louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03140098: Evaluation of COVA™+ CARD in Adult Cardiac Surgery
Official title: Evaluation of the Tolerance and Efficacy of COVA™+ CARD in Adult Cardiac Surgery. A Prospective, Observational and Single Center Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Safety
Tolerance
Keywords: Collagen membrane
Cardiac surgery
Postoperative complication
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2017-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo a cardiac surgery.

Brief summary: The aim of this observational study is to evaluate the safety of the guided healing and adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the collagen membrane according to the occurrence of peri and post-operative complications will be evaluated.

Detailed description: Assessment of the safety of COVA™+ CARD, collagen membrane to prevent adhesion appearance, in cardiac surgery in adult patients:

* collection of post-operative complications, causality of the membrane
* collection of complications in the 3-month period after the surgery, causality of the membrane
* collection of peri-operative complications, causality of the membrane
* collection of complications, 3 months after the surgery
* assessment of the efficacy of COVA™+ CARD if re-operation
* assessment of the surgeon's satisfaction

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Cardiac surgery using COVA™+ CARD

Exclusion Criteria:

* In accordance with the instruction for use (IFU) of the medical device.
* Refusal of participation to the study

Primary outcomes:
measure: Evaluation of the tolerance of COVA™+ CARD in cardiac surgery
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the tolerance of COVA™+ CARD in cardiac surgery
timeFrame: Hospitalization stay (up to 30 days)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Francesco Madonna
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06794398: Feasibility of Appropriate Smartphone Position During Video-assisted Cardiopulmonary Resuscitation
Official title: Feasibility of Appropriate Smartphone Position During Video-assisted Cardiopulmonary Resuscitation When the Bystander is Alone At the Scene - a Randomized Controlled Crossover Simulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest (CA)
Keywords: video-assisted cardiopulmonary resuscitation
cardiac arrest
cardiopulmonary resuscitation
lay responder
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is a gap in our knowledge regarding whether video-assisted cardiopulmonary resuscitation (V-CPR) is feasible when a lay responder is alone at the scene. The feasibility of V-CPR was measured in a simulated cardiac arrest scenario when a lay responder was alone with the patient.

Detailed description: There is a gap in our knowledge regarding whether video-assisted cardiopulmonary resuscitation (V-CPR) is feasible when a lay responder is alone. The feasibility of V-CPR was measured in a simulated cardiac arrest scenario when a lay responder was alone with the patient. A pilot study was conducted to measure the appropriate smartphone position and placement time when a lay responder is alone. Two simulated cardiac arrest locations were prepared: a living room and yard.

The performance of the participants were recorded. After that, the quality and assessability of the videos were evaluated by five experts (experienced in CPR teaching and evaluation).

Eligibility criteria: Inclusion Criteria:

* layperson or health care professional, who is phisically and mentally able to do a simulated CPR scenario (participants in the scenario)
* expert in CPR training (assessors)

Exclusion Criteria:

* technical issue during data collection

Primary outcomes:
measure: Smartphone camera placement and perspective (used objects and visible environment)
timeFrame: During procedure
Secondary outcomes:
measure: Smartphone camera placement time (time to the first chest compression)
timeFrame: During procedure
Other outcomes:
measure: General quality of the video-records (clarity, lagging, camera perspective, visibility of chest compressions; by using a Likert-scale: from "1 - very bad quality" to "4 - very good quality")
timeFrame: During post-analysis of the video-records (within 1 week after data collection)
Locations:
city: Pécs
country: Hungary
facility: Human Patient Simulation Center
Study officials:
affiliation: University of Pecs
name: Bálint Bánfai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687698: Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease
Official title: Effect of a Lipidic and Proteic Controlled Diet on Resting Energy Expenditure, Body Composition and Symptoms in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in patients with Parkinson's disease.

Detailed description: Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in Parkinson's disease patients.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of Parkinson's disease, treated with L-Dopa or other dopaminergic drugs.
* Mini Mental State Examination (MMSE) \>24.
* Activities of Daily Living \>3.

Exclusion Criteria:

* Mini nutritional assessment \<17; BMI \<18, hypoalbuminemia or lymphopenia.
* acute or chronic liver diseases;
* renal function impairment (Clearance creatinine \<30ml/min);
* cancer;
* acute inflammatory diseases;
* thyroid diseases;
* diabetes mellitus;
* dysphagia;
* dementia;
* dyslipidemia;
* history of recent cardiovascular or cerebrovascular events;
* psychiatric diseases;
* iatrogen parkinsonism.

Primary outcomes:
measure: Changes in resting energy expenditure
timeFrame: Baseline, week 4 and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Geriatric Section
Study officials:
affiliation: University of Padova, Geriatric Section
name: Caterina Trevisan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanitallie TB, Nonas C, Di Rocco A, Boyar K, Hyams K, Heymsfield SB. Treatment of Parkinson disease with diet-induced hyperketonemia: a feasibility study. Neurology. 2005 Feb 22;64(4):728-30. doi: 10.1212/01.WNL.0000152046.11390.45.
Clinical trial NCT04676698: Three Good Things 2020: a Brief Text-based Wellness Intervention
Official title: Three Good Things 2020: a Brief Text-based Wellness Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Job Related Stress
Keywords: Satisfaction
Depression
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial will be open to all Michigan Medicine Department of Family Medicine faculty, resident, or staff.

The intervention will consist of asking participants the "3 Good Things" based on positive psychology theory. Participants will be asked to list three things that went well that day and to consider their role in these outcomes. Pre and post surveys will be completed to evaluate this intervention.

At the end of the trial the study team will also select a limited number of entries from participants to share some of the "good things" which people listed. These will be edited to ensure writer anonymity and participants will be informed of this plan in the study introduction.


Eligibility criteria: Inclusion Criteria:

* Faculty, resident, or staff in the Michigan Medicine (MM) Department of Family Medicine

Exclusion Criteria:

* Not a member of Family Medicine at MM

Primary outcomes:
measure: Change in the Positive and Negative Affect Schedule (PANAS-SF) between the intervention and control group
timeFrame: Pre-Treatment (baseline), up to 6 months
Secondary outcomes:
measure: Change in self-reported physical health
timeFrame: Pre-Treatment (baseline), up to 6 months
measure: Change in self-reported mental health
timeFrame: Pre-Treatment (baseline), up to 6 months
measure: Change in Gratitude using the Gratitude Adjective Checklist (GAC)
timeFrame: Pre-Treatment (baseline), up to 6 months
measure: Change in depression using the Patient Health Questionnaire 9-item (PHQ-9) score
timeFrame: Pre-Treatment (baseline) to 6 months
measure: Change in Satisfaction with Life Questionnaire
timeFrame: Pre-Treatment (baseline), up to 6 months
measure: Change in the Hope Scale
timeFrame: Pre-Treatment (baseline), up to 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Katherine Gold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00330798: A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
Official title: A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Photorefractive Keratectomy
Keywords: Photorefractive Keratectomy
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Matthew Caldwell
First posted: 2006-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 19
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 compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.


Eligibility criteria: Inclusion Criteria:

* 19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Subjective pain
timeFrame: Day 5
Secondary outcomes:
measure: Rate of epithelial healing
timeFrame: Time to event
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Lackland Air Force Base
state: Texas
Study officials:
name: Matthew Caldwell
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caldwell M, Reilly C. Effects of topical nepafenac on corneal epithelial healing time and postoperative pain after PRK: a bilateral, prospective, randomized, masked trial. J Refract Surg. 2008 Apr;24(4):377-82. doi: 10.3928/1081597X-20080401-11.
Clinical trial NCT03773198: Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery
Official title: Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower Limb
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The need for a surgical procedure may cause a patient to experience reactive anxiety. This reaction is appropriate if it is of low to moderate intensity. On the other hand, various studies have shown that postoperative awakening is more complicated if the patient experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing chronic pain.

For several years now, the investigator's facility has been implementing Energy Resonance through Cutaneous Stimulation (ERCS), a method based on "listening" to the body's vibrations through the fingers on points based on the mapping of meridians in Chinese medicine.

ERCS practitioners have noted the benefits of this method, particularly in soothing patients. It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems appropriate in this situation.


Eligibility criteria: Inclusion Criteria:

* Patient who has given oral consent
* Adult patient requiring scheduled conventional orthopedic surgery of the upper limb (wrist, elbow, shoulder) or lower limb (ankle, foot, knee, hip)

Exclusion Criteria:

* Patient not affiliated to a national health insurance system,
* Patient subject to a legal protection measure (curatorship, guardianship)
* Patient subject to a justice protection measure
* Pregnant, parturient or breastfeeding woman
* Patient unable to give consent
* Minor
* Patient with a pace maker
* Patient with cognitive problems: Alzheimer's, senile dementia
* Patient who has already received ERCS as part of surgery
* Patient who does not speak or understand French
* Patient with psychiatric disorders: major depression, bipolar disorder, addictive disorders, psychotic disorders (psychosis, schizophrenia, acute delirium)

Primary outcomes:
measure: anxiety-state
timeFrame: During the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT03678298: Italian Register for the Study of Complicated Intra-Abdominal Infections
Official title: Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complicated Intra-abdominal Infections
Lead sponsor: World Society of Emergency Surgery
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with complicated intra-abdominal infections

Brief summary: The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy

Detailed description: The primary objectives of the study are: (1) the identification of specific risk factors for in-hospital mortality, in order to perfect the clinical management of patients with complicated intra-abdominal infections (cIAIs); (2) the identification of specific risk factors for multi-drug resistant organisms (MDROs) isolation in patients with cIAIs, in order to improve the adequacy of empirical antimicrobial therapy.

The secondary objectives are: (1) the description of the clinical, diagnostic and treatment profiles of patients with cIAIs in Italian surgical departments; (2) the analysis of epidemiology and patterns of antimicrobial susceptibility of the microorganisms isolated in samples in intra-operative samples of peritoneal fluid or purulent exudate/discrete abscesses in patients with cIAIs; (3) the identification of specific risk factors for post-operative complications in patients with cIAIs.

Eligibility criteria: Inclusion Criteria:

All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis)

Exclusion Criteria:

Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis

Primary outcomes:
measure: Mortality rates linked to different sources of infection
timeFrame: 12 months
measure: Mortality rates linked to different bacteria causing infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: WSES
Study officials:
affiliation: WSES
name: Massimo Sartelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03288298: Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line
Official title: Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Tongue Neoplasms
Carcinoma
Keywords: TSCC
OSCC
luteolin
nanoluteolin
nanotechnology
oral cancer
apoptosis
PCR
MTT
ELISA reader
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line.

Detailed description: This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell viability.

Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC).
* Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term).
* Application of luteolin as a chemotherapeutic drug.

Exclusion Criteria:

* Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.
* Luteolin glycosides.

Primary outcomes:
measure: gene expression of Caspase 3 to detect apoptosis
timeFrame: 6 hours
Secondary outcomes:
measure: cell viability
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: Center for Evidence Based Dentistry
name: Ahmed Elkhadem, PhD
role: STUDY_CHAIR
References:
citation: Ding S, Hu A, Hu Y, Ma J, Weng P, Dai J. Anti-hepatoma cells function of luteolin through inducing apoptosis and cell cycle arrest. Tumour Biol. 2014 Apr;35(4):3053-60. doi: 10.1007/s13277-013-1396-5. Epub 2013 Nov 28.
Clinical trial NCT00489398: Comparison of CL Wear Between Two Allergy Drops
Official title: Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Lead sponsor: Hom, Milton M., OD, FAAO
Sponsor class: INDIV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-06-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparison of two allergy drops for enhancing comfort and performance of contact lens wear

Detailed description: Contact lens patients will instill allergy drops and subjective and objective tests will be performed

Eligibility criteria: Inclusion Criteria:

* Males or females \> 18 years old
* Mild to moderate dry eye symptoms
* Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* Current use of topical cyclosporine
* Known contraindications to any study medication or ingredients
* Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
* Ocular surgery within the past 3 months

Primary outcomes:
measure: Contact lens objective and subjective clinical performance testing
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Private Practice
name: Milton M Hom, OD FAAO
role: STUDY_DIRECTOR
References: