louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05162599: Evaluation of Cardiags Trimod for Analysis of Cardiac Activity
Official title: Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Murmur, Heart
Rhythm; Abnormal
Keywords: Medical examination device
Connected cardiac auscultation
Sensors
Heartbeat
Heart sounds
Pulse wave
Electrocardiogram
Pathological heart sounds
Lead sponsor: CARDIAGS
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference tests) and the new device
Primary purpose: DIAGNOSTIC

Brief summary: The current study concerns Cardiags Trimod, a new non-invasive medical device for cardiac examinations. The evaluation of its effectiveness is done relative to specific standard devices.

Detailed description: Cardiags Trimod, the subject of this study, is a new medical device for rapid and early detection of some of cardiac abnormalities, easy to use by non-cardiologists and portable wherever the patient is. Cardiags Trimod, consisting of a device and software, allows simultaneous recording, visualization and analysis in real time of signals characteristic of cardiac function. It assists healthcare professionals by measuring characteristic time intervals of cardiac function by crossing the various signals, by detecting abnormal rhythms, and murmurs.

The study aims to assess the essential requirements : the effectiveness and safety of the device. The study is a research involving the human person.Cardiags Trimod is a medical device with low risk. There is no identified risk for the patient.The patient sample tested consists of sick and healthy individuals. The use of Cardiags Trimod is part of the patient's usual consultation. The identified Gold standards are EKG and echocardiography.

Eligibility criteria: Inclusion Criteria:

* Persons suitable for receiving an echocardiogram and an electrocardiogram,
* People who signed the consent form,

Exclusion Criteria:

* Protected and vulnerable people,
* People refusing to participate in the study,

Primary outcomes:
measure: Murmurs detection
timeFrame: 15 minutes
measure: Heart rhythm disorders
timeFrame: 15 minutes
Secondary outcomes:
measure: Accuracy of cardiac intervals measures
timeFrame: 15 minutes
measure: Reproductibilty of measurements
timeFrame: 15 minutes
measure: Security and usability
timeFrame: 1 year
measure: Acceptability
timeFrame: 1 year
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de Fourvière
Study officials:
affiliation: Hopital Fourvière Lyon France
name: Laurent Mr Boisson, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Fourvière Lyon France
name: Bernard Mr RITZ, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05360199: Are Postoperative Patient PROMS Influenced by Recall of Preoperative Scores?
Official title: Are Postoperative Patient Patient Reported Outcome Measures Influenced by Recall of Preoperative Scores? - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Diseases, Spinal Cord
Keywords: PROM
Recall bias
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias


Eligibility criteria: Inclusion Criteria:

* All adult patients with valid preoperative PROM scores submitted to spine surgery due to degenerative pathology from January 2019 to April 2020 at our center (spine unit of a neurosurgical department in a Portuguese university hospital) were included in the study and received PROMs questionnaires with a letter of consent.

Exclusion Criteria:

* Patients without valid preoperative questionnaires were excluded from the study while patients were lost to follow-up if mail questionnaires were not completed two months after PROMs remittance or if they had submitted incomplete or invalid answers.

Primary outcomes:
measure: Median COMI score results
timeFrame: 4 weeks
Secondary outcomes:
measure: Median ODI score
timeFrame: 4 weeks
measure: Median EQ-5D score
timeFrame: 4 weeks
measure: Median NDI
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário São João
city: Portugal
country: Portugal
facility: Centro Hospitalar Universitário São João
Study officials:
References:
Clinical trial NCT03052699: Medium and Long-term Complications of the Patients Having Had a Vaginal Caesarian in Hospital René Dubos
Official title: Medium and Long-term Complications of the Patients Having Had a Vaginal Caesarian in Hospital René Dubos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications; Cesarean Section
Keywords: Complications; Cesarean Section
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients operated to vaginal Cesarean in Hospital Rene DUBOS

Brief summary: This database has for objective to include the medical data of patients which underwent a vaginal Cesarean Section in our establishment. This collection will allow to determine the risk factors of the maternal morbi-mortality and to estimate the long-term results

Detailed description: It is about an operating technique little known which is used as an alternative of the abdominal Cesarean Section for very premature pregnancies and the main indication is the maternal rescue.

It has several advantages: simplicity of the technique, the dissection of tissues is limited, low risk of bleeding and no abdominal scar.

The purpose is to determine the risk factors of the maternal morbi-mortality and to estimate the long-term results

Eligibility criteria: Inclusion Criteria:

* patients operated to vaginal Cesarean in Hospital Rene DUBOS

Exclusion Criteria:

* patients followed in a maternity which do not participate to the study

Primary outcomes:
measure: Risk factors of the maternal morbi-mortality by collection of adverse events during the pregnancy, concomitant pathologies and antecedents
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rene Dubos Hospital
name: MARKOU Georges, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01023399: Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire
Official title: A Nested Open Labeled Study to Compare the Effectiveness and Safety of a Fixed-dose Combination of Artesunate Plus Amodiaquine (ASAQ Winthrop®) in the Unsupervised Treatment of Uncomplicated Plasmodium Falciparum Malaria Attacks in Two Patient Groups Enrolled at Two Year-intervals in a Pilot District of Côte d'Ivoire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Medicines for Malaria Venture
First posted: 2009-12-02
Enrollment: 580
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later.

The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine


Eligibility criteria: Inclusion Criteria:

* Body weight \>=5kg
* Plasmodium falciparum infection with parasite density \> 2000/µL
* Fever or history of fever
* Able to be treated by oral route
* No signs of severe malaria
* No known allergy to study drugs
* No other severe illnesses or underlying diseases
* No known pregnancy or negative urinary pregnancy test for women of child bearing age
* No participation in another ongoing clinical study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)
timeFrame: Day 28
Secondary outcomes:
measure: Number of patients without fever
timeFrame: Day 3
measure: Number of patients without parasite
timeFrame: Day 3
measure: Number of gametocytes
timeFrame: Day 3, Day 7, Day 14, Day 21 and Day 28
measure: Evolution of in vitro resistance rate
timeFrame: Day 3, Day 7, Day 14, Day 21 and Day 28
Other outcomes:
Locations:
city: Agboville district
country: Côte D'Ivoire
facility: Investigational Site Number 1
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Assi SB, Nguessan AF, Aba YT, Toure AO, Menan H, Yavo JC, San KM, Bissagnene E, Duparc S, Lameyre V, Tanoh MA. Sustained Effectiveness of a Fixed-Dose Combination of Artesunate and Amodiaquine in 480 Patients with Uncomplicated Plasmodium falciparum Malaria in Cote d'Ivoire. Malar Res Treat. 2017;2017:3958765. doi: 10.1155/2017/3958765. Epub 2017 Dec 7.
Clinical trial NCT06296199: Music, Virtual Reality for Patients in IUGM
Official title: Music, Virtual Reality and Mental Health of Inpatients in the Intensive Functional Rehabilitation Unit and Patients in the IUGM Geriatric Outpatient Clinic: Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Disorder, Neurologic
Lead sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Sponsor class: OTHER_GOV
First posted: 2024-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.

Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI and in patients attending the geriatric outpatient clinic, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.


Eligibility criteria: Inclusion Criteria:

* be hospitalized at the URFI of the IUGM, or being a patients attending the geriatric outpatient clinic
* be 60 years of age or older,
* not have an acute intercurrent pathology in the week preceding the procedure and during the two days of the procedure,
* have no psycho-behavioural disorders,
* no major neurocognitive disorder at a severe stage,
* no severe visual or hearing impairment,
* no vestibular balance disorders,
* give written consent to participate in the study.

Exclusion Criteria:

* Participate in another concurrent experimental clinical study, to avoid interference with our study.
* Do not understand written or spoken French or English. The participants are French and/or English speakers, and the questionnaires are only available in these 2 languages.

Primary outcomes:
measure: Feasability
timeFrame: 6 months
Secondary outcomes:
measure: Emotions variation
timeFrame: 1 day
measure: Affect variation
timeFrame: 1 day
measure: Well-Being Variation
timeFrame: 1 day
measure: Quality of life variation
timeFrame: 1 day
measure: Anxiety variation
timeFrame: 1 day
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CRIUGM
state: Quebec
Study officials:
References:
Clinical trial NCT04821999: Diode Laser 940 nm in Management of Loss of Taste Sensation
Official title: Diode Laser 940 nm in Management of Loss of Taste Sensation in Patients With Post SARS-CoV 2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV Infection
Keywords: SARS-CoV
, loss of taste
, Diode laser
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with SARS-CoV2 infection confirmed with PCR with loss of taste sensation
Primary purpose: TREATMENT

Brief summary: The global pandemic has recently emerged by transmission of SARS-CoV2 virus. The virus has had a massive impact on health, wealth and social aspects worldwide. Since the identification of this virus in Wuhan, China, millions of cases has been diagnosed worldwide with mortality rates ranging from 3% to 12 %

Detailed description: 'Long COVID' is emerging as a phenomenon where patients have long-term unresolved symptoms (8,9). These could be prolonged symptoms of SARS-CoV2 or a posteSARS-CoV2 syndrome for which dysfunction of smell and taste sensation has been proposed.

The proposal presents the diode laser 940 as possible treatment for the loss of taste sensation in patients with long SARS-CoV2. The effect of low levels of laser energy was first discovered by Dr Endre Mester in 1967.5 Since then it has been used for various applications in the field of medicine and dentistry and is broadly termed 'low level laser therapy'(LLLT) or 'biostimulation' or 'phototherapy'. It is defined as a 'non-thermal' laser light application using photons (light energy) from the visible and infrared spectrum for tissue healing and pain reduction (North American Association of Laser Therapy-NAALT). Several in vitro studies have demonstrated that the effects of laser light on wound healing are much greater than obtained with light from other sources, such as light-emitting diodes (LEDs).(10-13)

Eligibility criteria: Inclusion Criteria:

A diagnosis of SARS-CoV2 with PCR. Age range from 18-60 years old Loss of taste sensation

Exclusion Criteria:

Pregnancy or contraceptive pills Lactation Any auto-immune disease that could affect the oral mucosa On any neoplastic therapy. Uncontrolled diabetes.

Primary outcomes:
measure: taste sensation survey
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
citation: Halboub E, Al-Maweri SA, Alanazi RH, Qaid NM, Abdulrab S. Orofacial manifestations of COVID-19: a brief review of the published literature. Braz Oral Res. 2020 Oct 30;34:e124. doi: 10.1590/1807-3107bor-2020.vol34.0124. eCollection 2020.
Clinical trial NCT01389999: Validation of the French Version of the Back Belief Questionnaire
Official title: Validation of the French Version of the Back Belief Questionnaire
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Back Pain Lower Back Chronic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 131
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 consulting for back pain, present for at least three months.

Brief summary: The goal of this study is to carry out a transcultural validation of the Back Belief Questionnaire in order to assess its appropriateness for French-speaking populations.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has had back pain for at least 3 months

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding

Primary outcomes:
measure: Change in French BBQ questionnaire score
timeFrame: after physical theraphy (3 months)
Secondary outcomes:
measure: Change in FABQ score
timeFrame: post physical therapy (3 months)
measure: Change in TAMPA score
timeFrame: post physical therapy (3 months)
measure: Change in Québec questionnaire score
timeFrame: post physical therapy (3 months)
measure: Change in DALLAS questionnaire score
timeFrame: post physical therapy (3 months)
measure: Change in HAD questionnaire score
timeFrame: post physical therapy (3 months)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00193999: Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting
Official title: Do Nasogastric Tubes After Cardiac Surgery Reduce Nausea and Vomiting. A Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Disease
Keywords: Nasogastric Tubes
Nausea
Vomiting
Cardiac surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gastric emptying is delayed after cardiac surgery, but the efficacy of the nasogastric (NG) tube in preventing distension and reducing vomiting is unclear. Nasogastric (NG) tubes are routinely used in patients undergoing surgery. They are presumed to reduce postoperative nausea and vomiting (PONV) and to lessen the risk of aspiration by reducing residual gastric volumes; however, their insertion and use is not however without potentially serious complications. Existing literature does not address their efficacy in reducing PONV after cardiac surgery. However, current evidence suggests that up to 50% of patients in this group suffer significant nausea and vomiting. The objective of this study is to determine whether NG tubes should continue to be inserted routinely during cardiac surgery to reduce PONV.


Eligibility criteria: Inclusion Criteria:

* undergoing coronary artery bypass graft and/or valvular surgery,
* age 18-80 year olds
* signed informed consent
* elective or urgent surgery

Exclusion Criteria:

* past history of oesophageal surgery, oesophageal varices or stricture,
* patients who have received antiemetic medication in the 24 hours before surgery
* emergency surgery
* patients that require re-sternotomy, or are not extubated 24 hours after admission to the intensive care unit, will be excluded from the study.

Primary outcomes:
measure: Primary outcome measures will be the incidence and severity of postoperative nausea and vomiting as well as paint while the patient is in the CVICU
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: George Djaiani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Djaiani G, Katznelson R, Fedorko L, Rao V, Green R, Carroll J, Katski J. Early benefit of preserved cognitive function is not sustained at one-year after cardiac surgery: a longitudinal follow-up of the randomized controlled trial. Can J Anaesth. 2012 May;59(5):449-55. doi: 10.1007/s12630-012-9675-y.
Clinical trial NCT02985099: 1.2% Rosuvastatin Subgingivally Delivered In Chronic Periodontitis With Type 2 Diabetes Mellitus
Official title: 1.2% Rosuvastatin Subgingivally Delivered In Treatment Of Chronic Periodontitis With Type 2 Diabetes Mellitus: A Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Type2 Diabetes
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin (RSV) gel as an adjunct to scaling and root planing in chronic periodontitis (CP) with Type 2 diabetes mellitus patients.

Detailed description: Background: The purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of 1.2% Rosuvastatin gel as an adjunct to scaling and root planing (SRP) on clinical and radiographic parameters and compare this method with SRP plus placebo gel alone in chronic periodontitis (CP) with type 2 DM patients.

Methods: Eighty CP patients with type 2 DM are included in this study. They were divided into two groups: 1) SRP + 1.2% Rosuvastatin gel (RSV group); 2) SRP + Placebo gel (Placebo group). At baseline, 3, 6 and 9 months after treatment, clinical measurements, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and radiographic parameters intrabony defect depth (IBD), percentage change in radiographic defect depth reduction (DDR%) were assessed.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients with deep pockets (PD of ≥5mm or CAL ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs
* Patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy

Exclusion Criteria:

* Patients with any other known systemic disease
* Patients on systemic statin therapy
* Known or suspected allergy to statin supplementation
* Patients with aggressive periodontitis
* Tobacco use in any form, smokers, alcoholics
* Immunocompromised patients
* Pregnant or lactating females

Primary outcomes:
measure: Defect depth reduction (%)
timeFrame: Change from baseline to 9 months
Secondary outcomes:
measure: probing depth (mm)
timeFrame: Change from baseline to 9 months
measure: clinical attachment level (mm)
timeFrame: Change from baseline to 9 months
measure: modified sulcus bleeding index
timeFrame: Change from baseline to 9 months
measure: plaque index
timeFrame: Change from baseline to 9 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
References: