louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05519826: A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
Official title: A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm Abdominal
Peripheral Aneurysms
Arterial Disease Occlusive
Prothesis
Lead sponsor: Perouse Medical
Sponsor class: INDUSTRY
Collaborators: name: Eclevar Medtech
First posted: 2022-08-29
Enrollment: 373
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient population conditions that may indicate abdominal and/or peripheral vascular open surgical repair with implantation of a POLYMAILLE EXTRA THIN vascular graft include:

* Peripheral arterial diseases (PAD), characterized by reduced blood flow to the lower extremities, which may be categorized as:

  * Intermittent claudication (IC)
  * Chronic limb-threatening ischemia (CLTI)
  * Acute limb ischemia (ALI)
* Peripheral arterial aneurysms, characterized by a permanent localized (i.e., focal) modification of the parallelism of the vessel walls, which may be categorized by the following location:

  * Iliac arterial aneurysms (IAA)
  * Femoral arterial aneurysms (FAA)
  * Popliteal arterial aneurysms (PAA)

Brief summary: The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.

the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.


Eligibility criteria: Inclusion Criteria:

* Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study:

Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion Criteria:

* Patients who refused the collection of their personal data.

Primary outcomes:
measure: Primary performance endpoint
timeFrame: 1 year
measure: Primary safety endpoint
timeFrame: 1 year
Secondary outcomes:
measure: Procedural success rate
timeFrame: 5 years
measure: Primary patency rate
timeFrame: 5 years
measure: Primary assisted patency rate
timeFrame: 5 years
measure: -Secondary patency rate
timeFrame: 5 years
measure: Device Failure
timeFrame: 5 years
measure: Mortality rate
timeFrame: 5 years
measure: Limb salvage rate
timeFrame: 5 years
measure: Adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT02005926: The Accuracy of Sentinel Node Biopsy of Breast Cancer With Sonographic Abnormal Axillary Lymph Nodes
Official title: Phase II Trail of Removing Sonographic Abnormal Lymph Node in Sentinel Lymph Node Biopsy of Breast Cancer Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Sentinel lymph node biopsy
Ultrasonography
Fine needle aspiration
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: * This is a phase II, prospective, single-center, non-randomized, non-controlled study.
* Sentinel lymph node biopsy (SNB) is a standard staging procedure in early breast cancer. The potentially increasing false negative rate of SNB was concerned if the sonographic abnormal node was not excised. The aim of this study was to evaluate the accuracy of SNB in breast cancer with sonographic abnormal axillary lymph nodes.


Eligibility criteria: Inclusion Criteria:

* histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy
* abnormal axillary lymph node was found by ultrasound examination before SLNB (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness \>3mm)
* ultrasound-guided FNA cytology of these nodes were performed
* the result of FNA cytology was negative (no tumour cell was found)
* patient planed to perform SLNB

Exclusion Criteria:

* pathological diagnosed ductal carcinoma in situ by excisional biospy
* abnormal axillary lymph node was found by ultrasound examination but FNA cytology of these nodes were not performed
* the result of FNA cytology was positive (tumour cell was found)
* T4d tumour
* patient has recieved neo-adjuvant system therapy

Primary outcomes:
measure: False negative rate of sentinel node biopsy if sonographic abnormal node not be removed
timeFrame: one week after sentinel node biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Breast cancer, Peking University Cancer Hospital & Institute
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Zhaoqing Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06776926: Timing of Carbetocin Administration in Postpartum Hemorrhage
Official title: When Should Carbetocin Be Administered to Prevent Postpartum Hemorrhage After Normal Vaginal Delivery?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Hemorrhage
Carbetocin
Keywords: Postpartum hemorrhage
PPH
Carbetocin
Placental retention
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Postpartum haemorrhage (PPH) is one of the major contributors to maternal mortality and morbidity worldwide. Active management of the third stage of labour has been proven to be effective in the prevention of PPH. Syntometrine is more effective than oxytocin but is associated with more side effects. Carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of PPH. The use of carbetocin, being an important agent in the prevention of PPH, also increases its prevalence. It is planned to investigate the advantages and disadvantages of the timing of its use.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Vaginal delivery at or beyond 38 weeks of gestation
* Primipar

Exclusion Criteria:

* Multiparity
* Contraindications to carbetocin use (e.g., pre-existing hypertension, pre-eclampsia,asthma, cardiac, renal, or liver disease)
* High-risk factors for primary postpartum hemorrhage, including grand multiparity,presence of uterine fibroids, or a need for prophylactic oxytocin infusion
* Anemia or
* body mass index (BMI) over 35
* Baby weight over 4000 grams
* Comorbidities or chronic diseases
* History of curettage
* Use of propess or oxytocin during labor

Primary outcomes:
measure: Carbetosin effect
timeFrame: 24 hours after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Su LL, Chong YS, Samuel M. Carbetocin for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD005457. doi: 10.1002/14651858.CD005457.pub4.
citation: Maged AM, El-Goly NA, Turki D, Bassiouny N, El-Demiry N. A systematic review and meta-analysis of randomized trials comparing carbetocin to oxytocin in prevention of postpartum hemorrhage after cesarean delivery in low-risk women. J Obstet Gynaecol Res. 2025 Jan;51(1):e16194. doi: 10.1111/jog.16194.
citation: Jin B, Du Y, Zhang F, Zhang K, Wang L, Cui L. Carbetocin for the prevention of postpartum hemorrhage: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2016;29(3):400-7. doi: 10.3109/14767058.2014.1002394. Epub 2015 Sep 4.
Clinical trial NCT01895426: ArcadiusXP L Post Market Clinical Follow-Up
Official title: Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.


Eligibility criteria: Inclusion Criteria:

* all indications as given by the instructions for use
* Patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from L4 to S1
* Age 18 - 60
* at least 6 months of unsuccessful treatment including conservative measures
* Non-sequestrated and subligamentous prolapse

Exclusion Criteria:

* all contraindications, which are listed in the instructions for use.
* existing pregnancy, planned or occurring during study period
* patients with a higher degree of segmental degeneration in other than the segment to be operated
* body- mass-index (BMI) \> 30
* Systemic or local infection
* Increased risk of osteoporosis according to assessment by the SCORE evaluation
* Bone metabolism disorders
* Chemotherapy or radiotherapy (ongoing or planned)
* Participation in another clinical trial
* Scheduled for spinal litigation
* Other serious conditions that hinder the participation in the study
* Nanogel® filling of the cage, prior to implantation was not done

Primary outcomes:
measure: ODI (2y) - ODI(preop)
timeFrame: 2 years
Secondary outcomes:
measure: Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels
timeFrame: 2 years
measure: Overall success
timeFrame: 2 years
measure: Overall success
timeFrame: 2 years
measure: Pain (back and leg)
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
measure: Patient satisfaction
timeFrame: 2 years
measure: Concomitant pain medication
timeFrame: 2 years
Other outcomes:
Locations:
city: Kremmen
country: Germany
facility: Sana Kliniken Sommerfeld
city: Lingen
country: Germany
facility: St. Bonifatius Hospital Lingen
Study officials:
affiliation: St. Bonifatius Hospital Lingen
name: Peter Douglas Klassen, MD (PY)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04572126: Feasibility and Efficacy of a Brief Mindfulness-Based Intervention SMOKING INTERVENTION VIA THE INTERNET
Official title: Feasibility and Efficacy of a Brief Mindfulness-Based Smoking Intervention Via the Internet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Smoking Reduction
Keywords: Smoking Reduction
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the mindfulness intervention group or control group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The current study will examine both the feasibility and efficacy of a single session, web-based mindfulness-based intervention for smoking cessation. The study will explore (1) participants' subjective experiences of the intervention, (2) cravings and negative affect both before and after the intervention, and (3) changes in tobacco use one week and one month following the initial intervention. Further, the study will examine how often participants utilize the intervention between the initial study and follow-up periods.


Eligibility criteria: Inclusion Criteria:

* Daily Smoker
* Has a desire to quit or reduce smoking.
* Is not currently involved in another smoking reduction or cessation program.

Exclusion Criteria:

-

Primary outcomes:
measure: Subjective Ratings Questionnaire
timeFrame: Immediately post-intervention
measure: Change in Past Month Cigarette and E-Cigarette use.
timeFrame: Immediately before the intervention and at one-month follow-up.
measure: Change in Cigarette/E-cigarette Craving
timeFrame: Immediately preceding and following intervention.
measure: Change in Positive and Negative Affect
timeFrame: Immediately preceding and following intervention as well as at one-month follow-up.
Secondary outcomes:
measure: Intervention Use.
timeFrame: One-month after intervention.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References:
citation: Bowen S, Marlatt A. Surfing the urge: brief mindfulness-based intervention for college student smokers. Psychol Addict Behav. 2009 Dec;23(4):666-71. doi: 10.1037/a0017127.
citation: Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1.
citation: Witkiewitz K, Bowen S. Depression, craving, and substance use following a randomized trial of mindfulness-based relapse prevention. J Consult Clin Psychol. 2010 Jun;78(3):362-374. doi: 10.1037/a0019172.
Clinical trial NCT04688957: Osseodensification by Densah Burs Versus Osteotome
Official title: Osseodensification by Densah Burs Versus Osteotome for Transcrestal Maxillary Sinus Lifting With Simultaneous Implant Placement (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Sinus Lift
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended.

This study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.

Detailed description: a total of 12 patients with missing maxillary premolars or molars and with limited vertical bone height below the maxillary sinus floor will receive implants either with osteotome or with Densah burs transcrestal sinus lifting to compare clinically and radiographically transcrestal sinus lifting with Densah burs and osteotome with simultaneous implant placement

Eligibility criteria: Inclusion Criteria:

* Patient with missing maxillary premolas and molars
* Vertical bone height of 5-8 mm
* Non smokers
* Good oral hygiene

Exclusion Criteria:

* Bad oral hygiene
* maxillary sinusitis
* Presence of infection or periapical lesions in adjacent teeth
* Bruxism or clenching
* Alcoholism
* Medically compromised patients with a condition that affect the procedure
* Multiple sinus septa

Primary outcomes:
measure: implant stability
timeFrame: at 6 months
measure: change in bone height
timeFrame: at baseline and 6 months
measure: change in bone density
timeFrame: at baseline and 6 months
Secondary outcomes:
measure: Pain scores
timeFrame: at 2 weeks
measure: edema scores
timeFrame: at 2 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References:
citation: Elghobashy MTM, Shaaban AM, Melek LNF. Radiographic comparison between Densah burs and osteotome for graftless internal sinus lifting with simultaneous implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2023 Mar;52(3):388-395. doi: 10.1016/j.ijom.2022.06.020. Epub 2022 Jul 13.
Clinical trial NCT05514457: Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
Official title: Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslexia
Keywords: Dyslexia
Remediation
Visual attention span
Visual search
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 13
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dyslexia is first described as a phonological deficit. Several studies report a neurovisual deficit in dyslexics. Some dyslexics have a visual deficit without phonological impairment, others have a pure phonological deficit, and still others have both types of deficits. From this observation the idea emerged to propose specific remediation protocols for people with visual impairments and to assess their effects on reading. At the theoretical level, if visual stimulation is able to improve reading performance, it is the demonstration of the existence of visual origin of dyslexia. At the clinical level, such a result not only opens the prospect of a different and more adapted rehabilitation for these types of dyslexia, but also the prospect, if the visual deficits are pre-existing to the learning of reading, to use them for early diagnosis and management.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged 8 to 12
* Diagnosed dyslexics
* Normal or corrected to normal vision
* Legal guardians of children subjects providing their free, informed and written consent to participate in the study; With the child also giving orally his consent to participate.

Exclusion Criteria:

* other neurodevelopmental problem
* strabismus, amblyopia

For the glasses (group 2) : epileptic child are excluded

Primary outcomes:
measure: reading performance
timeFrame: for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes
measure: reading performance
timeFrame: for arm 1: at baseline at 1 month at 2 month at 3 month For arm 2: 4 times in the same day, 4 consecutive reading sessions with a break in-between of minimum 5 minutes
Secondary outcomes:
measure: score of Elementary Visuo-Spatial Perception test
timeFrame: one time at baseline
measure: visual attention span
timeFrame: one time at baseline
measure: Visual search time
timeFrame: one time at baseline
measure: performance score on the phonology tests (EVALéo 6-15 = Evaluation of written language and oral language 6-15 years)
timeFrame: one time at baseline
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de Recherche en Neurosciences de Lyon
state: Rhone Alpes
Study officials:
References:
Clinical trial NCT01544257: Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms
Official title: Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prematurity
Keywords: Osteopathic manipulative treatment
alternative medicine
complementary medicine
neonatology
neonatal care
prematurity
allied health care
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 29
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.


Eligibility criteria: Inclusion Criteria:

* preterm infants born at age between 29 and 37 weeks
* osteopathic treatment performed \< 14 days after birth
* preterms born in the same hospital

Exclusion Criteria:

* gestational age \< 29, \> 37 weeks;
* osteopathic treatment performed \> 14 days after birth;
* newborn transferred to/from other hospital;
* newborn from to HIV seropositive and/or drug addict mother;
* newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Primary outcomes:
measure: evaluate the effectiveness of OMT in reducing LOS
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: pre-post difference in weight gain
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Francesco Cerritelli
Study officials:
affiliation: European Institute for Evidence Based Osteopathic Medicine
name: Francesco Cerritelli, DO, MS
role: STUDY_CHAIR
References:
citation: Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65.