louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02109003: Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Official title: Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cuff Overinflation
Cuff Underinflation
Keywords: tracheal cuff
cuff overinflation
cuff underinflation
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.

Detailed description: The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.

Eligibility criteria: Inclusion Criteria:

* Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
* Predicted duration of mechanical ventilation \> or = 48h.
* Age \> or = 18 years.
* Signed informed consent.

Exclusion Criteria:

* Anticipated duration of mechanical ventilation\<48h after randomization.
* Tracheostomized patients.
* Patients with contraindication for semirecumbent position.
* Patients participating to another trial that might influence this study results.

Primary outcomes:
measure: Percentage of recording time spent with cuff overinflation or underinflation
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
state: Barcelona
Study officials:
affiliation: Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
name: Andrey Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nseir S, Rodriguez A, Saludes P, De Jonckheere J, Valles J, Artigas A, Martin-Loeches I. Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study. Ann Intensive Care. 2015 Dec;5(1):54. doi: 10.1186/s13613-015-0054-z. Epub 2015 Jun 2.
Clinical trial NCT02119403: Hand Held Nitrous Oxide Delivery Device
Official title: Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Minimal Sedation nitrous oxide
Lead sponsor: Strata Medical Innovations
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.

Detailed description: This study assesses the Hand Held Nitrous Oxide Deliver Device which is intended to be used in nitrous oxide sedation systems by delivering a limited 16 grams of nitrous oxide over a total of 120 seconds of inhalation time.

The device creates short term minimal sedation by delivering a maximum 72% USP grade nitrous oxide / 28 % ambient air combination which quickly drops to under 33% nitrous oxide / 67% ambient air in 60 seconds and stays steady until all the gas is expelled.

Eligibility criteria: Inclusion Criteria:

* Any patient undergoing a painful office procedure or exam

Exclusion Criteria:

* Women that are Pregnant
* Children under three years of age

Primary outcomes:
measure: This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide.
timeFrame: The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required.
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Lubbock Urology
state: Texas
city: Lubbock
country: United States
facility: Other Medical Practices
state: Texas
Study officials:
name: Howard Beck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03826303: The Impact of Vaping Ethanol in the Evaluation of Impairment
Official title: The Impact of Vaping Ethanol in the Evaluation of Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
First posted: 2019-02-01
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to find out about ethanol-containing e-cigarettes impact ethanol breath tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.


Eligibility criteria: Inclusion Criteria:

* Individuals must be e-cigarette users who are 21-65, willing to provide informed consent, attend the lab sessions as needed. Participants must agree to use designated products according to study protocol.

Exclusion Criteria:

* Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
* Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Primary outcomes:
measure: Preliminary breath test for ethanol
timeFrame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline reading at 27, 35, 40, 45, and 56 minutes after e-cigarette use)
measure: Evidentiary breath test for ethanol
timeFrame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 29, 37, 42, 47, and 58 minutes after e-cigarette use)
measure: Standard Field Sobriety Test
timeFrame: Conducted before and after the e-cigarette is used by the participant, at multiple time points (change from baseline at 30 and 49 minutes after e-cigarette use)
Secondary outcomes:
Other outcomes:
measure: Direct Effects of Vaping Questionnaire
timeFrame: Administered after e-cigarette use (at 39 minutes after e-cigarette use)
measure: Biphasic Alcohol Effects Scale
timeFrame: Conducted before and after the e-cigarette is used by the participant (change from baseline at 39 and 54 minutes after e-cigarette use)
measure: General Labeled Magnitude Scale
timeFrame: Administered after e-cigarette use (at 39 minutes after e-cigarette use)
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alison Breland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01838603: Patient Experience of Interventional Pain Management. Qualitative Study
Official title: Patient Experience of Interventional Pain Management. Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Eques Indolor AB
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic pain

Brief summary: There are quite a few qualitative studies done to find out patients experience of chronic pain. There are no studies on what the patients feel and what thoughts and feelings arise in the patients that are exposed to interventional pain management. This study aims to illuminate how it is to live through an interventional pain management program.

Detailed description: A qualitative interview is performed with patients that have passed through an interventional pain management program. The transcribed interviews are analyzed with qualitative content analysis according to Graneheim and Lundman in order to illuminate the experience, feelings and thoughts arisen among the patients.

Eligibility criteria: Inclusion Criteria:

Patients passed through an interventional pain management program

Exclusion Criteria:

Purposeful sampling will be applied

Primary outcomes:
measure: Experience of interventional pain management
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vallentuna
country: Sweden
facility: Smärtkliniken Eques Indolor
Study officials:
name: Johan Hambraeus, MD
role: STUDY_DIRECTOR
References:
citation: Hambraeus J, Hambraeus KS, Sahlen KG. Patient perspectives on interventional pain management: thematic analysis of a qualitative interview study. BMC Health Serv Res. 2020 Jul 1;20(1):604. doi: 10.1186/s12913-020-05452-7.
Clinical trial NCT06185803: Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction
Official title: Predictors of Anterior Patellofemoral Pain After Anterior Cruciate Ligament Reconstruction.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Vivactis M2Research
First posted: 2023-12-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The inclusion population will be described according to all patient characteristics.

Quantitative variables will be described by their number, mean, standard deviation, median, extreme values and missing data. Qualitative variables will be described by their number, percentage and missing data. Bilateral 95% confidence intervals will be provided if the criterion is considered relevant.

The population will be described overall and in each group.

Brief summary: Observational, ambispective, longitudinal, monocentric, open cohort study of a population of adult patients operated on for ACL reconstruction and receiving postoperative follow-up.

Detailed description: On a large population of adult patients operated on for anterior cruciate ligament reconstruction and followed over a 12-month period under standard medical practice conditions.

Primary objective: to investigate, six months after surgery, the presence of patellofemoral pain and to evaluate the factors predictive of the occurrence of such pain.

Secondary objectives:

* Evaluate the incidence of patellofemoral pain at 12 months.
* Compare the functional status of patients with and without patellofemoral pain at 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or over
* Patient who has been informed of the research and does not object to data collection
* Patient who has undergone or is about to undergo ACL ligamentoplasty surgery
* Regularly followed-up patient for whom the data required by the protocol will be available in the medical record History of contralateral ACL rupture

Exclusion Criteria:

* History of associated fracture
* History of multi-ligament reconstruction

Primary outcomes:
measure: Anterior patellofemoral pain
timeFrame: Month 6
Secondary outcomes:
measure: Returning to sport
timeFrame: Month 6
measure: Returning to sport
timeFrame: Month 12
measure: Subjective knee assessment
timeFrame: Month 6
measure: Subjective knee assessment
timeFrame: Month 12
measure: Subjective symptoms assessment
timeFrame: Month 6
measure: Subjective symptoms assessment
timeFrame: Month 12
measure: Sporting and occupational physical activity assessment
timeFrame: Month 6
measure: Sporting and occupational physical activity assessment
timeFrame: Month 12
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT02222103: Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles
Official title: Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Scripps Clinic
First posted: 2014-08-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be adults men and women suspected of having obstructive sleep apnea and already scheduled for an in-lab sleep study at the Scripps Clinic Viterbi Family Sleep Center.

Brief summary: The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm Diagnostic Systems, Inc. which has many sensors inside in a "Band-Aid" like strip in order to see if it can help diagnose capabilities in individuals suspected of having obstructive sleep apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered, flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen saturation, temperature, respiratory rate, depth of respiration and motion/position. One advantage of this device over current home diagnostic systems is the capability for recording over several nights.

The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated sleep study will help us to make these determinations. Subjects will wear the device, which is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects will go about their normal daily activities and return the device via mail once completed.


Eligibility criteria: Inclusion Criteria:

* Adults over age 18
* Considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study.

Exclusion Criteria:

* Congestive heart failure or other major medical illness that would complicate the diagnosis of OSA.
* Psychological or social situation that would make the study difficult for the patient.

Primary outcomes:
measure: Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea
timeFrame: 10 days
Secondary outcomes:
measure: Home monitoring
timeFrame: 10 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Translational Science Institute
state: California
Study officials:
affiliation: STSI
name: Steven Steinhubl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01743703: Utility of Whole-body MRI in the Detection of Traumatic Injuries of Undetermined Origin in Children
Official title: Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Injuries
Keywords: traumatic injuries
Whole-body MRI
Skeletal survey
Children
Diagnostic
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 199
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And the investigators have to complete the skeletal survey with either bone-scan or CT scan or whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. Thus, whole-body MRI would allowed to have total picture of children without ionising radiation exposure.


Eligibility criteria: Inclusion Criteria:

* Infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin

Exclusion Criteria:

* Sub-dural hematoma of accidental origin or skeletal injuries of accidental
* Origin or known origin of lesions.
* Subject already included in the study

Primary outcomes:
measure: sensibility of MRI for detecting skeletal injuries
timeFrame: one week
measure: positive predictive value of MRI for detecting skeletal injuries
timeFrame: one week
Secondary outcomes:
measure: sensibility of MRI for detecting children with skeletal injuries
timeFrame: one week
measure: specificity of MRI for detecting children with skeletal injuries
timeFrame: one week
measure: predictive positive value of MRI for detecting children with skeletal injuries
timeFrame: one week
measure: predictive negative value of MRI for detecting children with skeletal injuries
timeFrame: one week
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Rennes University Hospital
name: Catherine Treguier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proisy M, Vivier PH, Morel B, Bruneau B, Sembely-Taveau C, Vacheresse S, Devillers A, Lecloirec J, Bodet-Milin C, Dubois M, Hamonic S, Bajeux E, Ganivet A, Adamsbaum C, Treguier C; PEDIMA study research group. Whole-body MR imaging in suspected physical child abuse: comparison with skeletal survey and bone scintigraphy findings from the PEDIMA prospective multicentre study. Eur Radiol. 2021 Nov;31(11):8069-8080. doi: 10.1007/s00330-021-07896-9. Epub 2021 Apr 29.
Clinical trial NCT05743803: Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study
Official title: Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Preoperative Fasting Guidelines Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Keywords: fasting
quality of recovery
surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-02-24
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing a surgical procedure (scheduled or urgent) at the CHU d'Angers (France) during the inclusion period.

Brief summary: The goal of this before and after observational study is to evaluate the impact of a global sensitization campaign (targeted on surgeons, anesthetist and patients) about pre-operative fasting in an adult population. The main questions it aims to answer are:

* Does the sensitization campaign reduce fasting time?
* Does reduce fasting time increase quality of post-operative recovery?

Sensitization campaign will be performed between the before and after phases, it will include:

* Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics.
* Reminder display in surgical wards and consults.
* Individualized fasting cards for patients.
* Short message service reminder on pre-operative fasting rules for patients.
* Medical fasting prescription with clear fasting times.


Eligibility criteria: Inclusion Criteria:

- Adult undergoing a surgical procedure.

Exclusion Criteria:

* Already intubated patient before surgery.
* Redo surgery during the same hospitalization
* Medical indication of fasting (e.g : occlusive syndrome)
* Patient unable to anwser the questionnaire.
* Patient under lawful protection
* Pregnant women
* Minor (\<18 years)

Primary outcomes:
measure: Fasting time
timeFrame: Before surgery
Secondary outcomes:
measure: Preoperative oral carbohydrate loading
timeFrame: 2 hours preoperative period
measure: Fasting exceeding 12 hours
timeFrame: Before surgery
measure: Preoperative anxiety
timeFrame: Before surgery
measure: Preoperative discomfort
timeFrame: Before surgery
measure: Feeling of thirst
timeFrame: Before surgery
measure: Feeling of hunger
timeFrame: Before surgery
measure: Preoperative nausea or vomiting
timeFrame: Before surgery
measure: Rate of postoperative nausea or vomiting
timeFrame: Day of surgery
measure: Patient satisfaction toward communication and explanation about preoperative fasting.
timeFrame: Day of surgery
measure: Post-operative quality of recovery
timeFrame: Day 1 after surgery
measure: Length of stay
timeFrame: Maximum 30 days follow up
measure: Post-operative surgical complication
timeFrame: Maximum 30 days follow up
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References:
Clinical trial NCT00471003: The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension
Official title: A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Asses the Efficacy and Safety of Telmisartan, With the Special Attention on the Influence of Telmisartan on Selected Metabolic Parameters of Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-05-08
Enrollment: 5448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Untreated or ineffectively treated arterial hypertension

Exclusion Criteria:

* Cholestatic disorders and severe hepatic failure
* Allergy to telmisartan
* Pregnancy and lactation period

Primary outcomes:
measure: Efficacy and safety of the treatment with telmisartan reported by the physician
timeFrame: At the both of planned control visits. (Approx. interval between visits 3 months)
Secondary outcomes:
measure: Changes in metabolic parameters in telmisartan treated patients
timeFrame: At the both of planned control visits. (Approx. interval between visits 3 months)
Other outcomes:
Locations:
city: Many Locations
country: Croatia
city: Many Locations
country: Poland
city: Many Locations
country: Slovakia
city: Many Locations
country: Slovenia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: