louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01740518: Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy
Official title: Randomized Controlled Trial of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonoscopy [E01.370.372.250.250.200]
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 360
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Out-patients for colonoscopy in university hospital

Brief summary: The purpose of this study is to compare two regimens of low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-patients

Detailed description: Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated. a new low volume PEG-based bowel cleansing agents became available at foreign countries. Although several studies reported the efficacy and improved compliance of these low volume PEG plus ascorbic acid solution for colonoscopy, but result in Korean patients was not-recognized.

Eligibility criteria: Inclusion Criteria:

* Out-patients for colonoscopy

Exclusion Criteria:

* age under 19 years or over 80 years
* Intestinal obstruction
* Women of pregnant, breastfeeding, or at risk of becoming pregnant
* major psychiatric illness
* known allergy to PEG
* serious condition- severe cardiac, renal, or metabolic diseases
* past history of colon resection
* current acute exacerbation of chronic inflammatory bowel disease
* functional constipation defined by Rome III diagnostic criteria

Primary outcomes:
measure: The efficacy of bowel preparation
timeFrame: one day (after colonoscopy)
Secondary outcomes:
measure: Patient's compliance and acceptability
timeFrame: one day (after injestion of preparation solution)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Dong Il Park, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386318: Oxycodone Concentration in the Blood After Oral Premedication
Official title: Oxycodone Concentration in the Blood After Oral Premedication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxycontin
Keywords: concentration
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female between 30-60 years under 100 kg non-opiod tolerant

Brief summary: Oxycodone is an opioid frequently given orally as a premedication prior to any kind of surgery. The initial studies are performed on healthy testpersons and is not given in surgery. The investigators want to explore serum concentration over time (5h) and relate this to Visual Analoge Scale (VAS) postoperatively but also to given mg/kg

Detailed description: Oxycodone is an opioid frequently given orally as a premedication prior to any kind of surgery. The initial studies are performed on healthy test-persons and is not given in surgery. The investigators want to explore serum concentration over time (5h) and relate this to Visual Analoge Scale (VAS) postoperatively but also to given mg/kg 20 female patients between 30 and 60 years will be included after informed consent. They will have day-surgery. The patients will receive 5 mg oxycodone if weighing less than 60 kg and 10 mg if weighing over 60 kg. Serum samples will be taken 1, 2,3,4, and 5 hours after medication intake and serum concentrations will be analyzed

Eligibility criteria: Inclusion Criteria:

* Females \<100kg, non-opioid tolerant, day surgery and informed consent

Exclusion Criteria:

* In complying to inclusion criterias

Primary outcomes:
measure: Oxycodone concentration in the blood after oral premedication
timeFrame: 2 days
measure: Oxycodone concentrations and pain after oral premedication
timeFrame: 7 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Sahlgrenska UH
state: Västra Götaland
Study officials:
References:
Clinical trial NCT00727818: A Split-Blind Clinical Investigation to Compare the Performance and Safety of Inion GTR™ Biodegradable Membrane System to Resorbable Bilayer Bio-Gide®-Membrane of Geistlich Biomaterials in Enhancing Bone Regeneration After Removal of Wisdom Teeth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Regeneration Following Wisdom Teeth Extraction
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Inion Oy
First posted: 2008-08-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate by histology and histomorphometry, thirty human osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of implantation. This study is part of a splitting-blind clinical investigation to compare the performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of wisdom teeth.

The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson \& Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer Bio-Gide®-membrane.

This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation.

This study was conducted in accordance with the requirements of the FDA (Department of health and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997.

* Trial with medical device


Eligibility criteria: Inclusion criteria: Females or males between the age of 18 to 30 Subject for extraction of both lower fully impacted wisdom teeth Signed informed consent Able and willing to comply with all study procedures

Exclusion criteria: Heavy smoker (\>20/day) Insulin dependant diabetes Pregnant or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT04042818: Reliability of Rehabilitative Ultrasound for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
Official title: Reliability of Rehabilitative Ultrasound Imaging for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Stroke, Complication
Quadriceps Muscle Atrophy
Hemiplegia
Ultrasonography
Hand Strength
Keywords: Sarcopenia
Stroke
Quadriceps Muscle Atrophy
Hemiplegia
Ultrasonography
Hand Strength
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-02
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Poststroke patients

Brief summary: The purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients.

Detailed description: Poststroke patients often suffer from muscle atrophy in quadriceps muscle. Quadriceps muscle is essential for independent standing or ambulation after stroke. Quadriceps muscle consists of four different muscles: rectus femoris, vastus intermedius, vastus lateralis and medialis. The present study search for reliability for rectus femoris and vastus intermedius muscle thickness and cross-sectional area using rehabilitative ultrasound imagining. Longitudinal and transverse ultrasound imagining of the muscle thickness will be performed on both rectus femoris and vastus intermedius muscles for both extremities. The procedures will be repeated by two experts at two separate times (7-10 days). For sarcopenia measurement grip strength and DEXA measurements of the patients will be calculated. Totally 68 patients will be included in the study.

Eligibility criteria: Inclusion Criteria:

* Poststroke patients (\>6 months)

Exclusion Criteria:

* \< 6 months after stroke
* Multiple stroke

Primary outcomes:
measure: Thickness of Rectus Femoris Muscle
timeFrame: One week
measure: Thickness of vastus intermedius muscle
timeFrame: One week
measure: Cross-sectional area of Rectus Femoris Muscle
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Training and Research Hospital
Study officials:
affiliation: Gaziosmanpasa Taksim Training and Research Hospital
name: Ebru Y Yalçınkaya, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04549818: Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
Official title: Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.


Eligibility criteria: Inclusion Criteria:

* Age, 18-70
* Pain localized to the pelvic and perineal region
* The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer
* The intensity of pain assessed by VAS (visual analogue pain scale) \> 7
* Importantly, the included participants should gain \> 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root

Exclusion Criteria:

* Coagulopathy
* Infection at site of maneuver
* Abnormal Psychological behavior that interfere with integrity of obtained data

Primary outcomes:
measure: The change of intensity of pain
timeFrame: The outcome will be measured at day 15 postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03339518: Breast Cancer Recurrence Risk Counseling
Official title: BRIM3: Breast Cancer Recurrence Risk Informational Materials Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2017-11-13
Enrollment: 173
Sex: FEMALE
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: The number of breast cancer survivors is growing. Women with a personal history of breast cancer worry about their risk of getting cancer again. The current study will develop counseling about breast cancer recurrence risk and will also get an estimate of the preliminary impact of this counseling. The goal is to enable women to make better decisions about their treatment.


Eligibility criteria: Inclusion Criteria:

* Women who (1) have a personal history of a single stage 0-2 breast cancer, (2) were recently diagnosed within the past 6 months, and (3) are treated at a participating breast oncology clinic.

Exclusion Criteria:

* Women who are unable to read/write in English.

Primary outcomes:
measure: Comparative Perceived Risk of Breast Cancer
timeFrame: 6 months
measure: Absolute Perceived Risk of Breast Cancer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: 304-293-1453
name: Kimberly Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753818: Developmental Effects of Infant Formula Supplemented With LCPUFA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Development
Growth
Keywords: infant formula
visual development
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2008-09-17
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to compare the effects on visual development, growth, cognitive development, tolerance, and blood chemistry parameters in term infants fed one of four study formulas containing various levels of DHA and ARA.


Eligibility criteria: Inclusion Criteria:

* healthy, term, formula fed infants from 1-5 days of age

Exclusion Criteria:

* history of disease that effects normal growth and development
* breast fed, or formula intolerance

Primary outcomes:
measure: visual development
Secondary outcomes:
measure: Cognitive development
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
References:
citation: Liao K, McCandliss BD, Carlson SE, Colombo J, Shaddy DJ, Kerling EH, Lepping RJ, Sittiprapaporn W, Cheatham CL, Gustafson KM. Event-related potential differences in children supplemented with long-chain polyunsaturated fatty acids during infancy. Dev Sci. 2017 Sep;20(5):10.1111/desc.12455. doi: 10.1111/desc.12455. Epub 2016 Oct 16.
citation: Drover JR, Felius J, Hoffman DR, Castaneda YS, Garfield S, Wheaton DH, Birch EE. A randomized trial of DHA intake during infancy: school readiness and receptive vocabulary at 2-3.5 years of age. Early Hum Dev. 2012 Nov;88(11):885-91. doi: 10.1016/j.earlhumdev.2012.07.007. Epub 2012 Jul 25.
citation: Birch EE, Carlson SE, Hoffman DR, Fitzgerald-Gustafson KM, Fu VL, Drover JR, Castaneda YS, Minns L, Wheaton DK, Mundy D, Marunycz J, Diersen-Schade DA. The DIAMOND (DHA Intake And Measurement Of Neural Development) Study: a double-masked, randomized controlled clinical trial of the maturation of infant visual acuity as a function of the dietary level of docosahexaenoic acid. Am J Clin Nutr. 2010 Apr;91(4):848-59. doi: 10.3945/ajcn.2009.28557. Epub 2010 Feb 3.
Clinical trial NCT03460418: Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.
Official title: Treatment of Humerus Fractures by a Multiloc Nail, Through a Minimally Invasive Procedure.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humeral Fractures
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 30
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: All patients beeing treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.

Brief summary: Proximal humerus fractures are more common in older people. They can be caused by a minor trauma on an osteoporotic bone.

Non- or little-displaced proximal humerus fractures are treated orthopedically. When the displacement is more important, the choice of the treatment is crucial and the algorithm of treatment is in permanent evolution. The technology and design of the implants and the operative techniques of osteosynthesis and arthroplasty have evolved. Patients live longer, they lead a more active life and their expectations have changed. The goals of the treatment should be an increase in shoulder function and a decrease in treatment failure.

This study analyzes the results of the treatment by intramedullary osteosynthesis using a Multiloc nail from Synthes between 2012 and June 2017. The study will compare the functional results obtained after fixation by a Multiloc nail, a Philos plate or arthroplasty.The functionality of the shoulder and the quality of life will be evaluated according to the type of treatment.


Eligibility criteria: Inclusion Criteria:

All patients being treated for a proximal humerus fracture within the CHU Brugmann hospital between 2012 and 2017.

Exclusion Criteria:

None

Primary outcomes:
measure: Fracture classification (AO)
timeFrame: one year
measure: Fracture classification (NEER)
timeFrame: one year
measure: Dash score
timeFrame: one year
measure: Constant score
timeFrame: one year
measure: QoL 36
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Victorien Gauchez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01384318: Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Patients Intubated With Cuffed ETT
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 200
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intubated with cuffed ETTs.

Brief summary: In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.


Eligibility criteria: Inclusion Criteria:

* Having a cuffed ETT placed per treating anesthesiologist
* \< 18 yrs of age.

Exclusion Criteria:

* None

Primary outcomes:
measure: Cuff pressure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eschertzhuber S, Salgo B, Schmitz A, Roth W, Frotzler A, Keller CH, Gerber AC, Weiss M. Cuffed endotracheal tubes in children reduce sevoflurane and medical gas consumption and related costs. Acta Anaesthesiol Scand. 2010 Aug;54(7):855-8. doi: 10.1111/j.1399-6576.2010.02261.x. Epub 2010 Jun 15.
citation: Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.
citation: Weiss M, Dullenkopf A. Cuffed tracheal tubes in children: past, present and future. Expert Rev Med Devices. 2007 Jan;4(1):73-82. doi: 10.1586/17434440.4.1.73.
Clinical trial NCT03067818: Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
Official title: Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Cerebral Vascular Accident
Stroke, Ischemic
Keywords: arm
rehabilitation
non-invasive brain stimulation
transcranial magnetic stimulation
upper extremity
Lead sponsor: George Mason University
Sponsor class: OTHER
Collaborators: name: MedStar National Rehabilitation Network
First posted: 2017-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive stimulation targeting each brain area. The order in which the stimulation sites are targeted for each participant is randomized and there is a washout period of several weeks between each treatment.
Primary purpose: TREATMENT

Brief summary: This study examines the effect of non-invasive brain stimulation targeting different brain areas on movement of the affected arm post-stroke. Participants will receive stimulation to each of 3 different brain areas combined with a session of arm exercise.

Detailed description: Small improvements in affected arm movement can be made with intensive physical practice. These improvements could potentially be enhanced by combining non-invasive brain stimulation with practice.

To develop such an intervention, it is necessary to understand which brain areas should be stimulated in which types of patients. It is probably more beneficial to target one side of the brain vs. the other, for example, depending on the characteristics of the stroke.

This study will examine the effect of stimulating one side of the brain vs. the other on the amount of improvement that occurs from physically practicing functional arm movements.

Eligibility criteria: Inclusion Criteria:

* More than 6 months post-stroke
* Loss of voluntary finger movement in the affected hand
* Some voluntary movement of affected shoulder and/or elbow

Exclusion Criteria:

* Brainstem or cerebellar stroke
* Severe cognitive or language deficits
* Epilepsy or other seizure disorder
* Central nervous system disease or disorder other than stroke

Primary outcomes:
measure: Change in movement time
timeFrame: Baseline and 1 Day
Secondary outcomes:
measure: Change in maximum reaching distance
timeFrame: Baseline and 1 Day
measure: Change in hand path kinematics
timeFrame: Baseline and 1 Day
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
Study officials:
affiliation: George Mason University
name: Michelle Harris-Love, PhD
role: PRINCIPAL_INVESTIGATOR
References: