation
timeFrame: 7 years +/- 6months post treatment
measure: To Evaluate the Long Term Safety of Macrolane in Breast Enhancement
timeFrame: 7 years +/- 6 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Akademikliniken Öresund
city: Stockholm
country: Sweden
facility: Sophiahemmet
city: Stockholm
country: Sweden
facility: Akademikliniken
city: Stockholm
country: Sweden
facility: ProForma Clinic
Study officials:
affiliation: Akademikliniken, Stockholm
name: Per Hedén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02871375: Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal
Official title: DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: myopia
presbyopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 170
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.


Eligibility criteria: Inclusion Criteria:

* Must sign an informed consent document;
* Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
* Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
* Requires lenses within the power range of study lenses to be fitted;
* Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution \[logMAR\]) or better in each eye at distance;
* Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
* Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Monocular (only one eye functional) or fit with only 1 lens;
* Fitted with monovision;
* Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Currently wearing DT1 MF contact lenses;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)
timeFrame: Day 14, each product
Secondary outcomes:
measure: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
timeFrame: Day 14, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Project Manager, PLS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03613675: Acceptability of Video Games to Promote Asthma Education and Self-management in Children
Official title: Acceptability of Video Games to Promote Asthma Education and Self-management in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: video games
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Concordia University, Montreal
First posted: 2018-08-03
Enrollment: 5
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be asked to play 4 video games on asthma.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Asthma is a chronic lung disease affecting over 800,000 Canadian children. Knowing how to avoid asthma triggers, to take care of one's health, and to know when and why to do one's treatment can help prevent asthma crises, and have a better quality of life.

Games in health can make the management of asthma easier by helping the child better understand his condition, his triggers, and manage his asthma by himself. Games also offer a personalized experience, where players can receive feedback about their learning. However, few studies explored the use of games in childhood asthma.

This study will test 4 games for children with asthma. Through different characters and scenarios, the goals of the games are to help the child with asthma to better recognize and manage his asthma triggers and symptoms. The objectives of this study are:

* Evaluate the acceptability of these games in children with asthma
* Gather feedback on the games to guide future development


Eligibility criteria: Inclusion Criteria: Along with a parent, children

* aged 8-12 years inclusively
* with physician-diagnosed asthma
* who are on a daily controller medication
* who understand French or English.

Exclusion Criteria: children with

* chronic respiratory conditions other than asthma
* cardiovascular diseases
* neuromuscular disorders
* developmental delay.

Primary outcomes:
measure: Gaming experience, relevance for end-user, and areas of improvement of the games
timeFrame: Immediately after playing the games (same day)
Secondary outcomes:
measure: Asthma knowledge
timeFrame: Immediately after playing the games (same day)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT05327075: Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females
Official title: Premenstrual Dysphoric Disorder:Knowledge,Attitude and Practice Among Egyptian Females.Results of Surveying Two Centers in Delta Region
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premenstrual Dysphoric Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: the study will include females attending gynecological clinics in two hospitals in delta region

Brief summary: it is a cross-sectional study conducted in female patients attending outpatient clinc in our university hospital to assess their awareness regarding the symptoms of premenstrual dysphoric disorders.

Detailed description: this study will be conducted on females in the reproductive age attending the gynecological outpatient clinic to assess the prevalence of premenstrual dysphoric disorder(eeiPMDD) and their awareness regarding the symptoms of PMDD and the impact of these symptoms on their quality of life using questionnaire including ( knowledge , attitude and practice) of those Egyptian females.

Eligibility criteria: Inclusion Criteria:

females in reproductive age

history of regular menstruation

Exclusion Criteria:

history of any psychological disorders

history of chemotherapy in last 6 months

Primary outcomes:
measure: questionnaire " awareness of participants regarding PMDD symptoms"
timeFrame: during the study, an avarege 1 month
Secondary outcomes:
measure: questionnaire "impact of the PMDD symptoms on the participants life"
timeFrame: 3 months
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al Azhar University Hospital in Damietta
Study officials:
References:
Clinical trial NCT03804775: Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones
Official title: Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones: A Prospective Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstone
Dyslipidemias
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2019-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case group: patients from lahore city presented with gallstone disease in Services Hospital lahore

Control group: Patients admitted to Services Hospital with other diseases belonging from lahore

Brief summary: Gallbladder disease is one of the most common diseases of the gastrointestinal tract. Various studies have shown an association between gallstones and an alteration in the serum lipids. The objective of this study will be to compare serum lipid profile of gallstone patients with the controls.

Detailed description: This prospective cross-sectional study will be conducted in the Surgical Department of the Services Institute of Medical Sciences. A total of 50 patients will beincluded in the study after screening through the inclusion criteria. A control group of 50 inpatients with no personal or family history of gallstones will be also recruited for comparison. Results will be expressed as mean with standard deviation. Students t- test will be used to compare the data between the patients and the control groups (p\<0.05 will be considered statistically significant). SPSS software, version 20 will be used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Male or female patients with the gall stone disease
* Age from 20 to 70 years
* Gallstones were diagnosed through the ultrasound

Exclusion Criteria:

* Patients with acalculous gallbladder disease on ultrasound,
* Patients with terminal ileal resection,
* Patients with hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film),
* Patients with liver cirrhosis (on abdominal ultrasound) and
* Patients on antihyperlipidemic drugs

Primary outcomes:
measure: serum cholesterol levels
timeFrame: 1 week
measure: serum triglyceride levels
timeFrame: 1 week
measure: serum HDL levels
timeFrame: 1 week
measure: serum LDL leves
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT04657575: Optimisation of ECT Based on ASTI vs Narcotrend
Official title: Optimisation of Electro-Convusions-Therapie (ECT) Based on ASTI (Anaesthesia to Intervention Time Interval) Versus Narcotrend - a Randomised Prosepctive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal EEG-suppression.

- Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

Detailed description: The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal EEG-suppression.

- Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* Age: 18 -90 years
* Signed informed consent
* Severe depressive disorder

Exclusion Criteria:

* ASA \>3
* Age \< 18 or \> 90
* denial of the patient
* Impossibility to fix Narcotrend electrodes
* Patients unable to consent
* Pregnancy

Primary outcomes:
measure: Convulsion Quality
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Hospital Innsbruck
state: Tyrol
Study officials:
References:
Clinical trial NCT06627075: Optical Surface Guidance for External Radiotherapy of Head and Neck Cancer
Official title: Feasibility of Surface Optical Guidance to Replace the Restraint Mask for External Radiotherapy of Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Otorhinolaryngeal Cancer
Keywords: Radiotherapy
Optical surface guidance
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the use of surface repositioning alone, without a restraint mask, during radiotherapy sessions for patients with head and neck cancer.

Detailed description: In radiotherapy treatments for head and neck cancer, the use of a mask is recommended for patient immobilization. The mask completely covers the head and shoulders, ensuring reproducible positioning at every session. However, using a mask can be oppressive and anxiety-provoking for patients.

At the same time, technological developments have led us to use optical surface camera systems to position and monitor patients in the treatment room. In this way, if a movement exceeding the threshold is detected during a session, the treatment is automatically interrupted.

However, despite the use of the mask, movements are still possible underneath, and are not detected by the surface cameras.

The study's hypothesis is that the use of surface repositioning alone could guarantee reproducible treatment, as in combination with a thermoformed mask. In addition, eliminating the mask would mean greater comfort and improved quality of life for patients.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Patients undergoing palliative or curative treatment for oro-rhino-laryngeal cancer
* Patients with an indication for radiotherapy treatment, with or without complementary treatment (chemotherapy, immunotherapy), with a number of sessions between 10 and 35
* Patients who have dated and signed an informed consent form

Exclusion Criteria:

* Patients with uncontrollable movements
* Patients under psychiatric care
* Patients who do not understand or read French
* Patients participating in an interventional study testing another medical intervention
* Patients under guardianship, curatorship, safeguard of justice or deprived of liberty
* Pregnant or breast-feeding women
* Patients without social security coverage

Primary outcomes:
measure: Measurement patient displacement during surface-guided radiotherapy sessions
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre de Lutte contre le Cancer Eugène Marquis
state: Bretagne
Study officials:
affiliation: Centre de Lutte contre le Cancer Eugène Marquis
name: Coralie Geffroy
role: PRINCIPAL_INVESTIGATOR
References: