louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02053415: Krill Oil as Supplementation to Healthy Young Adults.
Official title: Study of the Effect of Krill Oil Supplement on Omega-3 Fatty Acid Index and Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: krill oil
omega-3 index
plasma lipid profile
tolerance
young adults
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Olympic Seafood AS
First posted: 2014-02-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine whether 4 weeks daily intake of krill oil can change the omega-3 index (content of the long chained fatty acids EPA and DHA in relation to the total fatty acids) in the membrane in red blood cells. We investigate this at two different doses. Furthermore, the purpose of the study is also to examine the effect of the krill oil intake on plasma lipids (triacylglycerol, phospholipids and cholesterol), plasma fatty acid composition, as well as product tolerance in healthy, young individuals.


Eligibility criteria: Inclusion Criteria:

* Healthy young adults

Exclusion Criteria:

* Disease/illness
* Not able to swallow supplements in capsule form
* Not willing to take blood samples

Primary outcomes:
measure: Fatty acid composition in red blood cells (the membrane)
timeFrame: Day 0 (baseline), and day 28 (end)
Secondary outcomes:
measure: Fasting plasma lipid status
timeFrame: Day o (baseline), and day 28 (end)
measure: Fatty acid composition in plasma.
timeFrame: Day 0 (baseline), and day 28 (end)
measure: Fasting glucose and glucose tolerance.
timeFrame: Day 0 (baseline), and day 28 (end)
measure: Tolerance of and compliance with intervention
timeFrame: Day 28 (end)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Clinical Science, University of Bergen
Study officials:
affiliation: University of Bergen
name: Per Bakke, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615315: Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asymptomatic General Population
Microscopic Hematuria
Keywords: aspirin
screening
microscopic hematuria
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2012-06-08
Enrollment: 60048
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic general population who underwent general health screening program

Brief summary: Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin treatment and hematuria in general population is not well known. The investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years, male or female

Exclusion Criteria:

* No result of urinalysis
* No record of medical history (including medication)

Primary outcomes:
measure: Incidence rate of the microscopic hematuria
timeFrame: at the screening
Secondary outcomes:
measure: Detection rate of significant cause for microscopic hematuria
timeFrame: whitin 12 months after screening
measure: Incidence rate of persistent microscopic hematuria
timeFrame: within 12 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sang Eun Lee, selee@snubh.org
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03950115: Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
Official title: Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators are going to Investigate the comparative efficacy of intense pulsed light therapy alone with that of intense pulsed light plus meibomian gland expression for meibomian gland dysfunction.

Detailed description: Enrolled patients are going to be randomly assigned to two groups. All of the patients will undergo four treatment sessions in total, which are two weeks apart. Group 1 will undergo two sessions of intense pulsed light therapy with meibomian gland expression, as well as two sessions of intense pulsed light alone. Group 2 will receive two sessions of intense pulsed light therapy alone, and two sessions of intense pulsed light therapy with meibomian gland expression. The following parameters will be measured at baseline, 2 weeks after the second treatment session, and 2 weeks after the fourth treatment session: tearfilm break-up time, Oxford grade for corneal staining, meibomian gland expressibility, meibum quality, and ocular surface disease index.

Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of meibomian gland dysfunction

Exclusion Criteria:

* Medical conditions in which IPL is contraindicated (pregnancy, breastfeeding, lupus, and any major uncontrolled health problem).
* Contact lens wearer
* Previous ocular surgery
* Previous thermal treatment for dry eye disease (e.g. LipiFlow)

Primary outcomes:
measure: Change from baseline tearfilm break-up time at 2 weeks after the last treatment session
timeFrame: Baseline and 2 weeks after the last treatment session
measure: Change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session
timeFrame: Baseline and 2 weeks after the last treatment session
measure: Change from baseline meibomian gland expressibility score at 2 weeks after the last treatment session
timeFrame: Baseline and 2 weeks after the last treatment session
measure: Change from baseline meibum quality score at 2 weeks after the last treatment session
timeFrame: Baseline and 2 weeks after the last treatment session
measure: Change from baseline ocular surface disease index at 2 weeks after the last treatment session
timeFrame: Baseline and 2 weeks after the last treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00639015: Phenylephrine in Septic Shock
Official title: Phenylephrine Versus Norepinephrine in Septic Shock: Effects on Systemic and Regional Hemodynamics. A Randomized, Controlled, Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Keywords: Sepsis
Septic Shock
phenylephrine
norepinephrine
catecholamine
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 32
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: The present study was conducted as a prospective, randomized, controlled study to compare:

* the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock
* to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic perfusion versus phenylephrine in patients suffering from septic shock

Detailed description: Thirty two septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. Patients will be randomly allocated to be treated with either a) titrated phenylephrine, b) titrated norepinephrine (control; each n = 16), to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, will be obtained at baseline and after 12 hours.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Septic shock
* Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

* Pregnancy
* Age \< 18 years
* Present cardiac dysfunction
* Present or suspected acute mesenteric ischemia

Primary outcomes:
measure: Systemic and regional hemodynamics
timeFrame: during the first 12 hours from the onset of septic shock
Secondary outcomes:
measure: Organ functions,adverse effects
timeFrame: during the first 12 hours from the onset of septic shock
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza" Viale del Policlinico 155
Study officials:
affiliation: Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
name: Andrea Morelli, M.D.
role: STUDY_DIRECTOR
References:
citation: Morelli A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Laderchi A, Bachetoni A, D'Alessandro M, Van Aken H, Pietropaoli P, Westphal M. Phenylephrine versus norepinephrine for initial hemodynamic support of patients with septic shock: a randomized, controlled trial. Crit Care. 2008;12(6):R143. doi: 10.1186/cc7121. Epub 2008 Nov 18.
Clinical trial NCT02529215: Improving Team Training During Mock Code Blue Simulations
Official title: Improving the Quality of Team Training and Performance During Interprofessional in Situ Mock Code Blue Simulations: A Randomized Controlled Mixed-methods Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Education, Simulation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Communication and teamwork failures are the leading causes of errors in healthcare settings. In situ mock code simulations are a potential means to train team-based skills using simulation within real clinical care environments where errors occur; however, debriefing discussions often focus on gaps in learners' clinical skills as opposed to team functioning. This study aims to determine whether learners who are pre-trained using just-in-time simulation regarding CPR quality and medication administration will exhibit improved performance with respect to these skills during in situ mock codes as well as improved team functioning.


Eligibility criteria: Inclusion Criteria:

* Health professionals, including nurses, pediatric residents, physicians and/or respiratory therapists scheduled to participate in interprofessional, team-based in situ mock codes.

Exclusion Criteria:

* None

Primary outcomes:
measure: Team-based non-technical skills
timeFrame: Time Frame: All data will be collected during the one hour when participants engage in the in situ mock code simulation
Secondary outcomes:
measure: CPR quality
timeFrame: Time Frame: All data will be collected during the one hour when participants engage in the in situ mock code simulation
Other outcomes:
measure: Medication errors
timeFrame: Time Frame: All data will be collected during the one hour when participants engage in the in situ mock code simulation
measure: Focus of debriefing
timeFrame: Time Frame: All data will be collected during the one hour when participants engage in the in situ mock code simulation
measure: Cognitive load
timeFrame: Time Frame: All data will be collected during the one hour when participants engage in the in situ mock code simulation
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children (SickKids)
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Catharine M Walsh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03838315: Effects of Neural Mobilization With or Without Soft Tissue Mobilization in Cervical Radiculopathy
Official title: Effects of Neural Mobilization With or Without Soft Tissue Mobilization in Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical Radiculopathy,
Neural Mobilizations,
Soft Tissue Mobilization
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be assigned randomly into two groups: Neural Mobilization with Soft tissue mobilization and Neural mobilization without Soft tissue mobilization.A coin will be flipped at start of data collection for the first patient to be assigned odd number and included in Neural mobilization with Soft tissue mobilization group. Later on odd and even numbered subjects will be included in specific group.
Primary purpose: TREATMENT

Brief summary: This study will evaluate Effects of Neural Mobilization with or without Soft Tissue Mobilization in Cervical Radiculopathy, half of the subjects will receive treatment of Neural Mobilization along with Soft Tissue Mobilization whereas half of the subjects will receive only Neural Mobilization.

Detailed description: Neural mobilization and Soft Tissue Mobilization both treatments are used to treat Cervical Radiculopathy but they work differently.

Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. Neural Mobilization Technique target the single nerve which is being compressed and showing symptoms.

Soft Tissue Mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.

Eligibility criteria: Inclusion Criteria:

* Patients with age 18 to 55years
* Patients having pain more than 3months
* Radiating pain in one of the upper limb
* Spurling's test positive

Exclusion Criteria:

* Traumatic injury of upper limb or cervical spine
* Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
* Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
* Circulatory disturbance of upper extremity
* Known history of high level of spinal cord injury and malignancy
* Thoracic Outlet syndrome

Primary outcomes:
measure: Neck Pain Numeric Scale
timeFrame: 4weeks
Secondary outcomes:
measure: Neck Disability Index
timeFrame: 4weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04097015: Using NI-ES to Treat Spinal Cord Injury (SCI)
Official title: Using Non-Invasive Electrical Stimulation (NI-ES) to Treat Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Pain, Neuropathic
Keywords: Electrical Stimulation, Transcutaneous
Spinal Cord Injury
Neutrophic Pain
Functional Movements
Lead sponsor: SCI Research Advancement
Sponsor class: OTHER
Collaborators: name: DuBois Vision Clinic
First posted: 2019-09-20
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention model is a single group assignment.
Primary purpose: TREATMENT

Brief summary: NI-ES therapy is a treatment that is being studied to potentially treat pain associated with SCI and may help movement below the injury site.

Detailed description: The overall goal of this study is to assess the use of externally applied micro-current electrical stimulation in a subject with SCI to reduce pain and patient perceived improvement of quality of life first, and second, movement below the SCI injury. The Hypothesis is that NI-ES is beneficial in reducing pain following SCI injury, patient perceived quality of life measures, and functional outcomes. We plan to achieve this goal by conducting a Pain Questionnaire and assessment of movement below the injury site prior to external micro-current electrical stimulation with the Spinal Stim (Alpha-Stim M with the Ocular Interface and the Spinal Interface) and again six weeks following the first treatment. These results will be used to characterize the extent and duration of any improvement in pain and movement as a result of treatment with the Spinal Stim.

Eligibility criteria: Inclusion Criteria:

* Male or female
* The presence of SCI
* Pain associated with the SCI
* Difficulty with body movement below the SCI

Exclusion Criteria:

* Absence of SCI
* Poor health
* Deemed unsuitable for participation by the Investigator.

Primary outcomes:
measure: Pain reduction measured by Pain Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: Functional movement as measured by the ASIA Motor Score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Buellton
country: United States
facility: Home site
state: California
Study officials:
References:
Clinical trial NCT03046615: Intraoperative Non-invasive Eye Movement Monitoring
Official title: Intraoperative Non-invasive Eye Movement Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: EEG electrodes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients determined by the PI

Brief summary: For procedures involving proximity to the nerves responsible for eye movement, the need to monitor eye movement exists. The current solution is to place needles in the muscles surrounding the eye. The Investigators have invented a non-invasive electrode and software designed to monitor eye movements non-invasively. The electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects the horizontal and vertical movements of the eye. The Investigators would like to prove efficacy compared to the standard monitoring.


Eligibility criteria: Inclusion Criteria:

- Subject will be undergoing surgery involved of the nerves controlling the eye

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of subjects with greater than 95% concordance in signal between the standard needles and EEG electrode patch
timeFrame: approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jamie J Van Gompel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109615: Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Official title: Phase II Study of Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal cancer
Metastatic colorectal cancer
Treatment resistant
Chemotherapy refractory
KRAS mutation
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with KRAS mutations.


Eligibility criteria: Inclusion Criteria:

* Histologically verified adenocarcinoma in colon or rectum
* Age \>18
* Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan.
* KRAS mutation in primary tumour or metastasis.
* Measurable disease according to RECIST
* ECOG performance status 0, 1 or 2
* Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment)
* EDTA clearance: Uncorrected GFR \> 45 ml/min.
* Neutrophilocytes ≥1.5 x 10\^9/l, leukocytes ≥3.0 x 10\^9/l, thrombocytes ≥100x10\^9/l
* ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases).
* Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research.
* Fertile men and women (women \<2 year after last menstruation) must use efficient birth control.
* Signed informed consent.

Exclusion Criteria:

* Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator.
* Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix.
* Other experimental treatment within 30 days prior to treatment start.
* Pregnant or breastfeeding women.
* Clinical or radiological signs of CNS metastases.
* Planned radiation of target lesions.
* Concurrent vaccination against yellow fever.

Primary outcomes:
measure: Response rate
timeFrame: Assessed every 3 weeks by CT and/or MR scan and evaluated according to RECIST 1.1. Up to 12 months.
Secondary outcomes:
measure: Progression free survival
timeFrame: Every 3 months until progression or death. Up to 12 months.
measure: Overall survival
timeFrame: 12 months.
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Anders Jakobsen, DMSc
role: STUDY_CHAIR
References: