louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04785183: Antioxidant Effects of Melatonin in Preterm
Official title: Early Supplementation of Melatonin in Preterm Newborns: the Effects on Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Morbidity
Oxidative Stress
Pre-Term
Melatonin Deficiency
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. In these studies, the dosages of melatonin varied over a wide range. The present study was designed to test the hypothesis that oral administration of melatonin reduced OS and consequentially, the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) in preterm newborns.


Eligibility criteria: Inclusion Criteria:

* Gestational age \<37 weeks
* Normal liver function tests
* Normal kidney function tests

Exclusion Criteria:

* All babies not born in the clinic
* All babies with severe congenital malformations
* Sepsis
* Inborn errors of metabolism
* Babies suffering from perinatal asphyxia
* Babies born from mothers with mental disorders
* Sample hemolysis
* Insufficient sample
* withdraw informed consent.

Primary outcomes:
measure: Measurement of the melatonin concentration
timeFrame: All participants will be evaluated at 24 hours of life
measure: Measurement of the melatonin concentration
timeFrame: All participants will be evaluated at 48 hours of life
Secondary outcomes:
measure: Measurement of AOPP
timeFrame: All participants will be evaluated at 24 hours of life
measure: Measurement of NPBI
timeFrame: All participants will be evaluated at 24 hours of life
measure: Measurement of isoprostanes
timeFrame: All participants will be evaluated at 24 hours of life
measure: Measurement of AOPP
timeFrame: All participants will be evaluated at 48 hours of life
measure: Measurement of NPBI
timeFrame: All participants will be evaluated at 48 hours of life
measure: Measurement of isoprostanes
timeFrame: All participants will be evaluated at 48 hours of life
Other outcomes:
measure: Evaluation of the free radical diseases of prematurity occurence
timeFrame: At 3 months of life
Locations:
city: Messina
country: Italy
facility: Eloisa Gitto
Study officials:
References:
Clinical trial NCT01102283: Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
Official title: Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Obstruction
Colonic Stricture
Large Bowel Obstruction
Keywords: Colonic obstruction
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Referral Centers

Brief summary: The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.


Eligibility criteria: Inclusion: per the IFU,

* colonic strictures caused by malignant neoplasms, and
* large bowel obstruction due to malignant strictures prior to colectomy.

Exclusion:

* central ischemia,
* any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement,
* suspected or impending perforation,
* intra-abdominal abscess/perforation,
* inability to pass wire guide or stent deployment system through the obstructed area,
* patients for whom endoscopic or percutaneous procedures are contraindicated,
* benign disease, and
* coagulopathy.

Primary outcomes:
measure: Relief of obstruction
timeFrame: At the Conclusion of the Procedure
Secondary outcomes:
measure: Implant Duration
timeFrame: 6 months
measure: Symptoms at Follow-up
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Milan
country: Italy
facility: Instituto Clinico Humanitas IRCCS
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Girona
country: Spain
facility: Hospital Universitari de Girona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: London
country: United Kingdom
facility: University College of London Hospital
Study officials:
References:
Clinical trial NCT01458483: Acute Carotid Sinus Endovascular Stimulation II Study
Official title: Acute Carotid Sinus Endovascular Stimulation II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Acute Carotid Sinus Endovascular Stimulation II (ACES II) Study is a multicenter, prospective, non-randomized study that is being conducted to evaluate the feasibility of endovascular stimulation of carotid sinus nerves via an electrophysiology (EP) catheter advanced into the internal jugular vein (IJV). The current study investigates the hypothesis that intraoperative electrical stimulation of the carotid sinus from the IJV will result in an acute and dose-dependent reduction in blood pressure and heart rate.

Detailed description: All study objectives are being assessed during the intraoperative baroreceptor stimulation. No subsequent testing will be performed. The follow-up visit is only intended to assess for adverse events.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years old
* Subject is hypertensive (defined as at least one in-office Systolic BP measurement ≥140 mm Hg or Diastolic BP ≥90 mm Hg within three months prior to enrollment
* Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures.
* Subject (or subject's legally authorized representative) is able and wiling to give informed consent

Exclusion Criteria:

* Subject has an ejection fraction (EF) less than 35% (by most recent echocardiography in the past 6 months) and there has been no change in clinical status relative to EF
* Subject is a woman who is pregnant, nursing, or of child bearing potential and is not on a reliable form of birth control
* Subject is enrolled or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the Medtronic study manager, documenting that there is not a concern that co-enrollment could confound the results of this trial.
* Subject is unable or unwilling to participate with study procedures

Primary outcomes:
measure: Change in systolic blood pressure during electrical stimulation
timeFrame: Intraoperative testing only
measure: Change in diastolic blood pressure during electrical stimulation
timeFrame: Intraoperative testing only
Secondary outcomes:
measure: Characterize number and type of side effects seen during stimulation
timeFrame: Intraoperative testing only
Other outcomes:
Locations:
city: Detroit
country: United States
state: Michigan
Study officials:
affiliation: Harper Hospital
name: Randy Lieberman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02061683: A Study of Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-02-13
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of bimatoprost as initial, replacement, or adjunctive intraocular pressure (IOP)-lowering therapy in patients with primary open angle glaucoma and ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension
* No use of Lumigan® in the past 3 months

Exclusion Criteria:

* Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

Primary outcomes:
measure: Intraocular Pressure (IOP) in the Study Eye
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Patients With an Adverse Event of Conjunctival Hyperemia
timeFrame: 3 Months
Other outcomes:
Locations:
city: Shanghai
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wang K, Xu L, Yuan Z, Yao K, Zhao J, Xu L, Fang A, Zhang M, Wu L, Ji J, Hou J, Liu Q, Sun X. Intraocular pressure-lowering efficacy and safety of bimatoprost 0.03% therapy for primary open-angle glaucoma and ocular hypertension patients in China. BMC Ophthalmol. 2014 Feb 25;14:21. doi: 10.1186/1471-2415-14-21.
Clinical trial NCT06020183: Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood
Official title: Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transverse Maxillary Deficiency
Keywords: maxillary expasnion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the Skeletal and Dento-alveolar expansion in adult patents using Four Mini-screws Supported Hyrax in compare with untreated control group.

Detailed description: Aim of the study: To evaluate the Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

Methodology:

* Essential record for orthodontic treatment will be taken.
* impression with bands on upper first molars will be taken.
* Four eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).
* CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.
* Delivery, check the retention and fitness of the appliance.
* The appliance will be cemented using band cement(compomer).
* Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.
* Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.
* Closure of the device, and leave the appliance in-situ for five months as a retention.
* Post-expansion CBCT will be taken and continue fixed orthodontic treatment.

Outcome: skeletal and dento-alveolar expansion will be evaluated

Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral Dental posterior cross-bite
* Skeletal Maxillary constriction
* Male and female patients.
* Chronological age (18-30 years).
* Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
* Good oral hygiene.
* No craniofacial anomalies or syndromes

Exclusion Criteria:

* Scissor-bite
* Orthodontically-treated
* functional cross bite due to premature occlusal contact
* patients with a syndrome
* cleft patients
* Mid-palatal suture maturation(Grade A.B,E) according to F Angileri classification

Primary outcomes:
measure: Skeletal maxillary expansion
timeFrame: 5 months interval between pre and post-expansion
Secondary outcomes:
measure: Dento-alaveolar expansion
timeFrame: 5 months interval between pre and post-expansion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo university
state: Giza
Study officials:
affiliation: Master Degree student ,Faculty of Dentistry, Cairo University
name: Elzubair Osman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05016583: Paula Method of Exercises in Patients With LARS Syndrome
Official title: Paula Method Muscle Exercises in Patients With Low Anterior Resection Syndrome After Sphincter Sparing Rectal Resection: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Anterior Resection Syndrome
Keywords: Paula Method
Sphincter sparing rectal resection
Anal incontinence
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.


Eligibility criteria: Inclusion Criteria:

* Over age 18
* LARS syndrome (LARS score of 21 or higher) up to 24 months post sphincter sparing rectal resection
* Able to read, understand and communicate in Hebrew

Exclusion Criteria:

* Pregnancy
* Actively undergoing Chemotherapy or Radiation
* Other causes of anal incontinence or bowel dysfunction (ex: Irritable Bowel Syndrome)
* Concurrent performance of other exercise methods
* Unable or unwilling to perform the Paula exercises

Primary outcomes:
measure: Improvement in LARS (Low Anterior Resection Syndrome) Score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Nocera F, Angehrn F, von Flue M, Steinemann DC. Optimising functional outcomes in rectal cancer surgery. Langenbecks Arch Surg. 2021 Mar;406(2):233-250. doi: 10.1007/s00423-020-01937-5. Epub 2020 Jul 26.
citation: Nguyen TH, Chokshi RV. Low Anterior Resection Syndrome. Curr Gastroenterol Rep. 2020 Aug 4;22(10):48. doi: 10.1007/s11894-020-00785-z.
citation: Liebergall-Wischnitzer M, Shaphir A, Solnica A, Hochner-Celnikier D. Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial. J Adv Nurs. 2021 Apr;77(4):2026-2032. doi: 10.1111/jan.14681. Epub 2020 Nov 29.
Clinical trial NCT03490383: Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP
Official title: ERCP Based Study of Microbiota in Bile From Patients With Common Bile Duct Stone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Common Bile Duct Calculi
Microbial Colonization
Keywords: ERCP
CBD stone
Microbial Colonization
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ERCP patients in our center

Brief summary: In this study, investigators will investigate the microbiota of bile in common bile duct stone participants. Three key questions are of concern. The first one is whether there is bacteriria in bile in participants without common bile duct stone. The second one is whether the microbiota of bile is similar with that of gut mucosa in common bile duct stone participants. The third one is whether the bacteria in bile of common bile participants with intact papillar is the same as that of participants underwent sphinctomy.


Eligibility criteria: Inclusion Criteria:

* CBD tumor or CBD calculi

Exclusion Criteria:

* contraindication for ERCP

Primary outcomes:
measure: microbiota in bile
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shang General Hospital
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Hang Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00296283: Family Workshops for Bipolar Disorder
Official title: An Acceptance Based Psychoeducation Intervention to Reduce Expressed Emotion in Family Members of Bipolar Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Disorder
Keywords: Relatives
Bipolar Disorder
Psychoeducation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2006-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study is looking at the effects of a brief psychoeducational workshop. These one day workshops are designed to increase family members knowledge about bipolar disorder and to help with processing emotions that go along with having a relative with bipolar disorder.


Eligibility criteria: Inclusion Criteria:

* self-identified adult relatives of people diagnosed with bipolar disorder between ages 18 and 64; up to two persons per family can participate in the multifamily group

Exclusion Criteria:

* relative with bipolar disorder will not be involved in the workshop

Primary outcomes:
measure: Knowledge
measure: Anger
measure: Attributions
measure: Expressed Emotion
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sheri Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102983: Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression
Official title: Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: MRI, Functional
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: GIPSA-LAB
First posted: 2017-04-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli.

Detailed description: Each participant will undergo two visits:

Phase 1: The Gipsa-Lab Laboratory's Department of Speech and Cognition. This first visit will make it possible to make recordings of their vowel productions and to verify that the participants correspond to the criteria necessary for the study (passing the Edinburgh manual laterality test and auditory thresholds checked using a " An audiogram). It will also be an opportunity to provide them with the consent documents and the fact sheet, which will give them time to read it before the MRI exam. The duration of this first visit will be approximately 1 hour.

Phase 2: fMRI review in the 3Tesla MRI Unit at the Grenoble University Hospital Center. Participants will first undergo a medical examination in order to verify their absence of contraindication to the MRI examination. At the end of this medical examination, the consent of participation will be signed. The participants will then be able to carry out the MRI examination for a duration of about 1h15, then the behavioral judgment test of perceptual distance. The total duration of this second visit will be approximately 1h45.

Eligibility criteria: Inclusion Criteria:

* Medicall exam before MRI
* Pregnant Women
* Patients aged 18-45 years, Right-handed
* without neurologic and/or psychiatric troubles
* normal audition
* Audition normale
* French mother tongue
* Social security affiliation

Exclusion Criteria:

* protected person
* MRI contraindication
* claustrophobia
* respirtaory and cardiovascular pathology
* toxic substances taking

Primary outcomes:
measure: Evaluate the involvement of the speech motor system in the perception of vowels, using functional magnetic resonance imaging (fMRI).
timeFrame: One hour and forty five minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: Alexandre KRAINIK, PhD
role: PRINCIPAL_INVESTIGATOR
References: