louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02818244: Accuracy of Commercially Available Heart Rate Monitors II
Official title: Accuracy of Commercially Available Heart Rate Monitors II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: commercial heart monitors
accuracy
EKG
varying degrees of exertion
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: In 2015, over 85 million fitness wearables were sold worldwide and the market is projected to expand to 110 million units sold in 2017. Of all wearable technology, fitness devices that track heart rate are predicted to be the most popular. At the elite level, commercial heart rate monitors are being used by athletes like LeBron James, Blake Griffin, and Matthew Dellavedova to monitor and alter their behaviors for peak athletic performance. Millions of ordinary consumers purchase fitness trackers that include heart rate monitors in order to help them to maintain their health and wellness. As popularity of these fitness devices grows, assessment of the accuracy of heart rate measurements becomes increasingly important.

Detailed description: In a previous trial, investigators compared the accuracy of four devices (Apple Watch, Fitbit Charge HR, Mio Fuse, Basis Peak) worn by subjects while performing a graded exercise program on a treadmill. Investigators discovered that the Apple Watch and Mio Fuse had a correlation coefficient (rc) of .91, Fitbit Charge HR had an rc of .84, and Basis Peak had an rc of .83. That study has been submitted for publication.

Reviewers of the first study raised an important question: how do commercial optical heart rate monitors perform when measuring heart rate during other popular forms of exercise? This study addresses that question.

Objective:

The objective of this study is to evaluate the accuracy of four heart rate monitors when used during three different exercises: treadmill, stationary bicycle, elliptical trainer.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Able and willing to exercise for a total of fifteen minutes

Exclusion Criteria:

* Health issues that preclude or contraindicate walking and/or jogging, including cardiovascular, orthopedic, pulmonary and other conditions
* Presence of a cardiac pacemaker
* Known cardiovascular disease
* Known heart rhythm disorders
* Use of Beta-blockers or antiarrhythmic medications
* Tattoos around the wrist or forearm area

Primary outcomes:
measure: Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.
timeFrame: 24 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Marc Gillinov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06767644: The Effect of Music on Pain and Anxiety During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women
Official title: the Effect of Music on Pain and Anxiety During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 124
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and anxiety in postmenopausal women

Detailed description: This study aims to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' levels of pain and anxiety in postmenopausal women.

Eligibility criteria: Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding

Primary outcomes:
measure: Intensity of pain
timeFrame: 5 minutes
Secondary outcomes:
measure: anxiety during procedure
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00435344: Provider and Peer Delivered Youth Smoking Intervention
Official title: Provider and Peer Delivered Youth Smoking Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Dependence
Keywords: Pediatric practice
Smoking cessation
Smoking prevention
Adolescents
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2007-02-14
Enrollment: 2711
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.

Detailed description: The majority of adolescent smokers are interested in quitting and have attempted to stop with limited success. A recent review of cessation trials for adolescents has concluded that there are no proven programs to help teens stop smoking, but suggested interventions based on cognitive behavioral therapy and sensitive to stages of change appear promising. The American Academy of Pediatrics suggests that pediatricians are well-positioned to intervene with adolescent smokers, as well as with nonsmokers to prevent initiation. A comprehensive, practice-based smoking prevention and cessation intervention for adolescents delivered by pediatric providers and peer counselors in the context of routine care has the potential for assisting nonsmoking adolescents in remaining smoke-free and smoking adolescents to quit.

Eligibility criteria: Inclusion Criteria:

* Aged 13 to 17, regardless of smoking status
* Scheduled for routine or acute care office visit
* Parental consent and youth assent

Exclusion Criteria:

* Unable to complete study requirements

Primary outcomes:
measure: Abstinence from smoking in the past 30 days at 6 months and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Lori Pbert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pbert L, Flint AJ, Fletcher KE, Young MH, Druker S, DiFranza JR. Effect of a pediatric practice-based smoking prevention and cessation intervention for adolescents: a randomized, controlled trial. Pediatrics. 2008 Apr;121(4):e738-47. doi: 10.1542/peds.2007-1029.
Clinical trial NCT01281644: Treatment of Keratosis Pilaris With 810 nm Diode Laser
Official title: Treatment of Keratosis Pilaris With 810 nm Diode Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratosis Pilaris (KP)
Keywords: Keratosis pilaris (KP)
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hope to establish whether or not the diode laser, a longer-wavelength laser, is effective in treating keratosis pilaris, and hopefully opening a door into the discussion and management of this skin condition. The primary outcome of interest is the difference in the overall blind rater severity scores of the treated versus the untreated sites. The secondary outcome of interest is the change in the patient's self-rated severity score of the treated site. To account for potential natural disease progression or regression, the investigators will also compare patient mean changes to the mean changes in severity scores of the untreated site.


Eligibility criteria: Inclusion Criteria:

* Subject is age 18 to 65
* Subject has diagnosis of keratosis pilaris involving both arms
* Subject has Fitzpatrick Skin Type I - III
* Subject is in good health
* Subject has the willingness and ability to understand and provide informed consen

Exclusion Criteria:

* Under 18 or over 65 years of age
* Subjects with Fitzpatrick Skin Type greater than III
* Subjects who have received any laser therapy to the armsin the past year
* Subjects with concurrent diagnosis of another skin condition or malignancy
* Subjects with tan or sunburn over the upper arms in the past month
* Subjects with open, non-healing sores or infections at any skin site
* Subjects who are unable to understand the protocol or give informed consent
* Subjects who take oral photosensitizing medications or who apply topical photosensitizing medications to either arm

Primary outcomes:
measure: Difference in Disease Severity Scores
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient Self-rated Severity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibrahim O, Khan M, Bolotin D, Dubina M, Nodzenski M, Disphanurat W, Kakar R, Yoo S, Whiting D, West DP, Poon E, Veledar E, Alam M. Treatment of keratosis pilaris with 810-nm diode laser: a randomized clinical trial. JAMA Dermatol. 2015 Feb;151(2):187-91. doi: 10.1001/jamadermatol.2014.2211.
Clinical trial NCT01997944: Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase Ib Study in Chronic Hepatitis B Patients
Official title: Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis B
Lead sponsor: Beijing Bio-Fortune Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18-75 years
* Chronic HBV infection (serum HBsAg detectable for \> 6 months)
* Serum HBeAg positive with HBV DNA \>10\^6copies/mL (or \>20,000 IU/mL),orSerum HBeAg negative with HBV DNA \>10\^5copies/mL (or \>2,000 IU/mL)
* Serum ALT must be \> 2 x ULN but below 10 x ULN

Exclusion Criteria:

* Steroid treatment or immunosuppression 3 months prior to entry.
* Interferon therapy or nucleotides analogues therapy in 6 months prior to entry.
* Active lung disease or history of interstitial lung disease.
* Hb\< LLN or, and ANC \< 750/mm3 or , and platelet count \< 75,000 mm3 ,or WBC\<3000/mm3 .
* Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
* Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
* Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
* History of thyroid disease or current treatment for thyroid disease.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of adverse events
timeFrame: 18 weeks
Secondary outcomes:
measure: Decrease of HBV DNA
timeFrame: 18 weeks
measure: AUCss
timeFrame: 18 weeks
measure: Css_av
timeFrame: 18 weeks
measure: Css_min
timeFrame: 18 weeks
measure: Css-max
timeFrame: 18 weeks
measure: T1/2
timeFrame: 18 weeks
measure: Tmax
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin University First Affiliated Hospital
state: Jilin
Study officials:
affiliation: Jilin University First Affiliated Hospital
name: Junqi Niu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02764944: Endoscopic Full Thickness Resection Without Exposure to Peritoneum
Official title: Endoscopic Full Thickness Resection Without Exposure to Peritoneum: Single Center Single Arm Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Submucosal Tumor of Stomach
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2016-05-06
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility of endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) in patients with gastric tumor.

Detailed description: Current endoscopic full-thickness resection (EFTR) methods are limited by their transmural communication and exposure of tumor to peritoneum. Recently, endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) was developed. This new technique includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.

This study evaluates the feasibility of simple non-exposure EFTR technique in patients with gastric tumor. This study is single arm study and will be performed in single center.

Eligibility criteria: Inclusion Criteria:

* Gastric subepithelial tumor
* Tumor invades of muscularis propria on endoscopic ultrasonography (EUS) finding
* Tumor size more than 1.5cm or increasing size during observation

Exclusion Criteria:

* Tumor size more than 5cm
* Refuse to be enrolled to study.
* Bleeding tendency,
* Inappropriate condition for surgery with general anesthesia

Primary outcomes:
measure: En bloc resection
timeFrame: During operation
Secondary outcomes:
measure: procedure time
timeFrame: During operation
measure: complication
timeFrame: 3 months
measure: successful closure of resection site
timeFrame: 1 week
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
affiliation: National Cancer Center
name: Chan G Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06004544: Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women
Official title: Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases in Pregnancy
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
Collaborators: name: Jinnah Postgraduate Medical Centre
First posted: 2023-08-22
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive obstetric patients attending routine antenatal visits

Brief summary: Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed. Ejection fraction (EF) was quantified using biplane Simpson's method.

Detailed description: Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed, including parasternal long and short, apical 4- and 2-chamber views. Continuous wave and pulse wave Doppler were used to assess left ventricular outflow tract (LVOT) gradients. Left ventricular (LV) function was quantified using biplane Simpson's method and visually assessed by two independent readers. Patients with significant valve disease or congenital heart disease underwent complete TTE. Those diagnosed with LV dysfunction or other cardiovascular diseases (CVD) were referred to the Cardio-Obstetrics clinic for further management and long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* Obstetric patients attending routine antenatal visits

Exclusion Criteria:

* Patients refused to give consent for echocardiography or participation in the study

Primary outcomes:
measure: Number of participants found to have abnormal left ventricular function
timeFrame: At the time of screening echocardiogram
measure: Number of participants found to have abnormal heart valve function
timeFrame: At the time of screening echocardiogram
Secondary outcomes:
measure: Number of participants found to have adverse Maternal outcomes
timeFrame: At the time of delivery
measure: Number of participants found to have adverse Fetal outcomes
timeFrame: At the time of delivery
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases (NICVD)
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diseases
name: Sabha Bhatti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04987944: Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma
Official title: A Phase 1b, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Oral Zavegepant in Subjects With Mild Allergic Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Asthma
Keywords: Allergy
Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.


Eligibility criteria: Inclusion Criteria:

* Subjects with Asthma

Exclusion Criteria:

-

Primary outcomes:
measure: Maximum Percentage Decrease From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Any Time Between 3 and 7 Hours Post-Allergen Challenge
timeFrame: Baseline (pre-allergen challenge on Day 27) and anytime between 3 and 7 hours post-challenge on Day 27
Secondary outcomes:
measure: Maximum Percentage Decrease From Baseline in FEV1 at Any Time Between 0 and 2 Hours Post-Allergen Challenge
timeFrame: Baseline (pre-allergen challenge on Day 27) and anytime between 0 and 2 hours post-challenge on Day 27
measure: Change in Methacholine PC20 From Pre-Allergen Challenge to Post-Allergen Challenge
timeFrame: From Day -15 to Day 28
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From start of treatment on Day 1 up to Day 41
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities on Treatment
timeFrame: From start of treatment on Day 1 to Day 28
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: The Lung Centre- Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: The Lung Centre-Vancouver General Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Universtiy
state: Ontario
city: Québec
country: Canada
facility: Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan/Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Institut universitaire en cardiologie et pneumologie de Quebec-Universite Laval-(IUCPQ-UL)
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05064644: Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy Product
Official title: Lipid Lowering Effect of Plant Stanol Ester in Oat-based, Fermented Spoonable Dairy Analogue -a 3-week Randomized, Double-blind, Placebo-controlled, Parallel-group Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to determine the effect of investigational products on serum LDL cholesterol.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l)
* Plasma triglyceride levels ≤ 4.0 mmol/l
* Age 18-65 years

Exclusion Criteria:

* Intolerance to oats or other ingredients of the test products
* Severe obesity (BMI ≥ 32 kg/m2)
* Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose.
* Consumption of plant stanol or plant sterol containing food products or supplements such as Benecol, Becel pro.active, Keiju Alentaja or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample)
* History of malignant diseases like cancer within five years prior to recruitment
* History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
* Diagnosed type 1 or type 2 diabetes requiring medical treatment
* Celiac disease
* Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza)
* Alcohol abuse (\> 4 portion/per day) or recreational drug abuse
* Pregnancy or planned pregnancy or lactating
* Clinically significant abnormalities in screening labs
* Participation in another clinical trial in the preceding 3 months

Primary outcomes:
measure: Change in LDL cholesterol concentration (%)
timeFrame: 0 vs 3 weeks
Secondary outcomes:
measure: LDL cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: total cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: HDL cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: non-HDL cholesterol concentration
timeFrame: 0 vs 3 weeks
measure: Total triglyceride concentration
timeFrame: 0 vs 3 weeks
measure: NMR blood biomarkers
timeFrame: 0 vs 3 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Nightingale Health plc
Study officials:
affiliation: Helsinki University Hospital, Helsinki, Finland
name: Helena Gylling, MD
role: PRINCIPAL_INVESTIGATOR
References: