louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02925858: Effect of Ketamine on Analgesia Post-Cardiac Surgery
Official title: Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Ketamine
Cardiac surgery
Pain
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.

Detailed description: This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery

Exclusion Criteria:

* Minimally invasive cardiac surgery
* Preoperative opioid use
* Preoperative hepatic or renal dysfunction

Primary outcomes:
measure: Quantity of Opioids Used in the First 48 Hours Postoperatively
timeFrame: First 48 hours after arrival to the ICU
Secondary outcomes:
measure: Quantity of Opioids Used
timeFrame: 24 hours postoperatively
measure: Pain Scores (Visual Analog Scale)
timeFrame: Postoperative days 2
measure: Postoperative Nausea and Vomiting
timeFrame: 48 hours after ICU arrival
measure: Intensive Care Unit Length of Stay
timeFrame: 1 day - 2 weeks
measure: Hospital Length of Stay
timeFrame: 5 days - 2 weeks
measure: Time to Extubation
timeFrame: 4 hours - 2 weeks
measure: Delirium
timeFrame: ICU stay
measure: Time to Mobilization
timeFrame: During hospital stay
measure: Time to Ambulation
timeFrame: 1 week postoperatively
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Matthew Cameron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01064258: Trial of Auto Continuous Positive Airway Pressure (CPAP)
Official title: Reliability of Automatic CPAP Devices. A Double Blind Dummy Controlled Phase 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstructive Sleep Apnea
Keywords: treatment
CPAP
sleep apnea
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background: In patients with obstructive sleep apnea, automatic continuous positive airway pressure machines (autoCPAP) are said to be capable of identifying various breathing abnormalities during sleep and to correct them by increasing progressively the positive pressure applied to the airway. Once breathing becomes normal, pressure slowly declines. AutoCPAP devices have never been tested in Phase I studies. The investigators hypothesised that normal breathing would not be recognised as such, and that pressure would increase even in a normal subject.

Detailed description: Material and Methods: We will submit one normal (confirmed with two polysomnographies, PSG) subject to a double blind study. Pairs of PSG will be performed on successive days once a week, one night with a 4 cm water fixed pressure CPAP device, previously shown not to disturb the subject's sleep and breathing, the other night with one of five well known autoCPAP devices programmed to work between 4 and 15 cm H2O pressure. The same mask and headgear will be used throughout the study. The subject and the physicians reading the tracings will ignore which device is being used on which night.

Eligibility criteria: Inclusion Criteria:

* normal subject
* male and female
* age 18 to 65 years old

Exclusion Criteria:

* obstructive sleep apnea
* unable to sleep with a CPAP device

Primary outcomes:
measure: number of episodes of increases in applied positive pressure, duration of each episode, and maximal pressure attained
timeFrame: one night
Secondary outcomes:
measure: reasons for pressure increase and consequences of the increase on sleep continuity
timeFrame: one night
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Daniel Rodenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mwenge GB, Dury M, Delguste P, Rodenstein D. Response of automatic continuous positive airway pressure devices in a normal subject. Eur Respir J. 2011 Jun;37(6):1530-3. doi: 10.1183/09031936.00139510. No abstract available.
Clinical trial NCT02919358: Music and Feeding in NICU
Official title: The Mozart Effect and the Assessment of Weight Gain and Development of Feeding Skills in the NICU.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding
NICU
Preterm Infants
Mozart
Weight Gain
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 28
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effect of classical music exposure on improved time to regain birth weight and improved feeding readiness in healthy premature infants in the NICU.


Eligibility criteria: Inclusion Criteria:

* • Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days

  * Parents ≥18 years of age
  * English speaking parents
  * Breastmilk as intended primary form of nutrition

Exclusion Criteria:

* Congenital anomalies affecting hearing or feeding skills
* Patients requiring HFOV or HFJV

Primary outcomes:
measure: The primary outcome is time to regain birth weight
timeFrame: 2 weeks
Secondary outcomes:
measure: Assessment of Feeding Cues
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
References:
Clinical trial NCT03140358: The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Official title: The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Myopia
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2017-05-04
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief summary: Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

Detailed description: High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.

Eligibility criteria: Inclusion criteria

1. One parent with myopia (\<-3D in at least one eye)
2. SE +1.00D to -1.50D
3. Astigmatism \< = 1.50D
4. Distance vision logMAR 0.2 or better in both eyes
5. Intraocular pressure of not greater than 21 mmHg
6. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion Criteria:

1. Any eye or systemic disease that affect vision or refractive error
2. Conditions where topical atropine contraindicated
3. Previous use of atropine or pirenzepine
4. Known past/current amblyopia or strabismus

Primary outcomes:
measure: Spherical Equivalent
timeFrame: 3.5 years
Secondary outcomes:
measure: Axial Length
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore eye research institute
Study officials:
affiliation: Singapore National Eye Center
name: Audrey Chia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05878158: Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars
Official title: Clinical and Digital Radiographic Evaluation of Simvastatin Versus MTA in Pulpotomy of Immature Permanent Vital Molars: A18 Month Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pulp Exposure, Dental
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 128
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: the study will be done to evaluate the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars

Detailed description: the clinical and digital radiographic success of simvastatin versus MTA in pulpotomy of immature permanent molars for the following patients which include: Healthy children aged from 6 to 8 years who will be classified as Class I or II Children according to the American Society of Anaesthesiologists (ASA) will be included. Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.

Eligibility criteria: Inclusion Criteria:

* Healthy children aged from 6 to 8 years
* Children with severe behavioral, or emotional disabilities, and medically compromised children will be excluded.
* Deep carious lesions of the first permanent immature molars with signs \& symptoms of reversible pulpitis will be included
* Normal radiographic findings and immature roots

Primary outcomes:
measure: Presence or absence of pain
timeFrame: one year
Secondary outcomes:
measure: Dentin wall thickness
timeFrame: 18 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01107158: LXRs, Cholesterol Metabolism and Uterine Dystocia
Official title: The Role of Two Nuclear Receptors for Oxysterols as a Molecular Cause of Uterine Dystocia: LXR Alpha and LXR Beta
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Uterine Inertia
Dystocia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population represents women undergoing a difficult, stagnating labor due to either physical or uterine dystocia.

Brief summary: Despite the fact that a link between cholesterol and the myometrium has been clearly established, no study investigating aspects of cholesterol metabolism and uterine dystocia currently exists. This study is a pilot study whose aim is to test the hypothesis that an association between uterine dystocia and single-nucleotide polymorphisms (SNPs) in the genes coding for the LXRs.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing C-section for a dystocia: 2 to 3 hours of stagnation in labor progress are observed (ie no increasing dilation, and uterine contractions less that 3-5 per 10 minutes) in spite of measures taken to overcome dystocia (oxytocin injection and artificial breaking of waters)
* the child is alive
* the child does not have apriori known malformations that could interfere with a vaginal birth
* foetus in cephalic position
* full term pregnancy (\>= 37 weeks of amenorrhea)
* single birth
* patient has signed consent
* patient is affiliated with a social security system

Exclusion Criteria:

* vaginal birth
* programmed C-section
* C-section is chosen because the fetus has a cardia rhythm problem, and there is no stagnation in the labor process
* multiple pregnancy
* the child is in a breech position
* premature birth (\<37 weeks amenorrhea)
* in utero fetal death
* fetal malformation known before birth that could interfere with a vaginal birth
* non french-speaking patient (impossible to correctly inform the patient)
* patient under guardianship

Primary outcomes:
measure: The multi-loci genotype of the target DNA sequence.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Kevin Mouzat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02208258: Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fecal Incontinence
Keywords: fecal incontinence, consure medical, semi formed stool, stool management system
Lead sponsor: Consure Medical Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.


Eligibility criteria: Inclusion Criteria:

* Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.
* Non-ambulatory, hospitalized patients.
* History of passage of at least 1 stool in 24 hours.

Exclusion Criteria:

* Patients with suspected or confirmed rectal mucosal impairment or pathology.
* Patients with have undergone descending colon or rectal surgery within the preceding six months.
* Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.
* Patients suspected to have impacted stool or is suffering from constipation.
* Patients with confirmed pregnancy or suspected to be pregnant.
* Patients that have planned MRI examination over the duration of the study.
* Patients who have suffered recent cardiac arrest within the preceding 3 months.
* Patients enrolled in another clinical study or clinical trial.
* Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).

Primary outcomes:
measure: Visual confirmation that fecal material is diverted into the external collection bag through the device.
timeFrame: 120 +/- 8 hours
measure: Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.
timeFrame: 120 +/- 8 hours
measure: Number of hours for which the device stays on without change or removal.
timeFrame: 120 +/- 8 hours
Secondary outcomes:
measure: Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.
timeFrame: 120 +/- 8 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp HealthCare
state: California
Study officials:
References:
Clinical trial NCT05251558: Efficacy of Telerehabilitation Based Exercises in Patients With Bell's Palsy
Official title: The Efficacy of Telerehabilitation Based Self Proprioceptive Neuromuscular Facilitation Exercises on Clinical and Psychosocial Parameters in Bell's Palsy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell Palsy
Keywords: Bells Pasly
Telerehabilitation
Peripheral Facial Paralysis
Proprioceptive Neuromuscular Facilitation
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: The study will be carried out with volunteer patients who are diagnosed with Bell's Palsy and comply with the study criteria.The aim of the study is to compare the home PNF exercise program with video-based telerehabilitation and the conventional training program in terms of outcome measures in patients with Bell's Palsy lesions.

Detailed description: With the telerehabilitation program, it is aimed that patients can easily adapt to home exercise programs and be followed up remotely. In this way, the most effective treatment of the disease will provide the patient with both motor function gain and psychosocial gain. This study was planned to examine the effectiveness of telerehabilitation in patients with Bell's Palsy.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 - 65 years
* Being diagnosed with Bell's Palsy by a specialist physician
* Having a lower motor neuron lesion
* Non-traumatic cases
* Not having any other neurological deficits
* Having signed the consent form

Exclusion Criteria:

* Situations that will prevent assessments or communication with the individual
* Bilateral involvement
* Having an operation for facial palsy
* Having an upper motor neuron lesion
* Neurological problems that would preclude evaluation and/or treatment.

Primary outcomes:
measure: FDI
timeFrame: Change from Baseline FDI at 4 weeks
measure: FaCE
timeFrame: Change from Baseline FaCE at 4 weeks
measure: SF-12
timeFrame: Change from Baseline SF-12 at 4 weeks
measure: HADS
timeFrame: Change from Baseline HADS at 4 weeks
measure: H-B
timeFrame: Change from Baseline H-B at 4 weeks
Secondary outcomes:
measure: TSUQ
timeFrame: Change from Baseline TSUQ at 4 weeks
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sıtkı Kocman University Hospital Emergency Service
state: Menteşe
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: STUDY_DIRECTOR
affiliation: Ege University
name: Mehmet Özkeskin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University
name: İsmet Tümtürk, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: Yalçın Gölcük, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03943758: a Low-residue Diet for Bowel Preparation
Official title: Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyp
Colorectal Adenoma
Keywords: Bowel preparation
Polyp
adenoma
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: Jinan Military General Hospital
name: Wuhan TongJi Hospital
name: Zhejiang University
name: First Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital with Nanjing Medical University
name: West China Hospital
First posted: 2019-05-09
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.


Eligibility criteria: Inclusion Criteria:

* Patients whose age is between 18-65.
* Patients who have indications for screening, surveillance and diagnostic colonoscopy.
* Patients who have signed inform consent form

Exclusion Criteria:

* subjects who had known or suspected heart failure, stroke or renal failure;
* subjects who had a history of colon surgery or inflammatory bowel disease;
* subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons;
* subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products;
* subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week;
* subjects who had participated in another interventional clinical trial in the previous 60 days;
* pregnant or lactating women and those planning to become pregnant.

Primary outcomes:
measure: Adequate bowel preparation rate
timeFrame: 30 mins
measure: BBPS scores of the entire colon
timeFrame: 30 mins
Secondary outcomes:
measure: adenoma detection rate (ADR)
timeFrame: 30 mins
measure: preparation completion rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: