louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03307590: Comparing Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone for Caudal Block in Supra - Umbilical Surgeries
Official title: Adding Dexmedetomidine to Caudal Bupivacaine for Analgesia in Supra - Umbilical Pediatric Surgeries: Would it Add More Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically or combined to local anesthetics during regional blocks. Investigators studied the combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in pediatric patients undergoing supra - umbilical surgeries.

Detailed description: Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared to caudal bupivavaine alone for analgesia following upper trunk surgery

Eligibility criteria: Inclusion Criteria:

* supra - umbilical surgeries

Exclusion Criteria:

* allergy to the drug or coagulopathy

Primary outcomes:
measure: Pain relief
timeFrame: 6 months study
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00538590: Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
Official title: Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open Angle Glaucoma
Keywords: ologen
collagen matrix
glaucoma
trabeculectomy
Mitomycin-C
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 20
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: To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Detailed description: To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Eligibility criteria: Inclusion Criteria:

* Open angle glaucoma
* Maxima anti-glaucoma medication failed
* Age\>18
* Able to complete the follow up

Exclusion Criteria:

* Topical eye inflammation
* Angle closure glaucoma
* Deformity glaucoma
* One eye glaucoma
* Previous conjunctiva opened
* Allergy to collagen

Primary outcomes:
measure: Postoperative Intraocular Pressure Change
timeFrame: 360 days
measure: Postoperative Intraocular Pressure Change
timeFrame: 180 days
measure: Postoperative Intraocular Pressure Change
timeFrame: 90 days
measure: Postoperative Intraocular Pressure Change
timeFrame: 30 days
Secondary outcomes:
measure: Complications
timeFrame: 360 days
Other outcomes:
Locations:
city: Koln
country: Germany
facility: Hospital of Universität Köln
Study officials:
affiliation: Universität Köln
name: Thomas Dietlein, Ph. D, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03576690: R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease
Official title: Expanded Access Protocol for Emergency Use of REGN3470-3471-3479 for the Treatment of Ebola Virus Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Ebola Virus Disease
Keywords: Positive Ebola Virus (EBOV) diagnostic test
symptomatic
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-07-03
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD).


Eligibility criteria: Key Inclusion Criteria:

* Males or females in an Ebola endemic region with documented positive polymerase chain reaction (PCR) for Ebola virus infection who are symptomatic
* Ability to provide informed consent personally or by a legal representative if the patient is unable to do so, based on local laws and regulations
* REGN-EB3 can be administered to pregnant women infected with Zaire ebolavirus, as defined in the protocol
* Children of any age will be eligible for enrollment, as defined in the protocol
* Neonates born to an infected mother who has not yet cleared the Ebola virus are eligible for enrollment, as defined in the protocol

Key Exclusion Criteria:

* Negative EBOV diagnostic test result
* A patient who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
* Any serious medical condition that, in the opinion of the site investigator, would place the patient at an unreasonable increased risk through participation in this study, including any past or concurrent conditions
* Eligible for an ongoing randomized clinical trial with REGN-EB3

NOTE: Other protocol defined inclusion / exclusion criteria apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02309190: Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity
Official title: Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Respiratory Insufficiency
Keywords: Transpulmonary pressure - morbid obesity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults mechanically ventilated with morbid obesity

Brief summary: The study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation.

* both gender
* only adults
* Medical intensive care patients.

Detailed description: We are studying adult patients with morbid obesity with respiratory failure requiring mechanical ventilation.

We are measuring transesophageal presssures to estimate ideal PEEP and evaluate hemodynamic parameters.

Eligibility criteria: Inclusion Criteria:

* both gender
* morbid obesity
* hemodynamically stable

Exclusion Criteria:

* pregnant patients
* cirrhotic patients with esophageal varicose

Primary outcomes:
measure: Transpulmonary pressure
timeFrame: one year
Secondary outcomes:
measure: hemodynamics
timeFrame: one year
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas - HSC at Houston
state: Texas
Study officials:
References:
Clinical trial NCT03229590: Slipped Capital Femoral Epiphysis Treatment
Official title: Safe Surgical Dislocation in Slipped Capital Femoral Epiphysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SCFE
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The purpose of this study is to evaluate management Of moderate and severe degrees Slipped capital femoral epiphysis cases by using surgical dislocation technique .

Brief summary: Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children. The primary source for the blood supply of the head of the femur is the deep branch of the medial femoral circumflex artery. Loder described a classification for Slipped capital femoral epiphysis based on ability of the child to walk or not(walking=stable, non-walking=unstable).

Detailed description: In slipped capital femoral epiphyses (SCFE), the severity of slippage correlates with poor long-term clinical outcome scores and radiographic evidence of osteoarthritis . In situ fixation of higher-grade SCFE has a low surgical risk and has been advocated by authors who believe the deformed hip has the potential to remodel with some restoration of the disturbed anatomic axes ; however, the remodeling potential remains controversial . Despite remodeling, the head-neck offset will remain abnormal . This is the cause of potential impingement of the femoral neck with the acetabular cartilage . Impingement in SCFE has been associated with damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after SCFE .

Ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip osteotomy and anterior capsulotomy preserving the blood supply to femoral head. The technique is based on extensive study of blood supply to the proximal femur. This technique allows us to completely dislocate the joint which allows complete access to intra articular pathology and allow reduction of the slipped capital femoral epiphysis .

Eligibility criteria: Inclusion Criteria:

* 1- Patients with moderate Slipped capital femoral epiphysis 2- Patients with severe Slipped capital femoral epiphysis

Exclusion Criteria:

* Patients with mild Slipped capital femoral epiphysis

Primary outcomes:
measure: Harris Hip Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Song MH, Jang WY, Park MS, Yoo WJ, Choi IH, Cho TJ. Slipped capital femoral epiphysis in children younger than 10 years old: clinical characteristics and efficacy of physeal-sparing procedures. J Pediatr Orthop B. 2018 Sep;27(5):379-386. doi: 10.1097/BPB.0000000000000485.
Clinical trial NCT01689090: Diameter Changes of Retinal Vessels During Hypoxia
Official title: Diameter Changes of Retinal Vessels During Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Diabetic Maculopathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are studied using the Dynamic Vessel Analyzer.


Eligibility criteria: Inclusion Criteria:

* Diabetes type 1 without retinopathy
* Diabetic retinopathy

Exclusion Criteria:

* Cardio-vascular disease
* Lung disease
* Pregnancy
* Previous ocular disease other than retinal branch vein occlusion
* Previous treatment with medications influencing on the intraocular pressure or the metabolism of nitric oxide or prostaglandins

Primary outcomes:
measure: Diameter changes of retinal vessels
timeFrame: Examination day 1 and 2
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Ophthalmology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Line Pedersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen L, Bek T. Post-hypoxic constriction of retinal arterioles is impaired during nitric oxide and cyclo-oxygenase inhibition and in diabetic patients without retinopathy. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1965-1971. doi: 10.1007/s00417-017-3746-2. Epub 2017 Jul 27.
citation: Petersen L, Bek T. The diameter response of retinal arterioles in diabetic maculopathy is reduced during hypoxia and is unaffected by the inhibition of cyclo-oxygenase and nitric oxide synthesis. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2339-2346. doi: 10.1007/s00417-016-3399-6. Epub 2016 Jun 7.
Clinical trial NCT05663190: Localization of Mental Foramen in Relation to Primary Molars A Cone Beam Computed Tomography Study
Official title: Localization of Mental Foramen in Relation to Primary Molars A Cone Beam Computed Tomography Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Foramen
Cone Beam Computed Tomography
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 11
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cone beam computed tomography lower arch images for less than 10-year-old children

Brief summary: . The aim of this study was to determine the location of mental foramen in relation to the lower primary molars using Cone Beam Computed Tomography. And develop simple guidelines for the injection of mental block anaesthesia for children.

Detailed description: Cone Beam Computed Tomographies in a private radiology centre will be screened, Cone Beam Computed Tomography images of less than 10 years old, boys or girls were included in the study. Included Cone Beam Computed Tomography images should have either or both sides of the lower arch in the field of view, with the lower first and second primary molars with no or minimal root resorption. Images with pathologies, fractures, malformations, or abnormal location of teeth that would affect the anatomy or location of mental foramen were excluded from the study.

The vertical diameter of mental foramen was measured on the cross-sectional Cone Beam Computed Tomography images, while the horizontal diameter was measured on the axial scans. The ratio between horizontal and vertical diameters (H:V) was calculated to determine the form of mental foramen

Outcomes

1: vertical and horizontal location of mental foramen in relation to 1ry molars 2. subgroup analysis for the 1st outcome according to age, (\< 6 years) vs (\> 6 yrs) 3. Mental foramen form according to the Horizontal/Vertical ratio 4. If there is any relation between (location, form, vertical or horizontal dimension of mental foramen) and (Side or Gender)

Eligibility criteria: Inclusion Criteria:

Included cone beam computed tomography images should have either or both sides of the lower arch in the field of view, with the lower first and second primary molars with no or minimal root resorption.

Exclusion Criteria:

Images with pathologies, fractures, malformations, or abnormal location of teeth that would affect the anatomy or location of mental foramen were excluded from the study.

Primary outcomes:
measure: horizontal location of mental foramen
timeFrame: Day 1
measure: vertical location of mental foramen
timeFrame: Day 1
Secondary outcomes:
measure: dimension and form of mental foramen
timeFrame: Day 1
Other outcomes:
measure: relation to age
timeFrame: Day 1
Locations:
city: Fayoum
country: Egypt
facility: Alpha Dent
Study officials:
affiliation: Fayoum University
name: maha M azab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00683384: Study Evaluating the Safety of Enbrel (Etanercept)
Official title: A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Etanercept (Enbrel) 25 mg by Subcutaneous Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Keywords: Arthritis
psoriatic
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-23
Enrollment: 93
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: Primary Care

Brief summary: The purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients.


Eligibility criteria: Inclusion Criteria:

* All patients from the study center who received or will receive at least one dose of Enbrel according to the approved product indication.

Exclusion Criteria:

* Previously discontinued Enbrel therapy due to significant safety concern.

Primary outcomes:
measure: Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection
timeFrame: 30 days post injection up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Metro Manila
country: Philippines
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00593684: The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Very Low Birth Weight
Keywords: neonate
central lines
very low birth weight
silver alginate
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: DeRoyal Industries, Inc.
First posted: 2008-01-15
Enrollment: 50
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in VLBW infants in preparation for a large efficacy trial.

Detailed description: We are conducting a pilot randomized controlled trial in VLBW infants to evaluate the safety of silver alginate (Algidex™) dressing compared to standard catheter care. Following parental consent, infants are randomized to receive silver alginate or standard of care dressing. Infants with birth weights less than 1,500 grams admitted to Baylor University Medical Center (BUMC) NICU with any of the following lines are eligible for inclusion into this study up to 72 hours after birth: umbilical arterial line (UAL), umbilical venous line (UVL), peripheral arterial line (PAL), peripheral long line (PLL), and central venous line (CVL). Safety is assessed by measuring silver levels and monitoring for cutaneous reactions. Dressings are changed every seven days. Silver levels are drawn on study days 1, 7, and 28. Blood culture results are used to compare infection rates between the two groups. Patient demographics and clinical conditions are recorded. Results will be analyzed based on intention to treat.

Eligibility criteria: Inclusion Criteria:

* Infants with birth weights less than 1,500 grams admitted to Baylor University Medical Center (BUMC) NICU with any of the following lines are eligible for inclusion into this study up to 72 hours after birth: umbilical arterial line (UAL), umbilical venous line (UVL), peripheral arterial line (PAL), peripheral long line (PLL), and central venous line (CVL).

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Serum Silver Concentration at 1 Day
timeFrame: 1 Day (first 24 hours from enrollment)
measure: Serum Silver Concentration at 7 Days
timeFrame: 7 Days from enrollment
measure: Serum Silver Concentrate at 28 Days
timeFrame: 28 Days from enrollment
Secondary outcomes:
measure: Infection Rate
timeFrame: infection per 1,000 Line Days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center - Women and Children's Services
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Furgan Moin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03482284: Effect of Monosaccharides on Intestinal Barrier Function
Official title: Exploratory Study on the Modulation of Endotoxemia and Metabolic Parameters: Role of Macronutrients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Endotoxemia
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants receive all interventional diets.
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to determine the effect of monosaccharides on intestinal barrier function in healthy subjects.

Detailed description: In the intervention study normal weight participants will receive defined amounts of monosaccharides for several days. Before and after intervention parameters of intestinal barrier function will be assessed.

Eligibility criteria: Inclusion Criteria:

* BMI \<25 kg/m2
* no kown history of metabolic disorders or fatty liver

Exclusion Criteria:

* food allergies or intolerances (esp. fructose intolerance and malabsorption)
* renal insufficiency
* chronic disease of the gastrointestinal tract
* taking drugs affecting lipid or glucose metabolism

Primary outcomes:
measure: Changes in parameters of intestinal barrier function
timeFrame: 1 week
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: 1 week
measure: Changes in markers for glucose metabolism
timeFrame: 1 week
measure: Changes in blood lipid levels
timeFrame: 1 week
measure: Changes in Uric Acid levels
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References: