louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05637242: Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study
Official title: Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Keywords: Ventricular Assist Device
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being implanted with a ventricular assist device.

Brief summary: This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy. The goal is to optimize the use of VAD therapy for patients, to create an online quality measurement tool for VAD treatment, and to create algorithms to estimate the prognosis for patients getting a VAD.

Detailed description: Patients eligible for VAD are being sampled before surgery for plasma as well as peripheral blood cells. After surgery patients are being sampled again at 24 h and 7 days. Inflammatory response is being monitored on gene expression as well as cell level and on cytokine level in relation to the outcome.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥ 18 years of age
2. Subject is treated with a VAD at the Butterworth Campus, Spectrum Health.

Exclusion Criteria:

1. Subject is less than 18 years of age.
2. Known prisoners of the state.
3. Subject is pregnant.
4. Non- English speaking patients will be excluded from the blood sub-study

Primary outcomes:
measure: One year mortality
timeFrame: One year
Secondary outcomes:
measure: Cytokine Analysis
timeFrame: Pre-implant, within 24 hours of implant, and 7 days post-implant
measure: Inflammatory cell subtype
timeFrame: Pre-implant, within 24 hours of implant, and 7 days post-implant
measure: Hospital readmissions
timeFrame: Will be assessed yearly until death or explant
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Frederik Meijer Heart Center
state: Michigan
Study officials:
affiliation: The DeVos Cardiovascular Research Program, Frederik Meijer Heart & Vascular Institute, Corewell Health
name: Renzo Loyaga, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04875442: Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions
Official title: Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions MemoWave Aimed at Increasing Slow Brain Waves During Sleep to Improve Memory Consolidation in Subjects With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Disorder
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The device studied is worn during the 2 polysomnogaphy nights. The device emits sounds during only one night in order to observe the difference of EEG signals.

The night during which the device emits sounds is determined by randomization. The nature of the second night with the device, will be the reverse of the first, in a crossover fashion.
Primary purpose: OTHER

Brief summary: Safety and performance study of the MemoWave electroencephalographic and sound recording device to increase slow brain waves during sleep to improve memory consolidation in subjects with mild cognitive impairment

Detailed description: 24 subjects aged between 40 and 85 years, presenting a mild cognitive disorder of the amnesic type (ie a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall of the RLRI16 test) will be included;

Each patient spends 3 polysomnography nights at hospital: 1 night of habituation without Memowave device and next 2 nights with Memovave.

The device emits sounds to increase slow brain waves but Memowave emits sounds during only one of the two nights of test (night placebo vs night "verum"). The attribution of the night is randomized.

Eligibility criteria: Inclusion Criteria:

* Subject presenting a mild cognitive disorder of the amnesic type, defined by a memory complaint, a Mini Mental State ≥ 24 and a score ≤26 on free recall or ≤45 / 48 on total recall) of the RLRI16 episodic verbal memory test
* At least 7 years of schooling

Exclusion Criteria:

* Severe psychiatric pathology
* Known neurological pathology
* High risk of apnea syndrome defined by at least 2 positive categories (each with a score ≥2) on the Berlin Questionnaire for Apnea Syndrome Screening
* High risk of behavioral disorder in REM sleep defined by an RBDSQ score\> 5.
* Taking sleeping pills or antidepressants
* Severe heart disease or unbalanced diabetes

Primary outcomes:
measure: accuracy of Electroencephalography signals of Memowave
timeFrame: 3 days
Secondary outcomes:
measure: Quality of the sleep
timeFrame: 3 days
measure: efficiency on mnesic consolidation
timeFrame: 3 days
measure: efficiency on mnesic consolidation
timeFrame: 3 days
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM
Study officials:
References:
Clinical trial NCT05726942: Efficacy of mHealth Applications in Weight Management in a Population Affected by Overweight or Obesity
Official title: Efficacy of mHealth Applications in Weight Management in a Population Affected by Overweight or Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: adiposity
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes in patients with overweight and obesity. This study will involve a 6-month long commitment where participants will be expected to use an mHealth app daily, weigh themselves and check their fasting blood glucose levels every morning.


Eligibility criteria: Inclusion Criteria:

* Between the age of 18-64
* BMI ≥ 25
* Owns or has access to a bathroom weight scale
* Owns a smartphone and willing to download mobile app

Exclusion Criteria:

* On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.
* Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay

Primary outcomes:
measure: Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months
timeFrame: 3 months
measure: Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
timeFrame: 3 months
measure: Long-term change in diabetes via fasting blood glucose
timeFrame: 3 months
measure: Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
Clinical trial NCT06142942: Effect of Sprint Interval Training Frequency on Improvements in Fitness
Official title: Effect of Sprint Interval Training Frequency on Cardiorespiratory Fitness Adaptations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiorespiratory Fitness
Keywords: sprint interval training
maximal oxygen consumption
training intervention
Lead sponsor: Wilfrid Laurier University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following pre-testing participants are assigned to one of the four groups based on their baseline cardiorespiratory fitness to ensure no differences between groups at baseline. Participants will train 2, 3, or 4 days a week, or be assigned to the control group (no training) and re-test following the 4 week intervention.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn how the number of weekly exercise sessions affects improvements in fitness in healthy university aged students. The main question it aims to answer is how training frequency affects improvements in fitness. Participants will complete a pre-testing sessions to assess fitness level and sprint performance. Following this participants are assigned to one of four groups. A group that exercises 2 days a week, a group that trains 3 days a week, a group that trains 4 days a week, or a no-exercise control group. Participants in this group will not complete any training and allow the researchers to compare the exercise groups to a group that didn't train. Each participant will train for 4 weeks. During each training session participants will complete 4-6 30 second all-out sprints with 4 minutes of rest between each. Participants will complete the same tests they did during the pre-testing session following the 4 weeks of training to see how frequency affects improvements.


Eligibility criteria: Inclusion Criteria:

* Recreationally active: exercising at least 2-3 days per week and not currently involved in, or had been involved in a systematic training program for at least 3 months prior to data collection.
* Safe to become physically active based on the Canadian Society for Exercise Physiology - Get Active Questionnaire.

Exclusion Criteria:

* Smoking
* Consuming supplements known to affect metabolism (e.g., creatine, carnitine, nitric oxide, brain chain amino acids).
* Failure to meet inclusion criteria

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: This will be assessed before and after 4 weeks of training (or control).
Secondary outcomes:
measure: Anaerobic performance
timeFrame: This will be assessed before and after 4 weeks of training (or control).
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Wilfrid Laurier University
state: Ontario
Study officials:
affiliation: Wilfrid Laurier University
name: Tom J Hazell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04394442: Hydroxychloroquine in COVID-19 Patients
Official title: Use of Hydroxychloroquine in Patients With COVID-19: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many reports argued about the possible beneficial effects of Hydroxychloroquine in treating COVID-19 patients and this study was designed to investigate this claim


Eligibility criteria: Inclusion Criteria:

Confirmed cases of SARS-CoV-2 by PCR

Exclusion Criteria:

less than 18 years old known hypersensitivity to the drug

Primary outcomes:
measure: time to viral clearance
timeFrame: 21 days after patients randomization
measure: % of mortality
timeFrame: 60 days after randomization
Secondary outcomes:
measure: Length of stay
timeFrame: 60 days after randomization
measure: time to be afebrile
timeFrame: 60 days after randomization
measure: need for mechanical ventilation
timeFrame: 60 days after randomization
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: SNH
Study officials:
References:
Clinical trial NCT03414242: Investigation of Neurocognitive Measures of Sport-Related Injury
Official title: Investigation of Neurocognitive Measures of Sport-Related Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Concussion, Brain
Keywords: brain
concussion
neck
strength
sport
prevention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.


Eligibility criteria: Inclusion Criteria:

* 12-30 year old competitive or recreational athletes

Exclusion Criteria:

* Pre-existing condition preventing the ability to perform neck range of motion or a neck strength assessment
* Recent exposure to head lice
* Known or suspected pregnancy

Primary outcomes:
measure: Change in blood metabolite profile
timeFrame: Through study completion, an athletic season average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Soma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03879642: Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes
Official title: Reducing Hypoglycemia Fear in Parents of Young Kids Via Video-based Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parents
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
First posted: 2019-03-19
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control pilot using a waitlist control group
Primary purpose: PREVENTION

Brief summary: Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.

Detailed description: This was a two group randomized controlled study using a wait-list control design. All participating parents had the opportunity to receive 10 video-based telemedicine sessions administered over 13 weeks. Study assessments took place at baseline, post-treatment, and 3 month followup. Study outcomes included parent reported hypoglycemia fear, parenting stress, diabetes distress, and child glycated hemoglobin.

Eligibility criteria: Inclusion Criteria:

* Parents of children, between 1-6 years old, with type 1 diabetes for at least 6 months, on either multiple daily injections or an insulin pump, and parents speak English

Exclusion Criteria:

* Families of children who are older than 6 years-old and or do not have type 1 diabetes; children follow a conventional insulin regimen

Primary outcomes:
measure: Hypoglycemia Fear Survey
timeFrame: absolute value at post-treatment (week 14)
Secondary outcomes:
measure: Child Hemoglobin A1c
timeFrame: absolute value at post-treatment (week 14)
Other outcomes:
Locations:
Study officials:
References:
citation: Patton SR, Monzon AD, Noser AE, Clements MA. Physical Activity, Glycemic Variability, and Parental Hypoglycemia Fear in Preschoolers With Type 1 Diabetes. Pediatr Exerc Sci. 2022 Jan 19;34(3):135-140. doi: 10.1123/pes.2021-0046. Print 2022 Aug 1.
citation: Patton SR, Clements MA, Marker AM, Nelson EL. Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP). Pediatr Diabetes. 2020 Feb;21(1):112-119. doi: 10.1111/pedi.12934. Epub 2019 Nov 3.
citation: Marker AM, Monzon AD, Nelson EL, Clements MA, Patton SR. An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability. Diabetes Technol Ther. 2020 Jan;22(1):25-33. doi: 10.1089/dia.2019.0244. Epub 2019 Nov 13.
Clinical trial NCT05338242: Monitoring Environmental Exposures and Behavioral Change
Official title: Environmental Exposures of the Northern Arapaho Tribe: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction
Environmental Exposure
Risk Behavior, Health
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2022-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to examine what effect real-time feedback on particulate matter (PM) air pollution levels has on risk recognition and behavior. The hypothesis is that real-time exposure feedback will change perceptions of risk and increase behaviors that avoid exposure to environmental risks. At least one representative household member in participating households will complete a questionnaire to fully understand environmental concerns, risk perceptions, and related behaviors. Half of the households will have PM monitors that continuously display real-time concentrations and an indication of the hazard level. The other participants will have the same device but it will only display the date and time. All participants will then be surveyed again: (a) immediately after sampling is complete (i.e., when the devices are removed from the home), (b) after 3 months and, (c) after 6 months. The goal of repeated surveys is to determine changing understanding of risks, how participating in research and/or receiving real-time exposure data may have changed participant behavior, and what concerns they continue to have. The questionnaire will include questions with categorical and/or quantitative answers (e.g., frequency of specific behaviors) so that changes in risk perception and behavior can be effectively analyzed.


Eligibility criteria: Participants must live in a household where at least one adult is a member of the N. Arapaho tribe who is a Primary Participant in the related exposure assessment study.

Primary outcomes:
measure: Behaviors Related to Reduction in Exposure
timeFrame: At removal of device
measure: Behaviors Related to Reduction in Exposure
timeFrame: 3 months after removal of device
measure: Behaviors Related to Reduction in Exposure
timeFrame: 6 months after removal of device
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT00276042: A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
Official title: Prospective, Randomized, Investigator-Blind Trial to Evaluate the Bacteriologic Eradication, Safety and Tolerability, and Pharmacokinetics of Different Dosages of Faropenem Medoxomil BID for 10 Days in the Treatment of Acute Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Otitis Media
Keywords: AOM
Lead sponsor: Replidyne
Sponsor class: INDUSTRY
First posted: 2006-01-12
Enrollment: 328
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel. The primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem

Detailed description: The study will be conducted in infants and children with acute otitis media, 6 months to \<7 years old, in Costa Rica and Israel. Faropenem is to be used as therapy for both simple and complicated AOM.

Eligibility criteria: Inclusion Criteria:

* Acute Otis Media

Exclusion Criteria:

* Any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment

Primary outcomes:
measure: To evaluate bacteriologic efficacy
Secondary outcomes:
measure: To describe investigator assessment of clinical response
Other outcomes:
Locations:
city: San Jose
country: Costa Rica
facility: Local Institution
city: Beer Sheva
country: Israel
facility: Local Institution
Study officials:
affiliation: Replidyne, Inc.
name: Roger M Echols, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03767842: Volumetric Impedance to Guide Stroke Response
Official title: Volumetric Impedance to Guide Stroke Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Acute
Lead sponsor: Cerebrotech Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for evaluation of acute stroke

Brief summary: Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry


Eligibility criteria: Inclusion Criteria:

* Being evaluated as a suspected stroke

Exclusion Criteria:

-

Primary outcomes:
measure: Hemispheric bioimpedance asymmetry sensitivity and specificity
timeFrame: At the time of device monitoring - day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University of Buffalo Neurosurgery
state: New York
Study officials:
affiliation: Sinai Health System
name: Christopher P Kellner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Andrei V Alexandrov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University School of Medicine, Grady Memorial Hospital
name: Raul G Nogueira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kellner CP, Sauvageau E, Snyder KV, Fargen KM, Arthur AS, Turner RD, Alexandrov AV. The VITAL study and overall pooled analysis with the VIPS non-invasive stroke detection device. J Neurointerv Surg. 2018 Nov;10(11):1079-1084. doi: 10.1136/neurintsurg-2017-013690. Epub 2018 Mar 6.