louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06705439: A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning (USF)
Official title: A Study of Detection of Paroxysmal Events Utilizing Computer Vision and Machine Learning (USF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Keywords: Nelli
Lead sponsor: Neuro Event Labs Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected motor seizures that are undergoing video-EEG monitoring for routine clinical care.

Brief summary: Increased computational power has made it possible to implement complex image recognition tasks and machine learning to be implemented in every day usage. The computer vision and machine learning based solution used in this project (Nelli) is an automatic seizure detection and reporting method that has a CE mark for this specific use.

The present study will provide data to expand the utility and detection capability of NELLI and enhance the accuracy and clinical utility of automated computer vision and machine learning based seizure detection.

Detailed description: This is a prospective, blind comparison to the clinical gold standard for seizure characterization. This study is intended to compare the Nelli Software's ability to identify seizure events to vEEG review in adults with suspected nighttime seizures. Simultaneously, Nelli will continuously record audio and video while video-electroencephalography (vEEG) is recorded per typical standard of care. Events with positive motor manifestations will be independently identified, following standard clinical practice, by three epileptologists using clinical vEEG data. Nelli Software will review the audio and video data and independently identify events with positive motor manifestations. The outcomes of event identification will be compared between Epileptologists and the Nelli Software. For each category of event captured the positive percent agreement will be calculated using the exact binomial method. The primary endpoint of this study is to demonstrate that Nelli is able to identify seizures that have a positive motor component with a sensitivity of \> 70%.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing video-EEG monitoring for clinical purposes who are suspected of having seizures.

Exclusion Criteria:

-

Primary outcomes:
measure: Sensitivity of a seizure detection system
timeFrame: During routine seizure monitoring in the hospital - up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: University of South Florida
name: Selim Benbadis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745939: Manipulation Effects on Abdominal Muscles
Official title: The Immmediate Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Subjects With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Back pain
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand how different physical therapy interventions affect the use of certain abdominal muscles in patients with low back pain.

Detailed description: Patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to measure resting and contracted thickness of the transversus abdominis muscle. Following the pre-intervention measurement, patients will receive one of two physical therapy interventions (side lying thrust joint manipulation or side lying non-thrust oscillations into slight rotation) which will have been randomly assigned. Immediately after intervention, ultrasound imaging will be repeated on the resting and contracted thickness of the transversus abdominis.

Eligibility criteria: Inclusion Criteria:

* Currently receiving physical therapy treatment for back pain or back pain symptoms
* 18-70 years of age
* Able to perform the abdominal drawing in maneuver

Exclusion Criteria:

* Presence of a serious pathology
* Diagnosis of spinal stenosis or symptoms in both lower legs (changes in sensation, muscle weakness)
* Any history of low back surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis

Primary outcomes:
measure: Transversus abdominis thickness change
timeFrame: Baseline to immediately after the intervention (within 5 minutes)
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline to immediately after the intervention (within 5 minutes)
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada, Las Vegas - Department of Physical Therapy
state: Nevada
Study officials:
affiliation: University of Nevada, Las Vegas
name: Jaclyn Durant, BSc
role: STUDY_DIRECTOR
affiliation: University of Nevada, Las Vegas
name: Jade Elkind, BA
role: STUDY_DIRECTOR
affiliation: University of Nevada, Las Vegas
name: Shawna Bohnet, BSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01253239: Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the Opposite
Official title: A Retrospective Evaluation Comparing Post Operative Visual Outcomes in Patients Implanted With the TECNIS IOL in Both Eyes Versus the ReZoom IOL in One Eye and TECNIS IOL in the Opposite Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Visual outcomes
Patient satisfaction
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 175
Sex: ALL
Minimum age (years): 42
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS multifocal IOLs in both eyes or TECNIS multifocal IOL in one eye and the ReZoom in the opposite eye

Brief summary: The purpose of this study is to evaluate the visual performance of two cohorts of patients who received multifocal intraocular lenses following cataract and clear lens extraction surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom Multifocal IOL in the opposite eye.

Detailed description: Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS Multifocal IOL in both eyes or TECNIS Multifocal IOL in one eye and theReZoom Multifocal IOL in the opposite eye.

Study Design-A retrospective chart review to collect visual outcomes to determine lens performance. Patient satisfaction questionnaire will be administered to determine spectacle independence.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone surgery and received either the TECNIS Multifocal Intraocular lens in one eye and the ReZoom Multifocal Intraocular lens in the other will be evaluated. Males and Females with ages ranging from 42 years to 86 years old.

Exclusion Criteria:

* Patients who have subsequently developed any visual limiting problems (e.g. corneal, retinal, infection) which could potentially limit their post operative visual potential.

Primary outcomes:
measure: Uncorrected visual acuity at distance and near
timeFrame: Six months
Secondary outcomes:
measure: Patients Satisfaction
timeFrame: Six months
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
Study officials:
affiliation: Bucci Laser Vision Institute
name: Frank A Bucci, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06474039: The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
Official title: The Efficacy of Fluticasone Furoate/Vilanterol/Umeclidinium Compared With Vilanterol/Umeclidinium in Reducing Air Trapping and Airway and Blood Cytokine Levels in COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: COPD
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to demonstrate the effects of triple therapy (ICS/LABA/LAMA) and dual bronchodilators (LAMA/LABA) on air trapping in the lungs' COPD patients and inflammatory mediators


Eligibility criteria: Inclusion Criteria:

* Patients who have met the criteria for COPD GOLD B defined by an exacerbation not more than 1 time in the last year prior to the study enrollment. These patients will be recruited in sequential sequence.
* Patients with COPD GOLD B are previously treated with either LAMA or LAMA/LABA or short-acting bronchodilators
* Patients who are able to provide informed consent.

Exclusion Criteria:

* - Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung, other malignancy, active heart diseases.
* Receiving long-term treatment with immunosuppressive drugs and systemic corticosteroids
* Being treated with triple therapy (ICS/LABA/LAMA)
* Being in terminally ill conditions

Primary outcomes:
measure: Changes in lung volume
timeFrame: 4 weeks
Secondary outcomes:
measure: Inflammatory cytokines
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Division of Respiratory Disease and TB, Siriraj Hospital
state: BKK
Study officials:
affiliation: Siriraj Hospital
name: Kittipong Maneechotesuwan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280539: The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Transcutaneous electrical nerve stimulation
Cortical Excitability
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Provinciale Hogeschool Limburg
First posted: 2011-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study the researchers want to investigate the effects of long-term transcutaneous electrical nerve stimulation on the cortical excitability of persons with multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* Expanded Disability Status Scale (EDSS) scores between 2 and 6.5
* Stable MS (no relapse during the last 3 months before study onset)
* sensory impairment
* age: between 18 and 68 years old

Exclusion Criteria:

- Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication

Primary outcomes:
measure: Change in cortical excitability
timeFrame: Baseline, immediately after and 3 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University (BIOMED)
state: Limburg
Study officials:
References:
Clinical trial NCT05655039: The Effect of Pre-rehabilitation and Rehabilitation Period on Functional Status in Inpatient Stroke Patients
Official title: The Effect of Pre-rehabilitation and Rehabilitation Period on Functional Status in Inpatient Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Rehabilitation
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40-90-year-old post-stroke patients

Brief summary: Patients who underwent inpatient rehabilitation for the last 5 years were retrospectively scanned. The pre-rehabilitation and rehabilitation periods of the patients were determined. At the beginning and end of rehabilitation, patients were evaluated with the Brunsstrom, Barthel and Stroke Impact Scale. The effect of the specified durations on these scales was investigated.


Eligibility criteria: Inclusion Criteria:

* 40-90 years old
* Have hemodynamic stability to participate in rehabilitation
* Having had an ischemic or hemorrhagic stroke

Exclusion Criteria:

* Having a serious comorbidity that may preclude rehabilitation
* Malignancy
* Aphasia
* Having a serious perception problem or psychiatric illness
* Having a history of stroke

Primary outcomes:
measure: Brunnsstrom Stages
timeFrame: immediately after Rehabilitation
measure: Barthel Index
timeFrame: immediately after Rehabilitation
measure: Stroke Impact Scale
timeFrame: immediately after Rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Şişli Hamidiye Etfal Training and Research Hospital
name: Banu Kuran, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06107439: Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects
Official title: Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lipodystrophy
Dunnigan Syndrome
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Few data and small numbers affect the inflammatory profile of Dunnigan patients. The levels of certain pro-inflammatory biomarkers would be found higher in these subjects compared to control individuals. However, in these studies, several confounding factors were not taken into account such as smoking, an underlying chronic inflammatory disease such as diabetes and could limit the interpretation of the results. There is no other observation of the anti-inflammatory status of these patients.


Eligibility criteria: Inclusion Criteria:

* Adult subject (\>18 years old) affected by partial Dunnigan lipodystrophy in the homozygous or heterozygous state (genetic search for the positive mutation carried out before inclusion in the study).
* Person affiliated to or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant and the investigator.

Exclusion Criteria:

* - Minor
* Persons placed under judicial protection, person participating in another research including a period of exclusion still in progress, severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study
* Previous known diabetes
* Pregnant woman
* Woman who gave birth less than 6 months ago
* Breastfeeding in progress
* Participation in other research that may have an impact on the evaluation of the main judgment criteria
* Hemoglobin b level \< 7 mg/dl or \< 9-10 mg/dl for patients with cardiovascular or respiratory pathology.
* Proven inflammatory pathologies
* Anti-inflammatory treatment: taking corticosteroids in the last 3 months.
* Active smoking

Primary outcomes:
measure: pro-inflammatory markers
timeFrame: inclusion day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: CHU La Réunion DRCI
Study officials:
References:
Clinical trial NCT06831539: Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
Official title: Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cancer
Healthy Participants
Keywords: PegLyte
Microbiome
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm study evaluating the impact of PEG bowel preparation on the gut microbiome in volunteer participants.
Primary purpose: TREATMENT

Brief summary: The main objective is to evaluate the impact of intestinal preparation on the composition, diversity and metabolome of the intestinal microbiota.

Detailed description: Based on the limited literature that PEG does not significantly impact the microbiome, certain investigators ascertain that administration of PEG without any subsequent FMT would represents the gold-standard control group. On the other hand, other investigators raised their concern that perturbation of the microbiome with PEG without subsequent replacement with FMT might negatively impact immune checkpoint inhibitor efficacy. Therefore, there is an unmet need to conduct a study using the metagenomic shotgun sequencing to precisely understand the impact of bowel preparation on gut microbiome composition and on the dynamics of recovery of the gut microbiome after bowel preparation to better design microbiome-centered trials.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer participant cohort:

  1. \> 18 years of age
  2. The participant has provided documented informed consent for the participation and to complete PEG bowel preparation and return collected stool samples.

Exclusion Criteria:

* An ileus
* Significant gastric retention
* Suspected or established mechanical bowel obstruction
* Inflammatory or infectious gastrointestinal condition
* Neurologic or cognitive impairment that prevents safe swallowing
* Recent history (\<1 year) of cancer that still requires ongoing treatment
* Recent use of antibiotics 1 month prior to participation in the trial
* History of cardiac disease
* History of active renal dysfunction
* Presence of any absolute contraindication to PEG bowel preparation according to manufacturer labeling

Primary outcomes:
measure: To evaluate the impact of bowel preparation on the gut microbiota at 1 week after bowel preparation.
timeFrame: At week 1
Secondary outcomes:
measure: Gut microbiome composition, diversity, and gut metabolome profile at 1 month and 3 months after bowel preparation
timeFrame: At 1 month and 3 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Arielle Elkrief, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03976739: Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Cross-sectional Study.
Official title: Study on the Effect of Bile Reflux on Gastric Cancer and Its Precancerous Lesions: a Multiple Center, Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Reflux Gastritis
Gastric Cancer
Helicobacter Pylori Infection
Intestinal Metaplasia
Precancerous Lesions
Keywords: gastric cancer; helicobacter pylori; precancerous lesion; bile reflux
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 1162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients are from several centers all around the China

Brief summary: To explore the effects of bile reflux on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.

Detailed description: This study was a multicenter cross-sectional study. Patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results. The bile reflux detection rate and Helicobacter pylori infection status were recorded for each group.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 75 years old, gender is not limited;
2. patients with upper abdominal pain, abdominal distension, belching, anorexia, early satiety, hiccup, acid reflux, upper abdomen burning sensation and other upper gastrointestinal symptoms;
3. Voluntary acceptance of Hp testing;
4. Voluntary acceptance of the endoscopy and pathological biopsy.

Exclusion Criteria:

1. had undergone upper gastrointestinal surgery;
2. Previous diagnosis of esophageal cancer;
3. Previous diagnosis of gastric cancer;
4. Previous diagnosis of MALT lymphoma;
5. pregnant and lactating women;
6. Those with mental disorders;
7. Refusal to sign the informed consent form.

Primary outcomes:
measure: corelation between the bile reflux and gastric mucosa diseases
timeFrame: up to 6 months
Secondary outcomes:
measure: the risk factors of primary bile reflux gastritis
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital of Digestive Disease
state: Shaanxi
Study officials:
References: