louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03290300: Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device
Official title: A Prospective, Multi-Center, Non-Randomized Study to Evaluate the Quality of Life Impact After Treatment of Nasal Airway Obstruction Using the Aerin Medical Vivaer Stylus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Obstruction
Keywords: Nasal valve
Nasal airway obstruction
Quality of Life
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2017-09-21
Enrollment: 39
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects in this study will all have completed participation in the TP 258 Nasal Obstruction study.

Brief summary: Evaluation of long-term (5-year) quality of life after nasal airway obstruction treatment with the Aerin Vivaer Stylus

Detailed description: This is a prospective, non-randomized, multi-center follow-up study to collect long term quality of life (QOL) data on a cohort of patients who participated in the Aerin Medical TP258 study "A Prospective, Multi-Center, Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device". The TP258 study followed subjects out to 26 weeks post-procedure. This QOL study will collect data at 12, 18, 24, 36, 48 and 60 months post-procedure.

Eligibility criteria: Inclusion Criteria:

* Received nasal obstruction treatment in Aerin Study TP 258

Exclusion Criteria:

* Unwilling to participate in this long-term study

Primary outcomes:
measure: Change From Baseline NOSE Score
timeFrame: Baseline, 12, 18, 24 months post-procedure
measure: Change From Baseline NOSE Score - Long Term Extended Follow-up
timeFrame: Update to include Extended Follow up to 36-, 48- months post-procedure
measure: Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items
timeFrame: 12, 18, 24 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT and Allergy
state: Colorado
city: Oradell
country: United States
facility: ENT and Allergy Associates, LLP
state: New Jersey
city: Bayside
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: Middletown
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: New Hyde Park
country: United States
facility: ENT and Allergy Associates, LLP
state: New York
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose and Throat Associates
state: North Carolina
city: McKinney
country: United States
facility: Ear, Nose and Throat Associates of Texas
state: Texas
Study officials:
affiliation: Aerin Medical
name: Scott Wolf, MD
role: STUDY_DIRECTOR
affiliation: ENT and Allergy Associates, Middletown, NY
name: Ofer Jacobowitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05835700: The Relationship Between Serum Gasdermin-D Levels and Pyroptosis and Preterm Labor
Official title: Research of the Relationship Between Serum Gasdermin-d Levels and Pyroptosis and Preterm Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gasdermin D Levels in Preterm Labor
Keywords: gasdermin D
preterm labor
pyroptosis
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 327
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Gastermin D and Pentaxin 3 levels were measured in the patients participating in the study. These are not routinely checked markers. Participants were assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on preeclampsia or HELLP related outcomes. Due to this, our work is interventional.
Primary purpose: OTHER

Brief summary: In this study, the investigators aimed to investigate the relationship between Gasdermin D levels measured from the maternal serum of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.

Detailed description: This prospective case- control study was conducted between 15 July 2021 and 15 July 2022 at Bursa Yüksek İhtisas Training and Research Hospital. The study was conducted with pregnant women between the ages of 18-45 who were idiopathic preterm labor. Pregnant women between the ages of 18-45 who were diagnosed with preterm labor between 24-37 weeks of gestational were included. This study was conducted with 160 pregnant women who were diagnosed with idiopathic preterm labor and 167 healthy pregnant women who were in the same gestational week as these pregnant women and were not diagnosed with preterm labor. Group 1 patients diagnosed with preterm labor between 24-37 weeks( study group) (n:160), Group 2 consisted of healthy pregnant women who were not diagnosed with preterm labor between 24-37 weeks ( control group) (n: 167) . In group 1, 80 patients were diagnosed with early preterm (between 24-34 weeks ) and 80 patients with late preterm labor (34-36+6 weeks).

Eligibility criteria: Inclusion Criteria:

* Pregnant women who were diagnosed with idiopathic preterm labor and gave birth in our hospital
* Pregnant women without vaginal infection
* Healthy pregnant women between 24-37 weeks without a diagnosis of preterm labor

Exclusion Criteria:

* Multiple pregnancies
* Pregnant women with a prediagnosis of chromosomal and congenital anomalies in the fetus
* Women with a known infective or autoimmune disease before pregnancy

Primary outcomes:
measure: relationship between Gasdermin-D levels in preterm labor
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT06815900: Correlation Between Sleep Quality , Physical Fitness and Body Mass Index
Official title: Correlation Between Sleep Quality , Physical Fitness and Body Mass Index in Physical Therapy Students
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sleep Quality , Physical Fitness and Body Mass Index
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: both male and female aged between 18-25 years old

Brief summary: It is estimated that 10-13% of adults suffer from chronic insomnia. Short sleep duration is linked to obesity, type 2 diabetes, high blood pressure, and cardiovascular diseases. Feeling tired during the day predicts poor sleep quality (SQ), while wakefulness is linked to better SQ. Previous studies have also reported a relationship between short sleep duration and increased Body Mass Index (BMI), and a high correlation between increased BMI and decreased SQ, with more frequent awakenings. Moreover, there is a connection between sleep disorders and weight gain. The study is significant because it aims to uncover the relationships between sleep quality, physical fitness, and body mass index (BMI) in physical therapy students, offering insights crucial for improving their health and academic performance. By identifying how these factors interact, the study can inform targeted interventions to enhance student well-being, clinical competence, and long-term health. Additionally, the findings can guide educational programs to support healthier lifestyles and enable students to serve as effective role models for their future patients, thereby contributing to overall healthcare quality.


Eligibility criteria: Inclusion Criteria:

* Student of both gender with age that ranges from 18 to 25 years old.
* Must be actively enrolled in an accredited physical therapy program.
* Open to students from any year of study within the physical therapy program.

Exclusion Criteria:

* Diagnosed with sleep disorders such as insomnia, sleep apnea, or narcolepsy.
* Chronic physical conditions like cardiovascular, respiratory, neurological, or musculoskeletal disorders.
* Metabolic or endocrine disorders such as diabetes or thyroid disorders.

Primary outcomes:
measure: sleep quality
timeFrame: six months
measure: physical fitness
timeFrame: six months
measure: body mass index
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01198600: Ocular Comfort and the "Aging" Lens (ERBIUM)
Official title: Ocular Comfort and the "Aging" Lens (ERBIUM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2010-09-10
Enrollment: 78
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.

Detailed description: Eligible participants began Phase 1, following either Cycle A or Cycle B, and crossing over to the second cycle after completing the first. After the Phase 1 results were evaluated, eligible participants entered Phase 2. After Phase 2 results were evaluated, participants who consistently reported the highest and the lowest comfort scores entered Phase 3 and were defined as either survivors or strugglers.

Eligibility criteria: Inclusion Criteria:

* At least 17 years of age.
* Ocular exam in the last two years.
* Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
* Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
* Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular disease.
* Systemic condition that may affect a study outcome.
* Using any systemic or topical medications that may affect ocular health.
* Wears lenses on an extended or continuous wear schedule.
* Habitually wears multifocal lenses.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1
timeFrame: Day 1
measure: Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10
timeFrame: Day 1
measure: Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day
timeFrame: Day 1
measure: Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1
timeFrame: Day 15
measure: Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10
timeFrame: Day 15
measure: Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day
timeFrame: Day 15
measure: Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1
timeFrame: Day 43
measure: Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10
timeFrame: Day 43
measure: Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day
timeFrame: Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo Centre for Contact Lens Research
name: Desmond Fonn, MOptom FAAO
role: STUDY_DIRECTOR
References:
Clinical trial NCT06602700: Effects of High-intensity Interval Training and Moderate-intensity Continuous Training on Functioning of Attentional Networks and Heart Rate Variability in Healthy Adults
Official title: Effects of High-intensity Interval Training and Moderate-intensity Continuous Training on Functioning of Attentional Networks and Heart Rate Variability in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: high-intensity interval training
moderate-intensity continuous training
attention networks
heart rate variability
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study investigated the effects of HIIT and MICT on functioning of attentional networks and explored the relationship between heart rate variability (HRV) and these networks in healthy adults.


Eligibility criteria: Inclusion Criteria:

* normal or corrected-to-normal vision
* normal auditory function without any reading disorders
* right-handed

Exclusion Criteria:

* color blindness
* color weakness
* dyslexia
* history of smoking
* cardiovascular diseases
* personal or family history of mental illness

Primary outcomes:
measure: reaction times of the ANT-I task
timeFrame: immediately after interventions
measure: accuracy of the ANT-I task
timeFrame: immediately after interventions
measure: HR
timeFrame: immediately after interventions
measure: heart rate variability
timeFrame: immediately after interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sports, Exercise and Brain Sciences Laboratory, Sports Coaching College, Beijing Sport University, Beijing 100084, China
state: Haidian district
Study officials:
References:
Clinical trial NCT01810900: To Assess the Anti-adhesive Effect and Safety of Protescal
Official title: To Assess the Anti-adhesive Effect and Safety of Protescal Following Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Laparoscopic Myomectomy
Keywords: anti-adhesive effect and safety, laparoscopic myomectomy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This multicenter, randomized, single-blind study assessed the safety and efficacy of Protescal for the reduction of post-operative adhesion formation following myomectomy.

Detailed description: The age of the patients participating in the study overed 20 years and included nonpregnant women requiring laparoscopic myomectomy and expected to undergo a second-look laparoscopy as part of their treatment plan 5 weeks after the initial surgery.

Eligibility criteria: Inclusion Criteria:

* a woman who is over 20 years old
* a woman who needs a laparoscopic myomectomy

Exclusion Criteria:

* a pregnant woman and a nursing mother

Primary outcomes:
measure: presence/absence of postoperative adhesions at second-look procedure
timeFrame: at second look laparoscopy after 5 weeks later initial laparoscopic myomectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
References:
Clinical trial NCT02596100: A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
Official title: A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.

Detailed description: Serial blood samples will be obtained for PK evaluation.

Eligibility criteria: Inclusion Criteria:

* All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents.
* A healthy man or woman between the ages of 18 and 60
* Has no clinically significant findings in medical history, physical examination, EKG and vital signs
* Weighs \> 45 kg (99 lbs.) and has body mass index (BMI) \< 30 kg/m2
* Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods
* Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods

Exclusion Criteria:

* None of the exclusion criteria may be present for enrollment
* Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation
* Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug
* History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug
* History of alcohol abuse (greater than 3 alcoholic beverages per day)
* Positive screen for drugs of abuse
* Positive serology test for HIV, Hepatitis B or C
* Has any allergy or sensitivity to fXa inhibitors

Primary outcomes:
measure: Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects
timeFrame: 120 hours
measure: Bioequivalance analysis using peak concentration in plasma (Cmax) after a single dose of Betrixaban in healthy volunteers
timeFrame: 120 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05337800: Stress Management on Nursing Students
Official title: The Effect of Stress Management Program on Clinical Stress of First Year Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Clinical Anxiety
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, it was aimed to determine the effect of the stress management program on the clinical stress of first year nursing students. This research will be carried out in a randomized controlled experimental design.

The data of the research; The descriptive characteristics form will be collected using the Perceived Stress Scale for Nursing Students, the Bio-Psycho-Social Response Scale for Nursing Students, and the Stress Coping Behaviors Scale for Nursing Students. students will be assigned as experiment (32) and control (32) by randomization. A four-session stress management program will be applied to the experimental group students. No intervention will be made on the control group.


Eligibility criteria: Inclusion Criteria:

The first to enroll in the Nursing Fundamentals course,

Exclusion Criteria:

* Have previously taken nursing fundamentals course

Primary outcomes:
measure: Perceived Stress Scale for Nursing Students
timeFrame: 15 minute
measure: Bio-Psycho-Social Response Scale for Nursing Students
timeFrame: 20 minute
measure: Stress Coping Behaviors Scale for Nursing Students
timeFrame: 15 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
References:
citation: Mackenzie CS, Poulin PA, Seidman-Carlson R. A brief mindfulness-based stress reduction intervention for nurses and nurse aides. Appl Nurs Res. 2006 May;19(2):105-9. doi: 10.1016/j.apnr.2005.08.002.
citation: Botha E, Gwin T, Purpora C. The effectiveness of mindfulness based programs in reducing stress experienced by nurses in adult hospital settings: a systematic review of quantitative evidence protocol. JBI Database System Rev Implement Rep. 2015 Oct;13(10):21-9. doi: 10.11124/jbisrir-2015-2380.
citation: Karaca A, Sisman NY. Effects of a Stress Management Training Program With Mindfulness-Based Stress Reduction. J Nurs Educ. 2019 May 1;58(5):273-280. doi: 10.3928/01484834-20190422-05.
Clinical trial NCT05227352: Bio-Experiential Spaces for Mental Health in Healthworkers
Official title: Exploring the Concepts of Bio-experiential Spaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Cognition
Anxiety
Keywords: biophilic design
mental health
cognition
PTSD
anxiety
stress
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Recharge Rooms are immersive, biophilic private spaces designed to ameliorate trauma, anxiety, and stress. They feature multisensory input that is inspired by nature, as has previously been found to confer physiological benefits. These environments include silk imitation plants, projected scenes of soothing natural landscapes, low lighting that is tailored in color to match the landscapes that are being projected, high definition audio recordings of nature sounds paired with relaxing music, and infusion of essential oils and calming scents.

The aim is to investigate the physiological and mental health outcomes that the short and long term exposure to these rooms have on healthcare workers. The data will be collected through online surveys. No identifiable information will be assessed or collected. The plan is to have 60 participants.


Eligibility criteria: Inclusion Criteria

* Adults over the age of 18
* Current healthcare employee of Mount Sinai Hospital or the Icahn School of Medicine at Mount Sinai

Exclusion Criteria

* Age under 18
* Not employed by Mount Sinai or Icahn School of Medicine at Mount Sinai

Primary outcomes:
measure: Well-Being Index
timeFrame: 6 weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder 7 (GAD7)
timeFrame: 6 weeks
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 6 weeks
measure: The Insomnia Severity Index (ISI)
timeFrame: 6 weeks
measure: The Fatigue Severity Scale (FSS)
timeFrame: 6 weeks
measure: Brief Resilience Scale (BRS)
timeFrame: 6 weeks
measure: Satisfaction With Life Scale (SWLS)
timeFrame: 6 weeks
measure: Maslach Burnout Inventory-Human Services Survey
timeFrame: 6 weeks
measure: Social Connectedness Scale
timeFrame: 6 weeks
measure: Situational Awe Scale
timeFrame: 6 weeks
measure: Heart Rate Pulse Oximeter
timeFrame: 6 weeks
measure: Oxygen Saturation (pO2) Oximeter
timeFrame: 6 weeks
measure: Automatic Blood Pressure
timeFrame: 6 weeks
measure: Galvanic Skin Response (GSR)
timeFrame: 6 weeks
measure: Power spectrum density by EEG
timeFrame: 6 weeks
measure: Coherence by EEG
timeFrame: 6 weeks
measure: Frequency band power by EEG
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Recharge Room at Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine
name: Mar Cortes, MD
role: PRINCIPAL_INVESTIGATOR
References: