louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02434887: Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women
Official title: Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Dry Genital Mucosa
Lead sponsor: Kley Hertz S/A
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 26
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to verify the effectiveness of the investigational product through Subjective Assessment and answered by volunteers.


Eligibility criteria: Inclusion Criteria:

* Female aged between 45 to 65 years old
* Sexually active volunteers, with a minimum of 1 intercourse per week
* In menopause for at least 6 months;
* Intact skin in the product analysis region;
* No prior reactions to topical products
* Reading, understanding, agreement and signature of the informed consent form

Exclusion Criteria:

* Use of anti-inflammatory and immunosuppressive ( in the last 30 days and during the study)
* Active skin diseases (local or disseminated) in the evaluation área;
* Diseases that cause imune suppression;
* Endocrine disorders such as thyroid, ovarian or adrenal gland disorders;
* Any infection in the region where the product will be analyzed diagnosed at enrollment;
* Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Primary outcomes:
measure: Evaluation of the product's efficiency as a moisturizer through subjective evaluation
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05509387: Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
Official title: Investigating if a Stronger tDCS Intensity is More Effective for Improving Naming Ability in People Living With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Alzheimer's Society
First posted: 2022-08-22
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is currently little symptomatic therapy for Alzheimer's Disease (AD) and nothing effective for individuals with Frontotemporal dementia (FTD). However, neuromodulation with transcranial direct current stimulation (tDCS) has the potential to be a clinically effective therapy for both AD and FTD. The challenge now is to specify the parameters and conditions under which tDCS is most effective to transition from the laboratory to clinical medicine. tDCS studies typically report significant group effects despite the variability demonstrated among participants, with some showing clear, meaningful improvement, while others only show statistical improvement or none at all. These variable results may be related to the conventional stimulation intensity level of 2mA. The investigators predict that administering tDCS at 4.0 mA, a more significant number of participants would show a meaningful response, and those who improve at 2mA may improve even more from 4.0mA due to having a larger electric field produced. The investigators aim to test this hypothesis in people with Alzheimer's Disease.


Eligibility criteria: Inclusion Criteria:

* Mild to Moderate AD
* Score between 18 and 25 on the MoCA
* Score on the Cambridge Naming Task during the pre-assessment

Exclusion Criteria:

* No history of stroke or TBI
* No shunts or metal in the body
* No history of significant heart disease, alcoholism and drug use

Primary outcomes:
measure: Naming Training
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT03604887: Umbilical Cord Length Index for Prediction of Cord Abnormalities Before Delivery
Official title: Umbilical Cord Length Index as a New Ultrasonographic Method for Prediction of Cord Abnormalities Before Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Cord Problem
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are in labor will be followed up through regular fetal heart rate monitoring and clinically using partograph to monitor the progress of labor. Fetal heart rate changes and cases with abnormal progress of labor will be recorded. Mode of delivery either vaginal or cesarean will be noted. Those who are scheduled for elective CS will be evaluated during and after cesarean section.

Brief summary: The umbilical cord plays an essential role in intrauterine life. It is the pathway between mother, placenta and fetus during pregnancy and delivery. Complete cord occlusion often leads to fetal demise, while intermittent occlusion has been associated with intrauterine brain damage. Compression and vasospasm in utero are important factors in fetal distress. Nuchal Umbilical Cord can be diagnosed antepartum using ultrasound, but the complications are unpredictable and unpreventable


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy.
* Pregnant ≥ 37 weeks gestation.
* Women who will accept to participate in the study

Exclusion Criteria:

* Preterm deliveries.
* Amniotic fluid abnormalities (oligohydramnios, polyhydramnios).
* Intrauterine growth retardation
* Early membrane rupture
* Women need urgent cesarean section.
* Multifetal gestation.
* Placenta previa.
* Fetuses with major congenital anomalies.
* Women with chronic maternal illness as hypertension

Primary outcomes:
measure: The sensitivity of "Umbilical cord length index" in diagnosis of long and short umbilical cords.
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT06691087: Sound Perception Study of Hearing-impaired People With Hearing Aids
Official title: ÉTude de la pERception soNorE de Personnes maLentendantes équipées d'Aides Auditives
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Auditory Perception
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut de l'Audition
First posted: 2024-11-15
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the ETERNEL project will be to study the influence of the perception of a single sound timbre on the understanding of a complex sound scene in hearing-impaired people with hearing aids. This will be done by quantifying the inability to manage a complex sound scene as a function of the timbre of the sounds making it up. The more a sound interferes with understanding the complex sound scene, the more salient that sound is considered to be. In this way, the investigators can determine which timbre dimensions make sounds particularly salient for the hearing impaired.


Eligibility criteria: Inclusion Criteria:

For all participants:

* Age between 60 and 75
* Native French speaker
* Have given their consent to take part in the study.
* Declare that they have an active social life or hobbies that stimulate their cognitive abilities
* Have a MOCA score above 26
* No tympano-ossicular dysfunction.
* Voice in noise audiometry results showing normal results.

For participants with impaired hearing :

* Pure tone audiometry showing audiograms of type N3 or N4 and symmetrical between the two ears.
* Report having experienced problems with abnormally prominent sound.

For participants with normal hearing:

- Pure tone audiometry showing audiograms with losses of less than 30 dBHl.

Exclusion Criteria:

* Be under guardianship or curatorship,
* Be deprived of liberty by judicial or administrative decision, or be under legal protection.
* Bear the consequences of an ear infection and/or have a history of an ENT disease that permanently affects hearing or balance (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis).

Primary outcomes:
measure: Percentage of correct answers in melody comparison tasks in the hearing-impaired group compared with the normal-hearing group,
timeFrame: 3-hours
Secondary outcomes:
measure: Characterisation of the dissimilarity between pairs of stimuli measured by a continuous perceptual scale
timeFrame: 3-hours
measure: Evaluation of the perceived loudness level of a set of stimuli, measured using scales of magnitude.
timeFrame: 3-hours
measure: Comparison between the results of speech audiometry in noise, i.e number of words correctly repeated, with native settings versus settings minimising the discomfort of salient sounds for each participant with hearing loss.
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: CERIAH
name: Paul Avan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02802787: Implementation and Evaluation of an Activity Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
Official title: Implementation and Evaluation of an Activity Based Program to Improve Quality of Life Outcomes in Women Diagnosed With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Quality of life
Occupation
Pain
Fatigue
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: University of the Sciences in Philadelphia
name: M.D. Anderson Cancer Center
First posted: 2016-06-16
Enrollment: 92
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Implementation and Evaluation of an Activity Based Program to Improve Quality of Life, Pain and Fatigue Outcomes in Women Diagnosed With Cancer. Demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods Quality of Life, Pain and Fatigue surveys).

Detailed description: This research study will focus on developing and implementing two one-week activity camps in the summer of 2016 for women diagnosed with cancer. One camp will be held in West Philadelphia and another in Camden, New Jersey, both of which have been identified as underserved areas for health access. The focus of this programming is to allow women to engage in activities they may not be engaged in since the diagnosis of cancer and to provide them with opportunities to socially interact and communicate with individuals who may have encountered the same difficulties as them. Quality of life, pain and fatigue information will be collected before, during and after implementation of the activity program. The main objective is to demonstrate improved life satisfaction, decreased pain and decreased fatigue (with evidenced gathered at three consecutive periods and geographical locations through Quality of Life, Pain and Fatigue surveys). The intended sample size is 57 women.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with cancer
* Age of 21 of older
* Clearance from their MD to participate in the activity program

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure Scores at Day1, Day 5 and Week 6
timeFrame: Day 1, Day 5 and week 6
Secondary outcomes:
measure: Change in Brief Pain Inventory
timeFrame: Day 1, Day 5, and week 6
measure: Change in Brief Fatigue Inventory
timeFrame: Day 1, Day 5, and week 6
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Community in Philadelphia
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Rochelle J Mendonca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05924087: Interventional Therapy of Tracheal Stenosis
Official title: Interventional Therapy of Tracheal Stenosis After Percutaneous Tracheotomia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheal Stenosis Following Tracheostomy
Lead sponsor: Asklepios Neurological Clinic Bad Salzhausen
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after successfull respiratory weaning with symptomatic trachealstenosis

Brief summary: After respiratory weaning, decannulation is sought. To do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. In the presence of tracheal stenosis there is increased breathing effort, possibly restlessness and stridor. This constellation of symptoms suggests the suspicion of tracheal stenosis, so in the next step a tracheoscopy is performed to confirm or exclude tracheal stenosis. In case of symptomatic tracheal stenosis and at least 30-50% stenosis of the trachea (clinical symptoms can be expected from a 30-50% stenosis) then appropriate therapy (here: cryotherapy, other techniques only in exceptional cases) is planned. The goal is to be able to remove the tracheal cannula (long term) after successful therapy, so that patients do not have to be permanently provided with a tracheal cannula. There is no definitive/evidence-based standard therapy for the treatment of tracheal stenosis. Cryotherapy is a gentle therapy that has already been applied and described for the treatment of tracheal stenosis (see above). The examination is performed as part of an analgesic dose, as is routine for a bronchoscopy (in-house SOP). After treatment, a follow-up is planned for about 10 days later.


Eligibility criteria: Inclusion Criteria:

* Tracheal stenosis after percutaneous tracheotomy.

Exclusion Criteria:

* Pregnant or breast-feeding women of childbearing potential who refuse pregnancy test.
* lack of consent to participate in the study.
* surgical tracheotomy.
* Involvement of the larynx (above the first tracheal brace).

Primary outcomes:
measure: Decannulation
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 12 months
measure: Reintervention(s)
timeFrame: 12 months
measure: Type of intervention
timeFrame: 12 months
measure: Clinical success
timeFrame: 12 months
measure: Additional treatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Nidda
country: Germany
facility: Neurologische Klinik Bad Salzhausen
Study officials:
References:
Clinical trial NCT05376787: Verify the Performance of the Neutral Electrode (NE) Adhesives
Official title: The Purpose of This Study is to Verify the Performance of the Neutral Electrode (NE) Adhesives in Accordance With the Testing Specified in IEC 60601-2-2:2017, Section 201.15.101.7, Pull Test.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adhesion of the Neutral Electrode 21pad
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
Collaborators: name: F2 Labs
First posted: 2022-05-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of at least 10 males and 10 females. Participants must be healthy and of at least 18 years of age. Participants must also fit inclusion and exclusion criteria.

Brief summary: The purpose of this research study is to determine the neutral electrode 21pad adhesion to the skin in accordance with international standard IEC 60601-2-2 section 201.15.101.7. A neutral electrode is placed on the body of patients undergoing surgery that involves the use of electric current, to protect them from the harmful effects of the electricity.

Detailed description: Two neutral electrodes will be applied to the front of your thighs. The study staff will set up and attach a pulley system to the neutral electrodes. The purpose of the pulley system is to apply a force pulling the neutral electrode away from your body. The force will be applied for 10 minutes on each neutral electrode in one direction, and then for another 10 minutes in a second direction. Site staff will mark any areas of separation and the neutral electrodes will be removed.

Eligibility criteria: Inclusion Criteria:

* Participants must be willing to comply with all study procedures
* Participants must be willing to shave, or to have shaved, the sites where the neutral electrodes will be placed.

Exclusion Criteria:

* The participant has any skin conditions (e.g. eczema, sensitivities, allergies to adhesives, sunburn, etc.) at the application sites that might be adversely affected by the application of an adhesive pad.
* The participant is pregnant or breastfeeding.

Primary outcomes:
measure: Number of Tests With No More Than 5% Separation - Neutral Electrode (NE) Adhesive Separation
timeFrame: Up to 20 minutes - (10 minutes w. Pull for 10 to 10.25 minutes, in a plane parallel to the NE pad & At 10 mins, change direction of pull to y direction)
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: United States
facility: F2 Labs
state: Maryland
Study officials:
References:
Clinical trial NCT03671187: Pulmonary Rehabilitation and Smoking
Official title: Effectiveness of Pulmonary Rehabilitation in Smoker Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Rehabilitation; Tobacco Use
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary rehabilitation (PR) is known to reduce dyspnea, increase exercise capacity, reduce psychological symptoms and improve quality of life in COPD patients. Some patients continue to smoke despite their illness. Smoking does not create a contraindication to PR. There is insufficient evidence on the effectiveness of PR programs in smoking COPD patients. The purpose of this study, PR completed the program to determine the effectiveness of PR smoker COPD patients.

Detailed description: Pulmonary rehabilitation (PR) is known to reduce dyspnea, increase exercise capacity, reduce psychological symptoms and improve quality of life in COPD patients. Some patients continue to smoke despite their illness. Smoking does not create a contraindication to PR. There is insufficient evidence on the effectiveness of PR programs in smoking COPD patients. The purpose of this study, PR completed the program to determine the effectiveness of PR smoker COPD patients. People who have completed the PR program, smoking and not smoking will be included into the study.

Data of carbon monoxide diffusion test, body plethysmography, 6-min walk test, blood gas analysis, mMRC dyspnea scale, hospital anxiety depression scale, SGRQ and SF-36 quality of life questionnaire performed before and after the program will be analyzed.

Eligibility criteria: Inclusion Criteria:

* COPD patients completed 8 PR program

Exclusion Criteria:

* Never smoked patients
* Participated PR program in last year

Primary outcomes:
measure: Six minute walk test
timeFrame: 6 minutes
Secondary outcomes:
measure: Pulmonary Function Test
timeFrame: 20 minutes
measure: Dyspnea Severity
timeFrame: 5 minues
measure: St. George Disease Related Quality of Life Scale
timeFrame: 20 minutes
measure: Short Form-36 Quality of Life Survey
timeFrame: 25 minutes
measure: Hospital Anxiety and Depression Inventory
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02896933: Electrophysiological Study of Spatiotemporal Gait Parameters in Patients in Early Stage of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 35 patients with multiple sclerosis progressing for less than 5 years, age 18 to 54 years old, and handicap score (EDSS) \< 2 in all the subscores concerning gait, have been enrolled in a previous observational study recording and analyzing gait parameters.

This study aims to enroll gender and aed matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.

The 35 patients have given their consent for this new data analysis.

Brief summary: 35 patients with multiple sclerosis have been enrolled in a previous study to record and analyze gait parameters.

This study aims to enroll gender and and matched healthy subjects for a control group, to compare patients' gait parameters with healthy subjects'.


Eligibility criteria: Inclusion Criteria:

* subjects without any gait trouble
* age ≥ 18 and \< 55 years old
* gender and age (+/- 5 years) matched

Exclusion Criteria:

* pathology with potential gait impairment
* pregnant or breast feeding patient
* patient under legal protection
* no health insurance coverage
* absence of written informed consent

Primary outcomes:
measure: Variation coefficient of gait cadence
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Raphaël DEPAZ, MD
role: PRINCIPAL_INVESTIGATOR
References: