louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06741280: Post-marketing Study for the Evaluation of Profilm Mouth Sores
Official title: Post-marketing Study for the Evaluation of the Efficacy and Safety of Profilm Mouth Sores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth Sores
Keywords: Ulcers
Recurrent aphthous stomatitis
Oral ulcers
Mouth ulcers
Mouth sores
Sore
Lead sponsor: i+Med S.Coop.
Sponsor class: INDUSTRY
Collaborators: name: Dr. Goya Análisis, SL.
name: Centro Médico Complutense Grupo Virtus
First posted: 2024-12-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Post-marketing, prospective, within-subject controlled clinical trial.
Primary purpose: TREATMENT

Brief summary: The study aims to assess the effect of Profilm Mouth Sores treatment for relieving symptoms caused by mouth sores. It will involve 35 participants and last around 14 days or until the sores heal, with three daily applications. A dermatology specialist will evaluate the results through tests and examinations of the treated area.


Eligibility criteria: Inclusion Criteria:

* Male / female / aged 18 years or older.
* Presence of an ulcer on the oral mucosa, regardless of the number of days since its appearance.
* At least 30 days have passed since the last episode.
* Willingness to return for all study-related visits.
* Sufficient willingness and ability, as judged by the investigator, to respond to the questionnaires included in the study.

Exclusion Criteria:

* Pregnant women or women in the breastfeeding period.
* Patients undergoing treatment with antiviral medications, hydrocortisone, or other medications.
* Patients with immunodeficiency diseases, such as acquired immunodeficiency syndrome or altered immune activity in the last 7 days.
* Patients undergoing other pharmacological therapy for oral conditions.
* Patients with other oral mucosa diseases simultaneously.
* Known allergy or hypersensitivity to any of the components.

Primary outcomes:
measure: Confirm the effectiveness of the treatment in terms of pain relief, using an EVA scale.
timeFrame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
measure: Serious adverse events.
timeFrame: Through study completion, apprroximately 2 weeks.
Secondary outcomes:
Other outcomes:
measure: Mild adverse events.
timeFrame: Through study completion, apprroximately 2 weeks.
measure: Healin time and lesion size.
timeFrame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
measure: Global treatment assessment by participants.
timeFrame: At the conclusion of the study, approximately 2 weeks later.
measure: Number, size, and location of sores
timeFrame: At baseline, in 24 hours, in 3 days, in 7 days and in 14 days.
Locations:
city: Alcalá de Henares
country: Spain
facility: Centro Médico Complutense Grupo Virtus
state: Comunidad de Madrid
Study officials:
References:
Clinical trial NCT02851680: Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.
Official title: Prospective Study on the Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Fungal Infections
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 476
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.


Eligibility criteria: Inclusion Criteria:

* Patients who have been informed about the study
* Patients over 18 years
* patients with acute myeloblastic leukaemia (AML) or lymphoblastic leukaemia (ALL) who have undergone cytotoxic chemotherapy with curative intent

Exclusion Criteria:

* Adults under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* allografts and autografts of Haematopoietic Stem Cells (HSC)

Primary outcomes:
measure: Comparison of the results of the 1-3 ß D glucan serum assay obtained with the Fungitell® test and the test currently used (in terms of specificity, sensitivity, negative predictive value and positive predictive value
timeFrame: 8 to 10 assays over 4 to 5 weeks of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01003080: Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
Official title: Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Keywords: The evaluation of hemostasis during total knee arthroplasty using the aquamantys device.
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.


Eligibility criteria: Inclusion Criteria:

* Patient indicated for total knee arthroplasty

Exclusion Criteria:

* Patients undergoing revision total knee arthroplasty
* Patients with blood disorders
* Patients on chronic anti-thrombotic medication such as Coumadin
* Patients with a history of deep vein thrombosis
* Patients with a history of pulmonary embolism

Primary outcomes:
measure: Drain Output.
timeFrame: First 24 hours following surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jack D. Weiler Hospital-Division of Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Sun Jin Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05172180: Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19
Official title: Correction of Metabolic Disorders and Its Effect on Respiratory Function of Lungs in Patients With Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
METABOLIC DISORDERS
Respiratory function of the lungs
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe novel coronavirus infection COVID-19 (NCI) who were treated at the intensive care unit (ICU)

Brief summary: Objective of the study: to investigate the effect of meglumine succinate solution on the dynamics of metabolic blood parameters and respiratory function of the lungs in intensive care patients with new coronavirus infection. An observational prospective study included 105 patients with a severe course of novel coronavirus infection


Eligibility criteria: Inclusion Criteria:

1. age 18-70 years;
2. diagnosis of SARS-COV-2 NCI confirmed by laboratory tests;
3. the lung lesion volume on CT scan is significant or subtotal - CT 3-4;
4. initiation of infusion therapy on the 1st day after patient admission to ICU

Exclusion Criteria:

* 1) presence of initial indications for transfer to invasive ALV at the time of screening; 2) history of Reamberin intolerance; 3) administration of other polyelectrolyte solutions with reserve alkalinity carriers; 4) pregnancy and postpartum; 5) severe renal failure requiring renal replacement therapy; 6) severe hepatic failure (Child-Pugh class C or higher); 7) diabetes mellitus; 8) terminal stage of other chronic incurable diseases

Primary outcomes:
measure: Mortality, %
timeFrame: from date of treatment start until the date of death or the date of discharge from hospital
measure: Duration of treatment at ICU, days
timeFrame: from date of treatment start until the date of death or the date of discharge from hospital
measure: Duration of treatment after ICU, days
timeFrame: from date of treatment start until the date of death or the date of discharge from hospital
Secondary outcomes:
measure: Glucose
timeFrame: baseline, day 2, day 3, day 5, day 11
measure: Lactate
timeFrame: baseline, day 2, day 3, day 5, day 11
measure: pH
timeFrame: baseline, day 2, day 3, day 5, day 11
measure: BE
timeFrame: baseline, day 2, day 3, day 5, day 11
measure: Dynamics of right diaphragm excursion, cm
timeFrame: baseline, day 2, day 3, day 5, day 11
measure: Total duration of inpatient treatment, days
timeFrame: from date of treatment start until the date of death or the date of discharge from hospital
Other outcomes:
Locations:
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital named after N.A. Semashko
Study officials:
References:
Clinical trial NCT04396080: Prospective Clinical Trial of Onlay-carrying Patients
Official title: Prospective Clinical Trial of Onlay-carrying Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Success
Survival Rate
Clinical Performance
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who require it, will be treated with posterior partial restorations. That will be the intervention.
Primary purpose: TREATMENT

Brief summary: A record of the type of onlay will be made with respect to its extension, tooth or teeth to be treated, the material of clothing and the substrate on which the adhesion and cementing method, as well as the type of antagonist. To complete it, a complete clinical oral examination will be performed with oral mirrors, examination probes, joint paper, disposable gloves, masks, paper napkins, plastic cups, dental equipment lighting lamp, cold spray , photogrammed camera, including an intraoral scan to have a 3D file of the patient's condition on the day of embedding placement.

Once treatment is complete, the patient should go to routine check-ups in which a full intraoral exploration and data collection intended to be carried out analyze the following variables (USPHS modificated): possible decemented and fractured, decay and marginal integrity, sensitivity or loss of vitality, as well as the degree of patient satisfaction (VAS).

Detailed description: The same intervention will be carried out during the duration of the project, collecting the variables:

* baseline recall. (cementing day)
* 1 month.
* 6 months.
* annually.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:
* Healthy adult patients (ASA I) susceptible to treatment with onlays in the posterior region treated at the University Dental Clinic (Master's Clinic in Dental Prosthetics of the Department of Stomatology of the Faculty of Medicine and dentistry)

Exclusion Criteria:

* Minor patients.
* Medically committed patients.
* Patients with active cavities.
* Patients with active periodontal disease.

Primary outcomes:
measure: Survival
timeFrame: Through study completion, an average of 5 years.
Secondary outcomes:
measure: Complications
timeFrame: Through study completion, an average of 5 years.
Other outcomes:
measure: Clinical behaviour
timeFrame: Through study completion, an average of 5 years.
Locations:
city: Valencia
country: Spain
facility: Lucia Fernandez-Estevan
Study officials:
affiliation: University of Valencia
name: Lucia Fernandez-Estevan, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03007680: Effect of Core Muscles Activation for the Increase of Quality in Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether core muscle activation is effective in the increase of quality of cardiopulmonary resuscitation.


Eligibility criteria: Inclusion Criteria:

* Registered nurses who have experiences of CPR education

Exclusion Criteria:

* 1. Acute/chronic pain on body 2. History of cardiovascular disease 3. History of vertebral disease including herniated disc 4. Pregnancy

Primary outcomes:
measure: chest compression depth
timeFrame: 4 min
measure: lean depth
timeFrame: 4 min
measure: high quality chest compressions
timeFrame: 4 min
measure: chest compressions rate
timeFrame: 4 min
Secondary outcomes:
measure: elbow angle
timeFrame: 4 min
measure: muscle fatigue
timeFrame: 4 min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Hospital
Study officials:
affiliation: Hallym University
name: Wonhee Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03891680: Intra Articular Botox Injection in Treatment of Osteoarthritis
Official title: Comparison Between Intraarticular Botox Injection Versus Genicular Pulsed Radio Frequency in Treatment of Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Knees Both
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

Detailed description: Compared the short and long term effects of sonography guided intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

Eligibility criteria: Inclusion Criteria:

* osteoarthritis

Exclusion Criteria:

* coagulopathy Organ failure

Primary outcomes:
measure: Pain visual analog scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Manal Hassanien
Study officials:
affiliation: Physical medicine Tanta university
name: Abdallah Allam
role: STUDY_CHAIR
affiliation: Biochemistry Tanta university
name: Rasha Gaber
role: STUDY_CHAIR
affiliation: Taiwan
name: Ke Vin
role: STUDY_CHAIR
References:
Clinical trial NCT06938789: How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study
Official title: The Impact of Bleeding on Delirium Outcomes in Older Patients With Hip Fractures: A Single-Blind, Randomized Controlled Trial - The IMPROVE-HIP Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bleeding
Hip Fracture
Delirium - Postoperative
Keywords: Hip fracture
Delirium
Blood transfusion
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Gødstrup Hospital
name: Aarhus University Hospital
First posted: 2025-04-22
Enrollment: 198
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. The main question the trial aims to answer is:

• Do patients aged 75 and older with hip fractures benefit from quicker treatment of anaemia (low blood count) to reduce the risk of delirium?

Researchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium.

Participants will:

* Undergo blood tests and have their vital signs checked, as well as be screened for delirium three times a day for the first 48 hours after surgery.
* Receive blood transfusions promptly if their haemoglobin levels drop below a specified threshold.
* Have a follow-up visit at 30 days to assess their memory and overall quality of life.
* Have another follow-up at 90 days to check for hospital readmissions and survival


Eligibility criteria: Inclusion Criteria:

* Hip fracture

Exclusion Criteria:

* Pathological hip fracture
* Periprosthtic fracture
* Unable to speak or understand Danish
* Does not wish to recieve blood transfusion
* If the investigator finds the patient unable to cooperate to the study (e.g. in case of severe dementia and externalizing behaviour)

Primary outcomes:
measure: Number of Participants with Delirium
timeFrame: From enrollment to 48 hours after surgery
Secondary outcomes:
measure: Change from baseline in Quality of Life
timeFrame: Will be evaluated at the 30 day follow-up
measure: Cognitive status
timeFrame: Will be evaluated at the 30 day follow-up.
measure: Readmission rate
timeFrame: Within 90 days after surgery
measure: 90-day mortality
timeFrame: 90 days after surgery.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
city: Herning
country: Denmark
facility: Gødstrup Hospital, Department of internal medicine
state: Central Denmark Region
Study officials:
References:
Clinical trial NCT01175889: Megadyne Ace Incision/Dissection Study
Official title: Megadyne ACE Incision/Dissection Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abdominoplasty
Bilateral Breast Reduction
Bilateral Breast Lift
Bilateral Brachioplasty
Bilateral Lateral Thigh and Buttocks Lift
Lead sponsor: Megadyne Medical Products Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Megadyne Ace™ Incision/ Dissection study is a post market, prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.


Eligibility criteria: Inclusion Criteria:

* Subject is \>18 years of age or \< 60 years old
* Subject is undergoing abdominoplasty, bilateral breast reduction, bilateral breast lift, bilateral brachioplasty, bilateral lateral thigh and buttocks lift, or any combination thereof
* Subject is able to discontinue anticoagulant therapy (including Aspirin)
* Subject is willing and able to comply with study follow-up procedures
* Subject is willing to provide written informed consent for their participation in the study

Exclusion Criteria:

* Subject has a history of smoking in the last 6 months prior to surgery.
* Subject has a history of type I or type II Diabetes.
* Subject has an active infection of any kind at the time of enrollment
* Subject has a known coagulopathy

Primary outcomes:
measure: Evaluate Wound Healing/Scar Formation
timeFrame: 120 Days
Secondary outcomes:
measure: Evaluate patient satisfaction relating to wound healing
timeFrame: 120 Days
Other outcomes:
Locations:
city: Twin Falls
country: United States
facility: Center for Plastic Surgery
state: Idaho
city: Fort Wayne
country: United States
facility: Southwest Surgical Suites, LLC
state: Indiana
city: Winston-Salem
country: United States
facility: Plastic and Reconstructive Surgery University Health Sciences
state: North Carolina
Study officials:
affiliation: Sponsor GmbH
name: Ryan D Lewis, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02720289: Video-Based Social Learning or Didactics for Car Seat Education
Official title: Car Seat Education: What Works Best?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Passenger Safety
Keywords: injury prevention
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study compares a video-based social learning method to the traditional didactic method as a new way to teach caregivers about child passenger safety, including how to install a car seat. Half of the caregivers will attend the video-based social learning class, while the other half will attend the traditional didactic class. The investigators hypothesize that the video-based social learning method will lead to an equal or greater increase in caregiver child passenger safety proficiency when compared to the traditional didactic method.

Detailed description: Previous studies have demonstrated the effectiveness of child passenger safety education, however, there is limited research identifying an optimal teaching method.

Social learning teaching methods are beneficial in promoting health-behavior change. The social learning theory hypothesizes that people learn and change their behavior by observation and modeling. The video used in the social learning method shows parents as role models methodically teaching proper car seat installation in a vehicle.

Traditionally, child passenger safety education classes are didactic in design, relying on lecture formats and live demonstrations. The didactic method includes verbal instructions from a child passenger safety technician about car seat installation.

Eligibility criteria: Inclusion Criteria:

* Parents or caregivers of car seat-age children (age zero to three years)
* Participation in the Kids Ride Safe Program

Exclusion Criteria:

* Spoke a language other than English or Spanish

Primary outcomes:
measure: 5-Item Car Seat Installation Demonstration Measure
timeFrame: 30 minutes
Secondary outcomes:
measure: 5-Item Confidence in Car Seat Installation Ability Assessment
timeFrame: 30 minutes
measure: 15-Question Car Seat Installation Knowledge Test
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Erin Kuroiwa, MHI
role: PRINCIPAL_INVESTIGATOR
References: