louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05170191: Effect of Sleep Deprivation on Sensory Integration of Balance, Fall Risk and Postural Stability
Official title: Effect of Sleep Deprivation on Sensory Integration of Balance, Fall Risk and Postural Stability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Deprivation
Keywords: sleep deprivation
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young adults aged 19-24 will be included in the study.

Brief summary: Sleepiness caused by sleep deprivation may increase the risk of injuries and damages during physical activity. Individual data so far indicates worsening of postural stability and control with females exhibiting better static postural stability regardless of sleeping conditions in comparison to men. However, the literature is deficient in terms of postural stability conditions with eyes open and eyes closed states, as well as fall risk and sensory integration of balance.


Eligibility criteria: Inclusion Criteria:

* Age 19 to 24
* Healthy young adults from Rawalpindi/Islamabad.
* Both males and females
* Participants should have normal sleep patterns without any signs or symptoms of insomnia or hypersomnia.
* Persons without any sleep disorders.
* Persons without any neurological disease.

Exclusion Criteria:

* Persons with sleep disorders such as hypersomnia, insomnia, parasomnia etc.
* Elderly population.
* Persons with any sort of neurological deficits.
* COVID positive and those with any suspected signs and symptoms of COVID-19.
* Alcoholics
* Pregnant females
* A participant with the history of or active diagnosed conditions of any of the following, which renders individual's performance will be excluded:

  * Neurological.
  * Musculoskeletal.
  * Cardiopulmonary.
  * Any congenital disorder or limb deformities.

Primary outcomes:
measure: Postural Stability Index
timeFrame: 24 hours
measure: Fall Risk Score
timeFrame: 24 hours
measure: Clinical Test of Sensory Integration and Balance
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Institute of Rehabilitation Sciences.
state: Federal
Study officials:
References:
Clinical trial NCT06085391: Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study
Official title: Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Regulation
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2023-10-17
Enrollment: 185
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This activity will have the objective of testing the validity of the integrated in-game assessment and personalized REThinkEMOTIONS platform in the prevention of emotional disorders in youth.


Eligibility criteria: Inclusion Criteria:

* children and adolescents between 8 and 16 years old
* provided written parental consent
* able to access mobile/internet applications on their device

Exclusion Criteria:

* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder

Primary outcomes:
measure: Levels of rational and irrational beliefs
timeFrame: baseline, pre-intervention
measure: Changes of rational and irrational beliefs
timeFrame: Post-intervention (one week after the intervention)
measure: Fluctuations in of rational and irrational beliefs
timeFrame: 6 months Follow-up
measure: Levels of emotion-regulation
timeFrame: baseline, pre-intervention
measure: Changes in emotion-regulation
timeFrame: Post-intervention (one week after the intervention)
measure: Fluctuations in emotion-regulation
timeFrame: 6 months Follow-up
measure: Levels of child behavioral difficulties
timeFrame: Pre-intervention (one week before the intervention)
measure: Changes in child behavioral difficulties
timeFrame: Post-intervention (one week after the intervention)
measure: Fluctuations in child behavioral difficulties
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Level of emotional distress
timeFrame: baseline, pre-intervention
measure: Changes in emotional distress
timeFrame: Post-intervention (one week after the intervention)
measure: Fluctuations in emotional distress
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
Study officials:
References:
Clinical trial NCT04371991: Kisspeptin Levels in Early Pregnancy
Official title: Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Pregnancy
Ectopic Pregnancy
Keywords: kisspeptin
ectopic pregnancy
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-01
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women were considered for the study if they presented between 5-6 weeks of gestation by last menstrual period. Patients were included if they had either confirmed intrauterine pregnancy (IUP) by ultrasound (n=22) or confirmed miscarriage (SAB) by ultrasound (n=20) or ectopic pregnancy.

Brief summary: Kisspeptins are a family of neuropeptides that are critical for the puberty initiation and female fertility. The investigators aimed to investigate in this study kisspeptin levels in early pregnancy, ectopic pregnancy, and early pregnancy loss.

Detailed description: Clinicians can easily do a differential diagnosis of early pregnancy, miscarriage, and ectopic pregnancy when the human chorionic gonadotropin (hCG) values higher than 2000 mIU/mL with transvaginal ultrasound. However, in cases where the hCG value is below the critical threshold of 1500 to 2000 mIU/mL (often called the discrimination level) and ultrasound is not likely to be diagnostic, the pregnancy is of unknown location. Plasma or serum kisspeptin is mainly derived from the placenta during pregnancy and plasma kisspeptin levels significantly increase across pregnancy. Plasma kisspeptin levels could be used as a potential biomarker for the discrimination of miscarriage and ectopic pregnancy.

All statistics will be carried out with the use of SPSS (ver. 21, IBM). A P value of \<.05 is considered to be statistically significant. Pearson chi-square test will be used to evaluate between-group differences by pregnancy outcome for categoric data. Kisspeptin differences will be calculated between groups with one way ANOVA.

Eligibility criteria: Inclusion Criteria:

Women aged between 18-37 years presented with between 5-6 weeks of gestation by last menstrual period.

Exclusion Criteria:

* Women older than 37 years or younger than 18 years
* Women with a molar pregnancy, multiple gestations, gestational age past 6 weeks at the time of blood draw, or if pregnancies were assisted conceptions

Primary outcomes:
measure: Kisspeptin levels in early pregnancy
timeFrame: January 2019-January 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Education and Research Hospital
Study officials:
affiliation: Gaziosmanpasa Taksim Education and Research Hospital
name: sibel bektas, proffessor
role: STUDY_CHAIR
References:
Clinical trial NCT02074891: Sustainable Healthcenter Implementation PrEP Pilot Study
Official title: Sustainable Healthcenter Implementation PrEP Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Chemoprophylaxis
HIV Preexposure Prophylaxis
Keywords: preexposure prophylaxis
PrEP
HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: CDC Foundation
name: Gilead Sciences
First posted: 2014-02-28
Enrollment: 1420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1200 adult men who have sex with men, injection drug users, and heterosexually-active men and women who are at substantial risk of acquiring HIV infection and initiate the use of daily oral antiretroviral preexposure prophylaxis (PrEP) with TDF/FTC

Brief summary: A health services implementation pilot study, conducted with an observational cohort of HIV-uninfected persons including men who have sex with men, heterosexual women and men, and injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at four federally qualified health centers that provide sexual health and primary care services to communities with high HIV incidence/prevalence.


Eligibility criteria: Inclusion Criteria:

* adult
* documented without HIV infection (acute or established)
* report sexual behaviors that indicate substantial risk of HIV acquisition
* report injection-related behaviors that indicate substantial risk of HIV acquisition

Exclusion Criteria:

* \<18 years of age
* documented HIV infection (acute or established)

Primary outcomes:
measure: Clinical safety
timeFrame: Every 3 months up to 36 months
measure: Medication adherence
timeFrame: Every 3 months up to 36 months
measure: Behavioral Responses
timeFrame: Every 3 months up to 36 months
Secondary outcomes:
measure: Costs
timeFrame: Up to 3 years
measure: Clinical practice variation
timeFrame: Every 3 months up to 36 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Whitman Walker Health
state: District of Columbia
city: Chicago
country: United States
facility: Access Community Health Network - Grand Boulevard Health and Specialty Center
state: Illinois
city: Chicago
country: United States
facility: Howard Brown Community Health Center
state: Illinois
city: Jackson
country: United States
facility: Open Arms Healthcare Center
state: Mississippi
city: Philadelphia
country: United States
facility: Strawberry Mansion Health Center
state: Pennsylvania
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Dawn K Smith, MD, MS, MPH
role: STUDY_CHAIR
affiliation: CDC Foundation
name: Rebecca Cook, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06934291: Full Mouth Ultrasonic Debridement Carried Out With Either Piezoelectric or Magnetostrictive Device
Official title: Clinical and Patient-Centered Outcomes of Full-Mouth Ultrasonic Debridement for Periodontitis: A Randomized Controlled Trial Comparing Piezoelectric and Magnetostrictive Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis, Adult
Keywords: periodontitis
patient centred outcomes
magnetostrictive
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of periodontitis requires the removal of dental biofilm through both professional mechanical plaque removal and at-home oral hygiene practices. This study aims to compare clinical and psychological outcomes following professional treatment using either piezoelectric or magnetostrictive ultrasonic devices.

Detailed description: Patients diagnosed with periodontitis will be screened for eligibility criteria. A comprehensive full-mouth periodontal assessment will be conducted by a calibrated examiner to determine the severity and extent of the disease. Subsequently, patients will receive oral hygiene instructions, and group allocation will be revealed using a sealed envelope. Based on the assigned group, full-mouth ultrasonic debridement will be performed by a trained operator. Patient perceptions regarding the treatment will then be recorded. After three months, patients will return for a follow-up periodontal evaluation.

Eligibility criteria: Inclusion Criteria:

* \>18 years
* periodontitis of stage 1 and 2
* absence of systemic chronic disease

Exclusion Criteria:

* anticoagulants treatment
* antibiotic treatment 3 months before the screening visit

Primary outcomes:
measure: Pain perception
timeFrame: through study completition, on average 6 months
measure: noise
timeFrame: through study completition, on average 6 months
measure: vibration
timeFrame: through study completition, on average 6 months
Secondary outcomes:
measure: pocket closure
timeFrame: through study completition, on average 6 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
state: SI
Study officials:
References:
Clinical trial NCT02795091: Comparision of Different Methods of Enviromennt Disinfection
Official title: Comparision of Different Methods of Enviromennt Disinfection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Enviroment Cleaning
Keywords: clean supplies
ICU floor
bacteria colony
catheter associated with infection
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Multidrug resistance bacteria infection is common in ICU. Infection incidence is associated with age, organ dysfunction, invasive treatment and enviroment cleaning. According to hospital hygienic standard for disinfection, total numbers of colony of air and the object surface in ICU must be ≤4CFU/cm2（5min）and≤10CFU/cm2. in this study, the two different methods will be used to evaluate the disinfection effects in ICU enviroments.


Eligibility criteria: Inclusion Criteria:

no patients recruitment

Exclusion Criteria:

no patients recruitment

Primary outcomes:
measure: incidence of infection
timeFrame: up to one month
Secondary outcomes:
measure: dose of antibiotics
timeFrame: up to one month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03477591: Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening Decisions
Official title: McMaster Choices Study: Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Screening
PSA testing
Patient Decision Aid
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2018-03-26
Enrollment: 308
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by men facing prostate cancer screening decisions.

Detailed description: Guidelines for prostate screening in Canada are based on low-moderate quality evidence of effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs) are tools that assist users to understand treatment options, risks and benefits to align decisions with values and preferences. The investigators would now like to know whether use of a PDA alongside evidence-based information provided through the McMaster Optimal Aging Portal, or simply access to evidence-based information alone, can help users to make informed decisions about prostate cancer screening in men.

Eligibility criteria: Inclusion Criteria:

* English speaking men, \> 50 years old

Exclusion Criteria:

* History of prostate cancer or PSA test in the last 12 months

Primary outcomes:
measure: Decisional conflict
timeFrame: Change from baseline to 6-mo
Secondary outcomes:
measure: Decision quality
timeFrame: Change from baseline to 6-mo
measure: Preparation for decision making
timeFrame: Change from baseline to 6-mo
measure: Screening behaviour
timeFrame: Change from baseline to 6-mo
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen Dobbins, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252691: Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients
Official title: Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lumbar Disc Herniation
Anular Tear of Lumbar Disc
Nucleus Pulp Hernia;Lumbosac
Lead sponsor: Intrinsic Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: One hundred and fifty (150) subjects will participate in the study. Participants will be between 18 and 75 years of age. All subjects will have been diagnosed with primary lumbar disc herniation requiring surgical discectomy as per the opinion of the treating surgeon. All subjects who meet the inclusion criteria, do not meet any of the exclusion criteria, and who elect to participate and sign the informed consent will be included in the study.

Brief summary: Lumbar discectomy study, collection and evaluation of incidence of large annular defects.

Detailed description: This study is designed as a single-site prospective data collection. Measurements will be collected during 150 consecutive standard of care primary lumbar discectomy procedures.

Eligibility criteria: Inclusion Criteria:

1. Must be 18-75 years of age, and skeletally mature
2. Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1.
3. Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care.
4. Subject must understand and sign the written Informed Consent.

Exclusion Criteria:

1. Prior surgery at the index lumbar vertebral level.
2. Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain
3. Morbid obesity (BMI ≥ 40 kg/m2)
4. Investigational drug or device use within 30 days

Primary outcomes:
measure: Incidence of large defects noted on primary lumbar discectomy procedure.
timeFrame: Intra-operatively
Secondary outcomes:
measure: Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.
timeFrame: Intra-operatively
measure: Verify access to annular defect with approved manual surgical instruments.
timeFrame: Intra-operatively
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Laser Spine Institute
state: Florida
Study officials:
affiliation: Laser Spine Institute
name: Reginald Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06589791: A Disease Area Study on the Awareness and Perceptions of Systemic Inflammation and hsCRP as a biomARKer in Patients With ASCVD and CKD in China Among Cardiologists and Nephrologists
Official title: A Disease Area Study on the Awareness and Perceptions of Systemic Inflammation and hsCRP as a biomARKer in Patients With ASCVD and CKD in China Among Cardiologists and Nephrologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Cardiovascular Disease (ASCVD)
Chronic Kidney Disease (CKD)
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiologists and nephrologists with patients that have ASCVD and CKD in China

Brief summary: This is a survey-based study with the objective to understand the awareness, perceptions and potential clinical management patterns among Chinese cardiologists and nephrologists towards the role of systemic inflammation in patients with ASCVD and CKD in real-world clinical setting.


Eligibility criteria: Inclusion Criteria:

* Work in cardiology, internal medicine, or nephrology department
* Specialize in one of the following: coronary interventional cardiology, HF, general cardiology, preventive cardiology, cardiac rehabilitation or nephrology
* Practice at consultant level for 3+ years after standardized training for resident physicians or 3+ years' working experience as a specialist
* Manage at least 20 adult patients with ASCVD and CKD (not dialysis-only) every month

Exclusion Criteria:

* Unwilling to provide informed consent
* Insufficient number of patients with ASCVD and CKD
* Do not fulfil inclusion criteria.

Primary outcomes:
measure: Health care professional's perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD
timeFrame: At the time of survey response (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Novo Nordisk Shanghai Pharmaceuticals Co., Ltd
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: