louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02795663: Deep Brain Stimulation and Parkinson's Disease
Official title: Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Keywords: Near-InfraRed Spectroscopy (NIRS)
Deep brain stimulation of SubThalamic Nucleus (DBS)
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: * Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
* Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
* Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.


Eligibility criteria: Inclusion Criteria:

* Patients presenting Parkinson disease and treated by STN-DBS.
* For comparison patients: Patients treated by DBS in other target.

Exclusion Criteria:

* Patients who cannot be treated by DBS

Primary outcomes:
measure: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
timeFrame: 1 month,
Secondary outcomes:
measure: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb)
timeFrame: 1 month
measure: Study of QUIP score (QUIP scale)
timeFrame: 3 month
measure: Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with the localisation of the contact use for STN-DBS stimulation
timeFrame: 1 month
measure: Comparison of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of STN-DBS stimulation
timeFrame: 1 month
measure: Study of local cortical hemodynamic changes (oxy-Hb, deoxy-Hb, and total Hb) with intensity of NonSTN-DBS stimulation
timeFrame: 1 month
measure: Study of delayed discounting task (DDT) score
timeFrame: 3 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Michel LEFRANC, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04970563: Detection of Asymptomatic SARS-Cov2 Infected Patients by Detection Dogs: "Proof of Concept" Study (CoviDetectionDog)-Covid-19
Official title: Detection of Asymptomatic SARS-Cov2 Infected Patients by Detection Dogs: "Proof of Concept" Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection by SARS-COV-2
Healthy Controls
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The spread of the new SARS-CoV-2 virus has led to a pandemic. Described for the first time in China at the end of 2019, it causes Covid-19 disease. Its characteristics in terms of contagiousness and lethality have led countries to adapt their screening and care strategies.

Early and accurate identification of people infected with SARs-CoV-2 is an essential measure to confront Covid-19 pandemic. A key aspect of Covid-19 is that diagnostic tests must be able to detect the virus in asymptomatic, pre-symptomatic and symptomatic patients.

Changes in human odor, as symptoms of specific diseases, have been observed. Dogs have already been used to detect breast or lung cancer, diabetes, epilepsy or kidney disease with some success There is currently a growing body of research and previous work, though preliminary, indicating the possibility that dogs identify persons infected with Sars-Cov-2 compared to healthy persons.

The purpose of this study is to determine whether trained detection dogs are able to identify asymptomatic patients infected by Sars-Cov-2.

The investigators aim to validate the possibility to identify / discriminate patients with Covid-19 according to their odor by a proof of concept (with specificity and sensitivity of the detection test), i.e. new non-invasive screening method using dogs odor detection capabilities.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Having given free and informed written consent
* Being affiliated to the center national security system social
* Patients infected by SARS-COV-2 with positive RT PCR on nasopharyngeal swab and without symptoms (fever, cough, anosmia, diarrhea) will be included in "experimental" Group 1.
* Patients infected by SARS COV 2 with positive RT PCR on nasopharyngeal swab and presenting at least one symptom will be included in Group 2 "control".
* Participants not infected by SARS-COV-2 with negative RT PCR on nasopharyngeal sample and showing no symptoms on Day 0 and Day 7 will be included in Group 3 "healthy controls".

Exclusion Criteria:

- Patient whose life expectancy is less than 3 months

Primary outcomes:
measure: Percentage behavioral response of trained dogs obtained on sweat samples from patients infected by asymptomatic SARS-Cov-2.
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Européen Marseille
Study officials:
References:
Clinical trial NCT06323863: Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation
Official title: Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Otosclerosis
Keywords: stapes
titanium
computed tomography
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with otosclerosis who underwent stapes replacement by a prosthesis and underwent ultra high resolution CT for follow-up

Brief summary: Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting.

Detailed description: Modern temporal bone imaging systems, using 0.5 mm slice thickness, are reputed not yet able to depict the stapes piston position with a sufficient degree of accuracy, as high-resolution CT measurements consistently overestimated intravestibular piston dimensions (width by 44%, length by 6.25%) and vestibular intrusion (by 39%) because of metallic artifacts. . The exact limits of intravestibular depth are also unclear. The "safe" intravestibular prosthesis depth varies widely between studies and has been reported to range from 0.2 to 2.5 mm, so 39% may represent up to 0.9 mm of misestimation. Ultra-high resolution CT (UHR-CT) has improved spatial resolution to 0.12 mm by using ultra-small detector elements (0.25 x 0.25 mm), allowing better visualization of temporal bone structures compared to high-resolution temporal bone CT (HR-CT). However, this technique has not been described for stapes prosthesis measurement.

Eligibility criteria: Inclusion Criteria:

- stapes prosthesis Ultra-high resolution CT available

Exclusion Criteria:

no materiovigilance report available

Primary outcomes:
measure: length
timeFrame: february 2020 - novembre 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chu Nancy
Study officials:
affiliation: CHRU de Nancy
name: romain gillet
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bozzato A, Struffert T, Hertel V, Iro H, Hornung J. Analysis of the accuracy of high-resolution computed tomography techniques for the measurement of stapes prostheses. Eur Radiol. 2010 Mar;20(3):566-71. doi: 10.1007/s00330-009-1582-4. Epub 2009 Sep 2.
citation: Fang Y, Wang B, Galvin JJ 3rd, Tao D, Deng R, Ou X, Liu Y, Dai P, Sha Y, Zhang T, Chen B. MPR-CT Imaging for Stapes Prosthesis: Accuracy and Clinical Significance. Otol Neurotol. 2016 Apr;37(4):321-3. doi: 10.1097/MAO.0000000000000987.
citation: Gil Mun S, Scheffner E, Muller S, Mittmann P, Rademacher G, Mutze S, Wilms K, Boga E, Bjorn Gehl H, Sudhoff H, Todt I. Stapes piston insertion depth and clinical correlations. Acta Otolaryngol. 2019 Oct;139(10):829-832. doi: 10.1080/00016489.2019.1637019. Epub 2019 Jul 12.
Clinical trial NCT05008263: Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis
Official title: Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibroses
Liver Cirrhosis
Keywords: Liver fibrosis
Liver cirrhosis
Liver biopsy
Shear wave imaging
Dynamic liver scintigraphy
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary diagnosis of chronic viral liver disease who are referred treating gastroenterologist/infectologist for liver biopsy prior to treatment.

Brief summary: The study "Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis" is designed to test the accuracy of non-interventional radiological imaging and compare its results with the "gold standard" liver biopsy. This is prospective non-randomized single patient group study.


Eligibility criteria: Inclusion Criteria:

* chronic liver disease
* signed informed consent
* liver biopsy indicated by treating gastroenterologist/infectologist

Exclusion Criteria:

* non-corrected blood coagulation tests
* acute liver disease
* age below 18 years or above 80 years
* disagreement to participate in the study
* pregnancy

Primary outcomes:
measure: Ultrasound elastography comparison to histological examination of liver biopsy specimen
timeFrame: Baseline only
measure: Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen I
timeFrame: Baseline only
measure: Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen II
timeFrame: Baseline only
measure: Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen III
timeFrame: Baseline only
Secondary outcomes:
measure: Comparison of radiological imaging tests between each other I
timeFrame: Baseline only
measure: Comparison of radiological imaging tests between each other II
timeFrame: Baseline only
measure: Comparison of radiological imaging tests between each other III
timeFrame: Baseline only
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
affiliation: Vilnius University
name: Algirdas E Tamosiunas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05775263: Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)
Official title: Validation of UK Protocols to Exclude Brain Blood Flow During Normothermic Regional Perfusion (NRP)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Blood Flow
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2023-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Donation after Circulatory Death (DCD) organ donors

Brief summary: This study aims to evaluate both Abdominal Normothermic Regional Perfusion (A-NRP) and Thoracoabdominal-NRP (TA-NRP) techniques, proving that brain blood flow is not resumed during NRP. This will be assessed through the use of two modalities: CT angiogram of the brain and continuous Hb02 readings. The study group hypothesise that such assessment methods will provide evidence to indicate that brain blood flow is not present during NRP and promote trust in the use of such novel techniques in routine practice.


Eligibility criteria: Inclusion Criteria:

* DCD donors in Cambridge University Hospital
* Planned A-NRP
* Consent for study has been obtained
* Those who meet the appropriate criteria for DCD donation following WOLST
* ≥ 18 years of age
* ≤ 75 years of age

Exclusion Criteria:

* DBD organ donors
* DCD organ donations outside of Cambridge University Hospital
* DCD donors without planned A-NRP
* DCD donors whose family have withheld consent for brain blood flow investigations.
* Patients who do not meet the appropriate criteria for DCD donation following WOLST
* Patients with injuries that will physically prevent use of the necessary assessment methods

Primary outcomes:
measure: CT angiogram
timeFrame: 30 minutes from establishment of NRP
Secondary outcomes:
measure: Cerebral oximetry
timeFrame: Prior to withdrawal of life sustaining treatment to 30 minutes after establishment of NRP
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04840563: Surface Refractive Index Shift and Lens Absorption/Adsorption of Tear Components of Kalifilcon A Lenses vs Dailies Total1 and Precision1
Official title: Evaluation of Surface Refractive Index Shift and Lens Absorption / Adsorption of Tear Components of Commercially Available Kalifilcon A Lenses Compared to Dailies Total1 and Precision1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Habitual Soft Contact Lens Use
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, participants will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older and have full legal capacity to volunteer.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Surface refractive index shifts
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch Site 001
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jeffery Schafer, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01184963: High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)
Official title: Effect of High-protein or Normal-protein Diet on Weight Loss, Body Composition, Hormone and Metabolic Profile in Women With Polycystic Ovary Syndrome From South Brazil: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
High protein diet
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-08-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the effects of a high protein (HP) and a normal protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index (BMI)-matched controls in a sample of southern Brazilian women.

Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30% lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.

The investigators hypothesis is that a different diet composition may have influences in changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* women of reproductive age
* BMI ranging from 18.5 to 39.9 kg/m²

Exclusion Criteria:

* Use of any drugs known to interfere with hormone levels for at least 3 months before the study
* Women with known type 2 diabetes, liver or renal disease or thyroid dysfunction
* Other hyperandrogenic disorders than PCOS

Primary outcomes:
measure: Changes in corporal weight
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in body composition
timeFrame: 8 weeks
measure: changes in hormone and metabolic profile.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Poli Mara Spritzer, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05005663: Incisional Hernia in Infants and Children
Official title: Incisional Hernia in Children and and Infants : a Tertiary Center Experience
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia
Keywords: incisional hernia
infants
children
tissue repair
wound healing
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 67
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study of development of incisional hernia in infants and children at a tertiary level experience.

Detailed description: Background: incisional hernia in children and infants (IHCI) represents a major complication following exploration. The condition is associated with prolonged hospital stay, readmission and the need for another operation to treat the resulting incisional hernia. The incidence is variable worldwide. The leading causes are still indeterminate as well as the management strategy. We aimed at studying IHCI at a tertiary level hospital as regard presenting symptoms, methods of management and its impact on the quality of life of patients.

Methods: a retrospective study included all infants and children presented with incisional hernia. Patients were categorized in to two groups according to the age of presentation, group A patients younger than two years of age and group B patients older than two years. All data related to the first operation in addition to data related to repair of the incisional hernia were collected in special charts.

Eligibility criteria: Inclusion Criteria:

* all infants and children with incisional hernia

Exclusion Criteria:

* congenital abdominal wall defects

Primary outcomes:
measure: repair of incisional hernia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT06767163: Developing a Daily-use Fall Risk Assessment Device in Clinical Setting
Official title: Development and Applications of Daily-use Fall Risk Assessment Device to Prevent Elderly People from Falling
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Falls
Balance Assessment
Keywords: Fall prevention
Older adults
Balance ability assessement systems
Sensor
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority Hong Kong West Cluster
First posted: 2025-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Study Objectives Objective 1: Compare the fall risk assessment results between balance sensors, traditional tests, and clinical diagnoses.

Objective 2: Improve the feasibility of using sensors to assess fall risk among older patients in the hospital.

The investigators select Hong Kong as the region for the experiment. Specifically, the community clinics and daytime hospitals are the actual onsite locations for experimenting. The specific venues of these locations need an electrical power supply and a flat ground for conducting the device test. Patients will be recruited for the development and testing of a device for fall risk assessment, study participants will be involved in balancing assessments, and questionnaire surveys, their medical records will be accessed. And during these tests and questionnaire surveys, the investigators will take photos, videos, and or audio recordings.


Eligibility criteria: Inclusion Criteria:

1. Older adults aged 60 years and above;
2. Understand Cantonese or Mandarin or English;
3. Clinical patients in the clinics.

Exclusion Criteria:

1. Unable to give written informed consent (e.g., illiterate or with cognitive impairment);
2. Inability to stand for 30 seconds without any assistance.

Primary outcomes:
measure: Precision assessment of falling risk prediction
timeFrame: six months
Secondary outcomes:
measure: Feasibility of fall risk assessment by using balance sensor in clinical settings
timeFrame: six months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References: