louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04182165: Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study
Official title: Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Usability
Lead sponsor: ContinUse Biometrics Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-center, prospective study in subjects visiting TASMC for various indications.

This study will be divided into two arms:

First Arm - Subjects measured by the study staff via the investigational device at the hospital (up to 50 subjects).

Second Arm - subjects measuring themselves autonomously with the investigational device at their homes (up to 10 subjects from the first arm).

Hence, total number of subjects for the study will be up to N=50. All subjects will be enrolled to the study only after signing an informed consent form.

Specifically for the second arm, subjects will undergo proper training by the sponsor's representatives prior to being discharged from the hospital. Training will focus on proper operation of the device, which is also designed for autonomous use in a simple and user-friendly manner. Subjects will be asked to monitor themselves periodically for a duration of up to a week. Ongoing support will be provided by the sponsor upon subject request, either by phone, or on-premise via a dedicated support team.

For both arms, device users (either study staff in first arm or subjects in the second arm) will be requested to answer questionnaires in order to assess usability with the investigational device. In both cases, a dedicated sponsor representative will observe the users to gather objective usability data, and aid in the questionnaire filling process.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age, male or female
* Hemodynamically stable as assessed by the investigator

Exclusion Criteria:

* Inability to comply with study protocol as assessed by the study staff (e.g. currently suffering from tremors, afraid of using tech-based devices etc.)
* Inability to provide informed consent
* Parallel participation in another clinical study

Primary outcomes:
measure: Questionnaires assessed by SUS score and answered by the study staff.
timeFrame: During the procedure
measure: Questionnaires assessed by SUS score and answered by the enrolled study subjects.
timeFrame: During the procedure
measure: Measurement of vital signs (Heart rate/ Respiratory rate) acquired via the investigational device along with de-identified subject medical data.
timeFrame: During the procedure
Secondary outcomes:
measure: Safety assessed by AE/SAE
timeFrame: During the procedure
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center (TASMC)
Study officials:
References:
Clinical trial NCT06298565: A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Official title: A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 680
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: Patients diagnosed with gMG

Brief summary: This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment
* Have provided appropriate written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: SFM Clinical Research, LLC
state: Florida
city: St. Petersburg
country: United States
facility: BayCare Health System, Inc. St Anthony's Hospital
state: Florida
city: O'Fallon
country: United States
facility: Prairie Education and Research Cooperative and HSHS Medical Group
state: Illinois
city: Louisville
country: United States
facility: Norton Neuroscience Institute
state: Kentucky
city: Austin
country: United States
facility: National Neuromuscular Research Institute
state: Texas
city: Leuven
country: Belgium
facility: UZ Leuven (University Hospitals Leuven)
Study officials:
References:
Clinical trial NCT06312865: Intermittent Exotropia in Egyptian Population
Official title: Clinical and Demographic Characteristics of Intermittent Exotropia in Egyptian Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Exotropia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian population

Brief summary: Strabismus is one of the most frequent ocular problems among developmentally normal children. The prevalence of strabismus varies among different regions, ranging from 0.06% in Japan to 5.65% in China. Exotropia is reported to be the most prevalent type of deviation in many of these studies. About 48-92% of the exotropic patients have intermittent exotropia (IXT). Jenkins reported that the prevalence of exodeviation was higher in countries near the Equator. Its prevalence is also higher in subequatorial Africa, the Middle East, and East Asia (where there is plenty of sunshine) in comparison to the USA and Central Europe. Intermittent exotropia is a disorder of binocular eye movement control, where one eye intermittently turns outward. The outward deviation is greatest and likely occurs at far distances viewing, when the oculomotor convergence effort is weakest, and occurs frequently when the patient is under stress, tired, ill, or in particular test situations. X(T) can also occur at near as convergence insufficiency.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with 8 prism diopters or more exodeviation at distant or near fixation, regardless of age or fusion control (including exophora, intermittent exotropia, and constant exotropia).

Exclusion Criteria:

* patients with congenital ocular anomalies or ocular mayopathies. Patients with limitation of ocular motility resulting in strabismus, including neurologic or paralytic disorders, previous ocular surgical history, including strabismus and visually affecting surgeries, or any conditions affecting the central visual acuity, including anterior segment abnormality, cataracts, retinal diseases, or blepharoptosis (ocular sensory disorders), were excluded. When a patient was suspected to visit multiple institutions

Primary outcomes:
measure: The difference in demographic criteria in Egyptian population
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07000565: The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients
Official title: The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Surface Disease
Keywords: ocular surface disease
eye care
pediatric intensive care
nursing
artificial tears
saline
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 42
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to comparatively examine the effects of eye care practices using artificial tears and normal saline on superficial ocular injuries in pediatric patients receiving mechanical ventilation in the intensive care unit. Based on the findings, the study seeks to provide evidence-based contributions to nursing practices. Additionally, it aims to identify educational strategies to enhance intensive care nurses' knowledge and practice levels and to support the development of clinical care protocols.

H0: There is no difference in the effect of eye care with normal saline and artificial tears on superficial ocular injury in mechanically ventilated pediatric patients.

H1:Eye care with normal saline is more effective than artificial tears in preventing superficial ocular injury in mechanically ventilated pediatric patients.

H2: Eye care with artificial tears is more effective than normal saline in preventing superficial ocular injury in mechanically ventilated pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 28 days to 18 years
* Receiving invasive mechanical ventilation
* Admitted to the pediatric intensive care unit
* Parent(s) or legal guardian(s) provide informed consent for participation

Exclusion Criteria:

-Having eye-related disease

Primary outcomes:
measure: Change in Ocular Dryness Score
timeFrame: Everyday for 5 days after the inclusion of participant
measure: Occurence of Ocular Surface Disease
timeFrame: 1 time Everyday for 5 days after the inclusion of participant
measure: Change in Eyelid Closure Degree
timeFrame: 1 time everyday for 5 days after the inclusion of participant
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
Study officials:
affiliation: Marmara University
name: Bilgi Gülseven Karabacak, MSc. PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00239265: Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Female Patients With Lower Urinary Tract Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Diseases
Keywords: tamsulosin
urinary tract diseases
female
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-10-17
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
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 determine whether Tamuslosin is effective in the treatment of lower urinary tract syndrome with female patients.


Eligibility criteria: Inclusion Criteria:

* Patients with urination disorder not accompanied by apparent organic or neurologic abnormality(lower urinary tract syndrome: LUTs)．

Exclusion Criteria:

* Patients with urination disorder accompanied by apparent organic or neurologic abnormality, active urinary tract infections, severe cardiovascular, hepatic and/or kidney complications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Chugoku region
country: Japan
city: Hokkaido region
country: Japan
city: Kinki region
country: Japan
city: Kyushu region
country: Japan
city: Touhoku region
country: Japan
Study officials:
affiliation: Clinical Development, Astellas Pharma Inc.
name: Study Director
role: STUDY_CHAIR
References:
Clinical trial NCT03274765: Improved Medically Assisted Procreation Monitoring
Official title: Improved Medically Assisted Procreation (MAP) Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: ovarian stimulation
blood test
Medically Assisted Procreation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 30
Sex: FEMALE
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: Women followed in the MAP center of the Rennes University Hospital for ovarian stimulation monitoring

Brief summary: Patient care in Medically Assisted Procreation (MAP) requires a close and regular monitoring of the evolution of the estradiol rate. This monitoring allows the dose and duration of treatment to be accurately adjusted for each woman (every 24 or 48 hours) up to 10 to 15 days of treatment with gonadotrophins. Oestradiol (E2) is secreted by the growing ovarian follicles and reflects their growth and maturity. Its plasma dosage makes it possible to monitor the ovarian response to stimulation.

This monitoring involves several constraints amongst which disruption of work life, stress, fatigue that can alter the response to treatment

Detailed description: In order to improve the comfort of patients already under severe stress, simplification of this monitoring is proposed. The development of an immediate-release whole blood test for simplified monitoring of estradiol levels will provide considerable comfort in the management of patients. These patients are subjected to significant emotional and physical stress and the development of this test will reduce the negative consequences that result.

Eligibility criteria: Inclusion criteria:

* Women over 18 years old
* Patient followed for monitoring of ovarian stimulation;
* Having received information on the protocol and given consent to participate

Exclusion Criteria:

* Adult under safeguard of justice, guardianship or curatorship
* Persons deprived of liberty.

Primary outcomes:
measure: Rate of successful tests
timeFrame: 1 hour
Secondary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 month
measure: Specificity
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: CHU Rennes
name: Celia RAVEL, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06428565: Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain
Official title: Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Low back pain (LBP) is a significant health issue. It impacts a significant portion of the adult population, reaching up to 80%, and results in substantial healthcare and socioeconomic expenses. To find out what changes occurred after the application of two exercise modalities \[Conventional Exercise (CE) and Laser-Guided Exercise (LGE)} and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia, and lumbar proprioception in subjects with NSCLBP.


Eligibility criteria: Inclusion Criteria:

* Both male and female ages between 18 and 45 years (11).
* Patients diagnosed with nonspecific low back pain (11).
* patients with pain intensity of "3" or greater on numeric pain rating scale

Exclusion Criteria:

* Patients with neurological symptoms.
* Patients diagnosed with fatigue syndrome
* Females having pregnancy
* History of low back surgery

Primary outcomes:
measure: The Numeric Pain Rating Scale (NRS)
timeFrame: 12 Months
measure: The Oswestry Disability Index (ODI)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hameed Latif Hospital Lahore
Study officials:
References:
Clinical trial NCT02948465: Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia
Official title: Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Infarct
Keywords: Neutrophil Extracellular Traps
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 125
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: Cerebral infact after wide calibre arterial occlusion

Brief summary: Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (NET) within the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct.

The aim of the research is to Study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).


Eligibility criteria: Inclusion Criteria:

* Patient over 18
* Having a cerebral infarct consecutive to a wide calibre arterial occlusion
* taken care for mechanical thrombectomy

Exclusion Criteria:

* Patient benefiting from a legal protective measure
* Pregnant or breast-feeding woman
* Opposition of the patient to participate in the study

Primary outcomes:
measure: Correlation coefficient between biochemical and histological composition of the thrombus and the sensibility in the in vitro fibrinolysis and the origin of the thrombus.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Arturo CONSOLI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Foch
name: Bertrand LAPERGUE, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05769465: MAP THE SMA: a Machine-learning Based Algorithm to Predict THErapeutic Response in Spinal Muscular Atrophy
Official title: MAP THE SMA: a Machine-learning Based Algorithm to Predict THErapeutic Response in Spinal Muscular Atrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Muscular Atrophy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 247
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients cared for at Policlinico Gemelli with confirmed genetic diagnosis of SMA (5q) type I or II or III; written informed consent obtained from the participants or their families.

Brief summary: Spinal Muscular Atrophy (SMA) is caused by the homozygous loss of the Survival Motor Neuron (SMN) 1 gene, which leads to degeneration of spinal alpha-motor neurons and muscle atrophy. Three treatments have been approved for SMA but the available data show interpatient variability in therapy response and, to date, individual factors such as age or SMN2 copies,cannot fully explain this variance.

The aim of this project is:

* collect clinical data and patient-reported outcome measures (PROM) from patients treated with nusinersen, risdiplam, onasemnogene abeparvovec,
* identify novel biomarkers and RNA molecular signature profiling,
* develop a predictive algorithm using artificial intelligence (AI) methodologies based on machine learning (ML), able to integrate clinical outcomes, patients' characteristics, and specific biomarkers.

This effort will help to better stratify the SMA patients and to predict their therapeutic outcome, thus to address patients towards personalized therapies.


Eligibility criteria: Inclusion Criteria:

* confirmed genetic diagnosis of SMA (5q)
* clinical phenotype of type I or II or III;
* able to provide (patient/caregiver) written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Collect clinical data and patient-reported outcome measures (PROM) from patients treated with nusinersen, risdiplam, onasemnogene abeparvovec
timeFrame: 30 months
measure: Identify novel biomarkers and RNA molecular signature profiling
timeFrame: 30 months
measure: Develop a predictive algorithm using artificial intelligence (AI) methodologies based on machine learning (ML), able to integrate clinical outcomes, patients' characteristics, and specific biomarkers
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Giorgia Coratti, PhD
role: PRINCIPAL_INVESTIGATOR
References: