louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04635358: Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
Official title: Feasibility Study of Smoking Cessation for the Staff of a Hospital Center Through a Treatment Proposal Combining Nicotine Substitutes, Psychological Support, Nutritional Assistance and Hypnosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking, hypnosis, nutrition support, psychological support
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The recorded prevalence of daily smoking among health professionals (doctors, nurses, midwives, etc.), regardless of their mode of practice (salaried or self-employed, etc.) varies between 14 and 23%. In health care institutions, according to the studies, the prevalence of daily smoking among staff, caregivers and non-caregivers ranges from 17% to 27%. These professionals who continue to smoke, although they are particularly well informed about the risks they run, probably constitute a group with specific withdrawal difficulties. Beyond the impact on their own health, the smoking status of caregivers could also have an impact on the management of tobacco patients. There are very few studies of the impact of interventions on the smoking status of caregivers in health care facilities. The combination of several intervention modalities can facilitate the participation of target professionals and generate efficiency synergies.


Eligibility criteria: Inclusion Criteria:

Professionals employed at the Nice hospital who are volunteers and have :

* an initial Fagerstrom test \> 3
* associated with expired carbone monoxide \> 10 ppm at least 60' after the last cigarette.

Exclusion Criteria:

* Reported associated addiction (cannabis, alcohol or any other psychoactive product)
* Professionals likely to no longer work at the Nice Hospital in the year following the start of the study
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Number of subjects enrolled in the program who participated in the full range of care offered
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Bernard PROUVOST-KELLER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03349658: Cerebral Oximetry and Anesthetic Technique
Official title: Evaluation of the Effects of Spinal Versus General Anesthesia on Transcranial Cerebral Oxygen Saturation in Geriatric Patients Undergoing Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Hip Joint
Keywords: total hip arthroplasty
cerebral oxygen saturation
general anesthesia
spinal anesthesia
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-11-21
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to compare the effects of spinal and general anesthesia on transcranial regional cerebral oxygen saturation in geriatric patients undergoing total hip arthroplasty.

Detailed description: Geriatric patients who received anesthesia undergoing total hip arthroplasty were randomized by means of a computer-generated randomization order into two groups; general anesthesia group (Group 1) and spinal anesthesia group (Group 2). Before and after induction of the general or spinal anesthesia, patients were monitorized with near infrared spectroscopy for regional cerebral oxygen saturation. Findings were compared statistically.

Eligibility criteria: Inclusion Criteria:

* patients who undergo elective total hip arthroplasty
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria:

* Pulmonary disease
* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Neurologic disease
* Coagulation disorders

Primary outcomes:
measure: Change in transcranial regional cerebral oxygenation (rSO2)
timeFrame: 60 minutes
Secondary outcomes:
measure: Post anesthetic complications
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ozge Dagdelen, MD
role: STUDY_DIRECTOR
affiliation: Antalya Training and Research Hospital
name: Nilgun Kavrut Ozturk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital
name: Ülkü Arslan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02164058: TandemHeart to Reduce Infarct Size (TRIS Trial)
Official title: A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Myocardial infarction
STEMI
ST elevation MI
Acute MI
Lead sponsor: CardiacAssist, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-16
Enrollment: 0
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 determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction \[STEMI\]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)


Eligibility criteria: INCLUSION CRITERIA

The following is a list of general inclusion criteria. More detailed information can be found in the study protocol.

1. ≥ 18 years of age
2. Presents within 6 hours of acute MI symptoms
3. Evidence of ST elevation
4. First myocardial infarction
5. Written informed consent

EXCLUSION CRITERIA

The following is a list of general exclusion criteria. More detailed information can be found in the study protocol.

1. Contraindications to antiplatelet/anticoagulation therapy
2. History of blood disorders or active bleeding
3. Renal dysfunction or failure
4. Neurologic damage
5. Cardiogenic shock
6. History of cerebrovascular disease
7. History of transfusion reaction
8. Prior coronary artery bypass surgery
9. Participation in another trial with an investigational drug or device
10. Pregnant

Primary outcomes:
measure: Primary Safety
timeFrame: 30 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01815658: "Bio-logical" Carbon Fiber Intramedullary Nail Biomechanical Test and Preliminary Clinical Results
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractures, Bone
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with broken humerus

Brief summary: The aim of this study is to present a novel Intramedullary Nail (IMN) made of CFR - PEED composite, that is biomechanically tailored to closely match cortical bone. This IMN should promote fracture healing and prevent stress shielding osteopenia.

Case records of patients with humurus shaft fracture will be retrospectively reviewed to determine whether the implant promotes bone healing.


Eligibility criteria: Inclusion Criteria:

* Broken humerus shaft

Exclusion Criteria:

* All others

Primary outcomes:
measure: Bone healing
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT01699958: A Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents
Official title: A Pilot Study of the "Healthy Living Study," a Randomized Controlled Trial of a Brief Outpatient Problem-solving Intervention to Promote Healthy Eating and Activity Habits in Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Problem solving therapy
Behavior change
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to refine, evaluate the feasibility, and to estimate the effect of the "healthy Living Study," a brief outpatient problem-solving intervention to promote healthy eating and activity habits in adolescents.

Detailed description: This study will refine, evaluate the feasibility, and estimate the effect of a brief problem-solving intervention to promote healthy eating and activity habits in adolescents. Intervention participants will receive 2 sessions of individual behavioral counseling on problem-solving skills utilizing educational videos, handouts, and worksheets. Intervention participants will be asked to generate unique health goals and practice utilizing problem-solving skills to achieve these goals.Control participants will receive standard of care. Outcomes will explore the ability to shorten the intervention, integrate the intervention into busy outpatient clinics, and estimate the effect of the intervention on confidence to maintain or improve healthy habits and to improve problem-solving skills.

Eligibility criteria: Inclusion Criteria:

* 13-18 years old
* Able to read and speak English
* Patient of the Lucile Packard Children's Hospital teen clinic, weight clinic, or mobile teen van

Exclusion Criteria:

* History of purging within the prior 12 months

Primary outcomes:
measure: Feasibility to conduct a brief problem-solving intervention in a busy academic outpatient setting.
timeFrame: From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
Secondary outcomes:
measure: Change in problem-solving skills
timeFrame: Change from baseline to 1-2 months
measure: Change in confidence to maintain or improve healthy eating habits
timeFrame: Change from baseline to 1-2 months
measure: Sufficient recruitment and retention rates
timeFrame: From recruitment of the first participant to completion of the intervention by the last participant, anticipated duration of time: 7-8 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Leslie Gee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06802458: Motivational Interviewing on Healthy Lifestyle Behaviors and Quality of Life in on Menopausal Women
Official title: The Effect of Motivational Interviewing on Healthy Lifestyle Behaviors and Quality of Life in on Menopausal Women: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Nursing
Keywords: motivational interviewing
healthy lifestyle behavior
menopause specific quality of life
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Munzur University
First posted: 2025-01-31
Enrollment: 136
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: This study aims to determine the effect of motivational interviewing on healthy lifestyle behaviors and quality of life in menopausal women.

Methods: This is a randomized controlled empirical study. The study was conducted with a total of 136 women, including 68 for experimental group and 68 for control group. The data were collected using an introductory information form, the Health Promoting Lifestyle Profile II (HPLPL II) and the Menopause-Specific Quality of Life (MENQOL). Women in the experimental group received 6 sessions of motivational interviewing and 2 follow-up interviews in two family health centers (FHCs) from the researcher. No intervention was applied to women in the control group. The data were analyzed using number, percentage, mean, standard deviation, chi-square test, Bonferroni test, independent samples t test and repeated ANOVA.


Eligibility criteria: Inclusion Criteria:

1. being literate;
2. being able to make a conscious decision to participate in the study, being able to communicate verbally, and being able to sign a consent form;
3. having had menopause naturally and within the last 3 years;
4. being sexually active;
5. having no hormone replacement therapy.

Exclusion Criteria:

1. unwilling to continue the study;
2. having a psychiatric diagnosis according to the FHC records.

Primary outcomes:
measure: Health Promoting Lifestyle Profile II
timeFrame: change from starting to 0. and 7. week
measure: Menopause-Specific Quality of Life
timeFrame: change from starting to 0. and 7. week
Secondary outcomes:
Other outcomes:
Locations:
city: Tunceli
country: Turkey
facility: Munzur University
Study officials:
References:
Clinical trial NCT02197858: Comparability of Invasive and Non-invasive Haemodynamic Monitoring
Official title: Clinical Comparison of Hemodynamic Parameters Using Invasive Versus Non-invasive Continuous Blood-pressure Technology During a Total Intravenous Anaesthesia (TIVA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Anesthesia, Intravenous
Keywords: invasive arterial pressure
extended hemodynamic monitoring
propofol
remifentanil
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that get an elective surgery under general anesthesia

Brief summary: During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called "extended hemodynamic monitoring" depending on the operation and patient. Frequently an invasive arterial cannula is used to provide continuous information on the blood pressure. This invasive method is very accurate and clinically established, but can be linked to adverse effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a non-invasive manner. It thus offers beat-to-beat information even about the extended hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform EV1000 (Edwards Lifescience).

Assuming that the two methods are equal we plan to measure extended hemodynamic parameters before, during induction and during ongoing anesthesia both invasive and non-invasive. Data will be recorded every 30sec.

Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters is to our knowledge rare and further assessment in this field is needed to offer patients a potentially equally reliable but less invasive monitoring. Furthermore the study should model the effect of remifentanil, propofol or its combination on haemodynamics .


Eligibility criteria: Inclusion Criteria:

* elective surgery with the necessity of an arterial catheter

Exclusion Criteria:

* patient not consented
* peripheral vascular disease

Primary outcomes:
measure: Mean arterial pressure
timeFrame: during anesthesia induction
Secondary outcomes:
measure: Cardiac output
timeFrame: during anesthesia induction
measure: Stroke volume variation
timeFrame: during anaesthesia induction
measure: Stroke volume
timeFrame: during anesthesia induction
measure: Heart rate
timeFrame: during anaesthesia induction
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital
state: Bavaria
Study officials:
References:
Clinical trial NCT06490458: Effects of Balance Training on Functional Capacity of Patients After Coronary Artery Bypass Grafting Surgery
Official title: Effects of Balance Training Post Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery(CABG)
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Heart Institute, Egypt
First posted: 2024-07-08
Enrollment: 60
Sex: MALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft.

Aims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery.

Detailed description: Methods: Sixty male patients under went CABG with ages 55-65 years Patients were randomly randomized into to two groups equal in number 30 in each group. (Group A: study group, Group B: control group).All patients were thoroughly evaluated one day after extubation and day 6 after operation.

Berg Balance Scale (BBS): is a test used to assess patients functional balance , the sit to stand test(STS) used to asses patients functional capacity and SF36 is questionnaire used to assess quality of life with patients. all of those tests done before and after training sessions with both groups. and compare the length of hospital stay between both groups.

Eligibility criteria: Inclusion Criteria:

1. Sixty male patients underwent CABG surgery, their age between 55 to 65 years old.
2. All patients were conscious, clinically and medically stable.
3. All patients are ambulant independently.
4. All patients are haemodynamically stable.
5. Good cognition level.
6. All patients are conscious and can perform physical activity.

Exclusion Criteria:

1. Hemodynamic instability.
2. Patients who need re-intubation.
3. Patients on high inotropic supports.
4. Patients with existing pulmonary disease or associated pulmonary complications.
5. Recent MI.
6. Patients who reported too much pain.
7. Neuromuscular disorders.
8. Active hemorrhage and hemoptysis.
9. Poor cognition and mentality.
10. Unstable angina.
11. Decompensated heart failure.
12. Deep vein thrombosis.

Primary outcomes:
measure: Berg balance scale(BBS)
timeFrame: 7 Days
Secondary outcomes:
measure: sit to stand test(SST)in seconds
timeFrame: 1st day and 7th day
measure: length of hospital stay (in Days)
timeFrame: from 1st day
measure: SF36 Questionnaire( scores)
timeFrame: 3rd day
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: National heart institute
Study officials:
affiliation: Cairo University
name: Hady Balabel, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02508558: Validation of Methods for Evaluating Operation Force, Motion and Visual Perception in Weightlessness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Previous studies have neglected two important aspects for the China National Space Administration. First, while biomechanical models are very sensitive to the characteristics of the subjects, data have been collected on subjects with biomechanical characteristics very different from those of "typical" Chinese astronauts. Second, pure video analysis techniques and kinematic data lack the necessary acceleration information important to understanding the forces exerted during movement and control of human motion. While some studies used force and moment sensors to aid in robot torque control and human joint work estimation, investigators are unaware of any studies performed in a microgravity environment that have combined the kinetic force and moment information with acceleration measurements to enable more reliable motion tracking without the need for acceleration estimation.

This is why MICR0-G sensors and accompanying kinematic video system have been developed in order to provide for detailed analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques permits us to calculate the joint and musculoskeletal dynamics required to execute the microgravity motions, as well to provide insight into the altered movement strategies in reduced gravity as compared to 1-G locomotion.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese volunteers (men or women)
* Living in France and affiliated to a French Social Security system
* Aged from 22 to 45
* Body Mass Index from 19 to 25
* Who accepted to take part in the study
* Who has given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women

Primary outcomes:
measure: motion perception performance under different gravity states
timeFrame: baseline
measure: locomotor operation performance under different gravity states
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References: