louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03447418: Multiple Breath Nitrogen Washout in Healthy Volunteers
Official title: Multiple Breath Nitrogen Washout in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Lung Clearance Index
Breath Nitrogen Washout
Healthy subjects
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 191
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)


Eligibility criteria: Inclusion Criteria:

* Informed consent by participant, parent, or legal guardian
* Healthy subjects with a social insurance

Exclusion Criteria:

* History of a lung chronic disease
* Premature birth (\<37th weeks of amenorrhea)
* Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout

Primary outcomes:
measure: Lung Clearance Index 2.5% (LCI 2.5%) Value
timeFrame: hour 1
Secondary outcomes:
measure: Lung Clearance Index 5% (LCI 5%) Value
timeFrame: hour 1
measure: Moment ratio M1/M0 Value
timeFrame: up to 1 hour
measure: Moment ratio M0/M2 Value
timeFrame: up to 1 hour
measure: Sacin value
timeFrame: hour 1
measure: Scond value
timeFrame: hour 1
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT05462418: Diathermy vs Scalpel in Abdominal Incision in Women Undergoing CS
Official title: Diathermy Versus Scalpel in the Transverse Abdominal Incision in Primigravida Obese Women Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incision, Surgical
Keywords: Diathermy
scalpel
cesarean section
obese
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cesarean section is surging worldwide. For an extended period of surgical practice, the scalpel has been well-known as a gold-standard tool for making surgical incisions. The diathermy, electrocautery, is a substitute.


Eligibility criteria: Inclusion Criteria:

* Women with BMI 30- 40 Kg/m2.
* Women pregnant with singletons and planned to have a repeat elective lower-segment CS at 38-39 weeks' gestation due to having had one previous CS.
* Women pregnant with singletons and planned to deliver by lower-segment CS at 38-39 weeks' gestation for the first time (primi-section) due to obstetric indication.

Exclusion Criteria:

* Cases with coagulopathies eg. Hemophilia, von Willebrand disease
* Cases on anti-coagulant therapy eg. Heparin, warfarin
* Cases with chronic diseases expected to affect wound healing, such as diabetes, hypertension, liver diseases, chronic anemia, and renal impairment.

Primary outcomes:
measure: blood loss
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine - Cairo university
state: Kasr El Ainy
Study officials:
affiliation: Cairo University
name: Mohammed A Taymour, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02150018: Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography
Official title: Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: - Critical Care
Non Invasive Ventilation
Electrical Impedance Tomography
End Expiratory Lung Volume
End Expiratory Lung Impedance
Keywords: - Critical Care
Non invasive ventilation
Electrical impedance tomography
End expiratory lung volume
End expiratory lung impedance
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital, Estaing
First posted: 2014-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients requiring non invasive ventilation

Brief summary: Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography

Detailed description: Prospective clinical study in ICU with patients requiring non invasive ventilation (NIV) comparing lung volumes determined by electrical impedance tomography before, during and after NIV.

Duration of NIV is 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Adult ICU patients requiring non invasive ventilation
* Consent of patients or family
* Arterial line

Exclusion Criteria:

* Tracheotomized patients
* Dressings in the thoracic area

Primary outcomes:
measure: - End-expiratory lung volume (EELV) determined by electrical impedance tomography before, during and after NIV
timeFrame: at day 1
Secondary outcomes:
measure: Anterior, medio-anterior, medio-posterior and posterior EELV
timeFrame: at day 1
measure: Ventilatory frequency
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sebastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05067218: Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.
Official title: Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Anesthesia, Local
Vibration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth
Primary purpose: TREATMENT

Brief summary: This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).

Detailed description: The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.

Eligibility criteria: Inclusion Criteria:

* Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour.
* Medically fit children (ASA I, II).
* Children mentally capable of communication.
* Children aged 6-11 years.
* First dental visit.
* Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment.

Exclusion Criteria:

* Children with a behavioral management problem.
* Children with known allergy to local anesthetic agents.
* Parental refusal for participation

Primary outcomes:
measure: Pain perception during LA injection
timeFrame: one hour
Secondary outcomes:
measure: Heart rate during injection of local anesthesia.
timeFrame: one hour
Other outcomes:
measure: Child's behavior during local anesthesia injection.
timeFrame: one hour
Locations:
Study officials:
References:
Clinical trial NCT04402918: Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy
Official title: Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sars-CoV2
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.


Eligibility criteria: Inclusion Criteria:

* pregnant woman
* diagnosed with Sars Cov-2 during pregnancy
* singleton or twin pregnancy
* informed consent

Exclusion Criteria:

* virological or serological samples not done the day of delivery

Primary outcomes:
measure: Vrological profile of newborns.
timeFrame: day of delivery
measure: Immunological profile of newborns.
timeFrame: day of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Chu Besancon
Study officials:
References:
Clinical trial NCT06636318: Immune Status After Being on Call for 24 Hrs
Official title: Impact of a 24-hour Shift Call on the Immune Status of Surgery Residents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Deprivation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General Surgery residents, on during 24-hour shifts

Brief summary: Sleep deprivation is a prevalent problem in modern societies. Sleep deprivation can cause hormonal changes, such as an increase in cortisol, as well as inflammation. Animal studies have shown an increase in inflammatory cytokine production following sleep deprivation. Additionally, humans experiencing sleep deprivation may experience a decrease in natural killer cells and lymphocytes.

Physicians, particularly those in surgical specialties, are often subjected to sleep deprivation as part of their medical residency training. This study hypothesizes that after 24-hour shifts, there is an increase in inflammatory response and impairment of the immune response against unspecific activation. This proposal aims to provide insight into the impact of sleep deprivation on the immune system of surgery residents by characterizing the phenotype and function of immune cells, as well as their correlation with biometric data.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Surgery residents in a 24-hour shift rotation
* Gender of subjects: Males and females
* Age of subjects: 18 years old and older
* Racial and Ethnic Origin: Any race or ethnicity

Exclusion Criteria:

* Unwilling/unable to sign informed consent
* Vulnerable Subjects/Subject Capacity to provide consent

Primary outcomes:
measure: Characterization of the phenotype and function of immune cells using flow cytometry
timeFrame: 24 hours
Secondary outcomes:
measure: Analyze the biometric data and correlate it with changes in sleep deprivation
timeFrame: One week before rotation and the last week of rotation
measure: Analyze the biometric data and correlate it with changes in the immune response
timeFrame: One week before rotation and the last week of rotation
measure: Analyze the biometric data and correlate it with changes in physical activity
timeFrame: One week before rotation and the last week of rotation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Angelica Perez-Gutierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156518: The Efficacy of Vocal Function Exercises for Laryngeal Cancers
Official title: Investigating the Efficacy of Vocal Function Exercises in the Treatment of Voice Problems in Adults Treated With Radiation Therapy for Laryngeal Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vocal Folds
Keywords: radiation therapy, laryngeal cancer, voice therapy, vocal function exercises
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if the systematic practice of Vocal Function Exercises (VFE) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a prescriptive vocal exercise program (VFE) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.


Eligibility criteria: Inclusion Criteria:

* Hearing level and cognitive ability to follow test directions
* Laryngeal cancer
* Radiation Therapy completed \>= 6 months
* Deemed disease free by the treating physician
* Subjects have to be willing to attend weekly voice therapy sessions

Exclusion Criteria:

* Adjuvant treatment: laser or any surgical intervention
* Neurological or cognitive impairment
* Hearing levels that interfere with following test instruction
* Vocal fold paralysis

Primary outcomes:
measure: Voice production
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky, Markey Cancer Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky, Department of Rehabilitation Sciences
name: Vrushali Angadi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02662218: Observational Study of Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing
Official title: Prospective, Multicenter, Observational Study to Evaluate the Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 32
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: Patients with superficial wounds of any etiology, that are treated at outpatients' clinic

Brief summary: This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.


Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 18 years old
* Written informed consent after patient education to participate in the study
* Superficial wounds of any etiology affecting only epidermis and dermis layers
* Maximum wound size: 6 x 16cm / 6 x 6cm
* Wounds with one or more clinical signs or infection or assessed as at high risk of infection according to the following:

  * Wounds assessed as critically colonized with malodour, abnormal tissue or absence of viable tissue, excessive or increased serous exudate, possible extension of wound dimensions and no sign of a healing process and/or
  * Wounds with one or more historical episodes of topical infection and/or
  * Wounds assessed as at a high risk of infection on other grounds by the investigator.
* Superficial wounds with high levels of exudate

Exclusion Criteria:

* Not willing to sign or incapable of signing an informed consent form
* Known allergy or sensitivity to one of the dressing components
* Pregnancy or lactation
* Subject is participating in another clinical study

Primary outcomes:
measure: Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).
timeFrame: 14 days
measure: Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ynysmaerdy
country: United Kingdom
facility: Welsh Wound Innovation Centre
state: Rhondda Cynon Taf
Study officials:
affiliation: Welsh Wound Innovation Centre
name: Nicky Ivins
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020018: Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection
Official title: Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: KCI USA, Inc
First posted: 2013-12-24
Enrollment: 1869
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.

Detailed description: Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.

Eligibility criteria: Inclusion criteria:

1. Transplant patients
2. BMI \>30
3. Type I (insulin-dependent) diabetics
4. Severe chronic obstructive pulmonary disease (COPD)
5. Steroid-dependent patients
6. Previous Tracheostomy

Exclusion criteria:

1. BMI\<30
2. Thoracotomy

Primary outcomes:
measure: Wound Infection After Open Heart Surgery
timeFrame: 30 days post-surgery
Secondary outcomes:
measure: Reoperation for Wound Infection
timeFrame: 30 days post surgery
Other outcomes:
measure: Length of Stay
timeFrame: postoperative to discharge
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hartzell V Schaff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01662518: DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Official title: A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Centro de Pesquisa Rubens Siqueira
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2012-08-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: intervention group: 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.

Detailed description: Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older with macular edema resulting from retinal vein occlusion
* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
* Visual acuity in other eye no worse than 20/200

Exclusion Criteria:

* Known anticipated need for ocular surgery within next 12 months
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Diabetic retinopathy
* Uncontrolled systemic disease
* Known steroid-responder
* Use of systemic steroids
* Use of warfarin/heparin

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Day 0 - Day 180
Secondary outcomes:
measure: Change in central foveal thickness at 48 weeks
timeFrame: 1 day to 48 weeks
Other outcomes:
Locations:
city: Sao Jose do Rio Preto
country: Brazil
facility: Centro de Pesquisa Rubens Siqueira
state: SP
Study officials:
affiliation: Centro de Pesquisa Rubens Siqueira
name: Rubens C Siqueira, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00670618: A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2
Official title: A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Caries Lesions
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: GC Europe
First posted: 2008-05-02
Enrollment: 325
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.


Eligibility criteria: Inclusion Criteria:

* No white spot lesion at the time of placement of fixed appliances

Exclusion Criteria:

* White spots already present before start orthodontic treatment

Primary outcomes:
measure: Prevention of the opacity of white spots during orthodontic treatment with fixed appliances
timeFrame: After 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Guy De Pauw, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: