louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02955576: Microneedle Patch for Psoriatic Plaques
Official title: Efficacy of Microneedle Patch on Topical Ointment Treatment of Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Administration, Topical
Keywords: Psoriasis
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 19
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 efficacy of microneedle patch on the psoriatic plaques.

Detailed description: As a novel minimally invasive approach, microneedle-mediated transdermal drug delivery has received increased attention. Microneedle patch effectively penetrates the skin barrier of the stratum corneum and create efficient pathways for the delivery of drugs.

A randomized controlled trial based on split-body was planned to evaluate the efficacy of enhanced transdermal delivery of topical agent by hyaluronic acid (HA)-fabricated microneedle patch in psoriatic plaques. Six psoriatic plaques in a patient will be randomized to either microneedle HA patch, patch, or control groups. Patch group is planned for rule out the occlusion effect of patches. All lesions will be treated with topical agent and patches daily for 2-week period. The severity of psoriasis will be grated with modified PASI score and the clinical improvement will be assessed as % from baseline every week. Overall 20 patients with 120 psoriatic plaques will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Age: older than 19
* A patient with psoriasis
* A patient with symmetrical psoriatic lesions
* A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
* A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages

Exclusion Criteria:

* Age: lower than 20
* A pregnant or lactating patient
* A patient who cannot understand the study or who does not sign the informed consent

Primary outcomes:
measure: The improvement of psoriasis
timeFrame: Baseline, 1 week, 2 weeks
Secondary outcomes:
measure: The adverse effects of microneedle patch
timeFrame: Baseline, 1 week, 2 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyeonggi-do
Study officials:
affiliation: The Catholic University of Korea
name: Jung Min Bae, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01793727: Infant Glidescope® Learning Curve
Official title: Learning Curve of the Infant Glidescope® Cobalt Video Laryngoscope in Anesthesiology Residents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tracheal Intubation
Keywords: infants
general anesthesia
tracheal intubation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective trial evaluating the learning curve associated with the use of a videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.


Eligibility criteria: Inclusion Criteria:

* infants under 10 kg undergoing general anesthesia and requiring tracheal intubation

Exclusion Criteria:

* Difficult airway, severe cardiorespiratory disease, emergency surgery

Primary outcomes:
measure: Time to optimum visualization of the vocal cords
timeFrame: Under 2 minutes
Secondary outcomes:
measure: Time to tracheal intubation
timeFrame: Under 2 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Cengiz Karsli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03886727: Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention
Official title: Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Dental Caries on Pit and Fissure Surface
Dental Leakage
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.


Eligibility criteria: Inclusion Criteria:

* Teeth having a clinical indication of sealing with bonded resin pit and fissure sealants
* Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures

Exclusion Criteria:

* Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
* Patients with systemic diseases.

Primary outcomes:
measure: The US Public Health Service criteria for retention of sealants
timeFrame: 12 months
Secondary outcomes:
measure: The US Public Health Service criteria for secondary caries on sealants
timeFrame: 12 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU School of Dentistry, Department of Pediatric Dentistry
state: Louisiana
Study officials:
References:
Clinical trial NCT03999827: A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Official title: A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Many persons with epilepsy have seizures which remain uncontrolled by anti-epilepsy medications and are unsuitable for or unwilling to undergo surgical treatments for their epilepsy, or have undergone such treatments and continue to have seizures. Dietary treatments for epilepsy have been shown to be effective in children, and are probably effective in adults, but compliance with the classic ketogenic diet (KD) and to some degree also the modified Atkins diet (MAD) seems difficult for many adults.

The LGI diet may be easier and in children appears to be of comparable efficacy to other dietary treatments (KD and MAD), but has been little studied in adults.

This is a randomised study of immediate versus deferred LGI diet in adults with seizures incompletely controlled by anti-epilepsy medications. 12 weeks of dietary treatment in those randomised to LGI will be followed by the opportunity for the control group to undertake 12 weeks of the LGI diet.


Eligibility criteria: Inclusion Criteria:

* adults (\>18 years)
* epilepsy refractory to at least two appropriate first line anti-epileptic drugs in adequate dose, unsuitable for or unwilling to undergo surgery for epilepsy.
* At least 1 seizure per week.
* BMI \>18

Exclusion Criteria:

* unable to give informed consent
* unable to comply with diet
* surgery for epilepsy or VNS within the last 12 months
* non-epileptic seizures
* pregnant or planning pregnancy
* significant renal impairment
* history of renal stones

Primary outcomes:
measure: % of patients who adhere to the diet as recorded in food diaries
timeFrame: 52 weeks
measure: Score on diet adherence likert scale questionnaire
timeFrame: 52 weeks
measure: Score on diet acceptability likert scale questionnaire
timeFrame: 52 weeks
Secondary outcomes:
measure: Proportion of patients showing a 50% or greater reduction in seizure frequency from baseline
timeFrame: 52 weeks
measure: Change from baseline in QOLIE-31 score
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Stephen Howell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04590027: Caudal Block Versus Local Wound Infiltration for Inguinal Procedures
Official title: Caudal Block Versus Local Wound Infiltration for Inguinal Procedures in Young Children. A Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Caudal
Keywords: caudal block
wound infiltration
postoperative pain
outpatient surgery
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 86
Sex: ALL
Minimum age (years): 3
Maximum age (years): 68
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient setting

paediatric inguinal procedures classifeind ASA 1 or 2 perfomed from the department of paediatric surgery

Brief summary: Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration

Detailed description: Inguinal procedures in children are surgical frequently performed in an outpatient setting. This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.A number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours .

Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.

Parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. If parents agreed to participate, written informed consent was obtained. Pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* no return of questionnaire
* parents do not understand language

Primary outcomes:
measure: Comparison of Analgesia Quality Between the Two Groups
timeFrame: Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,
Secondary outcomes:
measure: Set up Time
timeFrame: Time in minutes measured between start of induction of anesthesia to start of surgical incision
measure: Rescue Medication
timeFrame: 24 hours
measure: Neurological Outcome
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02564627: PENS T6 With Ambulatory Self-applied Patch vs Conventional Procedure
Official title: Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 With an Ambulatory Self-applied Patch vs PENS of Dermatome T6 With Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: Abdel Kadar Clinic
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized study, including moderately obese patients will be included. Patients will be randomized in 3 groups:

* PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet
* PENS of dermatome T6 with conventional procedure + 1200Kcal/day diet
* Only 1200Kcal/day diet

The effect on appetite and weight loss will be investigated.

Detailed description: A prospective randomized study, including moderately obese (BMI 30-39 Kg/m2) patients will be included. Patients will be randomized in 3 groups:

* PENS of dermatome T6 with an ambulatory self-applied patch + 1200Kcal/day diet
* PENS of dermatome T6 with conventional procedure (weekly stimulation in the Outpatient Clinic) + 1200Kcal/day diet
* Only 1200Kcal/day diet

The effect on appetite and weight loss will be investigated.

Eligibility criteria: Inclusion Criteria:

* Moderately obese patients (BMI 30-39 kg/m2)

Exclusion Criteria:

* Endocrinological diseases causing obesity
* Heart pacemaker
* Previous bariatric procedure

Primary outcomes:
measure: Appetite will be quantified with a visual analogic scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight loss
timeFrame: 12 weeks
measure: Compliance will be evaluated by means of a food diary filled by the patients and evaluated by a nutritionist
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Kadar Clinic
name: Mohammed Abdel Kadar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Kadar M. Percutaneous Electrical Neurostimulation (PENS) of Dermatome T6 with an Ambulatory Self-applied Patch vs PENS of Dermatome T6 with Conventional Procedure: Effect on Appetite and Weight Loss in Moderately Obese Patients. Obes Surg. 2016 Dec;26(12):2899-2905. doi: 10.1007/s11695-016-2214-0.
Clinical trial NCT01065727: Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis
Official title: Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Reemitting aggressive multiple sclerosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis


Eligibility criteria: Inclusion Criteria:

* Patients with remitting multiple sclerosis according to mac Donald criteria
* aggressive remitting multiple sclerosis according to following criteria:
* 2 or less disabling relapse during the 12 months before inclusion
* 1 or more
* EDSS between 2 and 5
* aged less or equal to 40 years old for the women
* effective contraception

Exclusion Criteria:

* patients less than 18 years old

Primary outcomes:
measure: cost effectiveness
timeFrame: 30 years
Secondary outcomes:
measure: progressive neurological disability
timeFrame: 3 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Cavale Blanche
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Rennes University Hospital
name: Edan Gilles, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812927: Evaluation of Glycemic Variability (GLAIVE)
Official title: Study of Glycemic Variability in Post-operative Intensive Care Unit Patients According to Two Insulin Infusion Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Anesthesia
Keywords: Glycemic lability index
Continuous glucose monitoring system
intensive care
Insulin
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under IIT in ICU. The main objective of the study was to show the superiority of the infusion system which permitted to dedicate a line for the insulin administration on the "standard" installation in terms of control of glycaemic variability.


Eligibility criteria: Inclusion Criteria:

* Patients under postoperative intensive care
* Treatment with insulin on bi-lumen central venous catheter over than 48 hours
* Eligibility for interstitial glucose monitoring
* Blood glucose control every 3 hours

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient unwilling to participate in the study
* Patients participating in another study biomedical over the same period
* Patient can not understand the study and its objectives
* Patient under guardianship, curatorship
* Patient malnourished (BMI \<18 kg / m²)
* Patient with morbid obesity (BMI\> 40 kg / m²)
* Patient in shock (septic or hemodynamic)
* Patients refusing to sign the Medtronic consent on the storage of personal data

Primary outcomes:
measure: index GLI (Glycemic Lability Index)
timeFrame: up to 48 hours
Secondary outcomes:
measure: Number of hypoglycaemic events
timeFrame: 48 hours
measure: Number of hyperglycaemic events
timeFrame: 48 hours
measure: Sequential Organ Failure Assessment score (SOFA)
timeFrame: during the 4 days of hospitalization period
measure: length of stay in Intensive Care Unit (ICU) or in hospital
timeFrame: during the 4 days of hospitalization period
measure: Death rate
timeFrame: during the 4 days of hospitalization period
measure: Mean Amplitude Glycemic Excusions score (MAGE)
timeFrame: every 3 hours during 48 hours
measure: standard deviation of blood glucose
timeFrame: every 3 hours during 48 hours
measure: average blood glucose
timeFrame: every 3 hours during 48 hours
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Lille
name: Gilles Lebuffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831127: Mobile Messages Affects Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
Official title: Mobile Phone Reminder Messages Improves the Adherence of Stent Removal or Exchange in Patients With Benign Pancreaticobiliary Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: short message service; adherence; stent exchange; ERCP
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 48
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: Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications. However, it is not uncommon that patients does not follow the recommendation for further stent management after ERCP. we hopothesized that short message service (SMS) intervention monthly could improve the adherence in patients with benign pancreaticobiliary after ERCP.


Eligibility criteria: Inclusion Criteria:

* be able to communicate via SMS by mobile phones of themselves or relatives living together

Exclusion Criteria:

* primary or secondary sclerosing cholangitis (PSC)
* malignant or suspected malignant stricture of biliary or pancreatic duct
* implantation of pancreatic duct (PD) stent for prevention of post-ERCP pancreatitis
* expected survival time less than 6 months
* plan of surgery within 6 months
* pregnant or lactating women
* patients who could not give informed consent.

Primary outcomes:
measure: Adherence rate of biliary stent removal/exchange
timeFrame: up to 1 year
Secondary outcomes:
measure: Stent-associated adverse event
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
affiliation: Xijing Hospital of Disgestive Diseases.The Fourth Military University
name: Yanglin Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gu Y, Wang L, Zhao L, Liu Z, Luo H, Tao Q, Zhang R, He S, Wang X, Huang R, Zhang L, Pan Y, Guo X. Effect of mobile phone reminder messages on adherence of stent removal or exchange in patients with benign pancreaticobiliary diseases: a prospectively randomized, controlled study. BMC Gastroenterol. 2016 Aug 26;16(1):105. doi: 10.1186/s12876-016-0522-4.