louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02875431: Multicentric Registry for the Detection of C5 Palsy After Anterior Cervical Discectomy and Fusion
Official title: Registry for the Detection of C5 Palsy After ACDF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Cervical Spinal Stenosis
Cervical Disc Herniation
Suspected Cervical Spine Instability
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
name: Charite University, Berlin, Germany
name: University Hospital, Geneva
name: Klinik für Neurochirurgie, Köln-Mehrheim
name: Wirbelsäulenzentrum, St. Josephs-Hospital, Wiesbaden
name: Vivantes Clinic Neukölln
name: Klinik für Neurochirurgie, Helios-Klinikum Krefeld
name: Universitätsklinikum Hamburg-Eppendorf
name: Klinikum Karlsbad-Langensteinbach
name: Ludwig-Maximilians - University of Munich
name: Zentrum für Wirbelsäulenchirurgie Kempen
First posted: 2016-08-23
Enrollment: 1087
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma

Brief summary: Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion

Detailed description: A registry which includes all known and individually analyzed but even new factors are evaluated in order to perform a multivariate analysis for the detection of risk factors of C5 palsy after anterior cervical discectomy and fusion which is a very disabling and still cryptic complication.

Eligibility criteria: Inclusion Criteria:

* ACDF or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma

Exclusion Criteria:

* infectious disease or neurodegenerative disease

Primary outcomes:
measure: C5 palsy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Neurosurgery
state: Bavaria
Study officials:
affiliation: TU München
name: Bernhard Meyer, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01848431: Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
Official title: Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Open Fracture of Foot
Tumor
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 0
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 scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below

Brief summary: The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold.

* Trial with surgical intervention

Detailed description: In study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. Patients in group 2 will receive transfusions to reach a hematocrit always above 30%.

Tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.

Eligibility criteria: Inclusion criteria:

* planned defect reconstruction with free flap and preoperative hematocrit of 28% or below

Exclusion criteria:

* coagulation disorder
* Jehovah's witness
* iodine allergy
* renal or hepatic insufficiency

Primary outcomes:
measure: Number of Blood transfusions peri- and postoperative
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Center for Reconstructive Surgery
state: ZH
Study officials:
affiliation: University Hospital Zurich, Clinic of Reconstructive Surgery
name: Maurizio Calcagni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03898531: Mineral Nano Pathology
Official title: Mineral-Nano-Pathology : Wear of Hip Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Keywords: hip arthroplasty
hip prosthesis resection
first implantation
wear particles
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: MINAPATH Développement
First posted: 2019-04-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be having a surgery for the resumption of a hip prosthesis or for a first implantation

Brief summary: Hip arthroplasty is a treatment widely used in most inflammatory, traumatic and degenerative conditions of this joint. The longevity of implants may be disappointing in some cases, despite the promising results obtained during in vitro simulations. Early loco-regional or systemic dissemination, known since the 1990s, of wear particles from these prosthesis may reduce their life span.

The analysis of the particles in the synovial fluid and in the articular tissues by electron microscopy after digestion or directly by optical microscopy, will improve the knowledge on the mechanisms of wear.

This category 3 study is based on the case-control model and will be conducted in a national reference center (hospital la Croix-Rousse- Lyon). It will include a population of adult patients.


Eligibility criteria: Inclusion Criteria:

* Adult patient,
* Patient including French,
* Patient witness: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for a first hip prosthesis
* Patient test: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for the removal of a hip prosthesis

Exclusion Criteria:

* Patient protected by law (guardianship, curatorship, safeguard of justice).
* Pregnant or lactating woman
* Patient with suspicion of infection on prosthesis
* Patient opposing his participation in the study

Primary outcomes:
measure: types of particles that cause the most tissue inflammation
timeFrame: day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Cécile Batailler, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03842631: Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination
Official title: Optimizing Timolol Maleate Treatment of Infantile Hemangioma by Doppler Ultrasound Examination: a Single Center, Open Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infantile Hemangioma
Keywords: Timolol Maleate
Doppler Ultrasound Examination
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 150
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with infantile hemangiomas presented to the outpatient clinic of Shanghai Ninth People's Hospital would be considered for enrolment in the study. The diagnosis of proliferating infantile hemangioma is based on medical history and B-ultrasonography.

Brief summary: The purpose of this study is to assess the safety and efficacy of Timolol Maleate treatment for different depth of infantile hemangioma based on B-ultrasonography. Based on the depth of hemangioma, patients will be proactively allocated to two groups. And then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.

Detailed description: Primary: Describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through IB-ultrasound.

Eligibility criteria: Inclusion Criteria:

* Infants of 0 to 6 months of age
* Skin Infantile hemangiomas (IHs) in the proliferation stage without prior treatment
* IHs with a surface area of less than 1% of body surface area
* Skin type III/IV

Exclusion Criteria:

* Ulcerated IHs.
* Unsuitable for topical Timolol treatment due to anatomical location of lesion, eg.

periorbital and lip IHs.

* Patients with severe systemic or congenital disease which may affect the patient's safety in this study

Primary outcomes:
measure: Depth of infantile hemangioma
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Color
timeFrame: through study completion, an average of 1 year
measure: Dimensions
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Xiaoxi Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577831: Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI
Official title: Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Deformity
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.

The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.

This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.

The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.

The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.


Eligibility criteria: Inclusion Criteria:

* Adult women, +/- of childbearing age, with or without effective contraception.
* Informed consent signed prior to any procedure described in the study.

Exclusion Criteria:

* Contraindication to MRI,
* Impossibility of performing the examination during thrust,
* Minor patients
* Pregnant or breast-feeding women,
* Women of legal age under guardianship
* Persons staying in a health or social institution,
* People in emergency situations,
* Persons not covered by a social security scheme,
* Persons deprived of their liberty.
* Specifically, women with IUDs will be excluded if they cannot remove them before the examination.
* For healthy volunteers: history of colorectal surgery.

Primary outcomes:
measure: Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.
timeFrame: 0 month
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille _ Hopital de la Timone
Study officials:
References:
Clinical trial NCT04491331: Hemodynamic Changes Due to Prone Position
Official title: Hemodynamic Changes Due to Prone Position in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamics Instability
Prone Position
Keywords: hemodynamics
prone position
cardiac output
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6 male and 6 female healthy, non-anesthetized volunteers

Brief summary: Perioperative prone position may be associated with hemodynamic instability. The causes of instability have not yet been precisely elucidated. The aim of this study is to demonstrate physiological changes during prone positioning in healthy volunteers .

Detailed description: The prone position could decrease the cardiac index (CI), mainly due to reduction in stroke volume, with little changes in heart rate. Mean arterial pressure (MAP) could be maintained by increased systemic vascular resistance (SVR) in the majority of patients.

The aim of this study is to describe hemodynamic changes in two different surgical prone positions in 10 healthy non-anesthetized volunteers (flat position and using a support system allowing a free abdomen) by non-invasive measurement of hemodynamics (ClearSight, Edwards) and indirectly evaluated intra-abdominal pressure using ultrasound. The ClearSight system provides advanced hemodynamic parameters (cardiac index CI, stroke volume SV, stroke volume variation SVV, systemic vascular resistance SVR, mean arterial pressure MAP) from a finger cuff.

Eligibility criteria: Inclusion Criteria:

* age \>18 years,
* American Society of Anesthesiologists (ASA) Physical Status Classification I
* agreement with study participation

Exclusion Criteria:

* disagreement with study participation,
* BMI over 40
* pregnancy

Primary outcomes:
measure: Change in Cardiac Index
timeFrame: 5 minutes
Secondary outcomes:
measure: Changes in vena cava diameter
timeFrame: 5 minutes
measure: Changes in vena jugularis diameter
timeFrame: 5 minutes
measure: Changes in vena saphena diameter
timeFrame: 5 minutes
measure: Changes in vena cephalica diameter
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: UH Hradec Kralove
name: Lucie Kukralova, MD
role: STUDY_DIRECTOR
References:
citation: Kukrálová L, Dostálová V, Dostál P. Hemodynamic changes in prone position - a non-invasive physiological study. Anest. intenziv. Med.. 2021;32(2):82-86. doi: 10.36290/aim.2021.010.
Clinical trial NCT04565431: Examining Effects of Tysabri on Cognitive Fatigue Using fMRI
Official title: Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Cognitive Fatigue
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: St. Barnabas Medical Center
First posted: 2020-09-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals diagnosed with Relapsing-Remitting Multiple Sclerosis and Healthy Volunteers

Brief summary: The purpose of this research study is to investigate the effectiveness of Tysabri on cognitive fatigue in persons with Relapsing-Remitting Multiple Sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

Detailed description: The researchers aim is to investigate the effects of Tysabri on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with RRMS. The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task and also on how cognitive fatigue changes as a function of duration of treatment.

Eligibility criteria: Inclusion Criteria:

* Age between 18-64
* Diagnosed with Relapsing-Remitting Multiple Sclerosis or a healthy volunteer
* If diagnosed with MS: has been newly prescribed Tysabri, but has not yet started taking the medication
* Can read and speak English fluently

Exclusion Criteria:

* History of head injury, stroke, seizures, or any other significant neurological event other than MS
* Flare up of MS symptoms within the past month
* History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder
* Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments
* Left-handed.
* Not able to have an MRI

Primary outcomes:
measure: Brain activation (BOLD signal)
timeFrame: Measured by change between 2 time points (baseline and six months after intervention)
Secondary outcomes:
measure: Fatigue onset (SDMT)
timeFrame: Measured by change between 2 time points (baseline and six months after intervention)
measure: Fatigue onset
timeFrame: Measured by change between 2 time points (baseline and six months after intervention)
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: John DeLuca, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913231: Impact of Whole-Body Vibration on Anthropometric Measurement and Body Composition in Overweight and Obese University Students
Official title: Impact of Whole-Body Vibration on Anthropometric Measurement and Body Composition in Overweight and Obese University Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Obesity has become a significant public health concern globally, particularly among university students, where lifestyle changes contribute to increased body weight and fat accumulation. The World Health Organization defines obesity as a condition characterized by excessive fat accumulation that presents a risk to health, with a body mass index (BMI) of 30 or higher being a common threshold for classification. In Saudi Arabia, the prevalence of obesity among young adults is alarming, necessitating effective interventions to combat this issue.


Eligibility criteria: Inclusion Criteria:

* Male and female University students with BMI ≥ 25, and their age between 18-25 years.

Exclusion Criteria:

* Musculoskeletal, neurological and cardiovacular conditionds,in addition to pregnancy and insrtion of pacemekers or other metal implants.

Primary outcomes:
measure: Body Mass Index
timeFrame: 6 weeks
measure: Waist circumference
timeFrame: 6 weeks
Secondary outcomes:
measure: Body fat percentage
timeFrame: 6 weeks
measure: Visceral mass
timeFrame: 6 weeks
measure: Lean body mass
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jouf
country: Saudi Arabia
facility: College of Applied Medical Sciences, Jouf University
state: Sakaka
Study officials:
References:
Clinical trial NCT02120131: Trapezoidal Flap vs. Envelope Flap in Mandibular Third Molar Extraction.
Official title: Trapezoidal Flap Versus Envelope Flap in Impacted Mandibular Third Molar Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Third Molar Tooth
Keywords: third molar surgery, periodontal probing depth , flap design
Lead sponsor: University of Firenze and Siena, Napoli, Italy
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a sample of 50 patients requiring mandibular third molar extracion was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study

Brief summary: the purpose of this study was to test the effectiveness of the envelope flap compared to trapezoidal flap in impacted mandibular third molar extractions.

Detailed description: a sample of 50 patients requiring mandibular third molar extraction was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study. A total number of 52 consecutive cases of mandibular third molar surgical extractions were performed using either a trapezoidal flap or an envelope flap. The choice of the flap was randomized. The following parameters were recorded: Probing Pocket Depth, Clinical Attachment Level, Bleeding on Probing, Full Mouth Plaque Score, Full Mouth Bleeding Score, total time for the surgical intervention, age of the patient, type of inclusion, ostectomy. All the patients received a questionnaire to evaluate the post-intervention discomfort (swelling, pain, number of pain-killers, bleeding). Periodontal parameters were checked at 6-month follow up.

Eligibility criteria: Inclusion Criteria:

* third molar impaction
* mild symptoms of pericoronitis

Exclusion Criteria:

* systemic diseases
* cigarettes smoking
* history of irradiation therapy

Primary outcomes:
measure: change from baseline on the periodontal status of adjacent second molar
timeFrame: 6 months
Secondary outcomes:
measure: post surgical complication
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Tuscan School of Dentistry
Study officials:
affiliation: tuscan scool of dental medicine of florence and siena
name: nicola nb baldini, oral surgeon
role: PRINCIPAL_INVESTIGATOR
References: