louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01128751: Elimination of Microemboli During Aortic Valve Replacement
Official title: ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurocognitive Outcome After Aortic Valve Replacement
Keywords: Cognition
Neuroprotection
Cardiopulmonary bypass
Aortic valve replacement
Micro-emboli
Lead sponsor: University of Giessen
Sponsor class: OTHER
Collaborators: name: Else Kröner Fresenius Foundation
First posted: 2010-05-24
Enrollment: 150
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: In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Elective aortic valve replacement
* Informed consent
* German language

Exclusion Criteria:

* Neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, TBI, schizophrenia, etc.); further major surgeries on CPB planned for within 3 months after valve replacement
* Contraindication against MRI assessment

Primary outcomes:
measure: Neuropsychological assessment 1
timeFrame: 3 weeks to 1 day before intervention
measure: Neuropsychological assessment 2
timeFrame: 3 months (+/- 1 week) post intervention
Secondary outcomes:
measure: MRI lesions detected after surgery
timeFrame: 2-6 days postoperative
Other outcomes:
Locations:
city: 35392 Giessen
country: Germany
facility: University Clinic Giessen
state: Hessen
city: 60590 Frankfurt
country: Germany
facility: Johann Wolfgang Goehte University Clinic
state: Hessen
city: 61231 Bad Nauheim
country: Germany
facility: Kerckhoff Clinic
state: Hessen
Study officials:
References:
Clinical trial NCT00957151: Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
Official title: Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pancreatitis
Keywords: chronic pancreatitis
exocrine pancreatic insufficiency
enzyme therapy
patients with chronic pancreatitis and exocrine pancreatic insufficiency
taking enzyme replacement therapy
Lead sponsor: Hospital Avicenne
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2009-08-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.


Eligibility criteria: Inclusion Criteria:

* subjects with chronic pancreatitis and taking enzyme replacement therapy

Exclusion Criteria:

* patients with hepatic impairment
* patients allergic to dairy proteins
* urinary incontinence affecting the measurement of nitrogen metabolism
* digestive disorder affecting the absorption of nutrients

Primary outcomes:
measure: To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis
Secondary outcomes:
measure: To determine the efficacy of enzyme therapy
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gastroenterology
name: Robert Benamouzig, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00441051: Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Single Center, Intra-Individual Comparative Study of the Efficacy and Safety of Diclofenac Sodium 1 mg/g (0.1%) Gel in Subjects With Painful UV-Induced Erythema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sunburn
Keywords: Sunburn, diclofenac, topical NSAID
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a certain level in order to evaluate the efficacy and safety of the treatment on this induced pain.


Eligibility criteria: Inclusion Criteria:

* Have no skin problem which could interfere with the study results or increase the risk of adverse events Have no exposure to excessive or chronic UV radiation (i.e., sunbathing, tanning salon use, phototherapy) within four weeks prior to inclusion, or planned during the study period Have non tanned skin on the areas to be exposed (back) Have a normal tolerance to UV and sun.

Exclusion Criteria:

* Women who are pregnant, planning pregnancy or lactating A known hypersensitivity to diclofenac, aspirin, ibuprofen or other NSAIDs; Use of oral or topical treatments during the month preceding the trial, which may interfere with the results of the trial Other protocol-defined inclusion/exclusion criteria may appl

Primary outcomes:
measure: Assess by Visual Analogue Scale (VAS)how products relieve provoked pain (by gloved finger)associated with sunburn in the first 24 hours after UV irradiation.
Secondary outcomes:
measure: Assess the spontaneous pain and provoked pain by VAS , the reduction of erythema by erythema scale and chromametry and the safety by reporting adverse event.
Other outcomes:
Locations:
city: Nice
country: France
facility: CPCAD
Study officials:
affiliation: Centre de Pharmacologie Clinique Applique a la Dermatologie
name: Catherine Queille- Roussel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873951: Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects
Official title: Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
Collaborators: name: Riddet Institute
First posted: 2009-04-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further metabolism. The primary goal of this work was to measure the metabolic fate of intact or hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of this study was to assess the true ileal digestibility of dietary protein using different methods including the hydrolyzed casein method and to measure its possible effect on endogenous intestinal N losses in humans.


Eligibility criteria: Inclusion Criteria:

* healthy subjects
* BMI between 18 and 25

Exclusion Criteria:

* allergy to dairy proteins
* positive serology to AgHbS, HCV or HIV
* pregnancy
* abusive drug or alcohol consumption.

Primary outcomes:
measure: Postprandial metabolic fate of dietary N
timeFrame: 0h-1h-2h-3h-4h-5h-6h-7h-8h postprandial
Secondary outcomes:
measure: Differences in ileal digestibility determination according to the method used
timeFrame: 8h postprandial
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Centre de recherche sur volontaires
Study officials:
References:
citation: Deglaire A, Moughan PJ, Airinei G, Benamouzig R, Tome D. Intact and hydrolyzed casein lead to similar ileal endogenous protein and amino acid flows in adult humans. Am J Clin Nutr. 2020 Jan 1;111(1):90-97. doi: 10.1093/ajcn/nqz268.
citation: Deglaire A, Fromentin C, Fouillet H, Airinei G, Gaudichon C, Boutry C, Benamouzig R, Moughan PJ, Tome D, Bos C. Hydrolyzed dietary casein as compared with the intact protein reduces postprandial peripheral, but not whole-body, uptake of nitrogen in humans. Am J Clin Nutr. 2009 Oct;90(4):1011-22. doi: 10.3945/ajcn.2009.27548. Epub 2009 Aug 19.
Clinical trial NCT04927351: Nudges for Opioid Reduction After Major Surgery Trial
Official title: Nudges for Opioid Reduction After Major Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgery
Keywords: Surgery
Discharge
Hospital Systems
Electronic Medical Record
Opioids
Prescription
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-06-16
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm parallel, cluster-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective pilot trial to evaluate a new electronic medical record based intervention to improve discharges after surgery. The investigators hypothesize that standard discharge medications after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.

Detailed description: This is a 2-arm parallel randomized trial comparing a new electronic medical record (EMR)-based intervention to usual care after surgery. All patients will receive their usual peri- and intraoperative care. Then, upon discharge, their providers will see the new EMR-based discharge order set (intervention arm) or not (usual care). The investigators hypothesize that standard discharge medication order sets after surgery will help to optimize opioid prescribing and potentially decrease healthcare utilization in the first 30 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Aged 18 and over
* Undergo selected general surgical procedures

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Total Discharge Opioid Burden
timeFrame: Immediately after study intervention
Secondary outcomes:
measure: Additional Opioid Burden within 30 days
timeFrame: Within 30 Days
measure: Proportion of cases with Phone Calls to Surgery Department
timeFrame: Within 30 Days
measure: Proportion of Cases with Emergency Room Visits
timeFrame: Within 30 Days
measure: Proportion of Cases with Hospital Readmissions to a Surgical Service
timeFrame: Within 30 Days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: David Flum, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Irene Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397851: Stimulating Private Sector Malaria Control
Official title: Stimulating Private Sector Malaria Control: The Outgrower Opportunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Lead sponsor: PATH
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 81597
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Preliminary evidence from ongoing research provides strong indications that protecting farmers from malaria would be profitable for outgrowing agribusinesses in sub-Saharan Africa. The study team invests in experimental research to investigate this conjecture in more detail.

Detailed description: The study evaluates whether the sourcing of insecticide-treated nets and their distribution to smallholder farmers for free would be a profitable investment for a cotton outgrowing agribusiness in Zambia.

The study therefore carries out a major net distribution through the existing distribution channels of a cotton outgrowing agribusiness, evaluates the impact of this distribution on smallholder cotton yields, and values the profitability implications for the outgrowing agribusiness.

Eligibility criteria: Inclusion Criteria:

* Farmers who contracted with the participating cotton outgrowing company in the 2010-2011 season

Primary outcomes:
measure: Cotton Yields
timeFrame: 2010-2011 season (up to 1 year)
Secondary outcomes:
measure: Contract Defaults
timeFrame: 2010-2011 season (up to 1 year)
measure: Increase in Maize Productivity
timeFrame: 2009-2010 and 2010-2011 seasons (up to 2 years)
measure: Self-reported Malaria Prevalence
timeFrame: 2010-2011 season (up to 1 year)
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: National Malaria Control Centre
Study officials:
References:
Clinical trial NCT00292851: Blown Nasal Secretion Measurements in Rhinosinusitis: Repeatability and Validity Compared to Nasal Lavage
Official title: Repeatability and Validity of Measurements in Blown Nasal Secretion in Patients With Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinosinusitis
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Merck Frosst Canada Ltd.
First posted: 2006-02-16
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with rhinitis

Brief summary: To process blown nasal secretions from subjects with rhinosinusitis and to obtain a specimen by nasal lavage. To investigate the reliability and validity of the measurements we will determine their repeatability and compare them with those of nasal lavage in the same subjects.


Eligibility criteria: Inclusion Criteria:

* patients suffering from rhinitis with our without sinusitis

Exclusion Criteria:

* unable to provide blown nasal sample

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health, St. Joseph's Healthcare
state: Ontario
Study officials:
affiliation: McMaster University
name: Frederick E Hargreave, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02896751: Use of a 3D Printer to Make Custom Sleep Masks for Positive Airway Pressure Treatment
Official title: Custom 3-D Printed Noninvasive Ventilation Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Pediatric Sleep Apnea
Keywords: CPAP
Noninvasive Ventilation Mask
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a small pilot study to look at the feasibility of creating a customized sleep mask for use with Continuous Positive Airway Pressure (CPAP) or other similar treatments for sleep apnea. The participant will have three dimensional (3D) pictures of the face taken by special cameras. The pictures will be sent to a 3D printer and a mask will be created based on the participant's face contours. The participant will use the mask for about 6 months. The study will measure the amount it is used during sleep and if there is an increase in reported comfort.

Detailed description: The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by decreasing the side effects commonly seen with noninvasive ventilation. Studies have shown that even though noninvasive ventilation (NIV) with positive airway pressure (PAP) is successful at treating obstructive sleep apnea and hypoventilation, individuals have poor compliance with therapy. The reasons for poor compliance are numerous, but one significant and continually reported reason is poor mask fit. A poor mask fit is not only uncomfortable, but frequently causes side effects such as dry eyes, congestion, skin irritation and breakdown, and ineffective ventilation from inadequate pressures due to air leaking around the mask. Pediatric patients tend to be especially difficult to fit with conventional masks because of their smaller facial features and the lack of masks developed for pediatric use.

In this study, patients will be fitted with a custom made NIV mask following facial imaging with a 3D camera (Artec 3D Scanner). The facial image will be used to construct an NIV mask model using computer design software that will then be created by using a 3D printer.

Eligibility criteria: Inclusion Criteria:

* On stable NIV settings for a minimum of 2 months.

Exclusion Criteria:

* New diagnosis

Primary outcomes:
measure: Adherence Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's Hopital Medical Center
name: Narong Simakajornboon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03684551: Improving Community Health Worker Performance With a Supervision Dashboard
Official title: Improving Community Health Worker Performance by Using a Personalised Feedback Dashboard for Supervision: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Health Worker Performance
Keywords: Community Health Worker
Health worker supervision
Mali
Randomized controlled trial
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Muso, Bamako Mali and San Francisco USA
name: Malaria Research and Training Center, Bamako, Mali
name: University of California, San Francisco
name: Harvard Medical School (HMS and HSDM)
name: Medic Mobile, San Francisco, USA
name: Malian Ministry of Health and Public Hygiene
First posted: 2018-09-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Countries across sub-Saharan Africa are scaling up Community Health Worker (CHW) programmes, yet there remains little high-quality research assessing strategies for CHW supervision and performance improvement. This randomised controlled trial aims to determine the effect of a personalised performance dashboard used as a supervision tool on the quantity, speed, and quality of CHW care. This study is a randomised controlled trial in a large health catchment area in peri-urban Mali. One hundred forty-eight CHWs conducting proactive case-finding home visits were randomly allocated to receive individual monthly supervision with or without the CHW Performance Dashboard from January to June 2016. Randomisation was stratified by CHW supervisor, level of CHW experience, and CHW baseline performance for monthly quantity of care (number of household visits). With regression analysis, we used a difference-in-difference model to estimate the effect of the intervention on monthly quantity, timeliness (percentage of children under five treated within 24 hours of symptom onset), and quality (percentage of children under five treated without protocol error) of care over a six-month post-intervention period relative to a three-month pre-intervention period.


Eligibility criteria: Inclusion Criteria:

* To be a CHW in the study site at the time of enrolment (n=148)

Exclusion Criteria:

* CHW who pretested the Dashboard tool (n=2)

Primary outcomes:
measure: Quantity of care
timeFrame: 9 months
Secondary outcomes:
measure: Timeliness of care
timeFrame: 9 months
measure: Quality of care
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
citation: Whidden C, Kayentao K, Liu JX, Lee S, Keita Y, Diakite D, Keita A, Diarra S, Edwards J, Yembrick A, Holeman I, Samake S, Plea B, Coumare M, Johnson AD. Improving Community Health Worker performance by using a personalised feedback dashboard for supervision: a randomised controlled trial. J Glob Health. 2018 Dec;8(2):020418. doi: 10.7189/jogh.08.020418.
Clinical trial NCT00520351: Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Official title: Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2007-08-24
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.

Detailed description: The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings

Eligibility criteria: Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer.
2. Has read, understood and signed an information consent letter.
3. Is willing and able to follow instructions and maintain the appointment schedule.
4. Is presently using either bi-weekly or monthly replacement lenses.
5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.
6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
7. Has clear corneas and no active ocular disease.
8. Has had an ocular examination in the last two years.

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is an asymptomatic lens wearer.
2. Is a daily disposable contact lens wearer.
3. Is a current extended wear contact lens wearer.
4. Currently uses one of the study lens care regimens.
5. Has any clinically significant blepharitis.
6. Has undergone corneal refractive surgery.
7. Is aphakic.
8. Has any active ocular disease.
9. Has any systemic disease affecting ocular health.
10. Is using any systemic or topical medications that may affect ocular health.
11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
12. Is participating in any other type of clinical or research study.

Primary outcomes:
measure: High Contrast Visual Acuity
timeFrame: 2 weeks
measure: Low Contrast Visual Acuity
timeFrame: 2 weeks
measure: In-vivo Wettability
timeFrame: 2 weeks
measure: Subjective Comfort Rating
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, School of Optometry, University of Waterloo.
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Desmond Fonn, M. Optom
role: PRINCIPAL_INVESTIGATOR
References: