louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05399433: Role of Glucose Metabolism in Migration of Cutaneous Dendritic Cells in Psoriasis
Official title: Rôle du métabolisme du Glucose Dans la Migration Des Cellules Dendritiques cutanées Dans le Psoriasis : étude Pilote Translationnelle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Dendritic cells (DC) paly a key role in the induction and chronicity of psoriasis by capturing the antigenes and activating the T cell repsonse. This activation requires their migration from the cutaneous sensitisation site to the lymph nodes. This migration requires an important intracellular metabolic activity, with a strong involvmenet of glucdic metabolism. This activity is linked with the systemic activity. This study aims to compare the migration and the phenotypic and metabolic caracteristics of blood and skin DCs in patients with or without psoriasis and with or without type 2 diabetes,


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* hospitalized in the Dermatology department of the CHU of Nice for moderate to severe psoriasis (defined by a PASI \> or = 10)
* covered by a social security scheme after obtaining a free
* Clinical diagnosis of plaque psoriasis by a dermatologist with or without type 2 diabetes (defined by glycated hemoglobin \>7%)
* For the control group: without psoriasis or other inflammatory dermatosis aged in the presence or not of type 2 diabetes (glycated hemoglobin \>7%).
* free and informed consent

Exclusion Criteria:

* Minor or incapable or unwilling to consent freely or in an informed manner Pregnant or nursing woman.
* Patient in a period of exclusion from other biomedical research
* Patient with generalized chronic inflammatory disease or other inflammatory dermatosis
* Patients on general corticosteroid, immunomodulator or immunosuppressant therapy in the month prior to local inclusion or treatment with corticosteroid therapy in the 15 days prior to inclusion, on anti- treatmentIL-23 or anti IL12/23 for less than 3 months or under anti-IL-17 or anti-TNF treatment for less than 1 month.
* Contraindication to cutaneous biospsis (known hemostasis disorder, taking anticoagulants, allergy to xylocaine, history of cheloid scars, congenital immune deficiency)

Primary outcomes:
measure: Percentage of dentridic cells producers of IL-23
timeFrame: at baseline
Secondary outcomes:
measure: Percentage of subpopulations dentridic cells producers
timeFrame: At baseline
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-maritimes
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: passeron thierry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05857033: Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children
Official title: Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, Local
Keywords: Dental injection
Palatal injection
Indirect palatal injection
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each
Primary purpose: OTHER

Brief summary: Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Patients who are in need of extraction of maxillary posterior teeth.
* Children free of any systemic disease or special health care needs (ASA I).
* Children with no learning disabilities.
* Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
* Patients whose parents will give consent to participate.

Exclusion Criteria:

* Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
* Signs of reversible pulpitis.
* Restorable tooth.
* Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
* Patients with acute oral or facial infection (swelling and/or cellulites )

Primary outcomes:
measure: Change in pain scores
timeFrame: Baseline and up to 1 hour
measure: Change in child's behavior
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00007033: Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alagille Syndrome
Cholestasis
Biliary Atresia
Keywords: Alagille syndrome
biliary atresia
cholestasis
gastrointestinal disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2000-12-07
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the role of magnesium deficiency in the pathogenesis of decreased serum vitamin D and reduced bone density in children with chronic cholestatic liver disease.

Detailed description: PROTOCOL OUTLINE:

Patients receive magnesium sulfate IV over 1 hour on day 3. Patients then receive oral magnesium gluconate supplementation daily. Treatment with magnesium sulfate repeats once at 3-6 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of liver disease with chronic cholestasis Nonsyndromic intrahepatic cholestasis Alagille's syndrome Extrahepatic biliary atresia
* Direct bilirubin greater than 2 mg/dL OR Bile acids greater than 20 micromoles/L
* No hepatic decompensation defined as one or more of the following: Ascites Peripheral edema PT at least 4 seconds longer than control Albumin less than 3 g/dL

--Patient Characteristics--

* Renal: No significant renal disease
* Cardiovascular: No significant cardiovascular disease
* Pulmonary: No significant pulmonary disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center - Cincinnati
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: James Heubi
role: STUDY_CHAIR
References:
citation: Heubi JE, Wiechmann DA, Creutzinger V, Setchell KD, Squires R Jr, Couser R, Rhodes P. Tauroursodeoxycholic acid (TUDCA) in the prevention of total parenteral nutrition-associated liver disease. J Pediatr. 2002 Aug;141(2):237-42. doi: 10.1067/mpd.2002.125802.
Clinical trial NCT06023433: Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement
Official title: Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement: a Split Mouth Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Tooth Movement
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 27
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The main objective of the study is to evaluate the impact of orthodontic tooth movement on gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis.
Primary purpose: BASIC_SCIENCE

Brief summary: A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on the expression of gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis during canine distalization following asymmetrical extraction treatment of upper first premolars.

Samples of gingival crevicular fluid on the mesial and distal side of the canines to be examined will be performed during the baseline and during various follow-ups.

Detailed description: A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on the expression of gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis during canine distalization following asymmetrical extraction treatment of upper first premolars.

Orthodontic tooth movement induces bone remodeling by various signaling pathways. The variations in miRNAs expression and their impact in inflammation and osteoclastogenesis during the various stages of orthodontic tooth movements is not fully understood.

58 patients requiring asymmetrical upper first premolar extraction for orthodontic purposes have been enrolled for this split-mouth study: the canines to be distalized on the extractive site are considered as the test group, the controlateral canines (on the side without first premolar extraction) areconsidered as normal controls.

Eligibility criteria: Inclusion Criteria:

* patients with excellent oral hygiene throughout the study period,
* patients requiring asymmetrical maxillary first premolar extraction so monolateral canine retraction will be performed as a part of the treatment,
* patients available to come back at the clinic at the times of sample collection.

Exclusion Criteria:

* poor oral hygiene and/or bleeding on probing,
* use medications, steroids or other anti-inflammatory medications,
* systemic health problems or smoking.

Primary outcomes:
measure: miRNAs expression
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04508933: Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
Official title: Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Distress Syndrome, Adult
Ventilation Perfusion Mismatch
Pulmonary Edema
Covid19
Keywords: ards
covid19
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with ARDS in the adult ICU that have a TPTD catheter inserted since 2018 will be eligible for recruitment

Brief summary: Covid-19 also primarily affects endothelium that line up the alveoli. The resulting hypoxemia may differ from "typical" Acute Respiratory Distress Syndrome (ARDS) due to maldistribution of perfusion related to the ventilation. Thus, pathophysiology of Covid-19 ARDS is different, which requires different interventions than typical ARDS. The investigators will assess whether extravascular lung water index and permeability of the alveolar capillary differs from typical ARDS with transpulmonary thermodilution (TPTD) technique. Extravascular Lung Water Index (EVLWI) and Pulmonary Vascular Permeability Index (PVPI) will be compared.


Eligibility criteria: Inclusion Criteria:

* ARDS defined by Berlin Criteria longer than 24 hours
* Undergoing mechanical ventilation
* Noradrenaline demand \>0.1 mcg/kg/min

Exclusion Criteria:

* Not meeting ARDS criteria
* Noninvasive mechanical ventilation
* ARDS resolved shorter than 24 hours
* Shock resolved

Primary outcomes:
measure: Extravascular Lung Water Index
timeFrame: 1 day
measure: Pulmonary vascular permeability index
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
affiliation: Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
name: Yalım Dikmen, Prof
role: STUDY_DIRECTOR
References:
citation: Monnet X, Teboul JL. Transpulmonary thermodilution: advantages and limits. Crit Care. 2017 Jun 19;21(1):147. doi: 10.1186/s13054-017-1739-5.
Clinical trial NCT03166033: Case-control Study on Individual Risk Factors of CTS
Official title: Case-control Study on Individual Risk Factors of Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
etiology
risk factor
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2017-05-24
Enrollment: 6048
Sex: ALL
Minimum age (years): 41
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present case-control study was based on the single medical center in Shanghai, China, in which more than 5000 CTS patients per year are treated. The hospital involved in the study is a university teaching hospital. Cases were recruited from the surgical wards and appropriate outpatient clinics, while the controls were recruited from the outpatient clinics.

Brief summary: This study is conducted to observe the characteristics of the risk factors of CTS in Chinese population.

Detailed description: Carpal tunnel syndrome (CTS), or median neuropathy at the wrist, is a medical condition in which the median nerve is compressed at the wrist, leading to paresthesia, numbness and muscle weakness in the hand. It's the most common neuro-compressive disease. With the development of the modern life, the morbidity of CTS is also raised. As a common disease, the study on etiology is very important in Carpal Tunnel Syndrome, which can improve the life quality of patients with carpal tunnel syndrome. The risk factors include individual factors such as age, gender, diabetes, Hypothyroidism, obesity, complication of systematic diseases, tobacco, injury and occupational factors.

As most of the research were based on the population in western country and the life style and the ethnicity between Chinese people and western country people is quite different, there may be some similarities and differences in epidemiology. There is seldom similar research in China so that this study was conducted to observe the characteristics of these risk factors in Chinese population.

Eligibility criteria: Inclusion Criteria:

* with the symptom "numbness"
* clinical and neural-electrophysiological diagnosed CTS

Exclusion Criteria:

* suffered from other diseases that could cause "numbness" diagnosed clinically

Primary outcomes:
measure: general risk factors
timeFrame: 2014-2015
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References:
citation: Gao KM, Hu JJ, Lao J, Zhao X. Evaluation of nerve transfer options for treating total brachial plexus avulsion injury: A retrospective study of 73 participants. Neural Regen Res. 2018 Mar;13(3):470-476. doi: 10.4103/1673-5374.228730.
Clinical trial NCT00155233: Interaction Between Nalbuphine and Morphine in PCA
Official title: Interaction Between Nalbuphine and Morphine in Postoperative PCA for Gynecologic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: analgeisa
postoperatve
side effects
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
2. This study was designed to investigate the interaction between nalbuphine and morphine

Detailed description: 1. Nalbuphine is opioid mu receptor antagonist and kappa receptor agonist
2. This study was designed to investigate the interaction between nalbuphine and morphine
3. The analgesic effect and opioid-related side effects will be investigated

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 y/o
2. Female patients of ASA physical status I to III
3. Scheduled for elective abdominal hysterectomy, myomectomy, or excision of ovarian tumor

Exclusion Criteria:

1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants)
2. Intraoperative fentanyl use \> 3 μg/kg
3. Patients with definite diagnosis of esophageal reflux syndrome
4. Use of sedatives, antiemetics, or antipruritics within 24 hours before operation
5. Surgery \> 4 hours or laparoscopy surgery

Primary outcomes:
measure: analgesic effect
Secondary outcomes:
measure: incidence of opioid-related side effects
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Zen Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04466033: Evaluation of the Safety and Performance of Magneto Microcatheter
Official title: Evaluation of the Safety and Performance of Magneto Microcatheter for Endovascular Thrombectomy in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Magneto Thrombectomy Solutions
Sponsor class: INDUSTRY
First posted: 2020-07-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, open label single arm feasibility study to evaluate the safety and performance of the Magneto Microcatheter in patients diagnosed with acute ischemic stroke and planned for thrombectomy procedure.


Eligibility criteria: Inclusion Criteria:

1. Clinical signs consistent with acute ischemic stroke
2. Patient with Acute Ischemic Stroke within 24 hours from symptoms o
3. Age 18-85 years old
4. Consent process is completed per international and local regulations

Exclusion Criteria:

1. Known use of cocaine or other vasoactive substance
2. Known bleeding diathesis
3. Any known hemorrhagic or coagulation deficiency.
4. Current use of oral anticoagulants with International Normalized Ratio (INR) \> 3;
5. PTT (Partial Thromboplastin Time)\>2 at screening
6. Uncontrolled hypertension (Systolic blood pressure\>185 or Diastolic blood pressure\>110) refractory to pharmacological management
7. Pregnant or lactating female
8. CT scan or MRI with evidence of acute intracranial hemorrhage, ASPECT score\<6, mass effect and/or intracranial tumor
9. Angiographic evidence of either carotid dissection or vasculitis at the target site or any condition that may limit device access to the target site (i.e high grade stenosis) per the treating physician's discretion.

Primary outcomes:
measure: Evaluation of the safety of Magneto Microcatheter in the acute post procedure duration by assessing the incidence of device related Serious Adverse Events within 24 hours post procedure
timeFrame: 24 hours
Secondary outcomes:
measure: Evaluation of the safety of Magneto Microcatheter by assessing the incidence of device related Serious Adverse Events within 90 days post procedure
timeFrame: 90 days
measure: Evaluation of the performance of Magneto Microcatheter by assessing its ability to remove the clot and evaluating its ease of use
timeFrame: During Procedure
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute of Mental Health, Neurology and Neurosurgery)
city: Jerusalem
country: Israel
facility: Shaare Zedek
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Dr. Marzelik
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek, Israel
name: Dr.Amsalem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01373333: Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome
Official title: Use Of 3,4-Diaminopyridine (3,4-DAP) In The Treatment Of Lambert Eaton Myasthenic Syndrome
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lambert-Eaton Myasthenic Syndrome
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-06-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Compassionate use of orphan drug 3,4-Diaminopyridine(DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). 3,4-DAP is used to decrease the muscle weakness associated with LEMS and hopefully will decrease the need for prednisone and all other therapies that were previously required to control symptoms. How long a patient will take 3,4 DAP depends upon if he/she is seeing benefits from the medication or experiencing side effects that will prevent them from continuation in the study.

Detailed description: 3,4-diaminopyridine (3,4-DAP) decreases symptoms of weakness in patients with LEMS, and therefore can be used to decrease the amount of immune modulation therapy needed to provide an equivalent degree of disease control.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of LEMS with or without any of the following: evidence of underlying malignancy, presence of P/Q or N-type calcium channel antibodies, electrodiagnostic evidence of a presynaptic defect of neuromuscular junction transmission.None of these laboratory findings are required for inclusion in this study.
2. P/Q and N type calcium channel antibodies are measured in the blood as a routine laboratory test during the course of initial diagnosis, but 10-20% of patients with LEMS do not have elevated levels of these antibodies.

Exclusion Criteria:

1. Hypersensitivity to any component of this medication.
2. History of past or current seizures.
3. History of asthma.
4. Evidence of prolonged QT syndrome. There is no absolute upper limit of normal for the QTc interval.
5. Family history of prolonged QTc syndrome, history of unexplained syncope, seizures or cardiac arrest.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kerry H Levin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: