louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05280808: Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss
Official title: Device Clinical Trial of the Efficacy of Using Novel Remote Self-fitting Software Compared With Standard Remote Fitting Software in the Customisation of Hearing-aid Settings for Adults With Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Sonova Audiological Care Australia Pty Ltd
First posted: 2022-03-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.

Detailed description: After being informed about the study and potential risks, clients giving written informed consent will be enrolled as participants. Each participant will use the app to self-fit and fine-tune the study aids over 30 days. Outcome measures include speech perception tests, questionnaires and the need for support with using the app. Own-aid performance is the reference, while unaided performance is the baseline.

Eligibility criteria: Inclusion Criteria:

* Online client
* Daily aid use
* Bilateral aid use
* Uses P70-R or P90-R aids (same model both ears)
* Does not use earmolds
* Uses same soft tip on both aids
* Owns iPhone7/iOS12 or later
* Willing to install prototype app on own phone and use it in study
* Willing to participate in study for 30 days

Exclusion Criteria:

* Dexterity or cognitive issues that would be problematic for using the app in the study

Primary outcomes:
measure: Change in speech perception after 30 days
timeFrame: Day 1 and Day 30
measure: Change in self-rated hearing ability after 30 days
timeFrame: Day 1 and Day 30
measure: Softest sounds that can be heard
timeFrame: Day 1
Secondary outcomes:
measure: Change in preferences for fitted settings and fitting method over 30 days
timeFrame: Day 1, Day 10, Day 20 and Day 30.
measure: Change in experimental self-fitting phone app use over 30 days
timeFrame: Days 1-30
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: Melbourne Support Office and Clinic/Teleaudiology
state: Victoria
Study officials:
affiliation: Sonova Audiological Care Australia
name: Justin A Zakis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05835908: Follow-up of Patients Referred to Unscheduled Care Centers by the Emergency Call Center in the Haut-Rhin Department, France
Official title: Follow-up of Patients Referred to Unscheduled Care Centers by the Emergency Call Center in the Haut-Rhin Department, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unscheduled Care
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who contacted the Emergency Call Center and were referred to an Unscheduled Care Center.

Brief summary: The objective of this study is to determine the follow-up of patients who were referred by the Emergency Call Center of the Haut-Rhin department to an Unscheduled Care Centers (UCC) and to determine whether they actuallly went to a UCC following their call, or if they were taken in charge by another care facility.

Detailed description: Conduct of research:

Patients who contacted the emergency call center and were referred to an unscheduled care center in the Haut-Rhin will be contacted by mail in the first instance. Ten to fifteen days after the call to the emergency call center, the investigator will contact the patient by phone, during which he/she will ask for the patient's oral consent to participate in the research and collect follow-up data using a standardized questionnaire.

If the investigator is unable to reach the patient, further attempts will be made to call the patient up to 30 days after the initial call. If there is no response after this time, patients will not be included the study.

Eligibility criteria: Inclusion Criteria:

* Call to the Emergency Call Centre of the Haut-Rhin department by an adult (age ≥ 18 years)
* Referral to the Unscheduled Care Center by the Emergency Call Center

Non-inclusion criteria:

* Patient who does not answer phone within 30 days of call to the Emergency Call Center
* Patient who refuses to participate in the study
* Call for someone other than him or herself (except when a parent calls for his or her minor child)

Primary outcomes:
measure: Phone questionnaire
timeFrame: Up to 30 days following the call to the Emergency call center
Secondary outcomes:
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA
state: Haut-Rhin
Study officials:
References:
Clinical trial NCT00950508: A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure
Official title: European Multicenter Plasma Exchange Trial (Empet): A Controlled, Open, Randomised, Multicenter Study In Patients With Acute Liver Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Liver Failure
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine if high-volume plasma exchange has a positive effect on mortality in patients with acute liver failure.


Eligibility criteria: Inclusion Criteria:

* Patients with acute liver failure in encephalopathy grade 2-4

Exclusion Criteria:

* alcoholic hepatitis
* primary non function liver graft or graft dysfunction
* known chronic liver disease
* known malignancies
* clinical suspicion of brain death

Primary outcomes:
measure: mortality
timeFrame: at day 3, day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Hepatology, Rigshospitalet
state: DK
city: Helsinki
country: Finland
facility: Department of Transplantation and Liver Surgery, Helsinki University Hospital
city: London
country: United Kingdom
facility: Institute of Liver Studies, King's College Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Fin S Larsen, PhD,Dr.M.Sc
role: STUDY_CHAIR
References:
citation: Larsen FS, Schmidt LE, Bernsmeier C, Rasmussen A, Isoniemi H, Patel VC, Triantafyllou E, Bernal W, Auzinger G, Shawcross D, Eefsen M, Bjerring PN, Clemmesen JO, Hockerstedt K, Frederiksen HJ, Hansen BA, Antoniades CG, Wendon J. High-volume plasma exchange in patients with acute liver failure: An open randomised controlled trial. J Hepatol. 2016 Jan;64(1):69-78. doi: 10.1016/j.jhep.2015.08.018. Epub 2015 Aug 29.
Clinical trial NCT04104308: Association of Egg and Dietary Cholesterol Consumption With Mortality and Diseases
Official title: Association of Egg and Dietary Cholesterol Consumption With Mortality and Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mets
Death
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 33453
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The CHNS is a nationwide cohort survey in China, which was established as a joint project of the University of North Carolina at Chapel and the China Center for Disease Control and Prevention (CCDC).This national-wide survey adopted a novel measure from multiple dimensions, which helped to understand how the long-term social and economic changes affected nutrition and health-related outcomes of Chinese. Until now, 10 rounds of survey (1989, 1991, 1993, 1997, 2000, 2004, 2006, 2009, 2011 and 2015) have been conducted.

Brief summary: To assess the associations between egg and dietary cholesterol consumption with mortality and metabolic syndrome (MetS).

Detailed description: Substitution models, sensitivity analyses, subgroup analyses and multiple linear regression analyses will be conducted to specifically estimate the hazard ratios and 95% confidence intervals of mortality and MetS associated with egg and cholesterol consumption.

Eligibility criteria: Inclusion Criteria:

* participants aged ≥20 y

Exclusion Criteria:

* missing creatinine, age, cannot be linked to socio-demographic data; aged less than 20; without complete dietary data .

Primary outcomes:
measure: mortality
timeFrame: participants were followed up from 1991 to 2015
Secondary outcomes:
measure: metabolic syndrome
timeFrame: The blood samples were collected in 2009 for the first time.
Other outcomes:
Locations:
Study officials:
References:
citation: Wu F, Zhuang P, Zhan C, Shen X, Jiao J, Zhang Y. Egg and Dietary Cholesterol Consumption and the Prevalence of Metabolic Syndrome: Findings from a Population-Based Nationwide Cohort. J Acad Nutr Diet. 2022 Apr;122(4):758-770.e5. doi: 10.1016/j.jand.2021.09.010. Epub 2021 Oct 11.
citation: Zhuang P, Jiao J, Wu F, Mao L, Zhang Y. Egg and egg-sourced cholesterol consumption in relation to mortality: Findings from population-based nationwide cohort. Clin Nutr. 2020 Nov;39(11):3520-3527. doi: 10.1016/j.clnu.2020.03.019. Epub 2020 Mar 28.
Clinical trial NCT04400708: Single-injection Adductor Canal Block for Total Knee Arthroplasty Under Spinal Anesthesia
Official title: The Effect of Postoperative Single-injection Adductor Canal Block for Multimodal Pain Control in Patients Receiving Total Knee Arthroplasty Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia.

Detailed description: This study aims to evaluate the effect of the single-injection adductor canal block in patients receiving total knee arthroplasty under spinal anesthesia. The effect of the single-injection adductor canal and continuous adductor canal block in patients receiving total knee arthroplasty under general anesthesia has been well established. However, due to the residual effect of spinal anesthesia, the effect of the single-injection adductor canal block needs to be determined. The investigators hypothesize that the single-injection adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.

Eligibility criteria: Inclusion Criteria:

* adult patients receiving total-knee arthroplasty under spinal anesthesia
* ASA class 1-3

Exclusion Criteria:

* infection at the needle injection site
* hard for pain evaluation
* CRPS patient with lower extremity symptom
* chronic opioid user
* those with side effect to local anesthetics
* those getting revision total-knee arthroplasty or with the previous operation at the same knee area
* those getting the surgery under general anesthesia due to the failed spinal anesthesia

Primary outcomes:
measure: the sum of pain score
timeFrame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
measure: Postoperative opioid consumption
timeFrame: 2 hours, 6 hours, 12 hours, and 24 hours intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03671408: Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients
Official title: Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients With and Without Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Transplant Failure
Periodontitis
Crp
Keywords: heart transplant
periodontitis
hsCRP
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 33
Sex: ALL
Minimum age (years): 11
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who underwent heart transplant between 2004 and April 2016 at Baskent University Hospital,will be asked to participate in the study during routine outpaient visits at Baskent University Hospital

Brief summary: Objectives: The outcomes of heart transplantation are very favorable but inflammation still plays a critical role in deterioration of chronic transplants. Periodontal diseases are not only limited to supporting structures of the teeth, they also cause systemic inflammation. Based on the importance of inflammation in heart transplant recipients and the association between periodontal disease and systemic inflammation, this study explored whether periodontitis may be a modifier of serum high-sensitivity C-reactive protein (HsCRP) in heart transplant patients.


Eligibility criteria: Inclusion Criteria:

be clinically stable be at least 1 year post-transplant; no history of antibiotic use during the preceding 4 months have had no periodontal treatment within the previous year.

Exclusion Criteria:

having other systemic infections

Primary outcomes:
measure: hscrp levels
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04782908: Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients
Official title: Hemodynamic Characterisation of Patients Undergoing Transcatheter Tricuspid Valve Edge-to-edge Repair in Patients With Severe Tricuspid Regurgitation and Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congestive Heart Failure
Tricuspid Regurgitation
Keywords: Heart failure with preserved ejection fraction
tricuspid regurgitation
transcatheter tricuspid valve edge-to-edge repair
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergoing transcatheter tricuspid valve edge-to-edge repair will undergo multimodal cardiovascular diagnostics before and after tricuspid valve repair including pressure volume loop analysis and cardiac magnetic resonance imaging
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
* Signs and symptoms of left-sided heart failure.
* Left-ventricular ejection fraction ≥50%
* Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure \[PCWP\] or left-ventricular end-diastolic pressure ≥15 mmHg)

Exclusion Criteria:

* Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
* Moderate aortic stenosis.
* Pregnancy
* Contraindication to perform cardiac magnetic resonance imaging.
* Conditions rendering patient unable to give informed consent to the study protocol.

Primary outcomes:
measure: Periprocedural change in enddiastolic pressure volume relationship of the left ventricle
timeFrame: Periprocedural.
Secondary outcomes:
measure: Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR)
timeFrame: Periprocedural.
measure: Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle.
timeFrame: Periprocedural.
measure: Change in dPdtmin
timeFrame: Periprocedural.
measure: Change in the early diastolic filling pattern as assessed by MRI.
timeFrame: Baseline and 1-month follow-up following TTVR.
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Centre at University Leipzig
state: Saxony
Study officials:
References:
Clinical trial NCT05167708: Effects of Micro-osteoperforation on the Maxillary First Molar Distalization
Official title: The Effect of Single and Repeated Micro-osteoperforation on the Maxillary First Molar Distalization: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accretions; Teeth
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.
Primary purpose: TREATMENT

Brief summary: the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.

Detailed description: in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.

Eligibility criteria: Inclusion Criteria:

* Space deficiency in the upper arch \> 5 mm, and \< 8 mm.
* Non-extraction lower arch.
* Full upper dentition up to the second molars.
* Third molar present in both sides, not yet erupted.

Exclusion Criteria:

* Systemic disease or syndrome.
* Evidence of root resorption.
* Poor oral hygiene.
* Previous orthodontic treatment
* Evidence of bone loss.
* Active periodontal disease.
* Pregnant females.
* Presence of oral habits

Primary outcomes:
measure: rate of maxillary first molar distal movement
timeFrame: through study completion, an average 1 year
Secondary outcomes:
measure: decrease in length of maxillary first molars in mm.
timeFrame: through study completion, an average 1 year
measure: bone density
timeFrame: through study completion, an average 1 year
measure: pain perception questionnaire
timeFrame: through study completion, an average 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: yasser lotfy, professor
role: STUDY_CHAIR
affiliation: Mansoura University
name: marwaa shamaa, ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04838808: Rivaroxaban in Type 2 Myocardial Infarctions
Official title: Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type II Myocardial Infarction
Keywords: myocardial injury
Type II myocardial infarction
Anticoagulation
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 8
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is the pilot phase of a randomized controlled trial to test the feasibility of recruiting patients with a type 2 myocardial infarction and randomizing them to low-dose rivaroxaban to reduce the risk of major cardiovascular events.

Detailed description: This trial is an investigator-initiated prospective, single-center, placebo-controlled, double blinded, pilot randomized controlled trial of low-dose rivaroxaban (2.5mg oral twice daily) for 90-days following a type 2 myocardial infarction. The primary feasibility outcome is time to recruitment of 100 participants, stratified by sex.

Eligibility criteria: Inclusion Criteria:

1. Participant age ≥ 65years or \>45 years and an additional risk factor (smoking, diabetes mellitus, hypertension, dyslipidemia or known atherosclerotic disease)
2. Rise in troponin level, with one troponin value above the 99th percentile of the upper limit of normal deemed to be due to a type 2 myocardial infarction by the attending team within the past 30 days
3. Alive at the time of hospital discharge

Exclusion Criteria:

1. Current use of anticoagulation
2. Current use of dual antiplatelet therapy
3. Advanced kidney disease (eGFR \<15ml/min)
4. Previous hemorrhagic stroke at any time or embolic stroke within the past year
5. Previous life-threatening bleeding event
6. Life expectancy less than one year
7. Anticoagulation recommended conditions - atrial fibrillation, pulmonary embolism, deep vein thrombosis, mechanical heart valves, rheumatic mitral valve disease, left ventricular thrombosis
8. Surgery in the previous 30 days
9. Inability to provide informed consent in English
10. Pregnancy, breastfeeding or child bearing potential

Primary outcomes:
measure: Feasibility outcome
timeFrame: Through study completion, estimated at 1-year
Secondary outcomes:
measure: Number of participants who experience a composite of death, stroke or myocardial infarction
timeFrame: 90-days
measure: Number of participants who experience major bleeding
timeFrame: 90-days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Michelle Graham, MD
role: PRINCIPAL_INVESTIGATOR
References: