louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06864559: Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study
Official title: Comparison of Three Types of Sutures in Oral Surgery. Study of Bacterial Colonization, Tissue Reaction and Clinical Characteristics: Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wound Healing Complication
Oral Surgery
Third Molar Extraction
Oral Infection
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Considering the wide variety of surgical sutures currently marketed in the field of Dentistry, it was decided to conduct a study comparing the microbial adhesion and antibacterial activity of three different types of sutures used in Oral Surgery (Silk, non-absorbable polyamide monofilament and non-absorbable expanded polytetrafluoroethylene).

Detailed description: The general or primary objective is:

• To compare 3 non-absorbable suture materials used in oral surgery: silk, polyamide monofilament and expanded polytetrafluoroethylene.

The specific or secondary objectives are:

* To evaluate how each type of suture influences wound healing and the patient's postoperative period.
* To study bacterial colonization in each type of suture.
* To determine the tissue reaction and clinical characteristics of each suture.

Eligibility criteria: Inclusion Criteria:

* Patients with indication for extraction of a third lower molar retained in an unfavorable position that requires a bayonet incision in the surgical procedure.
* Age: patients aged 18 years or older.
* ASA I patients (Classification of the American Society of Anesthesiology, 1979): healthy patients who tolerate stress well, without systemic pathology, no anxiety and in whom a therapeutic modification is not necessary.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Smoking patients.

Primary outcomes:
measure: Bacterial colonization
timeFrame: 7 days.
measure: Level of inflammation
timeFrame: 7 days.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01304459: Vancomycin Serum Concentrations in Pediatric Oncology Patients Under Intensive Care
Official title: Vancomycin Serum Concentrations in Pediatric Oncology Patients Under Intensive Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Lead sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric oncology patients on intensive care unit for treatment of infections.

Brief summary: Observational protocol to analyse routine vancomycin serum levels of patients under intensive care and to obtain percentage of patients that achieve therapeutic values.


Eligibility criteria: Inclusion Criteria:

* Hospitalized pediatric oncology patients
* Patients under vancomycin treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Grupo de Apoio ao Adolescente e à Criança com Câncer
Study officials:
References:
Clinical trial NCT05285059: Implicit Learning in Epileptic Children
Official title: Implicit Learning in Epileptic Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Keywords: Epilepsy,
children,
implicit learning
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study focuses on children with epilepsy.

Brief summary: Epileptic children suffer from impairments in various learning and memory tasks. Yet, no study investigated implicit learning in epileptic children. Implicit learning is not only underlying motor skills acquisition, but also social and cognitive ones. Because acquisition of new skills is optimal during childhood, the study of implicit learning mechanism in children is of major importance. The present study will be the first to explore implicit learning mechanisms in children with epilepsy. Implicit learning mechanisms can be preserved or altered.


Eligibility criteria: Inclusion Criteria:

* For Patient group only: Children with epilepsy
* For Control group only: Children without neurological, psychiatric or developmental impairments
* For both groups: Parent or tutors agreement
* For both groups: Affiliated to French social security

Exclusion Criteria:

* Neurological impairments unrelated to epilepsy
* Psychiatric impairments unrelated to epilepsy
* Developmental impairments unrelated to epilepsy

Primary outcomes:
measure: Response time
timeFrame: The day of the inclusion
measure: Response accuracy recorded during the ASRT task
timeFrame: The day of the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Agathe Marcastel, PhD
city: Bron
country: France
facility: Dezso Nemeth
city: Bron
country: France
facility: Service d'Epileptologie Clinique, des Troubles du sommeil et de Neurologie fonctionnelle de l'enfant, à Hôpital Femme Mère et Enfant,
Study officials:
affiliation: Service d'Epileptologie Clinique, des Troubles du sommeil et de Neurologie fonctionnelle de l'enfant - Hôpital Femme Mère Enfant
name: Marcastel Agathe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01093859: An Exploratory Phase 1 Microdose Study of PRX-105
Official title: An Exploratory Phase 1 Study to Assess the Safety and Pharmacokinetics of PRX-105, Administered as a Single, Microdose, Intravenous Slow Bolus Injection to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Organophosphate Exposure
Keywords: acetylcholinesterase
Lead sponsor: Protalix
Sponsor class: INDUSTRY
First posted: 2010-03-26
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Exploratory phase 1, first in human, open label, non-randomized, single-dose study of PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant physiological effect in healthy volunteers after a single, intravenous microdose administration.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged 18-45 (inclusive) years.
* Body Mass Index (BMI) 19 to 29 kg/m2 (inclusive) and weighing at least 60 Kg and up to 90 kg.
* Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.
* Blood pressure and heart rate within normal limits.
* Electrocardiogram (ECG) with no clinically significant abnormalities.

Exclusion Criteria:

* History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medication.
* Current / previous occupational exposure to organophosphates or pesticides.
* Previous receipt of any investigational butyrylcholinesterase product.

Primary outcomes:
measure: PRX-105 plasma concentration
timeFrame: 0 to 48 hours after injection
Secondary outcomes:
measure: Cardiovascular monitoring
timeFrame: 0 to 48 hours after injection
measure: Neurological examination
timeFrame: 0 to 48 hours
measure: Ophthalmic evaluation
timeFrame: 0 to 8 hours
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Protalix Ltd.
name: Einat Almon, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03576859: Pyrophosphate Homeostasis and Hepatic Expression of ABCC6.Pyro-TH
Official title: Pyrophosphate Homeostasis and Hepatic Expression of ABCC6. Pilot Study in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Failure
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In animals, normal hepatic expression of ABCC6 (ATP-binding transporter cassette, subfamily C, member 6) determines plasma pyrophosphate (PPi) concentration. PPi prevents the formation of hydroxyapatite crystals on tissues by precipitation of calcium and inorganic phosphate (Pi). It is an endogenous compound whose deficiency causes diffuse vascular calcifications in certain rare monogenic diseases, including the elastic pseudoxanthoma caused by the mutation of ABCC6. PPi is produced by enzymatic transformation of extracellular ATP and, in animals, the liver is the main supplier of ATP and PPi (more than 90%). In humans, liver transplantation offers the possibility of correlating the plasma concentration of PPi (\[PPi\]pl) with hepatic expression of ABCC6. Liver transplantation is performed in the treatment of chronic liver failure (Child B or C) or, in the absence of liver failure, in the treatment of hepatocellular carcinoma. By measuring\[PPi\]pl before transplantation and after liver function restoration and by measuring ABCC6 in the diseased liver and healthy liver, it is possible to determine whether liver failure is associated with decreased\[PPi\]pl and decreased liver expression of ABCC6, which is the objective of our pilot study. Its interest is to establish a physiopathological link between the frequent vascular calcifications in obese patients with hepatic steatosis and the production of PPi.

prupose: Look for a deficit in\[PPi\]pl in patients before the transplant compared to the phase of restoration of liver function


Eligibility criteria: Inclusion Criteria:

Indication for liver transplantation Age greater than or equal to 18 years Patients affiliated to social security

Exclusion Criteria:

Patient not affiliated to social security Non-consenting patient or unable to understand the protocol and how it works Fulminant Hepatitis

Primary outcomes:
measure: plasma PPi concentration between before transplantation and liver function restoration in the both arms
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Untiversity Hospital of Nice
Study officials:
References:
Clinical trial NCT02726659: Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression
Official title: Adjunctive Use of Celecoxib in the Treatment of Bipolar Postpartum Depression: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar Disorder
Postpartum Depression
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will conduct a 6-week, randomized, double-blind, placebo-controlled trial of celecoxib as an add-on treatment to the mood stabilizer among women with bipolar I or II postpartum depression. Women who are taking a mood stabilizer for treatment of bipolar disorder in the postpartum treatment will receive either a placebo or celecoxib add-on treatment. Patients will be monitored regularly to assess psychiatric symptoms and side effects. The investigators aim to evaluate the potential antidepressant effect of celecoxib in bipolar postpartum depression.


Eligibility criteria: Inclusion Criteria:

* women aged 18-45 who are within 3 months of delivering a healthy, term (37 to 40 weeks) singleton
* diagnosis of bipolar postpartum depression - depressed with peripartum onset
* have a 17-item Hamilton Rating Scale for Depression score of \>18
* have failed to respond to an adequate trial of the mood stabilizer
* are currently not on any psychotropic drug except a mood stabilizer (lithium, lamotrigine or quetiapine)
* are able to communicate (written and oral) in English and capable of giving consent

Exclusion Criteria:

* current major depressive episode of more than 6 months duration
* a current comorbid psychiatric disorder
* history of alcohol or substance abuse within the 12 months before screening
* concurrent psychotherapy
* high risk for suicide (actively suicidal or a score of = 3 on item #3 on HAM-D)
* current hepatic, renal, or cardiac disease, chronic pain, coagulation disorders, esophageal or gastro duodenal ulceration within the previous 30 days
* known immediate-type hypersensitivity to COX-2 inhibitors, sulfonamides, ibuprofen, or diclofenac
* breastfeeding mothers

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: 6 weeks
Secondary outcomes:
measure: Montgomery Asberg Depression Scale
timeFrame: 6 weeks
measure: Udvalg for Kliniske Undersogelser Scale
timeFrame: 6 weeks
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 weeks
measure: Clinical Global Impression Scale (CGI)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Institute, Mental Health Care Buildling
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Verinder Sharma, MB BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04424459: Evaluation of an Opioid Decrease Strategy in Chronic
Official title: Evaluation of an Opioid Decrease Strategy in Chronic Pain Patients at the Pain Assessment and Treatment Center in Montpellier: Prospective Study Over 6 Months.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Opioid analgesics
Opioid use disorders
Prescription drug abuse
treatments Prevention Identification
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 8
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: DCNC patients treated at the Montpellier Pain Assessment and Treatment Center hospitalized during the period from 10/01/19 to 12/31/19, for misuse of opioid treatment.

Brief summary: Increase in the consumption of analgesics observed in many countries with a mediatic crisis resulting in an increasingly frequent wish of patients to wean themselves from opiates. A recent update (B. Rolland 2017) suggests that upon initiation of an opioid analgesic treatment, the patient should be informed of the risk of opioid dependence and misuse. There is no clearly validated decay scheme in the event of dependence in patients with Chronic Non-Cancer Pain.

Hypotheses:

* Possibility of a rapid decrease in opioid analgesic treatments at DCNC sensitized to the risk of DOP and MOP. (Protocol implemented: Multidisciplinary assessment, workshops and information sheet on chronic pain, treatments and risk of DOP, pharmacological and nonpharmacological adaptation)
* Highlight the need for additional information from patients and prescribers on the risk of DOP and MOP in DCNC.

Detailed description: Main objective: Check if the rapid to semi-rapid regimen (- 25 to -60% dosage in 5 days of HDS) of opioid analgesics, without the use of methadone or buprenorphine agonists, in the case of DCNC at the CETD in Montpellier is efficient in the medium term (6 months).

Secondary objective:

* With our inclusion questionnaire we wanted to check if the patients had been made aware of the risk of opiate dependence and misuse.
* Detect the conditions of prescriptions that can promote the misuse of opiates.
* Evaluating the different components of residual pain at 6 months (type, intensity, anxiety component and depression, function).

Eligibility criteria: Inclusion criteria:

* chronic pain patient
* major
* supported at CETD

Exclusion criteria:

-patient with physical and mental incapacity to participate in the study

Primary outcomes:
measure: Change of the dosage of opioid and co-analgesic treatments
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Measuring quality of life
timeFrame: Inclusion, 3 and 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Théa GENDARME, MD, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01260259: Seattle Cardiorenal Remote Ischemic Preconditioning Trial
Official title: Effect of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Cardiopulmonary Bypass
Myocardial Injury
Acute Kidney Injury
Acute Lung Injury
Keywords: Pediatric
Cardiac
Surgery
Cardiopulmonary
Bypass
Myocardial
Kidney
Lung
Injury
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 90
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remote Ischemic Preconditioning (RIPC) is a treatment that may be associated with improved outcomes after cardiac surgery. It can be elicited noninvasively by using a tourniquet to elicit transient ischemia over a lower extremity. It is thought to promote anti-inflammatory and cell survival pathways, and thus protect remote organs against future ischemic injury. We hypothesize that compared to sham treatment, RIPC will be associated with decreased post-operative acute kidney, myocardial, and lung injury.

Detailed description: In children undergoing cardiac surgery and cardiopulmonary bypass (CPB), our primary aims are to determine whether RPC is associated with: 1) decreased AKI and 2) decreased acute myocardial injury. Secondary aims include investigating the effects of RPC on post-procedure: 1)acute lung injury and 2) morbidity/mortality.

Eligibility criteria: Inclusion Criteria:

Age birth to 18 years Cardiac surgery with planned cardiopulmonary bypass

Exclusion Criteria:

Any contraindication to compression of lower extremity/extremities Body weight \<2 kg Active infection going into surgery On renal replacement therapy (RRT) or mechanical circulatory support going into surgery On inotropic support going into surgery

Primary outcomes:
measure: Incidence of acute kidney injury (AKI)
timeFrame: 72 hours
measure: Incidence of acute myocardial injury
timeFrame: 48 hours
Secondary outcomes:
measure: Incidence of acute lung injury
timeFrame: 72 hours and duration of hospitalization
measure: Hospitalization
timeFrame: Duration of post-operative hospitalization
measure: Mortality
timeFrame: Duration of hospitalization, 30 days post-op, and at last follow-up
measure: Biomarkers for AKI
timeFrame: 72 hours
measure: Inflammation
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital and University of Washington
name: Christine W Hsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital and University of Washington
name: Yuk Law, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01828359: The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.
Official title: An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 199
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: The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.

Detailed description: * Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
* Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
* Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA

Eligibility criteria: Inclusion Criteria:

* 20 aged or over
* Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
* Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)

Exclusion Criteria:

* Patients with too high Blood pressure

  •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
* History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
* Secondary hypertension or suspected to be

Primary outcomes:
measure: Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change from baseline in MSDBP
timeFrame: Baseline, week 4
measure: Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)
timeFrame: Baseline, Week 4 and 8
measure: Blood pressure responder rate
timeFrame: Baseline, Week 4 and 8
Other outcomes:
Locations:
Study officials:
affiliation: Gachon University Gil Medical Center
name: Taehoon Ahn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: