louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06891222: A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening
Official title: Integrating Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening; Structural Cardiac Assessment With Networked AI-ECG & FOCUS (SCAN) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 10500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects aged 18 or older without known congenital or acquired SHD scheduled to undergo an elective outpatient electrocardiogram

Brief summary: The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years of age)
* Echocardiogram is not clinically indicated

Exclusion Criteria:

* Prior history of congenital or acquired SHD, as defined by the following

  1. Aortic Stenosis:
  2. Heart Failure
  3. Left Ventricular Dysfunction
  4. Cardiac Amyloidosis
  5. Hypertrophic Cardiomyopathy (HCM)
  6. Rheumatic Heart Disease
  7. Congenital Heart Disease
* Recent (within last 12 months) echocardiogram
* Scheduled clinically indicated future echocardiogram
* Inability to provide informed consent to participate in the study

Primary outcomes:
measure: Percentage of subjects to be diagnosed with SHD (structural heart disease)
timeFrame: Baseline, 6 months, 1 year
measure: Positive predictive value (PPV)
timeFrame: Baseline, 6 months, 1 year
Secondary outcomes:
measure: Number of deaths
timeFrame: 1 year
measure: Number of adverse cardiovascular events
timeFrame: 1 year
measure: Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction)
timeFrame: Baseline, 6 months,1 year
measure: Percentage of subjects to be diagnosed with cardiac amyloidosis
timeFrame: Baseline, 6 months,1 year
measure: Percentage of subjects to be diagnosed with aortic stenosis
timeFrame: Baseline, 6 months,1 year
measure: Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy
timeFrame: Baseline, 6 months,1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gal Tsaban, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01020422: Sexuality After Reduction Mammaplasty
Official title: Sexuality and Depression Predictors Among Breast Hypertrophy Women Undergoing Reduction Mammaplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Function
Depression
Keywords: breast hypertrophy
mammaplasty
sexuality
depression
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Universidade do Vale do Sapucai
First posted: 2009-11-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to determine the impact of reduction mammaplasty on sexuality and depression predictors in women with macromastia.

Detailed description: Breast hypertrophy is a common condition among women. Reduction mammaplasty is an effective and well established procedure performed for the relief discomfort associated with breast hypertrophy. Female breasts play an important role in sexuality, thus, the main purpose of this study is to determine whether reduction mammaplasty could influence sexual function and depression predictors on women with breast hypertrophy.

Eligibility criteria: Inclusion Criteria:

* breast hypertrophy
* candidate to reduction mammaplasty
* healthy volunteer with normal volume breasts (control group)
* body mass index under 30Kg/m2

Exclusion Criteria:

* pregnancy, delivery or breast feeding during the last 12 months
* body mass index over 30Kg/m2
* breast cancer history
* previous breast surgery
* hard smoking

Primary outcomes:
measure: Sexual function
timeFrame: 6 months
Secondary outcomes:
measure: depression predictors
timeFrame: 6 months
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clínicas Samuel Libânio - UNIVÁS
state: Minas Gerais
Study officials:
affiliation: UNIFESP and UNIVAS
name: Flavia N Beraldo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNIFESP and UNIVAS
name: Daniela F Veiga, MD, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, MD, PhD
role: STUDY_CHAIR
References:
citation: Garcia ES, Veiga DF, Sabino-Neto M, Beraldo Cardoso FN, Batista IO, Leme RM, Cabral IV, Novo NF, Ferreira LM. Sensitivity of the Nipple-Areola Complex and Sexual Function Following Reduction Mammaplasty. Aesthet Surg J. 2015 Sep;35(7):NP193-202. doi: 10.1093/asj/sjv034.
citation: Beraldo FN, Veiga DF, Veiga-Filho J, Garcia ES, Vilas-Boas GS, Juliano Y, Sabino-Neto M, Ferreira LM. Sexual Function and Depression Outcomes Among Breast Hypertrophy Patients Undergoing Reduction Mammaplasty: A Randomized Controlled Trial. Ann Plast Surg. 2016 Apr;76(4):379-82. doi: 10.1097/SAP.0000000000000380.
Clinical trial NCT04586322: Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.
Official title: Association Between Erosive Tooth Wear Progression and Dietary Risk Factors in Chileans Adolescents.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Erosion
Tooth Wear
Erosion
Dental Erosion
Keywords: Tooth Erosion
Tooth wear
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 71
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents subscribed at 2 Chilean high schools of the Community La Pintana, Santiago de Chile (Colegio Nocedal and Colegio Almendral). Schools belong to a low socio economic status sector.

Brief summary: Study to determine if whether or not exist an association between the tissue loss (ETW progression) and the frequency of an acidic diet. To accomplish the aim, a quantitative analysis of intraoral scans of study models will be performed to identify erosive tooth wear progression in a group of Chilean adolescents.

First, participants with different intake of dietary acids will be compared in terms of their baseline sociodemographic and clinical characteristics. Second, the association between baseline frequency of dietary acids and changes in volume loss over time will be evaluated using linear mixed models to account for the data structure (repeated assessments nested within teeth and teeth nested within children). Models will be adjusted for demographic factors, family socioeconomic position, health behaviours and chronic conditions.


Eligibility criteria: Inclusion Criteria:

* Male and female (age range 10-18) assisting in a school with low socioeconomic status.

They must have: -Complete record of questionnaires

* Baseline and Follow-up Intra oral scanners (with correct alignment when using Wearcompare software)
* BEWE scores
* Signed Inform consent

Exclusion Criteria:

* Patients not willing to participate
* Patients wearing orthodontic appliances

Primary outcomes:
measure: Volume loss
timeFrame: 14 months
Secondary outcomes:
measure: Dietary Risk factors
timeFrame: 14 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Francisca Marro
Study officials:
References:
Clinical trial NCT05796622: Evaluating an Innovative HIV Self-testing Service With Counseling Provided by a Chatbot
Official title: A Randomized Controlled Trial Evaluating an Innovative HIV Self-testing Service With Online Real-time Instruction, Pre-test and Post-test Counselling Provided by a Fully-automated Artificial Intelligence Chatbot (HIVST-Chatbot)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behaviors, Health
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 564
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A parallel-group non-inferiority randomized controlled trial will then be conducted to evaluate the performance of HIVST-Chatbot. A total of 528 Hong Kong Chinese speaking men who have sex with men (MSM) aged ≥18 years who have access to live-chat applications are recruited from multiple sources. Those who are diagnosed as HIV positive are excluded. Participants are 1:1 randomized into the intervention group (n=264) or the control group (n=264). The research team will implement the HIVST-Chatbot (HIVST services with real-time counselling provided by a fully-automated artificial intelligence Chatbot) in the intervention group and HIVST-OIC (HIVST with real-time counselling provided by trained administrators) in the control group. Participants completed two telephone surveys at baseline and six months afterwards.


Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese-speaking men aged at least 18 years old
* Having had anal intercourse with at least one man in the past six months
* Willing to leave contact information and be followed up at Month 6
* Having access to the online live-chat application (WhatsApp)
* Not intending to leave Hong Kong for one month consecutively within the next six months

Exclusion Criteria:

* Self-reported as HIV positive

Primary outcomes:
measure: Uptake of HIV self-testing
timeFrame: 6 months
measure: Proportion of HIV self-testing users receiving counselling along with testing
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Zixin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04449822: Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions
Official title: Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Hartmann's procedure, colostomy, colonic stenting.
Lead sponsor: Tbilisi State Medical University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 40
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 study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.

Detailed description: Acute colonic obstruction is one of the common clinical presentations of colorectal cancer. Surgical decompression with colostomy with or without resection and eventual re-anastomosis is the treatment of choice; however, emergency surgery is associated with higher morbidity and mortality.

The colonic stent insertion effectively decompressed the obstructed colon and avoid needs of emergency surgery. This method is a palliation and bridge to surgery. Colonic stents allowed surgery to be performed electively.

Eligibility criteria: Inclusion Criteria:

* Patient with malignant colorectal obstructions.
* Patient's approval to participate in the study.

Exclusion Criteria:

* Patient's preference for either treatment method.
* Patient's refusal to participate in the study.
* Patients in the ASA group 4 and 5.

Primary outcomes:
measure: The time of clinical relieve of obstruction
timeFrame: 24 hours after surgery/procedure
Secondary outcomes:
measure: Stent related complications
timeFrame: time of hospital stay, an average 10 day.
measure: Mortality
timeFrame: 30 day after surgery/procedure
measure: Blood loss
timeFrame: time of surgery/procedure
measure: operation time
timeFrame: during surgery/procedure
measure: Overall complications
timeFrame: 30 day after surgery/procedure
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University
state: Yes
Study officials:
affiliation: Tbilisi State Medical University
name: Zaza Demetrashvili
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merabishvili G, Agdgomelashvili I, Mosidze B, Demetrashvili Z. Emergency surgery versus colorectal stenting for the management of left-sided malignant colon obstructions:A prospective cohort study. Acta Scientific Medical Sciences 2021, 5(4):18-23. doi: 10.31080/ASMS.2020.05.0863
Clinical trial NCT00842322: Fluid Intake in Kidney Failure
Official title: The Effect of Increased Fluid Intake on Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Kidney Transplantation
Keywords: chronic kidney disease
transplantation
kidney function
fluid intake
osmolarity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with renal impairment are usually advised to increase their fluid intake. There is currently, however, no evidence supporting this recommendation. In contrast,high fluid intake could be dangerous if urine excretion is reduced. In this study the researchers investigate whether increasing fluid intake from 2 to 4 litres per day has any influence on long-term renal outcome.


Eligibility criteria: Inclusion Criteria:

* Patients with native kidney disease or chronic kidney transplant failure
* An effective glomerular filtration rate (eGFR) according the MDRD formula between 20 and 75ml/min/1.73m2
* Ejection fraction \>20%
* Absence of liver cirrhosis or ascites
* No evidence of active glomerulonephritis or immunosuppressive therapy if native kidney disease
* Acute transplant rejection
* Urinary protein excretion below 3g/d
* Age between 18 and 70 years.

Exclusion Criteria:

* Therapy resistant edema
* Severe pulmonary disease
* Mean arterial pressure (MAP) \> 120 mm Hg
* Pregnancy
* Kidney transplantation within three months prior to randomization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University Vienna
name: Martin Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750022: Feasibility of Integrating Indirect Calorimetry (IC) Technology in Primary Care
Official title: Feasibility Study of Integrating IC Technology With the WatchWT Comprehensive Weight Reduction Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Hypertension
Lead sponsor: Colorado Center for Chronic Care Innovations, Inc.
Sponsor class: OTHER
Collaborators: name: Microlife Medical Home Solutions, Inc.
First posted: 2008-09-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility of using indirect calorimetry (IC) within a comprehensive weight reduction program. Will individuals that receive a personalized nutrition program, at baseline, from IC technology respond better to treatment compared to individuals receiving IC technology at three months.


Eligibility criteria: Inclusion Criteria:

* BMI greater than 30 kg/m2
* 18-70 years of age

Exclusion Criteria:

* No participation in other weight loss efforts outside study.
* Pregnant or lactating

Primary outcomes:
measure: Bodyweight
timeFrame: Six Months
Secondary outcomes:
measure: Psychobehavioral: Self-Efficacy
timeFrame: Six Months
measure: Quality Life
timeFrame: Six Months
measure: Blood Pressure
timeFrame: Six Months
measure: Eating Behavior
timeFrame: Six Months
Other outcomes:
Locations:
city: Westminster
country: United States
facility: Colorado Center for Chronic Care Innovations
state: Colorado
Study officials:
References:
citation: McDoniel SO, Wolskee P, Shen J. Treating obesity with a novel hand-held device, computer software program, and Internet technology in primary care: the SMART motivational trial. Patient Educ Couns. 2010 May;79(2):185-91. doi: 10.1016/j.pec.2009.07.034. Epub 2009 Aug 20.
Clinical trial NCT03851822: Prevalence and Predictors of CCI in Patients With Acute Respiratory Failure (CCI)
Official title: Prevalence and Predictors of Chronic Critical Illness in Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Observational cohort

Brief summary: Chronic Critical Illness (CCI) is a condition associated to patients surviving an acute phase of disease and respiratory failure (ARF) although remaining dependent on mechanical ventilation (MV). The prevalence and the underlying mechanisms of CCI have not been elucidated in this population.An observational prospective cohort study was undertaken at the Respiratory Intensive Care Unit (RICU) of the University Hospital of Modena (Italy) from January 2016 to January 2018. Patients mechanically ventilated with ARF in this unit were enrolled. Demographics, diagnosis, severity scores (APACHEII, SOFA, SAPSII) and clinical conditions (septic shock, infections, acute respiratory distress syndrome \[ARDS\]) were recorded on admission. Respiratory mechanics and inflammatory-metabolic blood parameters were recorded on admission and within the first seven days of stay. All these variables were tested as potential predictors of CCI through appropriate univariate and multivariate analysis.


Eligibility criteria: Inclusion Criteria:

* older than 18 years of age
* consecutively admitted to RICU due to acute respiratory failure (ARF) requiring mechanical ventilation.

Exclusion Criteria:

* refractory shock (death \< 24h)
* patient goals of care not consistent with aggressive management
* end stage COPD requiring home oxygen long term therapy or home non invasive ventilation support
* presence of interstitial lung disease
* history of neuromuscular disease
* chest wall deformities
* pregnancy
* chemotherapy or radiotherapy within the past 30 days
* evidence of neurologic injury on CT scan and GCS \< 8
* tracheostomy.

Primary outcomes:
measure: Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure
timeFrame: 60 days from RICU admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03528122: Amniotic Membrane for Recurrent Macular Hole
Official title: The Safety and Efficacy of Using Amniotic Membrane for Closure of Recurrent Macular Hole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macula Hole
Retinal Detachment
Myopic Macular Degeneration
Keywords: amniotic membrane
retinal detachment
Myopic
macular hole
internal limiting membrane
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Individuals with recurrent macular hole associated retinal detachment
Primary purpose: TREATMENT

Brief summary: Macular hole surgery were tried by different surgeons using many techniques with different successes but still there were many recurrences. In this study the investigators try to close these distinct types including recurrent holes using pre-prepared amniotic membrane.

Detailed description: It is an interventional study of using amniotic membrane graft for closure of macular hole associated retinal detachment in patient who had a previous failed macular surgery.

Eligibility criteria: Inclusion Criteria:

* Patient with history of opened macular hole after previous pars plana vitrectomy and internal limiting membrane (ILM) peeling for treatment of myopic macular hole were included.
* Opened holes after 1 month of the surgery.
* Myopic macular holes only were included (Refraction of more than _6 D and/or axial length of more than 26 mm).

Exclusion Criteria:

* All other causes of macular hole (traumatic and idiopathic)
* Patients with diseases that can affect visual outcome (Diabetic retinopathy, choroidal neovascularization, age-related macular disease and advanced glaucoma patients.

Primary outcomes:
measure: Anatomical restoration of macular hole closure
timeFrame: 6 months
Secondary outcomes:
measure: Functional restoration after closure of the macular hole
timeFrame: 6 months
measure: Functional restoration after closure of the macular hole
timeFrame: 6 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia UNiversity hospital
state: Minia
Study officials:
References: