louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03128307: OTC Mouthpiece for Snoring
Official title: In-Home Study of Intraoral Device for Reducing Snoring Among Habitual Snorers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Snoring
Lead sponsor: Zyppah, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient serves as their own control
Primary purpose: TREATMENT

Brief summary: Online patient registration to participate in clinical trial to test OTC mouthpiece that controls position of the tongue to reduce snoring.

Detailed description: Patient will complete informed consent, inclusion/exclusion criteria, sleep apnea and snoring surveys online. If patient meets all criteria for the study, patient will be provided with a treatment device for use for a 10 day treatment period. Patient will complete the trial upon providing final online surveys.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Living in the United States
* Signing the Informed Consent Form

Exclusion Criteria:

* Missing teeth (as the device won't be properly fitted)
* Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition
* Poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores, or bleeding gums
* A dental implant placed within the last three months
* Diagnosed with a Temporomandibular joint condition (TMJ)
* Actively experiencing any mouth or jaw pain, including clenching of the teeth, grinding, or any other physical injury to the jaw or teeth
* Full dentures
* Braces
* Diagnosis of sleep apnea
* Less than 18 years of age

Primary outcomes:
measure: Snoring Severity Scale
timeFrame: Baseline and 10 Days
measure: Visual-Analogue Scale, Self-Reported Snoring Habits
timeFrame: Baseline and 10 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: The EyeDeas Company
state: California
Study officials:
affiliation: Zyppah, Inc.
name: Jonathan Greenburg, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05902507: Magnetic Resonance Imaging in Radiotherapy for Breast Cancer
Official title: Magnetic Resonance Imaging in RadiotheRapy fOr bReast Cancer (MIRROR): A Pilot Study of MRI Simulation
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Breast Cancer
Keywords: Imaging
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-06-15
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: PROBABILITY_SAMPLE
Study population: Female participants with breast cancer planning to undergo breast conserving surgery (BCS) and RT outside of this protocol.

Brief summary: This is a single-center, prospective pilot study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatment (RT) for breast cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To determine feasibility of acquiring MRI simulation prior to RT planning.

EXPLORATORY OBJECTIVE:

I. To determine change in target volume with MRI simulation compared to Computerized tomography (CT) simulation.

OUTLINE: MRI simulation will be performed once at baseline. There is no follow up planned for study purposes. Patients will be followed as part of their regular clinical care.

Eligibility criteria: Inclusion Criteria:

1. Participants with an Eastern Cooperative Oncology Group (ECOG) performance status \<=2 (or Karnofsky ≥\>=60%, see Appendix A).
2. Participants with the ability to understand and the willingness to sign a written informed consent document.
3. Participants may separately enroll on therapeutic clinical trials when they enroll on this trial. Note: All interventions on this protocol are standard of care, so enrollment on other therapeutic protocols is allowed at the discretion of the treating physician.
4. Patients must have pathologically confirmed invasive or in situ breast cancer.
5. Patients must have tumors in which adjuvant breast radiotherapy following breast conserving surgery is indicated, as determined by the treating physician.
6. Patients must be female. Note: Male patients are excluded due to the rarity of male breast cancer and difficulty in pursuing breast conserving surgery for male patients.

Exclusion Criteria:

1. Participants with a contraindication to MRI per the MRI checklist.
2. Patients with breast tumor or tumor bed not visualized at CT or MRI during RT planning.

Primary outcomes:
measure: Percentage of participants who completed scan
timeFrame: Day of MR imaging (1 day)
Secondary outcomes:
Other outcomes:
measure: Median absolute change in size of target
timeFrame: Day of MR imaging (1 day)
measure: Median relative difference in size of target
timeFrame: Day of MR imaging (1 day)
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lisa Singer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01143688: Characterization of Placebo Responses in Stable Asthma
Official title: Characterization of Placebo Responses in Stable Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma Placebo Effects
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-06-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. .

Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or "no treatment" in random order, on three different occasions each. At each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved and an 11-point, self-reported scale of improvement are examined.


Eligibility criteria: Inclusion Criteria:

* uncontrolled asthma

Exclusion Criteria:

* no bronchodilator response

Primary outcomes:
measure: Change in FEV1
timeFrame: FEV1 was assessed every 20 minutes for 2 hours at each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.
Secondary outcomes:
measure: Asthma Symptoms
timeFrame: Assesed over 2 hours during each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Michael Wechsler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940888: SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
Official title: SJ4 Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmias
Sudden Cardiac Death
Heart Failure
Keywords: ICD
CRTD
Heart Failure
DF4
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 1701
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: ICD and CRTD indicated patients

Brief summary: The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.


Eligibility criteria: Inclusion Criteria:

* Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
* Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.

Exclusion Criteria:

* Be currently participating in a clinical investigation that includes an active treatment arm.
* Have a life expectancy of less than 6 months due to any condition.
* Be less than 18 years of age.

Primary outcomes:
measure: Right Ventricle (RV) Bipolar Capture Thresholds
timeFrame: 5 years
measure: Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Clevleland Clinic Foundation
name: Bruce Wilkoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05317988: Online Training for the Reconstitution of Fosun/BioNTech
Official title: Online Training for the Reconstitution of Fosun/BioNTech: a Learning Platform to Determine Readiness for Complex Medication Preparation Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The COVID-19 vaccine by BioNTech requires specific, delicate storage and dilution procedures to be stringently followed for safety and effectiveness. Training should be completed prior to undertaking dilution procedures. Currently, the nursing and pharmacy curricula do not have content on specialized vaccine reconstitution techniques. E-learning has become an essential component of teaching and learning due to COVID. Yet, optimal online learning module development for clinical procedural skill acquisition and appropriate online formative assessment has not been adequately explored. To bridge this training gap for Hong Kong nurses and pharmacists, this project aims to develop a video-based online learning programme, coupled to a randomized controlled study to determine the effectiveness of online vaccine reconstitution training. The module, a supplement to the current teaching curriculum, will train students from both Nursing and Pharmacy disciplines. Outcome measures include formative assessment of student performance, which can be used to inform the design and content of experiential content in healthcare professional curriculums. If this learning platform is shown to be effective, the scope could be extended to other disciplines (not limited to healthcare) where learning complex procedural tasks are necessary for the absence of instructor-led teaching.


Eligibility criteria: Inclusion Criteria:

* Students currently enrolled in the Bachelor of Pharmacy and Bachelor of Nursing programmes (Years 1 to 4) at The University of Hong Kong

Exclusion Criteria:

* Students not from the aforementioned programmes and years of study

Primary outcomes:
measure: Factual knowledge
timeFrame: 1 week
Secondary outcomes:
measure: Procedural knowledge
timeFrame: 1 week
measure: Self-efficacy
timeFrame: 1 week
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre of Safe Medication Practice and Research
Study officials:
References:
Clinical trial NCT03780088: Improving Access to Care: Testing an Integrated Care Mobile Health Intervention
Official title: Improving Access to Care: Testing an Integrated Care Mobile Health Intervention to Improve Sleep and Mental Health in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Delayed Sleep Phase
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the feasibility, effectiveness, and dissemination potential of an innovative strategy for improving access to effective sleep health care for adolescents. The study will test an adaptation of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), a brief sleep intervention with demonstrated efficacy for improving sleep and mental health outcomes in youth.

Detailed description: This adaptation is designed to address the following key challenges to accessing care: (1) to overcome the challenge of low availability of qualified providers as a barrier to treatment access, we have adapted TranS-C for online and mobile device delivery (referred to as mTranS-C), thereby leveraging the high rates of mobile phone and internet use in adolescents; (2) to further increase access we will disseminate mTranS-C within primary care services, a proven strategy for improving access to behavioral health care; and (3) we focus on low-income communities, where there is a higher prevalence of sleep problems and low access to services.

Eligibility criteria: Inclusion Criteria:

* age 12-18 years
* a sleep health deficit
* youth has access to a mobile phone or internet
* youth is fluent in English.

Exclusion Criteria:

* current use of medications or herbs with known effects on sleep
* current substance use disorder
* current suicidality/thoughts of death
* thought disorder
* unstable major medical conditions
* current psychotherapy for sleep health deficits

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline to end of treatment (anticipated average exposure 2 months), and month 5
Secondary outcomes:
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: baseline to end of treatment (anticipated average exposure 2 months), and month 5
measure: Strengths & Difficulties Questionnaire (SDQ)
timeFrame: baseline and at months 2 and 5
Other outcomes:
Locations:
city: Atherton
country: United States
facility: Gardner Packard Children's Health Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lauren Asarnow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764088: A Retrospective Analysis of Patients With Full Thickness Wounds on a Case by Case Basis
Official title: A Retrospective Analysis of Patients With Full Thickness Wounds on a Case by Case Basis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Full Thickness Wounds
Keywords: full Thickness wounds
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic- Southwest Regional Wound Care Center

Brief summary: To demonstrate the effectiveness or ineffectiveness of novel treating agents or agents used for compassionate rescue, subjects and their wounds will be analyzed retrospectively and their non-identifiable information will be compiled in the form of case studies. Subjects who demonstrated characteristics of interest (e.g. healing) as determined by the PI will be chosen for case studies.

Detailed description: All wounds at the Southwest Regional Wound Care Center (WCC) are managed using anti-biofilm strategies. When determining the therapeutic course for a patient and his full thickness wound, all management agents that are available are considered for use; and the clinician uses his judgment to determine the most appropriate tools to use that will give the patient the most likely chance of success. Some of the agents that are used are novel, and it is appropriate to demonstrate to others the potential usefulness of these agents

Eligibility criteria: Inclusion Criteria:

* Male or female \> 18 years old
* Retrospective analysis

Primary outcomes:
measure: Retrospective Analysis of Patients with Full Thickness Wounds
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall Wolcott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01194388: Axium Coil in Completing Endovascular Aneurysm Surgery Study
Official title: Axium Coil in Completing Endovascular Aneurysm Surgery Study: A Single-center, Prospective Observational Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intracranial Aneurysm
Keywords: Patients presenting with an intracranial aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2010-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with an intracranial aneurysm will be evaluated by the neuro interventional team, in accordance with institutional practice, to establish an appropriate treatment plan based on the patient's medical condition and available diagnostic screening prior to recruitment.

Brief summary: The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.

Detailed description: Up to 25 patients from from US centers are anticipated to be enrolled for this evaluation. Published literature on coils with electrolytic, thermal or hydraulic detachment will serve as the basis for control comparisons to the Axium™ MicroFx™ Detachable Coil System for patients undergoing embolization of intracranial aneurysm. Comparison will be based on criteria evaluating the safety of the procedure, the reliability of detachment, the occlusion stability and the packing density impact.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
* Information on data collection provided to the patient or legally authorized representative and signed informed consent.
* Aneurysm diameter ≤10mm
* Age range of 18 - 90.

Exclusion Criteria:

* Aneurysm previously treated.
* Aneurysm AVM related or dissecting.
* Participation in a clinical investigation of other aneurysm treating or related devices.
* Any condition that would preclude the conduct of protocol follow-up.
* Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT04215588: Heparin and Protamine Titration in Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
Official title: Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Bypass
Keywords: anticoagulation
cardiopulmonary bypass
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* elective cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* known blood disorder
* contraindication to heparin administration

Primary outcomes:
measure: Total heparin dose
timeFrame: operation duration
measure: Total protamine dose
timeFrame: At the end of the cardiopulmonary bypass
Secondary outcomes:
measure: Red Blood Cells transfusion
timeFrame: intraoperatively
measure: Red Blood Cells transfusion
timeFrame: 24 hours after the end of the operation
measure: Fibrinogen concentrate transfusion
timeFrame: intraoperatively
measure: Fibrinogen concentrate transfusion
timeFrame: 24 hours after the end of the operation
measure: Prothrombin Complex Concentrate transfusion
timeFrame: intraoperatively
measure: Prothrombin Complex Concentrate transfusion
timeFrame: 24 hours after the end of the operation
measure: Platelets transfusion
timeFrame: intraoperatively
measure: Platelets transfusion
timeFrame: 24 hours after the end of the operation
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
affiliation: Associate Professor
name: Eleni Argiriadou, Dr
role: STUDY_CHAIR
References: