louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05277506: Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection VS MBT Placement Guide Bonding Strategies
Official title: Smile Arc Assessment in Orthodontic Patients Following Smile Arc Protection Versus MBT Placement Guide Bonding Strategies: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 22
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be performed on human subjects undergoing orthodontic treatment to correct mild crowding with both techniques enhancing the final smile characteristics of the patients.

Detailed description: The study concisits of two groups, the intervention group entails performing bonding of orthodontic brackets following smile arc protection bonding strategy while the control group entails performing bonding using the MBT placement guide and comparing the final smile outcomes after reaching steel archwires for both groups using customized questionnaires for orthodontists and laypersons.

Eligibility criteria: Inclusion Criteria:

* female patients
* no/mild/moderate crowding or spacing
* non-extraction treatment decision with non-extraction profile
* adults age 16-30 years
* full permanent dentition including fully erupted 7s not necessarily 8s
* good oral hygiene.

Exclusion Criteria:

* severe crowding
* cleft lip and palate/syndromic patients
* bad oral hygiene
* unerupted or partially erupted 7s
* extracted or missing teeth

Primary outcomes:
measure: smile arc assessment by orthodontists
timeFrame: 6 months follow up
Secondary outcomes:
measure: smile arc analysis using frontal extraoral photographs of the posed smile
timeFrame: 6 months follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University, Faculty of Dentistry.
Study officials:
References:
Clinical trial NCT00046306: Nevada Environmental Tobacco Smoke and Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Disease
Cancer
Keywords: Oxidative Stress
Cardiovascular Disease
Cancer
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-09-30
Enrollment: 375
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study is designed to test whether exposure to ETS in the workplace effects a person's risk of developing chronic diseases such as cardiovascular disease and cancer. The second part of this study is designed to test whether antioxidant supplementation in this group of ETS exposed individuals can reduce their risk of developing chronic disease.

The study will look at 375 non-smokers who either work on a casino floor or as bartenders or cocktail servers. Initial baseline data will be collected (questionnaires and blood samples taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant supplementation and high antioxidant supplementation. They will be followed over a two-year period, coming in for follow-up testing every six months. Statistical analysis will be conducted to see whether this group of ETS exposed individuals has a greater risk of developing chronic disease and whether the use of antioxidant supplements can moderate any risks.


Eligibility criteria: Inclusion Criteria:

Non-smoker Work in a casino - on the casino floor or work as a bartender or cocktail server for at least 1 year Do not take antioxidant supplements Healthy - not diagnosed with any major chronic diseases.

Exclusion Criteria:

Blood pressure SBP\>200,\<85 DBP\>100, \<40 Pulse \>120, \<45 Cholesterol \>400 Triglycerides \>700 Blood Cotinine \>10 ng/ml BMI \>35

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: ETS Clinic, University of Nevada, School of Medicine, 1707 W. Charleston Blvd Suite 100
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Chris A Pritsos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279706: Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test
Official title: Linguistic Adaptation of Rhinitis Control Assessment Test (RCAT) in Korean and Responsiveness to Disease Severity, Quality of Life, and Treatment in Adult Rhinitis Patients: A Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 130
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: rhinitis within 12 months from the time of study enrollment.

Brief summary: Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT).

Detailed description: Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.

Eligibility criteria: Inclusion Criteria:

1. Adults over 19 years
2. Past medical history and allergy skin test or who have been diagnosed with allergic or non-allergic rhinitis, based on serum specific immunoglobulin E .
3. People who have experienced symptoms of rhinitis within 12 months from the time of study enrollment.
4. People who have rhinitis symptoms requiring medication at the time of study enrollment.
5. People who can read and write korea language.
6. People who signed a written consent form approved by the Institutional Review Board of their respective organizations to participate in this study freely hearing to explain fully the purpose for the contents of this study prior to participation in research.

Exclusion Criteria:

1. People diagnosed with Rhinitis medicamentosa.
2. People determined that bacterial or viral respiratory infection at the time of study enrollment.
3. People who have evidence of nasal infection
4. People associated anatomical abnormality that causes severe nasal congestion as deviation of nasal septum.
5. People determined that acute or chronic sinusitis according to the researchers determined.
6. In case that pregnancy test is positive, or ambiguous conclusions among female patients.
7. people deemed unsuitable for clinical trial participation due to other reasons.

Primary outcomes:
measure: Korean linguistic adaptation of Rhinitis controlled assessment test (RCAT)
timeFrame: up to 4weeks
Secondary outcomes:
measure: rhinitis-related quality of life
timeFrame: up to 4weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
Study officials:
affiliation: Department of internal medicine
name: hae sim park, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01085006: The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
Official title: The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemorrhage
Keywords: cesarean delivery
Tranexamic acid
hemorrhage
Spinal analgesia
1-the amount of hemorrhage during cesarean delivery
2-the amount of hemorrhage in the first 2 hours of cesarean delivery
3-the amount of hemorrhage in the first 24 hour after cesarean delivery
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.


Eligibility criteria: Inclusion Criteria:

1. Term pregnancy
2. Single fetus
3. Maximally only one previous cesarean delivery

Exclusion Criteria:

1. More than one previous cesarean delivery
2. Hx of other abdominal or pelvic surgery
3. Hx of medical disorders
4. Hx of thromboembolic disorders
5. Polyhydramnios
6. Macrosomia
7. Preeclampsia
8. Hx of sensitivity to Tranexamic acid
9. Abnormal Pt, PTT, PT or INR

Primary outcomes:
measure: The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward
timeFrame: During the procedure and within 2 hours afterwards
Secondary outcomes:
measure: Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery
timeFrame: First 24 hours
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Laleh Eslamian
Study officials:
affiliation: Associated Prof, Obstetrician & Gynecologist
name: Laleh Eslamian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06691906: A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)
Official title: A Clinical Study to Evaluate the Relative Bioavailability of MK-0616 Formulations in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.


Eligibility criteria: Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
* Medically healthy with no clinically significant medical history.

Exclusion Criteria:

* Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
* Has a history of cancer (malignancy).

Primary outcomes:
measure: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 24 hours postdose)
measure: Area Under the Concentration-Time Curve from 0 to Time of Last Quantifiable Sample (AUC0-last) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Maximum Plasma Concentration (Cmax) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Apparent Terminal Half-Life (t1/2) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Apparent Clearance (CL/F) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of enlicitide decanoate
timeFrame: Predose and at designated timepoints (up to 168 hours postdose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 44 days
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 44 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03991806: Association of Centre of Excellence Self- Administered Questionnaire Score and Frailty Levels
Official title: Association of Centre of Excellence Self-Administered Questionnaire (CESAM) Score and Frailty Levels With Incident Health Adverse Events in Older Community Dwellers: Results of the Canadian Longitudinal Study on Aging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Frailty
Cognitive Decline
Injuries
Fall Injury
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 30000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this research study take part people that are enrolled in the Canadian Longitudinal Study on Aging. Moreover, they are community dwellers who are frequently exposed to different health adverse events.

Brief summary: This study evaluates the frailty and the health adverse events in the population of the Canadian Longitudinal Study on Aging. It will be used the Centre of Excellence Self-Administered questionnaire (CESAM) which assesses frailty of older adults by providing a score and a of frailty in 4 levels.

Detailed description: Age is broadly recognized to confer a risk for health adverse outcomes, but it is an insensitive and non-specific measure for use in individual decision-making. Frailty has been emerging to take its rightful place as a better measure for over past decades. Despite general consensus that the concept of frailty is clinically useful, the lack of agreement on its definition and the challenge of its measurement by front-line health providers mean that frailty remains only 'their apparent' to chronological age as a criterion to select older persons at risk.

Eligibility criteria: Inclusion Criteria:

* Being 65 years and over
* Being enrolled in the Canadian Longitudinal Study on Aging

Exclusion Criteria:

* Never being enrolled in the Canadian Longitudinal Study on Aging
* Undisclosed health adverse events

Primary outcomes:
measure: Dementia
timeFrame: around 18 months
Secondary outcomes:
measure: Medication
timeFrame: around 18 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04961606: Exercise Adherence of Home-based Cardiac Rehabilitation
Official title: Qualitative Research on the Influencing Factors of Exercise Adherence of Home-based Cardiac Rehabilitation in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Home-based cardiac rehabilitation
Exercise adherence
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 26
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary artery disease and medical professionals in home-based cardiac rehabilitation

Brief summary: The study explored the influencing factors of exercise adherence of home-based cardiac rehabilitation in patients with coronary artery disease.

Detailed description: The study used a qualitative exploratory design. Informants were recruited by purposive sampling. Semi-structured individual interviews were conducted among patients with coronary artery disease and medical professionals in home-based cardiac rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of coronary artery disease;
* Age ≤75 years old;
* Participated in home-based cardiac rehabilitation ≥12 weeks;
* Have good language skills;
* Volunteer to participate in this study.

Exclusion Criteria:

* Have other serious acute or chronic diseases;
* A previous history of mental illness or a positive family history of mental illness;
* Have severe audio-visual or speech impairments that may affect understanding and answering questions.

Primary outcomes:
measure: Influencing factors of exercise adherence
timeFrame: The influencing factors of exercise adherence in home-based cardiac rehabilitation will be measured by the construct of the theory of planned behavior through study completion, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Wei Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT05672706: A Study of Pressure Waveform Analysis in Coronary Artery-II
Official title: A Study of Pressure Waveform Analysis in Coronary Artery-II
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with angina and undergo invasive coronary angiography

Brief summary: The goal of this observational study is to test the feasibility of intracoronary adenosine administration during coronary flow reserve(CFR) and index of microcirculatory resistance(IMR) assessment in a population with angina. The main questions it aims to answer are:

* Repeatability of CFR and IMR assessment while hyperemia with intracoronary adenosine was administered.
* Evaluate the correlation of the intrinsic signal of coronary waveform versus physiologic ischemia, while defined by fractional flow reserve(FFR) and CFR respectively.
* The predictive value of FFR, CFR, and IMR on major adverse cardiovascular outcomes in 3 years Participants will undergo FFR, CFR, and IMR assessments in the catheterization laboratory of the National Taiwan University Hospital Hsin-Chu Branch, then clinical events follow up for 3 years.


Eligibility criteria: Inclusion Criteria:

* Participants with angina

Exclusion Criteria:

* Severe valvular heart disease
* History of asthma
* Heart rate less than 50 beats per minute
* systolic blood pressure less than 90 mmHg

Primary outcomes:
measure: Repeatability of CFR and IMR value
timeFrame: 10 minutes
Secondary outcomes:
measure: Major adverse cardiovascular outcomes
timeFrame: 3 year
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsin-Chu branch
Study officials:
References:
Clinical trial NCT02260206: Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion
Official title: Impact of Colchicine Therapy on Arrhythmia Recurrence After Acute Pericardial Effusion Following Catheter Ablation of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pericardial Effusion
Keywords: Pericardial Effusion
Colchicine
arrhythmia Recurrence
pericardiocentesis
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: None (Open label)
Primary purpose: TREATMENT

Brief summary: The effects colchicine administration for acute pericardial effusion after radiofrequency catheter ablation (RFCA) of atrial fibrillation on the recurrences of arrhythmia.

Detailed description: RFCA was started as a rhythm control of atrial fibrillation about 10 years before and the superiority of RFCA to medical treatment has been continuously reporting, so RFCA is globally performed nowadays. Acute pericardial effusion could occur during RFCA as complication, that might be developed to cardiac tamponade needed immediate pericardiocentesis. The inflammation developed after pericardiocentesis might be associated with the recurrences of atrial fibrillation, it could be presumed by the frequent occurrence of atrial fibrillation after open-heart surgery. The inflammation can be suppressed by administration of colchicine and the effects of colchicine have been proven to decrease the development of atrial fibrillation.

Eligibility criteria: Inclusion Criteria:

* Patients needed to pericardiocentesis during RFCA for paroxysmal or persistent atrial fibrillation.

Exclusion Criteria:

* Hypersensitivity on Colchicine
* The existence of intra-cardiac thrombus on trans-esophageal echocardiography
* Pregnancy

Primary outcomes:
measure: recurrence of atrial arrhythimia
timeFrame: 1 year after colchicines administration
Secondary outcomes:
measure: recurrence of atrial arrhythimia
timeFrame: 3 year after colchicines administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seo Cho Gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong Seog Oh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01196806: Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates
Official title: Comparison of Measurement of Arterial Blood Pressure by L&T NIBP Module With Invasive Arterial Blood Pressure in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: Non-Invasive Blood Pressure(NIBP)
Lead sponsor: Larsen & Toubro Limited
Sponsor class: INDUSTRY
First posted: 2010-09-08
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 20 numbers Neonates in NICU were studied during this study.

Brief summary: The purpose of this study is to compare Measurements of Arterial Blood Pressure by L\&T NIBP Module With Invasive Arterial Blood Pressure in Neonates.


Eligibility criteria: Inclusion Criteria:

* Neonates admitted to NICU in whom arterial catheterization (radial or umbilical) was clinically indicated for a purpose other than for the comparative study.

Exclusion Criteria:

* All neonates in whom arterial catheterization was not clinically indicated.
* If minimum of 5-paired measurements is not obtained either due to technical or clinical reason.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: