louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06580158: AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
Official title: The Clinical Utility of Artificial Intelligence-enabled Electrocardiograms in the Outpatient Practice - Diagnosing Aortic Stenosis and Diastolic Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Diastolic Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.

Brief summary: Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.


Eligibility criteria: Inclusion Criteria:

* ≥ 60 years of age must have a clinical scheduled ECG performed.

Exclusion Criteria:

* \< 59 years of age
* Is not scheduled for a clinical ECG
* Unable to provide consent.

Primary outcomes:
measure: Number of patients with positive AI-ECG
timeFrame: Baseline
measure: Number of studies with reasonable image quality in patients with positive AI-ECG
timeFrame: Baseline
Secondary outcomes:
measure: Number of times the AI ECG and TTE (transthoracic echocardiogram) are statistically comparative
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jae Oh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00765258: Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment
Official title: Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacro-iliac Insufficiency Fractures
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Winthrop University Hospital
First posted: 2008-10-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's with pain and decreased mobility as a result of sacro-iliac insufficiency fracture(s).

Brief summary: To examine, through retrospective and prospective chart review, the difference in pain and mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain scale and Roland Morris Disability Questionnaire (RMDQ).

CT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.

Detailed description: The purpose of the study is to report the use of CT fluoroscopy guidance during the performance of percutaneous sacroplasty. In addition, clinical results will be reported with the Roland Morris Disability Questionnaire(RMDQ)pre and post procedure, demonstrating the utility of the RMDQ in assessing improvement in patients pain, mobility and ability to perform activities of daily living.

Eligibility criteria: Inclusion Criteria:

* greater than 18 years of age and treated with or about to be treated with percutaneous CT fluoro-guided sacroplasty, regardless of gender or ethnicity.

Exclusion Criteria:

* less than 18 years old
* pregnancy
* inability to complete forms and surveys

Primary outcomes:
measure: Reduction of pain and improved mobility in patients post percutaneous sacroplasty effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.
timeFrame: 2008-2012
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin / Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Sean M Tutton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06797258: FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
Official title: Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implant Based Breast Reconstruction
Lead sponsor: Musculoskeletal Transplant Foundation
Sponsor class: OTHER
Collaborators: name: MCRA (an IQVIA business)
name: Bruder Consulting International, LLC
First posted: 2025-01-28
Enrollment: 259
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique


Eligibility criteria: Inclusion Criteria:

* Females at least 22 years of age
* Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
* Willing to provide Informed Consent
* Able to return for all required study visits
* Must read and understand English language

Exclusion Criteria:

* Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
* Has a residual gross tumor at the intended reconstruction site
* Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
* Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site
* Completed chemotherapy within 3 weeks prior to surgery
* Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
* Has a Body Mass Index (BMI) \>35
* Has used nicotine products within 1 month of screening
* Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study

Primary outcomes:
measure: Frequency of major complication
timeFrame: 12 months
measure: Frequency of reconstructive failure
timeFrame: 12 months
Secondary outcomes:
measure: Change in patient reported outcomes
timeFrame: 12 months
measure: Pain
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Jonathan Heistein, MD Plastic & Reconstructive Surgery
state: Texas
Study officials:
References:
Clinical trial NCT06324058: Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 85, male or female;
2. Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");
3. Good compliance and able to cooperate with observation;
4. Able to understand the purpose of the trial, agree to participate in this study, and have signed the informed consent form.

Exclusion Criteria:

1. Patients with severe infectious diseases such as bacteremia and toxemia;
2. Patients with severe coagulation dysfunction;
3. Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;
4. Patients with other concurrent malignancies;
5. Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;
6. Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage or above);
7. Preoperative assessment indicating distant metastasis or enlarged pelvic lymph nodes;
8. Pregnant or breastfeeding women;
9. Other situations assessed by researchers as unsuitable for inclusion in this study, such as inappropriate anatomical structure, mental or psychological disorders.

Primary outcomes:
measure: Tumor residual rate
timeFrame: 10-12 weeks after initial TURBt
Secondary outcomes:
measure: Recurrence
timeFrame: 2 years
measure: Progression
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Huashan Hospital
name: Haowen Jiang, Pro.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03722758: 36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions
Official title: Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Root Caries
Keywords: micro hybrid resin composite
resin-modified glass ionomer
split-mouth randomized clinical trial
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.

Detailed description: The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions.

Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).

Eligibility criteria: Inclusion Criteria:

* Root caries lesions (at least 1mm depth)

Exclusion Criteria:

* Complex medical history
* Poor dental hygiene/infrequent practise of oral hygiene habits
* Severe or chronic periodontitis
* Extreme carious activity
* Heavy bruxism
* Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm)
* Previously restored and abutment teeth for bridge or removable dental prostheses

Primary outcomes:
measure: Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Uzay Koc-Vural
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05713396: Diabetic Autonomic Neuropathy and Left Ventricular Function
Official title: Long - Term Effect of Quinapril or Losartan or Their Combination on Diabetic Autonomic Neuropathy and Left Ventricular Function Over a Period of 4 Years. A Radionuclide Ventriculography Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To investigate the effect of Quinapril (Q) or Losartan (L) or their combination on definite Diabetic Autonomic Neuropathy (DAN) and left ventricular systolic and diastolic function (LVF) over a period of 4 years.

Patients-methods: Fifty-nine patients with definite DAN \[2 or more of the 4 Cardiovascular Reflex Tests (CRTs) were abnormal\] were studied for 4 years. Patients were randomly allocated in 3 groups receiving A, 20 mg Q, B, 100 mg L and C, 20 mg Q +100 mg L respectively. CRTs analyzed with Mean Circular Resultant (MCR), Valsalva index, 30:15 ratio and postural hypotension. LV function was investigated with radionuclide ventriculography (RNV) at rest. Ejection fraction was used to assess LV systolic function, while peak filling rate, first third filling fraction, and atrial contribution to ventricular filling were used to investigate LV diastolic function. CRTs and RNV were performed at baseline and after 4 years.


Eligibility criteria: Inclusion Criteria:

1. \>18 years old
2. Diabetes mellitus
3. Diabetic autonomic neuropathy

Exclusion Criteria:

1. Coronary artery disease
2. Arterial hypertension
3. Heart failure with reduced ejection fraction LVEF\<40%
4. Any contraindication to undergo radionuclide ventriculography

Primary outcomes:
measure: MCR
timeFrame: 4 years
measure: AV
timeFrame: 4 years
Secondary outcomes:
measure: E/I Index
timeFrame: 4 years
measure: SD
timeFrame: 4 years
measure: Valsalva Index
timeFrame: 4 years
measure: 30:15 Index
timeFrame: 4 years
measure: Postural hypotension
timeFrame: 4 years
measure: EF
timeFrame: 4 years
measure: PER
timeFrame: 4 years
measure: PFR
timeFrame: 4 years
measure: 1/3 FF
timeFrame: 4 years
measure: TPF/FT
timeFrame: 4 years
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital
Study officials:
affiliation: AHEPA University Hospital, Thessaloniki, Greece
name: Triantafillos Didangelos, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06150196: Brain Health & Wellness Classes for Veterans With Traumatic Brain Injury
Official title: Comparison of Mindfulness-Wellness Class Versus Brain Health Education in Veterans With mTBI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injury Traumatic Mild
Post-traumatic Stress Disorder
Keywords: Mindfulness
Mindfulness-based Stress Reduction
TBI
Anxiety
PTSD
Veteran
Lead sponsor: East Bay Institute for Research and Education
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is testing the usefulness of two types of Brain Health \& Wellness classes for Veterans with a history of concussion to improve mental health.

Detailed description: This is a pragmatic, randomized controlled trial of Mindfulness-based Stress Reduction (MBSR) in 120 Veterans with comorbid PTSD and chronic mTBI. Half of the participants are randomly assigned to MBSR and the other half, to a Brain Health education class, which serves as an active control group. A battery of standardized psychological and cognitive measures are administered prior to and following the class interventions to assess change in response to the intervention, with an additional 6-month follow-up assessment to test for lasting changes. The primary outcome measures include the Mayo-Portland Adaptability Inventory IV (functional outcome), PTSD Checklist (psychological outcome), and cognitive control test (cognitive outcome).

Eligibility criteria: Inclusion criteria:

* 18-75 years old
* chronic history (\>6 months) of one or more mTBIs
* current diagnosis of PTSD
* at least one self-reported cognitive symptom

Exclusion criteria:

* no history of other neurologic disease (e.g., tumor, stroke, dementia, Parkinson's)
* no history of major brain surgery
* no history of moderate or severe TBI
* no active alcohol or drug dependence or abuse within previous 30 days
* no history of severe psychotic disorder (e.g., schizophrenia)
* no current suicidal ideation/risk
* no clinically severe medical illness requiring treatment

Primary outcomes:
measure: Mayo-Portland Adaptability Inventory
timeFrame: Within 2 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Martinez
country: United States
facility: VA Northern California Health Care System
state: California
Study officials:
References:
Clinical trial NCT03577496: Does Aromatherapy Decrease Postoperative Nausea and Vomiting?
Official title: Does Aromatherapy Decrease Postoperative Nausea and Vomiting?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea, Postoperative
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Aromatherapy has been proven to be effective for treating patients with postoperative nausea and vomiting (PONV) after surgery, but few studies analyze its effect on preventing PONV. Most studies use aromatherapy once patients become nauseous, but this study will address a gap in the literature with relation to the effect of aromatherapy in the prevention of PONV.

Detailed description: The purpose of this pilot study is to determine if aromatherapy will prevent postoperative nausea and vomiting (PONV). Peppermint aromatherapy will be used preemptively to test for effectiveness, decreased PONV, and the ability to avoid anti-emetics. This study will seek to demonstrate that peppermint aromatherapy is a simple, cost effective way to prevent PONV after anesthesia. By decreasing the need for anti-emetics and incidence of PONV, patients may have a quicker recovery time and experience less side effects from anti-emetics, such as increased sedation. This problem is significant to patients and society as it may demonstrate that the inhalation of peppermint can ease PONV and decrease costs due to anti-emetics, wound dehiscence, and prolonged hospital stay. This study may lead to higher levels of patient satisfaction; if the patients are not nauseated they may be more satisfied with their care.

Eligibility criteria: Inclusion Criteria:

* Adult surgical patients ages 18 and older.
* Patients deemed medically stable by their surgery team.
* Anesthesia and Surgeon faculty approval will be obtained prior to asking the patient for their consent.

Exclusion Criteria:

* Minors
* Unstable patients, such as ICU patients or intubated patients, pregnant women, and prisoners.
* Patients with a history of severe PONV or severe delirium on emergence from anesthesia will be excluded.

Primary outcomes:
measure: Decrease incidence of postoperative nausea and vomiting (PONV)
timeFrame: Patients will be monitored for up to one hour after surgery to test effectiveness of peppermint oil at decreasing PONV.
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Michelle S Karsten, RN, BSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02255396: Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia
Official title: Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: azoospermia

Brief summary: Estradiol and Testosterone are two important hormones for the regulation of an effective spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in seminal plasma of men with non-obstructive azoospermia may be a predictive test before surgical testicular biopsy to determine the chance of a positive sperm extraction to use for ICSI.

Detailed description: The aim of this study is to compare the levels of esttradiol and testosterone in seminal plasma of men with non-obstructive azoospermia. Indeed, for these patients, none biological test allows to predict a positive sperm extraction before the surgical testis biopsy is performed. Since the involvement of estradiol and testosterone in the regulation of spermatogenesis, the measurement of these hormones in seminal plasma may be a predictive tool for these men before testis biopsy.

Eligibility criteria: Inclusion Criteria:

* Azoospermia confirmed by two semen analysis (at minimum 74 days between the both analysis)
* Volume of seminal plasma \>0.6ml
* Testicular biopsy one month after the last semen analysis
* Informed consent signed by the patient

Exclusion Criteria:

* obstructive azoospermia
* cryptozoospermia

Primary outcomes:
measure: Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia
timeFrame: at 1 month
measure: Issue of testicular biopsy (sperm extraction positive or negative)
timeFrame: at day 1
Secondary outcomes:
measure: Degrees of alteration of testis histology
timeFrame: at day 1
measure: Serum levels of estradiol and testosterone
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
References: