louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04171349: Articaine vs Dexmedetomidine Supplemented Articaine
Official title: Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation Under Ultrasound- Guided Supraclavicular Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Renal Failure
Keywords: Hemodialysis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study to test efficacy of adding dexmedetomidine to articaine on sensory, motor and duration of analgesia during hemodialysis fistula creation under ultrasound guided supraclavicular block

Detailed description: Adult fifty patient with chronic renal failure on hemodialysis, scheduled for arteriovenous fistula creation under ultrasound guided supraclavicular block. Patients were randomly allocated in two group. The articaine group (group A) received 40 ml articaine hydrochloride 2% and articaine-dexmedetomidine group (group AD) received 40 ml. Of articaine 2% mixed with dexmedetomidine (1micogram/kg)

Eligibility criteria: Inclusion Criteria:

* adult patient with chronic renal failure on hemodialysis scheduled for radiocephalic fistula creation

Exclusion Criteria:

* Allergy to local anesthetics.
* Infection at the site of needle insertion.
* Those having international normalized ratio more than 1.5.
* Coagulopathy.
* Neuromuscular, or severe hepatic or severe pulmonary disease.
* Those having epilepsy.
* Patients who refused to participate.

Primary outcomes:
measure: Duration of sensory block
timeFrame: 24 hours
measure: Duration of motor block
timeFrame: 24 hours
Secondary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours
Other outcomes:
measure: Sedation
timeFrame: 24 hours
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hosptal
state: Abbasya
Study officials:
affiliation: Professor
name: Galal Mo Professor, Doctor
role: STUDY_DIRECTOR
References:
citation: Armanious SH, Abdelhameed GA. Articaine and Dexmedetomidine - Supplemented Articaine for Arteriovenous Fistula Creation under Ultrasound-guided Supraclavicular Block. Anesth Essays Res. 2020 Apr-Jun;14(2):248-252. doi: 10.4103/aer.AER_147_19. Epub 2020 Oct 12.
Clinical trial NCT00743249: Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers
Official title: A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Dry Eye
Keywords: Dry eye
Tear duct
Punctal plug
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months in subjects with or without dry eye.

Detailed description: This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.

Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent.
* With or without dry eye.
* Willing to discontinue contact lenses during the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Chronic, recurrent, or severe inflammatory eye disease.
* Ocular trauma within the past 6 months.
* Ocular hypertension or glaucoma.
* History of punctal plug/canalicular stent insertion.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Retention Time
timeFrame: From baseline (Day 0) up to Month 3
Secondary outcomes:
measure: Percentage of Subjects Retaining the Stent at Month 3
timeFrame: Month 3
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa A Landry, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05142449: Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery.
Official title: Effect of Systemic Antibiotic Therapy on Postoperative Complications in Patients Undergoing Wisdom Teeth Removal Surgery. A Double-blind, Randomised, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Third Molar Extraction Surgery
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 59
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 59 medically healthy patients, who are scheduled for third molar extraction surgery and give informed consent for the trial, are operated using a split-mouth technique.

One group of patients will be assigned to the test group (Amoxilan) for the first surgery and to the control group (placebo) for the second surgery, and vice versa, according to randomisation.

Patients receive 8 capsules Amoxilan or placebo (according to randomisation) perioperatively, and 6 capsules Amoxilan/placebo per day for 3 days postoperativeley.


Eligibility criteria: Inclusion Criteria:

* Symptom-free, bilaterally located third molars
* Medically healthy patient ≥ 16 years
* No allergies/intolerances against the investigational product/placebo
* Informed consent

Exclusion Criteria:

* General contraindications to wisdom tooth extraction surgery
* (Former) heavy smoking
* Use of antibiotics within the last three months or patients requiring antibiotic treatment prior to surgery
* (Planned) Pregnancy/lactating

Primary outcomes:
measure: Mouth opening restrictions: Change of interincisal distance
timeFrame: preoperatively as well as on the 1st and 7th postoperative day
Secondary outcomes:
measure: Change of swelling
timeFrame: preoperatively as well as on the 1st and 7th postoperative day
measure: Change of Visual Analogue Scale (VAS): Bleeding
timeFrame: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
measure: Change of Visual Analogue Scale (VAS): Swelling
timeFrame: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
measure: Change of Visual Analogue Scale (VAS): Pain
timeFrame: day of surgery, and on day 1, 2, 3, 4, 5, 6, 7 after surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz, Klin. Abteilung für Orale Chirurgie und Kieferorthopädie
Study officials:
References:
Clinical trial NCT03318549: BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Official title: Brain-Computer Interface (BCI) and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Macular Degeneration
Glaucoma Suspect
Optic Neuropathy
Retinal Degeneration
Visual Pathway Disorder
Keywords: virtual reality
glaucoma
age related macular degeneration
quality of life
visual field
optical coherence tomography
brain-computer interface
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2017-10-24
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to better understand the impact of visual impairment caused by different eye diseases on the ability to perform daily activities and compare it to that in patients without eye diseases.


Eligibility criteria: Inclusion Criteria:

* Subjects must be between the ages of 18 and 90 years old;
* Both males and females will be included.
* Be able and willing to provide signed informed consent and follow study instructions

Exclusion Criteria:

* Subjects will be excluded if they present with any systemic conditions that in the opinion of the Principal Investigator may prevent them from completing the tests.

Primary outcomes:
measure: Visual Impairment Measured by Visual Functioning Test
timeFrame: 4.5 years
measure: Number of Eyes Showing Progression
timeFrame: 4.5 years
measure: Time to Detect Progression Measured in Years
timeFrame: 4.5 years
Secondary outcomes:
measure: Standard Automated Perimetry Will be Assessed by the C-index
timeFrame: 4.5 years
measure: Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25
timeFrame: 4.5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Felipe A Medeiros, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Henry Tseng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01805349: Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis
Official title: Study of the Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Knee and Hip) in Terms of Severity and Evolution - Khoala Group Ancillary Project / Cohort Khoala
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digital Arthrosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 479
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).


Eligibility criteria: Inclusion Criteria:

* men or women aged 40 to 75 years
* with symptomatic osteoarthritis of the hip and / or knee (femoro-tibial), unilateral or bilateral
* with a confirmed diagnosis (criteria of the American College of Rheumatology :ACR) and Kellgren and Lawrence radiological stage ≥ 2.

Exclusion Criteria:

* painful hip or knee prosthesis
* osteotomy in the past

Primary outcomes:
measure: Kellgren and Lawrence score
timeFrame: Change at 2 years
Secondary outcomes:
measure: Harris score
timeFrame: Harris score at 2 years
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of rheumatology, nice university hospital
Study officials:
References:
Clinical trial NCT04808349: Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery
Official title: Safety and Efficacy in a ReAl-Life Study in Patients With Haemophilia Treated wIth NovoEight® for Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to respect the independence of the physicians, this study is conducted with patients for whom the decision to prescribe turoctocog alfa (NovoEight®) treatment is not related to the study. The prescription of turoctocog alfa (NovoEight®) will therefore have been carried out on the initiative of the physicians of the participating centers, in collaboration with the patients involved. This study therefore does not lead to any change in the usual medical care of the people entering the study, nor does it affect the physical or psychological integrity of the patients.

Brief summary: the aim of the SERAPHINE study is to gather data stemming from the French research database BERHLINGO (= Base d'Etude et de Recherche en Hémostase pour Les Investigateurs du Grand-Ouest, i.e. Database for Research on Hemostasis for the Investigators of Western France), in order to get a detailed report about the therapeutic management and use of turoctocog alfa (NovoEight®) in surgery in pwHA (Patient with inherited Hemophilia A).


Eligibility criteria: Inclusion Criteria:

* Male or female
* Regardless of age
* No inhibitor (anti-FVIII alloantibodies) at the time of treatment.
* No objections expressed to participate in the study after having been informed of its purposes and the data involved.
* No other inherited hemorrhagic disorders than HA

Exclusion Criteria:

In order to reflect the reality of daily practice, no criteria for non-inclusion are provided for other than the refusal of the patient or his or her legal representative to participate in the study or the existence in the patient of a contraindication to the use of turoctocog alfa (NovoEight®) treatment.

Primary outcomes:
measure: Assessing the effectiveness of turoctocog alfa (NovoEight®) to prevent hemorrhagic complications during minor and major surgery procedures in pwHA
timeFrame: 1 year
Secondary outcomes:
measure: Assessing the safety of turoctocog alfa (NovoEight®) when used during surgery in patients with the occurrence of adverse events (AEs), especially hemorrhagic and thrombotic complications or development of inhibitors.
timeFrame: 1 year
measure: Assessing the duration of replacement therapy and factor VIII consumption in clinical practice during surgery in patients treated with turoctocog alfa (NovoEight®)
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Le Mans
country: France
facility: CH Le Mans
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
References:
Clinical trial NCT00059449: Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis
Official title: Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Enterocolitis
Premature Birth
Keywords: Enterocolitis
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-04-29
Enrollment: 372
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Necrotizing enterocolitis (NEC) is a serious gastrointestinal disorder that primarily affects preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it. Overall, 30% of babies who develop NEC will die from it, with many others developing long term gastrointestinal problems. The most important factor in its development is a premature intestinal tract. Epidermal growth factor (EGF) is an important growth factor in the development and maintenance of the gastrointestinal tract. This study will look for a relationship between EGF levels in premature babies and the development of NEC.


Eligibility criteria: Inclusion Criteria:

* Gestational Age greater than 23 weeks at birth
* Birth weight greater than 500 grams
* Age less than 72 hours of life

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02337049: Preeclampsia Subtypes and Surrogate Markers of CVD Risk
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Keywords: Preeclampsia. Cardiovascular Disease (CVD) Risk.
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
name: Karen Elise Jensen Foundation
name: Central Denmark Region
First posted: 2015-01-13
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008. Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.

Brief summary: In order to assess surrogate markers of cardiovascular risk in subtypes of preeclampsia, we will conduct a 10-year follow-up study comparing 40 women with a history of early onset preeclampsia; 40 women with a history of late onset preeclampsia and 40 women with a history of normotensive pregnancies.

Eligible participants delivered at the Department of Obstetrics at Randers Regional Hospital 1998-2008.

Early-onset preeclampsia is defined as preeclampsia that develops before 34 weeks of gestation, whereas late-onset preeclampsia develops at or after 34 weeks of gestation.


Eligibility criteria: Inclusion Criteria:

* Women who delievered at the Department of Obstetrics at Randers Regional Hospital 1998-2008

Exclusion Criteria:

* Current pregnancy or breastfeeding

Primary outcomes:
measure: Echocardiographic Markers of Cardiac Strain
timeFrame: 10 years postpartum
Secondary outcomes:
measure: Markers of arteriosclerosis and atherosclerosis
timeFrame: 10 years postpartum
measure: Circulating biomarkers of cardiovascular disease.
timeFrame: 10 years postpartum
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Regional Hospital
state: Randers NØ
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Aarhus University Hos
name: Ulla B Knudsen, Professor
role: STUDY_CHAIR
affiliation: Clinical Research Unit, Randers Regional Hospital
name: Martin Christensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, Aarhus University Hospital
name: Camilla S Kronborg, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00013949: Cardiovascular Vulnerability to Particulate Exposure
Official title: Active Elderly Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Lung Disease
Keywords: Holter monitoring
ECG
Cardiac
particulate exposure
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: This project is part of a program project directed toward assessing cardiac effects of particulate and other ambient air pollutants. In this project active elderly adults living in the communities of Boston and Steubenville have attended 12 weekly sessions including approximately 40 minutes of Holter monitoring, blood pressure, and oximetry evaluation before, during, and after outdoor exercise. To investigate the relation of air pollution to cardiac and pulmonary rehabilitation, a second portion of this study involves abstraction of blood pressure and symptom data and downloading of available repeated measures telemetry data in two populations. These populations include: 1) 200 outpatients attending 8 to 36 repeated weekly exercise training sessions in a major hospital cardiac rehabilitation unit.

Detailed description: Approximately 60 subjects have participated fully in Boston and Steubenville in the repeated 40 minute measurement of continuous EKG (Holter), blood pressure, and oximetry. In Steubenville we have also measured exhaled nitrogen oxide, an index of pulmonary inflammation. The exposure monitoring has included outdoor particle mass of PM2.5, outdoor gaseous pollutants, and indoor home and personal monitoring to evaluate the indoor contribution of pollution to health effects.

Eligibility criteria: Participants are 50 to 90 years of age, but almost all are 60 and older. They have been enrolled as volunteers from communities in Mission Park, Boston, and Steubenville. Inclusion criteria includes the ability to walk on level ground. Exclusion criteria includes unstable anginal, and baseline EKG patterns such as left bundle branch block that would make difficult the detection of repolarization abnormalities. Participants live at or near the study center which was located in an office or apartment in the apartment building of the majority of the participants.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Diane Gold, MD
role: STUDY_DIRECTOR
affiliation: Harvard School of Public Health (HSPH)
name: Frank E Speizer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346449: Making Calories Count: Information Format and Food Choice
Official title: Making Calories Count: Information Format and Food Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-05-03
Enrollment: 292
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to better understand how individuals make decisions regarding the meals they order. Participants' ordering decisions at lunchtime at a chain restaurant will be recorded over several weeks to study ordering habits over time. Lunch menus will be provided by the study, and the menu format will vary the way in which information on caloric content is displayed.

The impact of different labeling formats on total calories in the chosen meal will be assessed.


Eligibility criteria: Inclusion Criteria:

* Customers of two chain restaurants

Exclusion Criteria:

* Unable to read a written menu

Primary outcomes:
measure: Calories chosen
timeFrame: One time only or 6 months
Secondary outcomes:
measure: Weight change
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Julie Downs, PhD
role: PRINCIPAL_INVESTIGATOR
References: