louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04594278: COVID-19 Burnout Study
Official title: Remote Delivery of a Mindfulness-based Intervention to Decrease Anxiety Levels and Burnout Among Health-care Professionals During the Covid-19 Pandemic
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 44
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: The aims of this study are to assess whether the use of a MBI therapy delivered remotely is associated with a reduction of perceived stress among HCPs in the Radiation Medicine Program (RMP) and with a decrease risk of burnout during and post COVID-19.


Eligibility criteria: Inclusion Criteria:

* -Employee in the radiation medicine program in UHN
* Health Care Professional (Therapist, Nurse, Physician, Resident, Physician assistant, Physician admin assistant)
* Over 18

Exclusion Criteria:

* Not working at the radiation medicine program at UHN

Primary outcomes:
measure: Perceived Stress
timeFrame: 6 months
Secondary outcomes:
measure: Burnout
timeFrame: 6 months
measure: Coping with Stress
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02603978: Interventions for Sanctioned Ohio University Students
Official title: Examining the Efficacy of Interventions for Sexual Assault: A Preliminary Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alcohol Drinking
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
First posted: 2015-11-13
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander and social norms intervention are effective at reducing alcohol use and sexual-related behaviors among college men mandated to receive an alcohol intervention by their university.


Eligibility criteria: Inclusion Criteria:

* Must be 18 or older; must be an ohio university student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University

Exclusion Criteria:

* Under the age of 18; not attending the main Ohio University campus (Athens)

Primary outcomes:
measure: The Alcohol Use Disorders Identification Test
timeFrame: 6 months post-intervention
measure: Bystander Behavior Scale
timeFrame: 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03006978: Pilot Study of the TearCare System
Official title: Pilot Study of the TearCare System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-30
Enrollment: 24
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 purpose of this study is to evaluate the clinical utility, safety, and effectiveness of the TearCare™ System compared to standardized warm compress therapy for the application of controlled, localized heat therapy in adult patients with dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Dry eye symptoms within 30 months of the screening exam with a SPEED score \>=6
* Schirmer 1 value of \<010 mm in at least one eye or a Tear Breakup time \<10 seconds in at least one eye

Exclusion Criteria:

* Any active ocular or peri-ocular infection or inflammation
* Recurrent eye inflammation within the past 3 months
* Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster
* Ocular surface abnormalities that may affect tear film distribution or treatment
* Abnormal eyelid function in either eye
* Diminished or abnormal facial, periocular, ocular or corneal sensation
* Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies
* Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome)
* Allergies to silicone tissue adhesives
* An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia).
* Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.)
* Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days.
* Unwillingness to washout and remain off certain dry eye medications for the duration of the study.
* Participation in another ophthalmic clinical trial within the past 30 days
* Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)

Primary outcomes:
measure: Tear Breakup Time
timeFrame: 4 weeks
Secondary outcomes:
measure: Meibomian Gland Assessment
timeFrame: Day 1, Week 2, Week 4, 3 Month, 6 Month
measure: Dry Eye Symptoms and Quality of Life
timeFrame: Week 2, Week 4, 3 Month, 6 Month
measure: Change in Medication Use
timeFrame: Day 1, Week 2, Week 4, 3 Month, 6 Month
measure: Adverse Events
timeFrame: Day 0, Day 1, Week 2, Week 4, 3 Month, 6 Month
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Central Eye Care, Ltd.
state: Illinois
Study officials:
References:
Clinical trial NCT01505478: Comparing an Automated to a Conventional Sepsis Clinical Prediction Rule
Official title: Comparing an Automated to a Conventional Sepsis Clinical Prediction Rule
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sepsis
Keywords: Sepsis
Clinical Prediction Rule
Clinical Informatics
Machine Learning
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: New York University
name: United States Department of Defense
First posted: 2012-01-06
Enrollment: 0
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: Patients admitted from the Emergency Department with suspected infection.

Brief summary: The investigators will conduct a prospective cohort study to compare an automated sepsis severity score to a conventional clinical prediction rule to risk stratify patients admitted from the emergency department (ED) with suspected infection for 28 day in-hospital mortality.


Eligibility criteria: Inclusion Criteria:

* All consecutive adult (age 18 or older) Emergency Department (ED) patients during the study period that have been admitted from the ED and identified by the treating clinician to have a suspected infection at the time of ED disposition will comprise our study population.

Exclusion Criteria:

* No patients will be excluded from the study.

Primary outcomes:
measure: 28 day in-hospital mortality
Secondary outcomes:
measure: ICU Admission
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Steven Horng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02616978: Retrospective Study on the Use of CEFALY® Device During Migraine Attacks
Official title: Retrospective Study on the Use of CEFALY® Device During Migraine Attacks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Lead sponsor: Cefaly Technology
Sponsor class: INDUSTRY
First posted: 2015-11-30
Enrollment: 807
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French speaking patients in Belgium, Switzerland and France, having ordered new electrodes during the last year will be identified as regular users.

Brief summary: This is an Internet survey to collect data on the use of the Cefaly device to treat migraine attacks in regular Cefaly users.

Detailed description: About 1000 CEFALY users, having the device since more than one year and having reordered electrodes in the last year, will be invited to participate to an Internet survey. This survey contains at most 8 questions, and data will be collected completely anonymously. Questions concern the use or not of the CEFALY during migraine attacks, the number of treated attacks and the number and type of acute anti-migraine drugs that were avoided thanks to the use of the CEFALY.

Eligibility criteria: Inclusion Criteria:

* Subjects using Cefaly device regularly for more than a year identify by reordering of electrodes during the last year.
* History of likely episodic or chronic migraine with or without aura diagnosed by a physician

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack
timeFrame: Maximum 1 year
Secondary outcomes:
measure: Proportion of Cefaly users that report using also the device to treat migraine attacks
timeFrame: Maximum 1 year
measure: Proportion of migraine attacks treated with the Cefaly device
timeFrame: Maximum 1 year
measure: Proportion of migraine attacks for which the use of the Cefaly device generate a reduction of drug intake
timeFrame: Maximum 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Penning S, Schoenen J. A survey on migraine attack treatment with the CEFALY(R) device in regular users. Acta Neurol Belg. 2017 Jun;117(2):547-549. doi: 10.1007/s13760-017-0757-z. Epub 2017 Feb 9. No abstract available.
Clinical trial NCT04269278: Dexmedetomidine and Blood Coagulation
Official title: The Effect of Dexmedetomidine on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Disorder
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Dexmedetomidine may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of dexmedetomidine. The investigators have therefore performed the present study to measure the effect of dexmedetomidine on the coagulation pathway according to the drug concentration level using a rotational thromboelastometry test.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication

Primary outcomes:
measure: FIBTEM
timeFrame: During the rotational thromboelastometry analysis/ an average of 1 hour
Secondary outcomes:
measure: INTEM
timeFrame: During the rotational thromboelastometry analysis/ an average of 1 hour
measure: EXTEM
timeFrame: During the rotational thromboelastometry analysis/ an average of 1 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin HJ, Boo G, Na HS. Effects of dexmedetomidine on blood coagulation: an in vitro study using rotational thromboelastometry. J Anesth. 2021 Oct;35(5):633-637. doi: 10.1007/s00540-021-02969-x. Epub 2021 Jul 15.
Clinical trial NCT01298778: High Pain Intervention in Cesarean Sections
Official title: Improving Pain Relief For Those Who Need It Most After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Chronic Postoperative Pain
Keywords: chronic pain post delivery
postpartum depression
tailored pain management
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In previous studies the investigators have seen that the severity of pain one day after cesarean delivery can predict the presence of pain and depression 2 months later. The investigators believe those at risk for severe acute post-partum pain can be identified, and medical interventions can be tailored to manage postoperative pain more effectively.

Detailed description: This study is randomizing patients into 2 different groups and seeing if by altering our pain management with this group of patients their acute 24 hour evoked pain is less than anticipated; and the incidence of persistent pain and depression when contacted 2 months after delivery is decreased. This study is designed to see if these additional interventions would prove effective for patients at risk of having high pain level after cesarean surgery.

Eligibility criteria: Inclusion Criteria:

* elective cesarean section
* age \>/= 18 years old
* not allergic proposed study medications
* predicted to experience high pain postop based on preoperative evaluation

Exclusion Criteria:

* allergy to study medications
* known hepatic disease
* weight \> 300 lbs

Primary outcomes:
measure: Severity of Acute Pain
timeFrame: 24 hour
Secondary outcomes:
measure: Incidence of Persistent Pain
timeFrame: 2 months
measure: Pain
timeFrame: 24 hour
measure: Analgesic Consumption
timeFrame: 24 hour
measure: Incidence of Depression
timeFrame: 2 months
measure: Average Pain Over 24 Hours
timeFrame: 24 hours
Other outcomes:
measure: Pruritus
timeFrame: 24 hours
measure: Emetic Symptoms
timeFrame: 24hours
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center-Sara Lee Center for Women's Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter H. Pan, MD, MSEE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872078: A Study of AZD4901 in Females With Polycystic Ovary Syndrome
Official title: A Randomised, Double-blind, Placebo-controlled Phase IIa Study to Assess the Pharmacodynamics, Safety, and Pharmacokinetics of AZD4901 When Given in Multiple Doses to Females With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
Keywords: Pharmacokinetics, Pharmacodynamics, endocrinopathies, PCOS, female, hormone, LH
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome


Eligibility criteria: Inclusion Criteria:

Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined as ≤ 6 menses per year). Negative serum pregnancy test at screening. Negative urine pregnancy test before randomisation. Not be breast-feeding. Not have been pregnant within the 6 months prior to screening.

Exclusion Criteria:

Perimenopausal or reached natural menopause, defined as FSH \> 10 IU/L. Menstruated within the month prior to the baseline visit. Hysterectomy or bilateral oophorectomy or both. Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding.

Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit.

Primary outcomes:
measure: Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Springfield
country: United States
facility: Research Site
state: Missouri
city: Berlin
country: Germany
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: University of Oxford
name: Jyothis George, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: George JT, Kakkar R, Marshall J, Scott ML, Finkelman RD, Ho TW, Veldhuis J, Skorupskaite K, Anderson RA, McIntosh S, Webber L. Neurokinin B Receptor Antagonism in Women With Polycystic Ovary Syndrome: A Randomized, Placebo-Controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4313-4321. doi: 10.1210/jc.2016-1202. Epub 2016 Jul 26.
Clinical trial NCT05458778: Detection of Urinary Human Chorionic Gonadotropin (hCG)
Official title: Detection of Urinary HCG During The Not Pregnancy and Pregnancy Cycles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Detection
Lead sponsor: Quanovate Tech Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Include more than 200 worldwide women aged 18 and over taking part in this study.

Brief summary: The Mira Pregnancy Test is an over-the-counter urine hCG test intended for early detection of pregnancy. The test is indicated for use four days before the expected period. Throughout this study, volunteers with non-medical backgrounds were recruited to test hCG with urine samples using the Mira Pregnancy Test during the not pregnancy cycle or pregnancy cycle. To perform the study, a total number of more than 200 volunteers will be recruited to participate in the study.

Detailed description: The studies include two parts, which are a lay user study and a urine samples test during the trying to conceive cycle.

Part 1: Lay user study Part 2: Detection of hCG in Early Pregnancy Clinical Samples

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 and over
* Willing to give informed consent
* Willing to conduct a personal home pregnancy test and reveal their pregnancy status
* Have a working smartphone

Exclusion Criteria:

* Have a medical background or have been in a related industry/occupation
* Volunteers who are unfit to participate in the research by the researcher
* Used the investigational pregnancy test previously
* Has a medical condition
* Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)

Primary outcomes:
measure: Cognitive evaluation via survey and calculating the consistency
timeFrame: From July 2022 to August 2022
measure: The accuracy of data was expressed as per the Pregnancy Detection Rate
timeFrame: From July 2022 to August 2022
Secondary outcomes:
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: Quanovate Tech Inc.
state: California
Study officials:
affiliation: Quanovate Tech Inc.
name: Ning Li, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03445078: Correction of Selenium Deficiency Has Effect on Thyroid Function
Official title: Correction of Selenium Deficiency Has Effect on Thyroid Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Selenium Deficiency
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 20 participants with selenium deficiency (confirmed in previous phase (ID: Liuyanping3)) will be recruited to receive selenium-rich corn powder (20g/d, offering selenium 100μg/d) and ordinary corn powder (20g/d, offering selenium \< 0.5μg/d ) in two different sequences (10 subjects each) with a four-week washout period.Plasma samples were obtained at different time points before and after administration of the selenium-rich corn powder and ordinary corn powder.
Primary purpose: DIAGNOSTIC

Brief summary: Previous literature has found potential association between selenium deficiency and inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent elevation of T4 and ratio of T4/T3. Conduction of a case-control study (ID: Liuyanping3) has been applied on Clinicaltrials.gov to further elucidate effect of selenium deficiency on thyroid function. Based on its data, the investigators will perform a randomized, placebo-controlled,single-blinded crossover study on 20 participants with selenium deficiency to verify health consequence of selenium.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of selenium deficiency through serum selenium test in previous phase (ID: Liuyanping3) of the study
* Should have stable body weight in the latest 3 months;
* Should be not prescribed with thyroid hormone replacement therapy
* Should be without medical history of thyroid surgery or iodine radiotherapy
* Should have normal FT3, FT4 and TSH.

Exclusion Criteria:

* Clinical diagnosis of acute critical illness in the latest 1 year
* Have had weight fluctuation by more than 5%
* Eating disorders
* Neuropsychological disorders
* Allergy to corn or yeast

Primary outcomes:
measure: comparison of thyroid function
timeFrame: plasma sample will be collected at -1w/4w/8w/12w
Secondary outcomes:
measure: comparison of serum selenium
timeFrame: plasma sample will be collected at -1w/4w/8w/12w
measure: comparison of erythrocyte glutathione peroxidase activity
timeFrame: plasma sample will be collected at -1w/4w/8w/12w
measure: comparison of serum deiodinase activity
timeFrame: plasma sample will be collected at -1w/4w/8w/12w
Other outcomes:
Locations:
Study officials:
References: