louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05372185: Expanding Reach of Evidence-based Psychotherapy for Veterans With Co-occurring Anxiety and Substance Use Disorders.
Official title: Expanding Reach of Evidence-based Psychotherapy for Rural Veterans With Co-occurring Anxiety and Substance Use Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Substance Use Disorders
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 26
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 current study seeks to better understand how to improve access to evidence-based psychotherapy (EBP) for rural Veterans with co-occurring anxiety and substance use disorders (SUD) using a web-based cognitive behavioral therapy tool (VA Coordinated Anxiety Learning and Management, Substance Use Version; VA CALM-S).


Eligibility criteria: Inclusion Criteria:

* current anxiety disorder diagnosis
* current SUD

Exclusion Criteria:

* current substance withdrawal such that medically supervised detoxification is necessary (determined by evaluation of substance use history and report of current symptoms),
* acute suicidality
* current delusions/hallucinations.

Primary outcomes:
measure: Generalized Anxiety Disorder-7
timeFrame: 12 weeks
Secondary outcomes:
measure: Substance use frequency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E DeBakey VAMC
state: Texas
Study officials:
References:
Clinical trial NCT06677385: Effect of Low-Level Laser on Crevicular Interleukin-1β Concentration in Patients With Periodontal Disease: A Relation to Periodontal Inflammaging
Official title: Effect of Low-Level Laser on Crevicular Interleukin-1β Concentration in Patients With Periodontal Disease: A Relation to Periodontal Inflammaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Old Age
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is done to compare between young age and old age patients with periodontitis (inflammaging) and the effect of diode laser as adjunctive to scaling and debridement


Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Aged below 40 or above 60.
3. Provide informed consent and willingness to cooperate with study protocol.
4. Periodontitis stage II patients:

   * CAL from 3-4 mm.
   * Radiographic bone loss (15% to 33%).
   * No tooth loss due to periodontitis.
   * Maximum probing depth ≤ 5 mm, mostly horizontal bone loss

Exclusion Criteria:

1. Patients with heavy smoking habits
2. History of antibiotics in the previous three months.
3. Pregnant or lactating female.
4. Treatment with any systemic drug.
5. History of systemic disease.
6. Patients who received periodontal treatment in the last 6 months

Primary outcomes:
measure: Gingival index
timeFrame: first visit, second follow up after 1 month and final follow up after 6 months
measure: Clinical attachment loss
timeFrame: first visit, second follow up after 1 month and final follow up after 6 months
measure: Interleukin 1 beta
timeFrame: first visit, second follow up after 1 month and final follow up after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University foe Science and Technology
Study officials:
References:
Clinical trial NCT05203185: Nudging Provider Adoption of Clinical Decision Support
Official title: Nudging Provider Adoption of Clinical Decision Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Clinical Decision Support
Pulmonary Embolism
Behavioral Design
Health Informatics
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-01-24
Enrollment: 1612
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers. Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. This study will use a behavioral theory-informed process to develop a new CDS tool that includes a nudge that addresses barriers to adoption.

Detailed description: The research team developed and pilot tested two CDS tools for pulmonary embolism (PE) risk stratification in the Emergency Department (ED). One of the tools incorporated two behavioral theory-informed nudges in the user interface. The research team's objective was to pilot test the tools to demonstrate feasibility as well as examine preliminary efficacy of the nudges on provider adoption of the tool. This cluster non-randomized controlled trial took place between September 20th, 2021 and March 3rd, 2022 in two EDs that are a part of a large academic health system in the New York City metropolitan area. All ED providers (physicians, physician assistants and nurse practitioners) seeing patients for the evaluation of PE during this time were included in the trial. The EDs were chosen based on their comparable size and acuity levels.

Eligibility criteria: Inclusion Criteria:

* Medical doctors, nurse practitioners and physician assistants working full time at Huntington Hospital and Long Island Jewish Valley Stream

Exclusion Criteria:

* Does not meet the inclusion criteria

Primary outcomes:
measure: Percentage of Patient Visits Where the Provider Adopted the Pulmonary Embolism Risk Kalculator (PERK) Tool
timeFrame: Up to Month 6
Secondary outcomes:
measure: Percentage of PE-Designated CTPA Tests That Are Positive for PE
timeFrame: Up to Month 6
Other outcomes:
Locations:
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Valley Stream
country: United States
facility: Long Island Jewish Valley Stream
state: New York
Study officials:
affiliation: NYU Langone Health
name: Safiya Richardson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03855085: Kidney Transplant Volumetry
Official title: Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant; Complications
Keywords: Kidney transplant
volumetry
ultrasound
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 100
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: Kidney transplant recipients

Brief summary: This study assesses the reproducibility of 3 different formulas in calculating the volume of a transplanted kidney by ultrasound in-vivo measurements.

3 series of measurements will be performed by 2 different operators during the usual ultrasound follow-up of the renal transplant.

Detailed description: The 3 series of measurements

1. Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area
2. Transverse section at the hilum : thickness, width, hilar cross-sectional area
3. Largest transverse section : thickness, width, maximum transverse cross-sectional area

Clinical and biological patient data collection:

age, gender, date of transplantation, serum creatinine and glomerular filtration rate (GFR), kidney transplant placement (right or left iliac fossa), acute illness or usual follow-up

Eligibility criteria: Inclusion Criteria:

* Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours
* Age more than 18 years old

Exclusion Criteria:

* Renal deformity of extrinsic origin
* Early post-transplant period (first 3 days post-transplant)
* Transplanted organ out of the field of view
* Dual kidney transplant
* Opposition to the data collection

Primary outcomes:
measure: Intraclass coefficient of correlation of the ultrasound volume measurement
timeFrame: 6 months
Secondary outcomes:
measure: Intraclass coefficient of correlation of the volume formula parameters.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Gradinaru
Study officials:
References:
Clinical trial NCT06776185: Recurrence Patterns and Cost-Effectiveness of Surgical Approaches in Early-Stage Hepatocellular Carcinoma
Official title: Recurrence Patterns and Cost-Effectiveness of Robotic-assisted, Laparoscopic, and Open Liver Resection in BCLC 0/A Hepatocellular Carcinoma:
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC - Hepatocellular Carcinoma
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This multicenter study included BCLC stage 0/A HCC patients who underwent RALR, LLR, or OLR across 27 centers from July 2017 to July 2019

Brief summary: This study aims to investigate the recurrence patterns and cost-effectiveness of robotic-assisted, laparoscopic, and open liver resections in patients with early-stage (BCLC 0/A) hepatocellular carcinoma. By analyzing data from 3000 patients across 27 centers, the research evaluates recurrence-free survival, overall survival, and long-term economic impacts using metrics such as quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Findings will provide insights into optimal surgical approaches to improve patient outcomes and healthcare resource utilization.


Eligibility criteria: Inclusion Criteria:

* (1) HCC diagnosis confirmed by two independent radiologists using contrast-enhanced computed tomography (CT) and/or magnetic resonance imaging (MRI) combined with postoperative pathology; (2) BCLC stage 0 or A; and (3) curative liver resection

Exclusion Criteria:

* (1) concurrent malignancies in other organs; (2) diagnosis of combined hepatocellular-cholangiocarcinoma; (3) prior neoadjuvant or adjuvant treatment before liver resection; (4) recurrent HCC; (5) ruptured HCC; and (6) incomplete follow-up or missing data.

Primary outcomes:
measure: Recurrence-free Surival
timeFrame: 2017-01-01--2024-01-01
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Tongji Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT05409885: The Effect of General and Spinal Anesthesia on Neutrophil-to-lymphocyte Ratio
Official title: Comparison of the Effect of General and Spinal Anesthesia on Umbilical Neutrophil-to-lymphocyte Ratio, Platelet-to-lymphocyte Ratio and Mean Platelet Volume in Patients Undergoing Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Anesthesia, Spinal
Umbilical Cord
Keywords: anesthesia
cesarean section
neutrophil-to-lymphocyte ratio
platelet-to-lymphocyte ratio
mean platelet volume
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elective ceserean surgery

Brief summary: The aim of the study was to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and mean platelet volume (MPV) in patients undergoing cesarean section.

Detailed description: This study was designed to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord NLR, PLR and MPV in patients undergoing cesarean section.

The primary endpoint was to compare the effects of general and spinal anesthesia on umbilical cord NLR. Secondary endpoints were determined the general and spinal anesthesia on routine umbilical cord PLR, MPV and newborn Apgar scores at 1st and 5th min.

Eligibility criteria: Inclusion Criteria:

* 18 - 45 years
* American Society of Anesthesiology (ASA) II-III
* elective ceserean surgery

Exclusion Criteria:

* declining to give written informed consent
* under 18 years of age or over 45 years of age
* factors affecting NLR, PLR and MPV such as preeclampsia, HELLP syndrome or premature rupture of membranes
* history of neurological and/or neuromucular disease
* cooperation cannot be established
* emergency surgery

Primary outcomes:
measure: neutrophil-to-lymphocyte ratio
timeFrame: within 5 minute, following delivery
Secondary outcomes:
measure: platelet-to-lymphocyte ratio
timeFrame: within 5 minute, following delivery
measure: mean platelet volume
timeFrame: within 5 minute, following delivery
measure: Newborn Apgar score 1st minute
timeFrame: 1st minute after birth
measure: Newborn Apgar score 5th minute
timeFrame: 5th minute after birth
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya TRH
name: Kerem İnanoğlu
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya TRH
name: Esra Bağ
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya TRH
name: Arzu Karaveli
role: STUDY_DIRECTOR
References:
Clinical trial NCT06989385: CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
Official title: CORALINE - Correlation Between Physiological and Clinical Variables and Failure of Non-Invasive Respiratory Support in Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Respiratory Failure
Keywords: Acute respiratory failure
High flow nasal cannula
Non-invasive ventilation
Inspiratory effort
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 325
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 admitted to the Respiratory Disease Unit of the University of Modena and Reggio Emilia

Brief summary: This observational study aims to evaluate the relationship between clinical and physiological variables and the failure of non-invasive respiratory support (NIRS), including high-flow nasal oxygen (HFNO) and non-invasive ventilation (NIV), in patients with acute respiratory failure (ARF), both hypoxemic and/or hypercapnic. The study includes both retrospective and prospective components. Retrospective data will be collected from patient charts, while prospective data will be collected at defined time points during clinical care. The primary outcome is NIRS failure, defined as the need for orotracheal intubation. Secondary outcomes include in-hospital and 90-day mortality, ICU and hospital length of stay, and duration of non-invasive and invasive support.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Hospitalization in the Respiratory Medicine Unit at AOU Policlinico di Modena
* Acute respiratory failure (hypoxemic and/or hypercapnic) with PaO₂/FiO₂ \< 300 mmHg
* Undergoing treatment with HFNO or NIV

Exclusion Criteria:

* Immediate need for invasive ventilation upon admission
* Known neuromuscular disease
* Pregnancy
* Lack of informed consent

Primary outcomes:
measure: Rate of failure of non-invasive respiratory support
timeFrame: 30 days
Secondary outcomes:
measure: Clinical impact
timeFrame: From enrollment to 90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02614885: Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue
Official title: Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prophylactic Mastectomy
Lead sponsor: Innoblative Designs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Arkansas
First posted: 2015-11-25
Enrollment: 11
Sex: FEMALE
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 presenting for prophylactic mastectomy.

Brief summary: This is a single-arm, prospective study of a radiofrequency ablation device on the excised breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by the device will be analyzed histologically.

Detailed description: This study is a single-center, prospective, open label study of a radiofrequency ablation device. 10 patients who are scheduled to undergo prophylactic mastectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. Once the breast tissue is removed, the radiofrequency ablation device will be used on the ex vivo tissue to ablate a lesion around a cavity created in the tissue. The ablation lesion will be characterized. The study period per subject is the time it takes to assess the ablation lesion histologically.

Eligibility criteria: Inclusion Criteria:

1. Female
2. At least 18 years of age
3. Scheduled to receive a standard of care prophylactic mastectomy (or prophylactic bi-lateral mastectomy)
4. The patients' breast(s) to be included in the study are undiseased
5. The patient has adequate breast volume for ex vivo ablation procedure

Exclusion Criteria:

1. The patient is receiving a skin sparing mastectomy(s)
2. The patient has had previous exposure to chemotherapy or radiation therapy
3. The patient has implants in the breast(s) to be included in the study
4. The patient is currently pregnant or lactating
5. The patient has tissue markers implanted in the breast to be included in the study (unless these can be removed when creating a cavity in the ex vivo breast tissue)
6. The patient has had previous surgery on the breast(s) to be included in the study (unless study investigator determines that this will not affect the validity of data in this study)
7. The patient in participating in any other clinical study of a device or drug that may impact the participant safety of the validity of data acquired in this study

Primary outcomes:
measure: Histologic measurement of cavitary ablation lesions created by the Innoblative radiofrequency ablation device in ex vivo breast tissue to correlate ablation size with ablation parameters.
timeFrame: Two weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UAMS
name: Daniela A Ochoa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02755285: Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)
Official title: A Concurrence Study of Diagnostic Visualization Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy
Keywords: BLI
FICE
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is intended to demonstrate substantial equivalence of visualization using BLI to the predicate device, FICE, so as to support the addition of BLI as an adjunct to white light imaging in the company's video processor.

Detailed description: This clinical study will consist of acquisition of images, followed by a reader study.

Eligibility criteria: Inclusion Criteria:

* Referred for clinically indicated gastrointestinal diagnostic endoscopy
* Ability to understand the requirements of the study, to provide written informed consent and to comply with the study protocol
* Ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling.

Exclusion Criteria:

* Under the age of 21 years
* Is an inmate (see US Code of Federal Regulations 45 C.F.R. 46.306)

Primary outcomes:
measure: Image Quality Scores Using Likert Scale
timeFrame: Two to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic AZ
state: Arizona
Study officials:
affiliation: FUJIFILM Medical Systems, U.S.A., Inc.
name: Aiji Matsunuma
role: STUDY_DIRECTOR
References:
Clinical trial NCT06735885: fMRI Neurofeedback With Matter Neuroscience App
Official title: Stanford-Matter Neuroscience High-Resolution fMRI Advanced Neurofeedback Feasibility Trial (fMRI Neurofeedback) Medical
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression Mild
Depression
Depression Moderate
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study will utilize an app, Matter Neuroscience, designed to help users with depression understand positive emotions and the neurotransmitters that create them. We hope to learn the safety and efficacy of neurofeedback for treating depression and lay the groundwork for a pivotal clinical trial.


Eligibility criteria: Inclusion Criteria:

1. Male or Female, between the ages of 18 and 80 at the time of screening.
2. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
3. Must possess an iPhone with iOS 17 or higher.
4. Single-SSRI-resistant depressive disorder patients with a MADRS scale between 20-34

Exclusion Criteria:

1. Contraindication to MRI (ferromagnetic metal in their body)
2. Claustrophobia
3. Severe Major Depressive Disorder (MDD)
4. MADRS scale of \>34
5. Treatment-resistant depression (TRD) from 3 or more treatments.
6. Any other condition deemed by the PD to interfere with the study or increase risk to the participant

Primary outcomes:
measure: Determine the safety and efficacy of neurofeedback for treating depression through MADRS (Montgomery-Åsberg Depression Rating Scale) scale changes.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: