louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06301542: Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation
Official title: Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-stroke
Keywords: functional electrical stimulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2024-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty post-stroke community-dwelling adults will participate in a single in-laboratory and in-home visit, performing 5x sit-to-stand (5XSST), 5x Comfortable and 3x Fast walking speed at a 5M distance, and 5x modified Timed Up and Go (TUG). The tests will be performed twice: once with and without the task aware-neuroprosthesis.

Brief summary: The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Capacity to consent
* Post-stroke community-dwelling adults
* Ability to follow 3-step commands

Exclusion Criteria:

* Undomiciled
* Active substance use disorder
* Active psychosis
* Domestic violence or neglect
* Inability to communicate with investigators
* Other comorbidities that prevent full participation in the research

Primary outcomes:
measure: Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients
timeFrame: 1 deployment visit in the laboratory, approximately 4 hours
Secondary outcomes:
measure: Accurate motion assistance while using the functional electrical stimulation in the laboratory.
timeFrame: 1 deployment visit in the laboratory, approximately 4 hours
measure: Accurate motion assistance while using the functional electrical stimulation in the home.
timeFrame: 1 deployment visit in the home, approximately 4 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT03701542: The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.
Official title: The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Holes
Microperymetry
Vitrectomy
M-charts
Keywords: macular hole
microperymetry
vitrectomy
m-charts
metamorphopsia
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 22 patients

Brief summary: To examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (FTMH).


Eligibility criteria: Inclusion Criteria:

The diagnosed full thickness macular hole and psuedophakia.

Exclusion Criteria:

macular pseudohole, non-full thickness macular hole, retinal detachment, other ocular comorbidities.

Primary outcomes:
measure: The best-corrected visual acuity (BCVA)
timeFrame: 1 to 6 months
measure: Amsler test
timeFrame: 1 to 6 months
measure: Central retinal thickness
timeFrame: 1 to 6 months
Secondary outcomes:
measure: Retinal sensitivity
timeFrame: 1 to 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Wrzesinska D, Nowomiejska K, Nowakowska D, Toro MD, Bonfiglio V, Reibaldi M, Avitabile T, Rejdak R. Secondary Vitrectomy with Internal Limiting Membrane Plug due to Persistent Full-Thickness Macular Hole OCT-Angiography and Microperimetry Features: Case Series. J Ophthalmol. 2020 Sep 21;2020:2650873. doi: 10.1155/2020/2650873. eCollection 2020.
citation: Wrzesinska D, Nowomiejska K, Nowakowska D, Brzozowska A, Avitabile T, Reibaldi M, Rejdak R, Toro M. Vertical and Horizontal M-Charts and Microperimetry for Assessment of the Visual Function in Patients after Vitrectomy with ILM Peeling due to Stage 4 Macular Hole. J Ophthalmol. 2019 May 6;2019:4975973. doi: 10.1155/2019/4975973. eCollection 2019.
Clinical trial NCT06300242: Incentives for Influenza Vaccination
Official title: Financial Incentives for Influenza Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccination
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: J-PAL North America
First posted: 2024-03-08
Enrollment: 69972
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this work, we are assessing the impact of messaging with or without a $50 financial incentive on influenza vaccination rates in a county health system. Our main hypothesis is that a message with a $50 financial incentive will increase vaccination rates relative to a control/"treatment as usual" group. We further hypothesize that the financial incentive will increase vaccination rates relative to the message only arm.


Eligibility criteria: Inclusion Criteria:

* Ages 18 and over
* Empaneled patients or non-empaneled patients with a primary care visit in past 18 months with valid insurance
* Due for an annual flu shot according to the electronic medical record
* Active phone number or email
* Do not have "Do not contact" flag

Exclusion Criteria:

* Under age 18
* Received an annual flu shot based on medical record

Primary outcomes:
measure: Vaccination status at 1 week
timeFrame: 1 week
Secondary outcomes:
measure: Vaccination status at 2 weeks
timeFrame: 2 weeks
measure: Vaccination status at 1 month
timeFrame: 1 month
Other outcomes:
Locations:
city: Martinez
country: United States
facility: Contra Costa Health Services
state: California
Study officials:
References:
Clinical trial NCT05226442: Safety and Feasibility of Argatroban As Anticoagulant in Adults with ECMO
Official title: A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban As Anticoagulant in Patients with Extracorporeal Membrane Oxygenation (ECMO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Extracorporeal Membrane Oxygenation Complication
Anticoagulants and Bleeding Disorders
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization ratio of 1:1 for anticoagulation with Argatroban or Unfractionated Heparin
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.


Eligibility criteria: Inclusion Criteria:

* Minimum Age 18 years
* VV- or VA-ECMO therapy
* Minimum of 24h planned ECMO-therapy

Exclusion Criteria:

* History of Heparin-induced thrombocytopenia (HIT)
* High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count \<50G/l, congenital bleeding disorder)
* Pregnancy
* Severe Liver disease (SOFA score liver domain 4 points = Bilirubin \>12mg/dl)
* Postoperative admission
* Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT \>50 sec without anticoagulation).

Primary outcomes:
measure: Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)
timeFrame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Secondary outcomes:
measure: study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO
timeFrame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Other outcomes:
measure: Transfusion rate of packed red blood cells assessed as total units/ECMO day
timeFrame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
measure: Grading of bleeding
timeFrame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
measure: Mortality rate at day 28/90
timeFrame: Until 90 days after start of study drug administration
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Thomas Staudinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03704142: Comparison of PSAPs in Different Maskers
Official title: Personal Amplification Devices in Noise and Speech Maskers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Auditory Perception
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 48
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will be tested with one of the models of devices.
Primary purpose: TREATMENT

Brief summary: This study will measure the performance of three personal amplification devices when used by middle-aged adults. Speech understanding will be assessed with two different types of background noises at three different input levels.

Detailed description: Speech understanding will be measured both unaided and aided with three different models of Personal Amplification devices (PSAPs). Sentences will be played to the participant from a loudspeaker located in front. Different types of background sounds (noise and other sentences) will be played from loudspeakers located to the right and left of the participant. Participants will be instructed to repeat back the sentence coming from the front. They also will rate subjective effort at the end of each block of trials.

Eligibility criteria: Inclusion Criteria:

* mild high-frequency hearing loss (pure-tone thresholds of 25 decibels hearing loss - 45 decibels hearing loss between 2000 Hz and 6000 Hz)

Exclusion Criteria:

* history of prior hearing aid use
* history of neurologic or otologic disorders
* score of \< 26 on Montreal Cognitive Assessment (cognitive screening tool)

Primary outcomes:
measure: Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise
timeFrame: One 2-hour lab session
Secondary outcomes:
measure: Difference in Self-rated Listening Effort
timeFrame: One 2-hour session
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts Amherst
state: Massachusetts
Study officials:
References:
Clinical trial NCT03938142: Goalsetting in Patients With Chronic Pain: a European Survey
Official title: Goalsetting in Patients With Chronic Pain: a European Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-05-06
Enrollment: 1494
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pain.

Brief summary: The aim of this survey is to get insight in the individual goals of chronic pain patients according to the ICF framework.


Eligibility criteria: Inclusion Criteria:

* patients who are suffering from chronic pain

Exclusion Criteria:

* healthy participants or patients with acute pain

Primary outcomes:
measure: Individual goalsettings
timeFrame: at the moment of filling in the survey (cross-sectional)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT04647942: Is Meniscal Volume Critical to Post-meniscectomy Symptoms?
Official title: Is Meniscal Volume Critical to Post-meniscectomy Symptoms? A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meniscal Tear
Keywords: meniscectomy
volume
pain
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
* Age between 14 and 60 years old
* Women of child bearing age can be included: the study has no effect on their methods of contraception.

Brief summary: With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

Detailed description: 1. Background and rationale It is known that a partial meniscectomy of the knee is a risk factor to the development of early osteoarthritis with complaints of pain.
2. Trial objectives and Design 2.1 Trial objectives With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

   2.2 Primary endpoints How much volume can be resected peroperatively without developing postoperative pain.

   2.3 Secondary endpoints A possible correlation between the resected volume and the severity of the pain.
3. Selection and withdrawal of subjects

3.1 Inclusion criteria

* All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
* Age between 14 and 50 years old
* Women of child bearing age can be included: the study has no effect on their methods of contraception.

3.2 Exclusion criteria

* A history of a tibia plateau fracture or severe deformity of the knee
* Rupture of the ACL/PCL/collateral ligaments of the knee
* Focal cartilage defects of the knee

Eligibility criteria: Inclusion Criteria:

* All patients who were treated with a partial meniscectomy for a meniscal tear and have postoperative MRI's.
* Age between 14 and 60 years old
* Women of child bearing age can be included: the study has no effect on their methods of contraception.

Exclusion Criteria:

* A history of a tibia plateau fracture or severe deformity of the knee
* Rupture of the ACL/PCL/collateral ligaments of the knee
* Focal cartilage defects of the knee

Primary outcomes:
measure: How much volume can be resected peroperatively without developing postoperative pain.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals of Leuven
state: Antwerp
Study officials:
affiliation: UZ Leuven
name: Johan Bellemans, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02489942: Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus
Official title: Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-07-03
Enrollment: 8145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3,000 Japanese patients with the assessment of 3-year completed administration

Brief summary: Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus


Eligibility criteria: Inclusion criteria:

Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment

Exclusion criteria:

None

Primary outcomes:
measure: Number of Patients With Adverse Drug Reactions (ADRs)
timeFrame: From first drug administration until 7 days after last drug administration, up to 247 weeks.
Secondary outcomes:
measure: Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period
timeFrame: At start of treatment and at last observation on treatment, up to 246 weeks.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period
timeFrame: At start of treatment and at last observation on treatment, up to 246 weeks.
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Kaku K, Chin R, Naito Y, Iliev H, Ikeda R, Ochiai K, Yasui A. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study. Expert Opin Drug Saf. 2020 Feb;19(2):211-221. doi: 10.1080/14740338.2020.1694659. Epub 2019 Nov 26.
Clinical trial NCT01169142: Study of Vitamin D in the Severely Mentally Ill
Official title: A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Vitamin D
Schizophrenia
Severely Mentally Ill
Lead sponsor: Bronx Psychiatric Center
Sponsor class: OTHER_GOV
First posted: 2010-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.

Detailed description: Subjects with levels of Vitamin D between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on Vitamin D for three months or to start after a delay of three months. Those with levels below 7gn/ml will start immediately. All will be evaluated monthly with blood tests, PANSS, movement disorder ratings and information on health and progress from the clinical chart.

Eligibility criteria: Inclusion Criteria:

* Age 19-70,
* Schizophrenia or Schizoaffective disorder
* stabilized but not expecting to be discharged soon
* capacity to give informed consent

Exclusion Criteria:

* acutely psychotic
* acutely medically ill
* renal insufficiency
* hypercalcemia
* hyperparathyroidism

Primary outcomes:
measure: Psychopathology as measured by the PANSS
timeFrame: 3 months
Secondary outcomes:
measure: movement disorder
timeFrame: three months
measure: General Health
timeFrame: three months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx Psychiatric Center
state: New York
Study officials:
affiliation: Bronx Psychiatric Center
name: NIgel Bark, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02287142: Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
Official title: Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Pain
Shoulder Joint
Pathologic Processes
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 189
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 aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.


Eligibility criteria: Inclusion Criteria:

* Unilateral total shoulder arthroscopy for rotator cuff surgery ASA physical status I-III, \>18 years old, Non-pregnant, Consent to participate in the study

Exclusion Criteria:

* Refusal to participate, \< 18 years old, Chronic opioid use, Localized infection, Pregnancy or lactating, Pre-existing coagulopathy, Allergy to ultrasound gel or local anesthetics, Diaphragmatic dysfunction

Primary outcomes:
measure: Pain
timeFrame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Secondary outcomes:
measure: Lung function
timeFrame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
measure: Sensory and Motor Function
timeFrame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
measure: Diaphragmatic excursion
timeFrame: Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: David Auyong, MD
role: PRINCIPAL_INVESTIGATOR
References: