louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00469885: Reduction of Smoking in Cardiac Disease Patients
Official title: Harm Reduction Treatment for Smokers With Cardiovascular Disease {Reduction of Smoking in Cardiovascular Disease Patients (ROSCAP)}
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Tobacco Use Disorder
Keywords: Smoking cessation
cardiovascular disease
smoking reduction
nicotine replacement
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2007-05-07
Enrollment: 152
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: This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for individuals with peripheral arterial disease who smoke.

Detailed description: This study randomly assigns smokers who do not have a quit date set to either a smoking reduction grop or usual care group. The smoking reduction group receives behavioral counseling on smoking reduction and nicotine patch and/or gum to reduce the number of cigarettes smoked per day by at least 50%. The usual care group is given brief advice to quit smoking and referral to local cessation services. To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily). Participants complete questionnaires that measure mood, functional ability, smoking history, and motivation to quit smoking. Participants will be followed in this study for up to 24 months.

Eligibility criteria: Inclusion Criteria:

* To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily).

Primary outcomes:
measure: Number of cigarettes per day
timeFrame: 6 months
measure: ASCVD health changes
timeFrame: 6 months
measure: Days of abstinence from cigarettes
timeFrame: 6 months
measure: Number of quit attempts
timeFrame: 6 months
Secondary outcomes:
measure: Withdrawal symptoms
timeFrame: ongoing through 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Univeristy of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: Univerisity of Minnesota
state: Minnesota
Study officials:
affiliation: Veteran's Administration Hospital
name: Anne Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643485: Pedobarographic Changes After Forefoot Reconstruction
Official title: Dynamic Pedobarography With a New Insole After Forefoot Reconstruction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Plantar Foot Pressure
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for forefoot surgery

Brief summary: Static pedobarography is routinely used for pre- and postoperative questions regarding plantar foot pressure. This Investigation does insufficiently detect dynamic Forces. Hence, dynamic pedobarography might give some important insights in detecting plantar foot pressure after forefoot reconstruction.


Eligibility criteria: Inclusion Criteria:

* Forefoot surgery for hallux valgus or rigidus planned at out departement

Exclusion Criteria:

* No given consent

Primary outcomes:
measure: AOFAS-Score (American Orthopedic Foot and Ankle Society)
timeFrame: 2 years
Secondary outcomes:
measure: Plantar Peak Pressure
timeFrame: 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Head of Orthopedic Dept.
name: Rüdiger Eisenhart-Rothe, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04492085: National Survey of Workplace Violence
Official title: National Survey of Workplace Violence Against Chinese Physicians of Obstetrics and Gynecology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Workplace Violence Against Physicians
National Survey
Obstetrics and Gynecology
China
Random Sample
Questionnaire
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All physicians of obstetrics and gynecology from the hospitals randomly samples

Brief summary: China has witnessed a surge in violence against medical personnel, including widely reported incidents of violent abuse, riots, attacks, and protests in hospitals, but little is known about the definite prevalence of workplace violence against physicians of obstetrics and gynecology in China. The aim of this study is to analyze prevalence of workplace violence against physicians of obstetrics and gynecology in China. A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.

A random sampling will be performed in all 32 provinces, municipality or autonomous regions in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and the sample size under the condition of simple random sampling is 600 persons. If the homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3, the sample size of every level needs is 1800. Considering 10% population refusing to be surveyed, in all mainland of China, three levels of hospitals will include at least 6000 physicians who accept survey.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years old
* Belonging to and registered at specific hospital
* Active employment in obstetrics, reproduction, or gynecology
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all the inclusion criteria
* Not completing the whole questionnaire

Primary outcomes:
measure: Prevalence of workplace violence in all physicians
timeFrame: In past 12 months
Secondary outcomes:
measure: Potential reasons of workplace violence in all physicians
timeFrame: Two months
measure: Potential solution of workplace violence in all physicians
timeFrame: Two months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06462885: Living Alone is Predictive of Non-home Discharge Following Elective Total Hip Arthroplasty: a Matched-pairs Cohort Analysis
Official title: Living Alone is Predictive of Non-home Discharge Following Elective Total Hip Arthroplasty: a Matched-pairs Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Hip
Perioperative/Postoperative Complications
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 5677
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective total hip arthroplasty patients, ACS-NSQIP 2021

Brief summary: The goal of this observational study is to assess the effect of living alone on total hip arthroplasty thirty-day outcomes. The main questions it aims to answer are:

Is living alone associated with discharge disposition (home versus non-home)? Is living alone associated with greater incidences of secondary adverse events?

Participants will be sampled from the 2021 American College of Surgeons National Surgical Quality Improvement Program


Eligibility criteria: Inclusion Criteria:

* Elective, non-emergent cases
* Living alone
* Living with others

Exclusion Criteria:

* Fracture in surgical diagnosis
* Hospital admission \>1 day preoperatively
* End-stage renal disease (preoperative)
* Metastatic disease (preoperative)
* Sepsis (preoperative)
* Bleeding diathesis (preoperative)
* American Society of Anesthesiologists Physical Status Classification 5

Primary outcomes:
measure: Discharge disposition
timeFrame: Thirty days
Secondary outcomes:
measure: Requiring home services
timeFrame: Thirty days
measure: Functional status at discharge
timeFrame: Thirty days
measure: Postoperative delirium
timeFrame: Thirty days
measure: Hospital length of stay
timeFrame: Thirty days
measure: Unplanned resource utilization
timeFrame: Thirty days
measure: Wound complications
timeFrame: Thirty days
measure: Systemic complications
timeFrame: Thirty days
measure: Bleeding events
timeFrame: Thirty days
measure: Mortality
timeFrame: Thirty days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Zhiyi Zuo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04303637: The Impact of Phone Use on Everyday Outcomes
Official title: The Impact of Phone Use on Everyday Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Sleep
Depression
Anxiety
Keywords: Smartphone
Screen time
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents aged 13-18 years old recruited from Singapore schools.

Brief summary: Participants will download a phone-tracking app for a week to track phone usage, providing objective data on usage patterns. Quantitative tasks and questionnaires will also be carried out before and after the tracking period.

Detailed description: A notable shortcoming of existing mobile phone research is that 'phone use' has almost exclusively been measured through subjective reports - by simply asking respondents how much time they spend on their mobile phones each day. This operational definition, however, is a major shortcoming as phone use is difficult to track - and is thus likely to be highly inaccurate.

To address this gap, the investigators describe in this proposal a first step to characterize phone usage in an objective manner - by asking adolescents to download a phone-tracking app for a week. This circumvents measurement errors inherent to self-reports, and allows us to probe: (1) how accurate adolescents' estimates are of their own phone usage, and (2) whether objective phone usage predicts any cognitive, socio-emotional, or physical outcomes. The completion of this study will represent an important step forward in the development of empirically-driven guidelines on phone use amongst adolescents.

Eligibility criteria: Inclusion Criteria:

* Owns a smartphone

Exclusion Criteria:

* Parents not willing to give consent
* History of medical or psychiatric disorder
* History of motion sickness, dizziness or epilepsy

Primary outcomes:
measure: Depression Anxiety Stress Scale (DASS 21)
timeFrame: 11 minutes (single measurement)
measure: Body mass index
timeFrame: 1 minute (single measurement)
measure: Sleep duration
timeFrame: 2 minute (single measurement)
Secondary outcomes:
measure: Digit Span Task
timeFrame: 10 minutes (single measurement)
measure: Psychomotor Vigilance Task
timeFrame: 10 minutes (single measurement)
measure: Pediatric Daytime Sleepiness Scale (PDSS)
timeFrame: 5 minutes (single measurement)
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 10 minutes (single measurement)
Other outcomes:
measure: General Questionnaire on Media Consumption
timeFrame: 5 minutes (single measurement)
measure: Subjective Report of Phone Usage
timeFrame: 10 minutes (single measurement)
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
affiliation: Yale-NUS College
name: Jean Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663637: Removal of Endotracheal Tube Secretions Comprehensively Until Extubation
Official title: Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mechanical Ventilation
Pneumonia
Keywords: endotracheal tube obstruction, occlusion
mechanical ventilation, complication
work of breathing
airway resistance
secretions
pneumonia, ventilator associated
biofilms
endotracheal tube
Lead sponsor: O. M. Neotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Saint Francis Medical Center
name: Statistical Consulting
First posted: 2008-04-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (Complete Airway Management Catheters: CAM Rescue Cath and CAM Endotrach Cath).

Detailed description: Thirty mechanically ventilated adult patients will be managed with standard suction catheters. Just prior to extubation, their physiological parameters (including work of breathing) will be recorded and acoustic reflectometry used to measure the degree of secretion accumulation within the endotracheal tube. The endotracheal tubes will then be cleaned using the CAM Catheters (Rescue Cath followed by Endotrach Cath) and the physiological parameters and endotracheal tube reflectometry measurements repeated for comparative analysis.

Eligibility criteria: Inclusion Criteria:

* Patients receiving medical care in adult intensive care unit setting
* Patients who have been intubated and mechanically ventilated for at least 12 hours
* Patients intubated with an endotracheal tube with an internal diameter of 7.0 mm or greater

Exclusion Criteria:

* Patients receiving medical care in a setting not compatible with an adult intensive care unit
* Patients who have been intubated and mechanically ventilated for less than 12 hours
* Patients intubated with an endotracheal tube with an internal diameter of 6.5 mm or less
* Patients intubated with dual lumen or steel-reinforced endotracheal tubes

Primary outcomes:
measure: work of breathing
timeFrame: pre-extubation
Secondary outcomes:
measure: endotracheal tube patency
timeFrame: pre-extubation
Other outcomes:
Locations:
city: Cape Girardeau
country: United States
facility: Saint Francis Medical Center
state: Missouri
Study officials:
affiliation: Saint Francis Medical Center; Omneotech
name: Orlando V. Morejon, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06735937: The Effects of Automatic Gas-Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries
Official title: The Effects of Automatic Gas-Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low-flow Anesthesia
Keywords: end-tidal controlled
low flow anesthesia
consumption
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries.

Detailed description: In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries. This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Aged between18-73

Exclusion Criteria:

* heart failure
* liver disease
* lung disease
* kidney disease

Primary outcomes:
measure: anesthesic gas consumption
timeFrame: At the end of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Elzem Sen
state: Sehitkamil
Study officials:
affiliation: University of Gaziantep
name: Elzem Sen, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06520137: Third Molars Extraction and Periodontal Disease
Official title: Correlation Between Upper Third Molars Extraction and Upper Second Molars Periodontal Disease: a Prospective Clinical Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Periodontal Diseases
Lead sponsor: Azienda Ospedaliera Universitaria Senese
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 126
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital population.

Brief summary: The aim of the study is to evaluate the changes in periodontal conditions on the distal aspect of the second maxillary molar after the extraction of the maxillary wisdom tooth. As secondary outcome patient- related and tooth-related factors will be analysed to evaluate their effects on the periodontal varibales during time.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years or older
* Presence of an impacted upper wisdom tooth that need to undergo surgical extraction
* Participants need to be able to sign and understand the informed consent and to follow the study-related procedures.

Exclusion Criteria:

* People that have compromised general health conditions (ASA 3, 4, 5, 6)
* Patients that assumed antibiotics in the last 6 months
* Pregnant or breastfeeding women
* Patients who suffer from periodontitis stage III and IV
* Presence of a third molar with incomplete root formation is not taken into account for the surgical extraction.
* Smoker patients

Primary outcomes:
measure: Probing Pockeet Depth (PPD)
timeFrame: Baseline, 1 month, 6 months, 12 months, 24 months
measure: Bone Level (BL)
timeFrame: Baseline, 1 month, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Type of impaction
timeFrame: Baseline
measure: Clinical Attachment Level (CAL)
timeFrame: Baseline, 1 month, 6 months, 12 months, 24 months
measure: Recession (REC)
timeFrame: Baseline, 1 month, 6 months, 12 months, 24 months
measure: Keratinized Tissue (KT)
timeFrame: Baseline, 1 month, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: University of Siena
state: Italy/SI
Study officials:
References:
Clinical trial NCT05034237: The Effect of Long-pulsed 1064 nm nd: Yag Laser-assisted Hair Removal on Some Skin Flora and Pathogens: an in Vivo Study
Official title: The Effect of Long-pulsed 1064 nm nd: Yag Laser-assisted Hair Removal on Some Skin Flora and Pathogens: an in Vivo Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Changes in Bacterial Count in Axilla After Laser Hair Removal
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. To evaluate the effect of ND-YAG laser hair removal on some skin flora and pathogens: an in vivo study.
2. To determine the immediate and long term effect of ND-YAG laser on total viable bacterial count, some skin flora and pathogens of laser-assisted hair removal in axilla.
3. To assess the relation between this effect and bromohidrosis.

Detailed description: This Quasi-experimental interrupted time series study will be conducted on 30 female participants who will be recruited from the Dermatology Outpatient Clinic of the Alexandria Main University Hospital.

Four sessions of laser assisted hair removal at 4 weeks intervals (S1, S2, S3 and S4) using long pulsed ND: YAG (Cynosure Elite+™, Westford, USA). The following parameters will be used according to the nature of hair (1064 nm, 15-18 mm spot size, fluence of 24-35 J/cm2, pulse duration 30-40 ms).

4. Swabs will be collected immediately and after each session

Eligibility criteria: Inclusion Criteria:

No previous laser hair removal sessions involving axilla. Fitzpatrick skin type III-VI.

Exclusion Criteria:

1. Skin diseases such as atopic dermatitis, psoriasis, fungal or herpetic infections.
2. Systemic diseases such as diabetes or endocrinal dysfunction.
3. Patients receiving immunosuppressive therapy.
4. Pregnant or lactating females.

Primary outcomes:
measure: to compare changes in bacterial count and composition of axillary flora after laser hair removal
timeFrame: 4 month
Secondary outcomes:
measure: To determine the immediate and long term effect of ND-YAG laser on total viable bacterial count, some skin flora and pathogens of laser-assisted hair removal in axilla
timeFrame: 4 month
measure: To assess the relation between this effect and bromohidrosis.
timeFrame: 4 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Faculty of Medicine
Study officials:
References:
Clinical trial NCT01521637: The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Muscle Loss
Official title: The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Disuse
Neuromuscular Electrical Stimulation (NMES)
Critical Illness
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an attenuated loss in muscle fiber size.


Eligibility criteria: Inclusion Criteria:

* Male
* Age between 18 and 80 years
* Expected sedated time of \>24h

Exclusion Criteria:

* Spinal Cord Injury
* Arterial operaties on the legs
* Local wounds that prohibit NMES
* Chronic use of corticosteroids
* Intake of certain antithrombotic drugs
* Presence of implantable cardioverter defibrillator and/or pacemaker

Primary outcomes:
measure: Change in muscle fiber cross sectional area (CSA)
timeFrame: 3 hours before and 12 hours after 10 days of twice-daily NMES
Secondary outcomes:
measure: Change in upper leg circumference
timeFrame: 3 hours before and 12 hours after 10 days of twice-daily NMES
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
References: