louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03438955: Phase I Drug-drug Interaction of Omega-3 and Atorvastatin
Official title: A Two-cohort, Single-sequence, Parallel, Open Label, Multiple Oral Dosing Phase I Study to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Omega-3 and Atorvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hyperlipidemia, Hypertriglyceridemia
Lead sponsor: DongKoo Bio & Pharma
Sponsor class: INDUSTRY
First posted: 2018-02-20
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and atorvastatin in healthy male volunteers. Half of the participants will receive omega-3 for 16 days to be steady state of omega-3 and followed by omega-3 and atorvastatin in combination for 7 days. The other half will receive Atorvastatin for 7 days to be steady state of Atorvastatin, and followed by Atorvastatin and Omega-3 in combination for 16 days.


Eligibility criteria: Inclusion Criteria:

* 50kg or less of body weight and body mass index of 18 \~ 30kg/m²
* No congenital or chronic disease requiring treatment, and no pathological symptoms or findings as a result of medical examination
* Eligible for the clinical trial as a result of a clinical laboratory test, 12-lead ECG, V/S test at the screening

Exclusion Criteria:

-

Primary outcomes:
measure: Cohort A
timeFrame: Day 1 -20hours, -16hours, -12hours, 0hours, Day 13, 14, 15 0hours, Day 16 0, 1, 2, 3, 4, 6, 8, 12, 24hours, Day 23 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24hours
measure: Cohort B
timeFrame: Day 1 0hours, Day 5, 6 0hours, Day 7 0, 0.25 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12 ,24hours, Day 23 0, 0.25, 0.5, 0.75, 1, 1.25, 2, 3, 4, 6, 8, 12, 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A National University Hospital
Study officials:
affiliation: Dong-A National Univ. Hos.
name: Min Kyu Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01888055: Influence of tDCS on Cortical Plasticity in Healthy Older Adults
Official title: Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy Older Adults
Keywords: Healthy older adults Cortical Plasticity
Transcranial Direct Current Stimulation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).


Eligibility criteria: Inclusion Criteria:

* right-handed according to the Oldfield Händigkeits inventory (lateralization index \>70)(1971)
* no obvious cognitive impairment (MMSE\>26, Demtect\>13)
* age between 50 and 80 years

Exclusion Criteria:

* Severe neurological / psychiatric or pre-existing internist conditions because additional cognitive deficits are expected
* Epilepsy, epileptic seizure in medical history
* Cognitive deficit (MMSE \<20)
* Depressive episode (Beck Depression Inventory (BDI) \> 12)
* intake of centrally active drugs \<3 months , particularly acetylcholinesterase inhibitors
* Pregnancy
* Pacemaker (contraindication for MRI)
* Other metal parts in the body (contraindication for MRI)

Primary outcomes:
measure: anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in healthy older adults
timeFrame: 1 week
Secondary outcomes:
measure: Comparison of tDCS-induced changes on central cholinergic activity
timeFrame: 1 week
measure: Comparison of tDCS-induced changes in the learning success
timeFrame: 1 week
measure: MR elastography
timeFrame: 1 week
measure: genetic polymorphism, ApoE4
timeFrame: once
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
Study officials:
References:
Clinical trial NCT00213655: URO-BCG-4 : Bladder Tumors Immunotherapy
Official title: Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bladder Cancer

Brief summary: Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.

Detailed description: BCG maintenance immunotherapy 1/3 dose : 27 mg two randomized arms : 3 or 6 months for 36 months clinical side effects according to OMS score efficacy regarding recurrence : cytology and cystoscopy PSA, leucocyturia and N-ramp gene evaluation

Eligibility criteria: Inclusion Criteria:

* Ta and T1 bladder tumors

Exclusion Criteria:

* BCG contra-indications

Primary outcomes:
measure: Tumoral response
timeFrame: Month 36
Secondary outcomes:
measure: Tumoral response
timeFrame: Month 24
Other outcomes:
Locations:
city: Rouen
country: France
facility: Charles Nicolle, University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Christian PFISTER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03477955: PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration
Official title: PEEK Versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration Following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjacent Segment Degeneration
Keywords: spinopelvic alignment
short lumbosacral instrumentation
PEEK
silicon spacer
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
Collaborators: name: St. Andrew's General Hospital, Patras, Greece
First posted: 2018-03-27
Enrollment: 55
Sex: ALL
Minimum age (years): 49
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Although ASD is a common complication following lumbar fusion, the effect of an Interspinous Spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately.

Detailed description: Methods From 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years, 17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS and compared with 20 controls (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI. Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI and supradjacent segment disc heights. All spines were preoperatively balanced.

Eligibility criteria: Inclusion Criteria:

Preoperative MRI with degeneration grades\<III at the 1st supradjacent lumbar segment.

Exclusion Criteria:

* Body mass index≥40kg/m\*m
* Severe osteoporosis
* Lumbar fracture
* Preoperative SVA\>4cm
* Spondylolisthesis grades\>II or spondylolytic lesion and acquired spinous process insufficiency in the supradjacent segment cephalad to instrumentation

Primary outcomes:
measure: Quality of Life
timeFrame: Three years
Secondary outcomes:
measure: Disc heights
timeFrame: Three years
measure: Sacral Slope
timeFrame: Three years
measure: Pain
timeFrame: Three years
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of Patras
name: Panagiotis Korovessis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korovessis P, Syrimpeis V, Tsekouras V, Vardakastanis K, Fennema P. PEEK versus Silicon Interspinous Spacer for Reduction of Supradjacent Segment Degeneration following Decompression and Short-Segment Instrumentation for Degenerative Lumbar Spinal Stenosis. Adv Orthop. 2018 Aug 8;2018:1623647. doi: 10.1155/2018/1623647. eCollection 2018.
Clinical trial NCT03234855: Laparoscopic Measuring Device Study
Official title: Laparoscopic Measuring Device Usability Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physician Feedback
Lead sponsor: Boehringer Labs LLC
Sponsor class: INDUSTRY
First posted: 2017-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients whose physician has already decided that laparoscopic hernia repair surgery is the best route of treatment for a hernia defect.

Brief summary: This study is gathering opinions from surgeons on the usability of our laparoscopic measuring device.

Detailed description: In June of 2016, SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) issued a recommendation stating that:

"Surgeons should measure and document the size of the hernia defect they are repairing. The total area encompassing all the defects should be measured, and surgeons should be familiar with internal and external measurement techniques for all hernia locations, as well as how to avoid common measurement errors."

An incorrect mesh size can have detrimental consequences to the effectiveness of the mesh. According to the SAGES recommendation:

"Overestimating the defect size will result in the choice of a larger prosthetic size, which may be more difficult to handle and may have more laxity, allowing it to bulge into the defect more than if it was placed taut. The difficulty in prosthetic handling may also lead to errors in fixation, and the prosthetic can more easily sway between fixation points, due to the larger dimensions."

While a smaller mesh size can also be problematic:

"Underestimating the defect size may lead to choosing a prosthetic that is too small, thus increasing the risk of hernia recurrence." In order to aid surgeons in more accurately measuring hernia defects, Boehringer Labs LLC has developed a laparoscopic surgical measuring device. This study aims to obtain feedback from surgeons on the usefulness and design of the device.

Eligibility criteria: Inclusion Criteria:

* Adult patients with hernia defect that requires laparoscopic measurement

Exclusion Criteria:

* Minors

Primary outcomes:
measure: Physician Feedback
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01187355: Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers
Official title: SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Contact Lens Wearers
Keywords: Symptomatic, Contact lens care
Multi-purpose solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-08-24
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.


Eligibility criteria: Inclusion Criteria:

* Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
* Vision correctable to 20/30 or better with contact lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Sensitivity to multi-purpose solutions.
* Use of any topical ocular OTC or prescribed topical ocular medications.
* History (6 months) or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Medical condition or use of medications that cause ocular side effects.
* Participation in any investigational study within the past 30 days.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
timeFrame: Day 30
Secondary outcomes:
measure: Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.
timeFrame: Day 30
measure: Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.
timeFrame: Day 30
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT04660955: MOON Onsite MRI 10 Years After ACL Reconstruction
Official title: Imaging Post-traumatic Osteoarthritis 10-years After ACL Reconstruction
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Osteoarthritis, Knee
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: Ohio State University
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-12-09
Enrollment: 219
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This patient cohort include patients who had ACL reconstruction 10 years ago and were recruited in the previous MOON onsite study based on the inclusion criteria listed above.

Brief summary: In this study, a total of 219 subjects from the MOON nested cohort will be studied at CCF, Vanderbilt and OSU, Table 1. Among them, some will have added MRI during their 10-year visit for the MOON study. Some subjects who finished their 10-year visit for the MOON Onsite study already will be called back to have MRI. PROMs and other information of these subjects will be collected through the MOON study.

Detailed description: In this study, a total of 219 subjects from the MOON nested cohort will be studied at CCF, Vanderbilt and OSU, Table 1. Among them, some will have added MRI during their 10-year visit for the MOON study. Some subjects who finished their 10-year visit for the MOON Onsite study already will be called back to have MRI. PROMs and other information of these subjects will be collected through the MOON study.

In addition, 30 age-, sex- and BMI-matched control subjects (10 from each site) will be recruited and scanned for MRI. PROMs (KOOS, IKDC, Marx, SF-36) will be collected from these controls.

Among the 10 controls recruited locally at CCF, five will also travel to OSU and Vanderbilt to be scanned at the other two sites for cross-validation among the three sites. There will be a separate consent for the 5 controls that will be traveling to each of the 3 sites for the scans. The remaining 25 controls will be tested at only their local site.

Eligibility criteria: Inclusion Criteria:

* Enrolled in MOON Onsite Study
* 12-33 years old at baseline (22-45 years for this study);
* ACL tear during a sport; no previous knee injury;
* No graft rupture during follow-up;
* No history of surgery on the contralateral knee;
* No MRI contraindications

Exclusion Criteria:

* History of surgery on contralateral knee
* Afraid of enclosed spaces

Primary outcomes:
measure: Cartilage health status
timeFrame: At 10-years after ACL reconstruction
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: At 10-years after ACL reconstruction
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Xiaojuan Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06250855: Observational Prospective Clinical Investigation on Monofocal Toric Intraocular Lens
Official title: At Least One-year Long-term Clinical Outcomes Following Monofocal Toric Intraocular Lens Implantation: Observational Prospective Clinical Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Astigmatism
Keywords: Cataract
Astigmatism
Monofocal IOL
Toric IOL
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (males and females) ≥18 years with cataract and pre-existing corneal astigmatism who have undergone monocular or binocular Mini Toric Ready implantation. Subjects enrolled in the investigation underwent cataract surgery in which the cataract lens was removed by phacoemulsification, with circular capsulorhexis, leaving the posterior capsule intact.

Brief summary: Evaluation, at least one-year long-term, of the clinical performance and safety of Mini Toric Ready Intraocular Lens (IOL), a monofocal toric intraocular lens.

Detailed description: Observational prospective clinical investigation based on the medical records of patients who undergone uncomplicated cataract surgery with implantation of Mini Toric Ready IOL and on a clinical visit after at least one year from the surgery. Eyes with corneal astigmatism ≥0.75 diopters were included. Postoperative evaluations included monocular or binocular uncorrected and corrected distance visual acuity; contrast sensitivity measured after at least one-year postoperatively.

Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older at the time of surgery and diagnosed with unilateral or bilateral cataracts;
* Preoperative total corneal astigmatism ≥0.75D;
* Unilateral or bilateral cataract removal by phacoemulsification;
* Clear intraocular media other than cataract;
* Willing and able to complete all required postoperative visits;
* Able to comprehend and sign a statement of informed consent consistent with local regulation for research in human subjects.

Exclusion Criteria:

* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days before the surgery.

Primary outcomes:
measure: Evaluation of the Visual Performance
timeFrame: From 12 to 24 months post-surgery
Secondary outcomes:
measure: Evaluation of the Stability
timeFrame: From 12 to 24 months post-surgery
Other outcomes:
measure: Evaluation of the safety profile: Adverse Events (AEs)
timeFrame: From 12 to 24 months post-surgery
measure: Evaluation of the safety profile
timeFrame: From 12 to 24 months post-surgery
Locations:
city: Bacau
country: Romania
facility: Gauss Clinic Bacau
city: Sfântu-Gheorghe
country: Romania
facility: Immunoeye SRL
Study officials:
References:
Clinical trial NCT02194855: Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis
Official title: Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: C.Delivery; Surgery (Previous), Gynecological
Keywords: rocuronium
cisatracurium
pharmacokinetic
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators investigated whether laparoscopic versus open surgical approaches affected the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or cisatracurium.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology 1-2
* BMI 18-30 kg.m-2
* elective gynaecological operations under general anaesthesia

Exclusion Criteria:

* cirrhosis
* hepatitis
* hepatoma
* heart failure
* arrhythmia
* renal dysfunction
* electrolyte disturbances
* acid-base imbalances
* neuromuscular disorders

Primary outcomes:
measure: the blood flow in the right and middle hepatic veins
timeFrame: up to 9 months
Secondary outcomes:
measure: the plasma Concentration of rocuronium and cisatracurium
timeFrame: up to 9 months
Other outcomes:
measure: pharmacodynamic comparison of rocuronium and cisatracurium
timeFrame: up to 9 months
Locations:
Study officials:
affiliation: Obstetrics and Gynecology,Fudan University
name: Shaoqiang Huang, doctor
role: PRINCIPAL_INVESTIGATOR
References: