louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01458938: This Study is to Determine if Degenerative Spinal Pain and Disorders Cause the Levels of Substance P to Change in a Patients Saliva, Blood and/or Cerebrospinal Fluid.
Official title: Substance P Neuropeptide Levels in Saliva, Serum and Cerebrospinal Fluid in Patients With Spinal Disease: A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal Disease
Spinal Radiculopathy
Myelopathy
Neurogenic Claudication
Lead sponsor: Carolina Neurosurgery & Spine Associates
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The objective of this pilot study is to determine if degenerative spinal disorders such as acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot study shows a correlation between Substance P levels and pain associated with degenerative spinal disorders, then a larger study will be initiated to determine the feasibility of using Substance P levels in the diagnosis and treatment of degenerative spinal disease.


Eligibility criteria: Inclusion Criteria:

* Undergoing spinal surgery for medically refractory spinal radiculopathy,
* myelopathy or neurogenic claudication based on either history, physical examination or radiologic studies demonstrating neural compression or degenerative disc disease.
* Undergoing surgery for medically refractory axial spinal pain.

Exclusion Criteria:

* Previous spinal procedures or operations,
* radicular pain,
* history of fibromyalgia,
* chronic pain,
* rheumatoid arthritis,
* autoimmune disorders,
* HIV,
* PTSD,
* Major Depressive Disorder,
* migraine headaches or active rhinosinusitis,
* nicotine intake

Primary outcomes:
measure: Substance P Neuropeptide Levels in Saliva And Serum in Patients with Spinal Disease: A Pilot Study
timeFrame: 2009-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates, P.A.
state: North Carolina
Study officials:
affiliation: Carolina Neurosurgery & Spine Associates
name: Vinay Deshmukh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799838: Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients
Official title: Local, Phase IV, Multicenter, Double-blind, Randomized, Parallel, With Two Treatment Arms, Placebo-controlled Study to Evaluate the Reduction of Inflammatory Symptoms in the Treatment of Bacterial Pharyngitis With Ketoprofen and Amoxicillin in Pediatric Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pharyngotonsillitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 106
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.

Detailed description: The total duration of the study period per patient is 10 ± 1 day

Eligibility criteria: Inclusion Criteria:

* Quick-test positive for Streptococcus pyogenes;
* Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation;
* Pain (for swallowing) evaluated by Wong Baker Faces Pain scale with at least grade 3;
* Presence of at least two of the follow symptoms:

  * Hyperemia and edema evaluated with at least 2 out of 4 crosses
  * Fever in the previous 48 hours
  * Cervical adenomegaly
  * Tonsilla with erythema or erythema and white exsudate.

Exclusion Criteria:

* History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions;
* History and laboratorial confirmation of hematologic, hepatic or renal disorders;
* Use of nonsteroidal antiinflammatory drugs (NSAID) during the last 3 weeks and gastroesophageal reflux during the last 6 months;
* Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours;
* History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
timeFrame: 24 hours
Secondary outcomes:
measure: Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment
timeFrame: 72 hours
measure: Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication
timeFrame: 24 hours and 72 hours
measure: Number of patients who used rescue medication after randomization.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06765538: Video Versus Face-to-face Preoperative Anaesthetic Assessment
Official title: Video Versus Face-to-face Preoperative Anaesthetic Assessment: a Randomized Clinical Trial on Safety and User Satisfaction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Telemedicine
Keywords: anaesthetic preassessment
telemedicine
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 2260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized clinical trial rewieving difference between anaesthetic preassessment in physical consultations vs. video consultations.

Detailed description: Preoperative anaesthetic assessment aims to reduce morbidity and mortality and are currently accepted as the gold standard of care for elective surgery. Technical advances in society have led to explora-tions within the telemedicine area which continues providing safe and effective services. The video versus face-to-face preoperative anaesthetic assessment (VIDFACE) trial aims to compare videobased preoperative anaesthetic assessment to standard face-to-face consultations with focus on patient safety and satisfaction including possible beneficial eco and economical effects compared to standard face-to-face consultations.

This is a randomised, single-centre, two-arm, assessor, and data analyst blinded clinical trial. We will enrol 2260 participants undergoing elective Ear-Nose-Throat or Tooth-Mouth-Jaw surgery. Participants will be randomised 1:1 stratified by malignant versus benign surgery to either video based preoperative anaesthetic assessment or face-to-face consultation. Data will be analysed by two blinded statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind.

Results:

The primary outcome is the incidence of six predefined serious adverse events (SAE). Secondary outcomes are the proportion of participant with a change in anaesthesia plan as well as delays or cancellations on the day of surgery and patient satisfaction.

The VIDFACE trial will contribute valuable knowledge on the efficacy and safety on using video consultations in the an-aesthetic preoperative assessment.

Eligibility criteria: Inclusion Criteria:

* ENT and TMJ patients
* Adults \> 18 years
* Informed consent obtained after a consideration period of minimum 24 hours

Exclusion Criteria:

* If a patient is assessed unsuitable for the video technology in example, patients with severe mental challenges (dementia, retardation, etc.), they will not be included in the trial. If excluded, the patient receives standard care, face-to-face preoperative anaesthetic assessment.
* Local protocol screen patients

Primary outcomes:
measure: SAE
timeFrame: 30 day follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Zealand
Study officials:
References:
Clinical trial NCT01629238: Characteristics of Plant Sterols Consumers in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: cardiovascular risk
dairy enriched product with plant sterols
general practitioners
adults followed by general practitioners
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-06-27
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults followed by general practitionners

Brief summary: The purpose of this study is to describe the cardiovascular risk profile in subjects who consume a marketed drinkable low fat fermented milk enriched with plant sterol. Investigations are lead prospectively and retrospectively among adults enrolled from general practitioners' database.


Eligibility criteria: Inclusion Criteria:

* male and female aged 18-70 years, regular visits to GP (at least once every six months within the past 2 years), agreeing to a written informed consent

Exclusion Criteria:

* any clinical, psychological or language problem that would prevent from completing the questionaires or communicating with GP

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: BKL Consultant
Study officials:
References:
Clinical trial NCT05914038: Individualized rTMS for Motor Recovery in Stroke Patients
Official title: Efficacy of Individualized Repetitive Transcranial Magnetic Stimulation Based on Cortical Laterality for Motor Recovery in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Transcranial Magnetic Stimulation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.

Detailed description: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.

High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode.

However, the current rTMS studies for stroke patients utilized the same therapeutic protocol and there is no individualized rTMS protocol based on the value of lateralization index.

This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.

Eligibility criteria: Inclusion Criteria:

1. Unilateral ischemic or hemorrhagic stroke
2. Stroke within 3 months
3. Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
4. No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
5. Patient could sit over 15 minutes
6. Age over 20

Exclusion Criteria:

1. Previous stroke, traumatic brain injury, brain tumor
2. With central nervous system disease (spinal cord injury, Parkinson's disease)
3. Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
4. Patients unable to cooperate the treatment
5. Pregnancy
6. Depression

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 12 weeks post intervention
Secondary outcomes:
measure: Medical Research Council (MRC) Scale for Muscle Strength
timeFrame: 1 week, 4 weeks, 12 weeks post intervention
measure: National Institutes of Health Stroke Scale
timeFrame: 1 week, 4 weeks, 12 weeks post intervention
measure: Barthel Index
timeFrame: 1 week, 4 weeks, 12 weeks post intervention
measure: Modified Rankin Scale
timeFrame: 1 week, 4 weeks, 12 weeks post intervention
measure: MEP
timeFrame: 1 week, 4 weeks, 12 weeks post intervention
measure: Fugl-Meyer Assessment
timeFrame: 1 week, 4 weeks post intervention
measure: functional NIRS
timeFrame: 1 week, 4 weeks, 12 weeks post intervention
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei
Study officials:
affiliation: The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
name: Meng Ting Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03782038: Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars
Official title: A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scars
Keywords: Acne Scars
Stretchmarks
Surgical Scars
Lead sponsor: Cytrellis Biosystems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.

Detailed description: The study subject population will consist to up to 30 subjects who meet the inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post last treatment.

An study results will be assessed on the following:

* POSAS - Patient Observer Scar Assessment
* ASAS - Acne Scar Severity Scale
* Subject Satisfaction Scale

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Fitzpatrick scale I-VI.
* Any type of scar except for keloid scars
* Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.

Exclusion Criteria:

* Previous treatment of the scar tissue within last 6 months.
* Silicone, fat, collagen or synthetic material in the treatment area.
* History of keloid formation.
* Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.
* Active, chronic, or recurrent infection.
* Compromised immune system (e.g. diabetes).
* Hypersensitivity to analgesic agents.
* Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
* Pregnant or breastfeeding.
* Any issue that, at the discretion of the investigator, would contra-indicate the subject's participation.
* Any medication that may cause bleeding such as anticoagulants.
* Allergy to lidocaine and/or epinephrine

Primary outcomes:
measure: Assess level of aesthetic improvement using POSAS scale 6 months post last treatment
timeFrame: 6 months post last treatment
measure: Assess level of aesthetic improvement using ASAS scale 6 months post last treatment
timeFrame: 6 months post last treatment
Secondary outcomes:
measure: Assess safety profile by recording all adverse events reported during study
timeFrame: 6 months post last treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Dermatology & Laser Institute
state: Florida
Study officials:
References:
Clinical trial NCT03624738: Femorofemoral Bypass in Redo Cardiac Surgery
Official title: Femorofemoral Bypass in Redo Cardiac Surgery: A Safe and Effective Operative Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Femoro-femoral bypass
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Femorofemoral bypass in redo cardiac surgery
Primary purpose: TREATMENT

Brief summary: Redo cardiac surgery are becoming more common with a patient population at greater risk. Sternal re-entry poses the hazard of probable injury to vital structures. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB).

Detailed description: Redo cardiac surgery are more frequent with a patient population at greater risk. Repeat sternal entry poses the risk of possible injury to vital structures. These include laceration of the myocardium, especially the right ventricle, injury of great vessels or crossing coronary bypass grafts as the internal mammary grafts in particular, or dislodgement of emboli from patent vein grafts. To minimize the risk associated with sternal re-entry, the investigators adopted the method of establishing femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac drain prior to sternotomy. Also, femorofemoral bypass support the hemodynamics in cases of redo emergency cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* 25-65 years old
* Patients scheduled for repeat open heart surgery with sternotomy
* informed consent has been obtained

Exclusion Criteria:

* Planned off-pump cardiac surgery
* Vascular disease
* previous operation on femoral artery
* under 25 years of age

Primary outcomes:
measure: invasive monitoring of arterial blood pressure
timeFrame: Baseline during operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt
name: Mohamed mahmoud ahmed, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaneko T, Vassileva CM, Englum B, Kim S, Yammine M, Brennan M, Suri RM, Thourani VH, Jacobs JP, Aranki S. Contemporary Outcomes of Repeat Aortic Valve Replacement: A Benchmark for Transcatheter Valve-in-Valve Procedures. Ann Thorac Surg. 2015 Oct;100(4):1298-304; discussion 1304. doi: 10.1016/j.athoracsur.2015.04.062. Epub 2015 Jul 21.
citation: Agrifoglio M, Gennari M, Kassem S, Polvani G. Saphenous vein cannulation in re-redo cardiac surgery. J Card Surg. 2012 Nov;27(6):676-7. doi: 10.1111/jocs.12004. Epub 2012 Oct 15.
citation: Knight JL, Cohn LH. Left thoracotomy and femoro-femoral bypass for reoperative revascularization of the posterior coronary circulation. J Card Surg. 1987 Sep;2(3):343-9. doi: 10.1111/j.1540-8191.1987.tb00192.x.
Clinical trial NCT03893838: Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery
Official title: Chromatic and Monochromatic Optical Aberrations After Corneal Refractive Surgery - Preliminary Study Assessing Their Prevalence, Methods of Reductions of Symptoms and Time-dependent Changes in Patients Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractive Errors
Aberration, Corneal Wavefront
Lead sponsor: Wrocław University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
First posted: 2019-03-28
Enrollment: 100
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: Patients after refractive surgery

Brief summary: Refractive surgeries can be divided into two distinct categories: 1) corneal surgeries (superficial and deep procedures) carried on the surface of the eye and 2) lens surgeries (phakic IOL, refractive lens exchange) - an intraocular intervention, performed in the anterior or posterior chamber or on the lens. In the proposed protocol focus is on the corneal refractive surgeries impact on monochromatic higher-order aberrations on the one hand and chromatic aberrations on the other. During the surgery in order to get the patient emmetropic, refractive surgery corrects optical defects by decreasing aberrations of lower orders ) simultaneously increases high-order aberrations (that is perceived by the patient as halo, glare or starburst). Informations about prevalence and causes of higher order aberrations after refractive surgery are numerous but there is no information about chromatic aberrations.


Eligibility criteria: Inclusion Criteria:

* patient after corneal refractive surgery at least for 4 months
* post surgical refraction within +/- 0.75 diopter of spherical and +/- 1.0 diopter of cylindrical error
* willing and able to understand and sign an informed consent form.

Exclusion Criteria:

* patient unable to participate in the study
* any corneal diseases, eyes trauma or systemic diseases history; keratoconus or tendency of keratoconus
* corneal macula and obvious pannus; current enrolment in another clinical trial/research project

Primary outcomes:
measure: number of high order and chromatic aberrations after refractive surgery
timeFrame: 6 months
measure: Chromoretinoscopy for near (MEM) and distance
timeFrame: 6 months
measure: Aberrometry reading for corneal HOA
timeFrame: 6 months
measure: Transverse chromatic aberration
timeFrame: 6 months
Secondary outcomes:
measure: Change in Hue 100 test
timeFrame: 6 months
measure: Change of contrast sensitivity for near vision
timeFrame: 6 months
measure: Visual Function Questionaire 25
timeFrame: 6 months
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Optics and Photonics
Study officials:
affiliation: Wrocław University of Science and Technology
name: Joanna Przeździecka-Dołyk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598138: Clinical and Biological Strokes Collection in Reunion Island
Official title: Clinical and Biological Strokes Collection in Reunion Island
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 795
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cross-sectional regional multicenter hospital study of all neurological events (stroke, AIT and mimics) for diagnostic and prognostic purposes. Cost of illness study.


Eligibility criteria: Inclusion Criteria:

* affiliated to a social security scheme
* clinical signs suggestive of stroke : hemiparesis or hemiplegia, unilateral sensory disorder, language disorder, balance disorder, dizziness, loss of total or partial bilateral or monocular vision, sudden neurological deficit

Exclusion Criteria:

* current pregnancy
* Recent clinical history of head trauma
* patients aged \< 18 years old
* patient under guardianship or curatorship
* Person deprived of liberty

Primary outcomes:
measure: clinico-biological score
timeFrame: 24 hours after the stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de La Réunion
city: Saint-Pierre
country: Réunion
facility: CHU de La Réunion
Study officials:
References: