louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02776670: Clinical Outcomes Following Treatment With SYSTANE® BALANCE
Official title: Clinical Evaluation Following Use of SYSTANE® BALANCE in Subjects With Lipid-Deficient Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 308
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 purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.


Eligibility criteria: Inclusion Criteria:

* Willing and able to attend all study visits;
* Must sign an informed consent form;
* Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
* Willing to take study products as directed for entire study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
* Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
* Use of medication excluded by the protocol;
* Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
* Ocular surgeries or procedures excluded by the protocol;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35
timeFrame: Baseline (Day 0), Day 35
Secondary outcomes:
measure: Change From Baseline in TFBUT at Day 35
timeFrame: Baseline (Day 0), Day 35
measure: Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35
timeFrame: Day 35
measure: Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35
timeFrame: Baseline (Day 0), Day 35
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, a Novartis Company
name: Clinical Project Manager, PLS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00764270: The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Official title: The Role of R-alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atherosclerosis
Keywords: atherosclerosis
lipoic acid
thioctic acid
triglycerides
overweight
obesity
oxidative stress
inflammation
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-10-02
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors in people with documented heart disease and increased levels of inflammation.


Eligibility criteria: Inclusion Criteria:

* Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis \> 50% on angiography, or history of documented myocardial infarction)
* Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
* Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
* On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
* No tobacco use within 3 months of the study
* No laboratory evidence of renal, hepatic, or hematological abnormalities
* Not currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;
* Elevated levels of urinary and plasma F2-isoprostanes
* Elevated plasma levels of hs-CRP

Primary outcomes:
measure: hs-CRP
timeFrame: 12,20 & 32 weeks
Secondary outcomes:
measure: 8-lso-PGF2a
timeFrame: 12, 20 & 32 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Gerd Bobe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01984970: McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation
Official title: Evaluation McGrath Series 5 Videolaryngoscope for Double-lumen Tube Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult
Intubation Complication
Keywords: McGrath Videolaryngoscope
double-lumen tube intubation
Thoracic surgery
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients scheduled for thoracic surgery requiring double-lumen tube insertion for one-lung ventilation

Brief summary: 1. Double-lumen tube intubation is difficult, compared with single lume tube.
2. McGrath Series 5 videolaryngoscope hase been used in difficult airway management, both in anesthetized and awake patients.
3. But there was little information about McGrath Series 5 videolaryngoscope for double-lumen tube intubation.

Detailed description: In this study, the purpose was to evaluate the success rate and intubation time of McGrath Series 5 videolaryngoscope for double-lumen tube intubation in patients without predictors of difficult intubation.

Eligibility criteria: Inclusion Criteria:

* adult patients
* thoracic surgery
* ASA classification 1-3

Exclusion Criteria:

* Emergent operation
* predicted difficult airway
* difficult ventilation
* limited mouth opening

Primary outcomes:
measure: intubation time
timeFrame: at intubation
Secondary outcomes:
measure: number of successful intubation at first attempt
timeFrame: at intubation
Other outcomes:
measure: BMI
timeFrame: one day before operation
measure: mouth opening
timeFrame: one day before operation
measure: Thyromental distance
timeFrame: one day before operation
measure: Airway evaluation with Mallampati Score
timeFrame: one day before operation
measure: Airway evalutaion with Cormack-Lehane Score
timeFrame: at intubation
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Yuke Tian, Ph.D.,M.D.
role: STUDY_DIRECTOR
References:
citation: Yao WL, Wang XR, Xu H, Zhang Y, Zhang CH. McGrath((R)) series 5 videolaryngoscope evaluation for double-lumen tube intubation. Anaesthesia. 2014 Jun;69(6):646-7. doi: 10.1111/anae.12720. No abstract available.
Clinical trial NCT02613299: Surgery for Mesothelioma After Radiation Therapy "SMART" for Resectable Malignant Pleural Mesothelioma
Official title: Surgery for Mesothelioma After Radiation Therapy "SMART" for Resectable Malignant Pleural Mesothelioma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mesothelioma
Solitary Fibrous Tumor of the Pleura
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 200
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: Patients receiving treatment at the Mayo Clinic Rochester that have been diagnosed with mesothelioma and will undergo radiation therapy followed by surgical resection as their standard of care.

Brief summary: The purpose of this study is to determine whether radiation therapy decreases tumor size and tumor spread. The investigators will consent subjects that have been diagnosed with mesothelioma and will undergo radiation therapy followed by surgical resection as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and CT scans.


Eligibility criteria: Inclusion Criteria:

* Subject provides informed consent
* Subject is \>18 years of age
* Subject is deemed competent for making medical decisions
* Subject is scheduled to undergo radiation followed by extrapleural pneumonectomy.
* Subject is a surgical candidate
* A negative pregnancy test is required in women of child-bearing potential, as standard of care.

Exclusion Criteria:

* Subject is \<18 years old.

Primary outcomes:
measure: Survival status upon review of patient records annually
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05096299: OCS Heart EXPAND + CAP Continued Follow-Up
Official title: OCS Heart EXPAND + CAP Continued Follow-Up Post-Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials will comprise the patient population for this PAS.

Brief summary: Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.


Eligibility criteria: Inclusion Criteria:

* Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials

Primary outcomes:
measure: Patient survival
timeFrame: 5 years post transplant
Secondary outcomes:
Other outcomes:
measure: Cardiac patient survival
timeFrame: 5 years post transplant
measure: Graft survival
timeFrame: 5 years post transplant
Locations:
Study officials:
References:
Clinical trial NCT01610999: Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
Official title: Pilot Study of Lymphoid Tumor Microenvironmental Dysruption Prior to Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Lymphoma
Multiple Myeloma
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to keep our immune systems healthy over our lifetime, certain cells in the bone marrow and lymph nodes called stromal cells nurture the immune cells and protect them from damage. Stromal cells and blood cells communicate using a protein called SDF1a. The investigators think that cancer cells including lymphoma and multiple myeloma can trick the stromal cells into helping them avoid damage from chemotherapy by using SDF1a.

Plerixafor is a drug developed to block the effects of SDF1a and has been approved by the Federal Drug Administration (FDA) for use in humans to help release blood stem cells from the bone marrow for use in transplantation. The use of plerixafor to interrupt communication between stromal cells and cancer has not been approved by the FDA and is experimental.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Subjects must have documented, relapsed/refractory or high-risk primary lymphoid malignancy
* Subjects must have evidence of residual disease prior to transplant, but need not have measurable or strictly evaluable disease
* Subjects must be eligible candidates for high dose chemotherapy with either BEAM or single-agent melphalan preparative regimens and autologous stem cell transplantation at Tufts Medical Center (See Appendix B for anticipated transplant schedules)
* Subjects must be able to provide informed consent to the research procedure

Exclusion Criteria:

* Uncontrolled infection
* Active heart disease as evidenced by myocardial infarction within 6 months, uncontrolled arrhythmia, or angina.
* Creatinine clearance estimated \< 50 ml/min.
* HIV infection or evidence of active chronic hepatitis
* Unable or unwilling to comply with required study procedures

Primary outcomes:
measure: The rate of grade 2 or greater adverse events related to study participation will be compared to historical controls matched for diagnosis and chemotherapy regimen.
timeFrame: 2 hours before high dose chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Andreas K Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04181099: Influence of Different Zirconia Surface Treatments on Biofilm Formation
Official title: Influence of Different Zirconia Surface Treatments on Biofilm Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surface Finish
Keywords: dental implant
zirconia
biofilm
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim is to test the influence of surface finish on biofilm formation on the transmucosal part of zirconia implants in an in vivo study. Sixteen test person will therefore receive an orthodontic apparatus containing the specimens with the respective surfaces and carry them for 2x 24h. The primary outcome is the spectormetrical quantification (OD value) of biofilm on the specimens that have been carried by the test person over 24h. Biofilm will be analysed using scanning electron microscopy.


Eligibility criteria: Inclusion Criteria:

* No systematic antibiotic therapy during the last 3 months
* Good oral health and compliance (PI and BI \<20%)
* No sign of parodontal disease or other inflammatory changes in the mouth
* Non-smoker

Exclusion Criteria:

* Disease that requires antibiotic therapy
* Pressure marks due to the orthodontic apparatus that can not be eliminated
* Other unexpected complications that could be related to the orthodontic apparatus

Primary outcomes:
measure: Safranin Staining
timeFrame: 3 months
Secondary outcomes:
measure: SEM
timeFrame: 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Center for Dental Medicine Basel
state: Basel-Stadt
Study officials:
affiliation: University Center for Dental Medicine Basel
name: Jens Fischer, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02011399: Brain Computer Interfaces (Mu Rhythm Learning)
Official title: EEG-based Brain Computer Interface and Mu Rhythm for Computer Access
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mobility Impairments
Keywords: brain
computer
interfaces
mobility impairments
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Sensorimotor (also know as mu) rhythm based brain-computer interfaces (BCIs) are a tool for controlling electronic devices using only brain signals.

The Mu rhythm is a naturally occuring wave produced by the brain. This research project will determine how to best train subjects to use the Mu rhythm for computer control.

Detailed description: As a method of BCI control, Mu rhythms are difficult to learn and involve extensive training. The investigators want to keep users motivated and determine the best way to provide effective training. Healthy users will be trained to control a computer by wearing an electrode cap that is connected to a computer. They will have their levels of motivation and interest measured while learning to use the Mu rhythm. Two different types of learning programs will be used to determine which is most effective for Mu rhythm training. This method will be used for device control by people with severe physical impairments, who may be able to communicate or carry out other desired tasks using a BCI.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older.
* Able to read text on a computer screen
* Able to understand and remember instructions concerning participation

Exclusion Criteria:

* Unable give informed consent.
* Unable to understand and follow instructions.
* Have abnormal tone or uncontrolled movements in the head-and-neck that would interfere with EEG recordings.
* Known to have photosensitive epilepsy.
* Open head lesions or sores

Primary outcomes:
measure: Efficacy of Mu Rhythm Learning
timeFrame: 20 sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jane E. Huggins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06236399: An EEG Study on the Rhythmic Nature of Perception and Attention
Official title: EEG Study of the Rhythmic Nature of Human Visual Perception and Attention
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Brain and Cognition
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy human volunteers

Brief summary: The study involved healthy volunteers (n= 200), in a single center, low-risk intervention protocol of a non-profit nature. The objective of the study is to investigate the neural mechanisms of visual perception and attention, with particular reference to neural oscillations, in the general population through electroencephalogram (EEG) recording and the administration of simple visual tasks on a PC. The study presented is not associated with risks, as EEG is a non-invasive technique for which there are no known contraindications or adverse reactions.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 35 years
* able/willing to sign the informed consent
* normal or corrected-to-normal vision and hearing

Exclusion Criteria:

- history of severe/major neurological or psychiatric conditions

Primary outcomes:
measure: Electroencephalographic (EEG) oscillatory amplitude
timeFrame: during the intervention
measure: Electroencephalographic (EEG) oscillatory frequency
timeFrame: during the intervention
measure: Electroencephalographic (EEG) oscillatory phase coherence
timeFrame: during the intervention
measure: Autism Quotient (AQ)
timeFrame: during the intervention
measure: Schizotypal Personality Questionnaire (SPQ)
timeFrame: during the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT07025499: Piloting and Evaluation of a Group Intervention for People With Psychosis Designed to Boost Access and Usage of ICT
Official title: Piloting and Evaluation of a Group Intervention for People With Psychosis Designed to Boost Access and Usage of ICT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Serious Mental Illness
Keywords: Information and Communication Technology
Recovery
social connection
community participation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2025-06-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot evaluation
Primary purpose: TREATMENT

Brief summary: Participants will be given access to a tablet. With this technology, participants will be invited to set personal goals related to using this technology to foster social connection and community participation. Participants will attend a group led by two occupational therapy students and an occupational therapist focused on digital literacy and how to use technology to meet their goals. In the group, participants will learn how to use their device and how to safely access various online resources and tools to support their recovery. Participants will keep their provided devices upon conclusion of the group sessions. Participants will complete quantitative outcome measures at the start and end of the group intervention. Participants will be invited to attend a semi-structured interview one month after the completion of the group about their experiences with the program.


Eligibility criteria: Inclusion Criteria:

* Specific inclusion criteria for participants in this study will include being diagnosed with a psychotic disorder, living in the Hamilton area, ability to communicate in English, and having more than one episode of psychosis. Every effort will be made to recruit participants from study with HiREB approvals #17367 and #18549, as indicated in that study's previous consent form, for those that have consented to be contacted for future research.

Exclusion Criteria:

* Exclusion criteria include currently experiencing an acute psychotic episode or medical condition that would render them incapable of meaningfully participating in the study.

Primary outcomes:
measure: Qualitative interviews
timeFrame: From end of group intervention to 3 months
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: From enrolment to end of 7-week group
measure: The Media and Technology Usage and Attitudes Scale (MTUAS)
timeFrame: From enrolment to end of 7 week group
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Rebecca Gewurtz, PhD, MScOT
role: PRINCIPAL_INVESTIGATOR
References: