louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02760706: Preliminary Assessment of Added Diagnostic Value of Dual Energy CT Images Using Data Acquired on a Spectral Detector CT
Official title: Preliminary Assessment of the Added Diagnostic Value of Dual Energy Computed Tomography (DECT) Images Using Data Acquired on a Spectral Detector Computed Tomography (SDCT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Compare Image Quality Between SDCT and Conventional CT Images of Any Tissue Lesion, Determine Optimal Monochromatic Energy Level for a Coronary Artery Image
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a clinically-necessary CT scan

Brief summary: Study hypothesis: Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.

The CT examination would be a clinically-necessary, standard-of-care CT performed as per the clinical indication. The protocol and scan parameters for the CT exam will be similar to that of an equivalent scan performed with any other CT scanner. There would be no additional scanner of injection of any drug specifically for the study. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced.


Eligibility criteria: Inclusion Criteria:

* a patient scheduled for a clinically indicated CT scan for one or more of the following body regions/organ systems:
* head and neck
* body (chest and abdomen/pelvis)
* cardiovascular structures.
* these scans may be without contrast, with contrast enhancement, or CT angiograms.

Exclusion Criteria:

* under the age of 18 years old
* standard exclusion criteria for CT scans

Primary outcomes:
measure: Determine if Post-processed SDCT images provide additional diagnostic value over conventional CT datasets.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Robert C Gilkeson,, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: Prabhakar Rajiah,, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04099706: Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
Official title: Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postherpetic Neuralgia
Shingles
Varicella Zoster
Herpes Zoster
Chronic Pain
Keywords: Chronic pain
Postherpetic Neuralgia
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-09-23
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: This randomized clinical trial investigates the possible beneficial effect of autologous fat grafting on postherpetic neuralgia.

Detailed description: Herpes Zoster (HZ), is a condition caused by Varicella-Zoster virus (VZV), The disease is caused by reactivation of a latent VZV-infection in the sensory ganglia.

Clinically the condition is characterized by a painful, unilateral, vesicular rash. Pain is the most prominent symptom in around 90% of patients. In 10% of patients, this pain remains and becomes chronic.

Post-herpetic neuralgia is a chronic pain syndrome that occurs after the dermal manifestation disappears. Treatment is complex and mainly topical or systemic. For many patients, this is not sufficient and they live with constant pain.

Autologous fat grafting has shown promise in treating several different painful conditions such as post-mastectomy pain syndrome, painful scars, etc. Our previous pilot study (NCT03584061) investigating the effect of autologous fat grafting on PHN, showed a marked reduction in pain with half of the patients being pain-free after the procedure.

The aim of this study is to test the hypothesis that autologous fat grafting is more effective than a sham operation in treating PHN.

Eligibility criteria: * Inclusion Criteria:
* Age over 18
* Pain in area of former VZV-infection.
* Pain present over 3 months after reactivation of VZV and is present at least 4 days a week and of intensity \>3 on the VAS-scale
* Exclusion criteria:
* Psychiatric illness that could potentially affect the study.

Primary outcomes:
measure: Neuropathic pain [LEVEL OF PAIN]
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life [QUALITY OF LIFE/ SATISFACTION]
timeFrame: 6 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Funen
Study officials:
affiliation: Professor
name: Jens Ahm Sorensen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00540306: Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy
Official title: Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accessory; Breast Tissue
Keywords: breast tissue
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-10-08
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, community sample

Brief summary: The purpose of this study is to do determine the changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue components are 2) how predictable and repeatable these variations are 3) the effects of endogenous hormones on breast tissue physiology.

Detailed description: Variations in breast physiology due to hormonal fluctuations during the menstrual cycle can correlate to quantitative changes in Diffuse Optical Spectroscopy functional parameters such as hemoglobin, lipid and water concentration and tissue scattering. Diffuse Optical Spectroscopy imaging can show increase blood flow in breast tissue after ovulation with a concomitant increase in mitotic activity, changes in hemoglobin concentration and in tissue scattering. Increases in fibroglandular breast tissue after ovulation have also been observed. Diffuse Optical Spectroscopy imaging can determine after time of ovulation has been detected during the two months of self-monitoring.

Eligibility criteria: Inclusion Criteria:

* Pre-Menopausal female 18 years of age or older with normal breast tissue
* Undergoes regular menstrual cycle cycles that do not vary by more than 5 days

Exclusion Criteria:

* Peri-Menopausal and Post-Menopausal
* Subjects taking oral contraceptives or any birth control medications in the past six months
* Diagnosed with breast cancer or cancer survivor,a history of breast surgery
* Subjects taking light sensitive drugs for photodynamic therapy

Primary outcomes:
measure: Breast Tissue Physiology
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute University of California Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Bruce J Tromberg, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02944006: Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Based on Incoherent Undersampling
Official title: Establishment of Radiomics Database by Clinical Application of Multiparametric MRI Including DCE-MRI Based on Incoherent Undersampling
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Cancer
Keywords: MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo pancreatobiliary MRI as a preoperative workup for suspected resectable pancreas cancer (adenocarcinoma)

Brief summary: This study aims to establish radiomics database for pancreas cancer from multiparametric MRI including DCE-MRI obtained by using incoherent undersampling and radial acquisition for clinical staging as well as quantitative analysis.


Eligibility criteria: Inclusion Criteria:

* surgical candidate for pancreatico-duodenectomy
* characteristic finding of pancreatic adenocarcinoma on prior CT or MRI
* OR histologically diagnosed with pancreatic adenocarcinoma
* signed for informed consent

Exclusion Criteria:

* under 18 years
* not eligible for pancreatico-duodenectomy
* unresectable patients (locally advanced on prior CT/MRI or metastatic disease)
* tumors with suspicion of other histologic types (neuroendocrine, IPMN, etc)
* any contra-indication of contrast-enhanced MRI
* recurred pancreatic cancer

Primary outcomes:
measure: T-staging
timeFrame: 4 weeks after MR acquisition
Secondary outcomes:
measure: N-staging
timeFrame: 4 weeks after MR acquisition
measure: arterial blood flow
timeFrame: 4 weeks after MR acquisition
measure: arterial fraction
timeFrame: 4 weeks after MR acquisition
measure: mean transit time
timeFrame: 4 weeks after MR acquisition
measure: extracellular volume
timeFrame: 4 weeks after MR acquisition
measure: true diffusion
timeFrame: 4 weeks after MR acquisition
measure: pseudodiffusion
timeFrame: 4 weeks after MR acquisition
measure: perfusion fraction
timeFrame: 4 weeks after MR acquisition
measure: kurtosis
timeFrame: 4 weeks after MR acquisition
measure: mean diffusivity
timeFrame: 4 weeks after MR acquisition
Other outcomes:
measure: T1 value
timeFrame: 4 weeks after MR acquisition
measure: T2 value
timeFrame: 4 weeks after MR acquisition
measure: fat fraction
timeFrame: 4 weeks after MR acquisition
measure: global textural feature
timeFrame: 4 weeks after MR acquisition
measure: local textural feature
timeFrame: 4 weeks after MR acquisition
measure: attenuation
timeFrame: 4 weeks after MR acquisition
measure: transient dyspnea
timeFrame: 1 day after MR acquisition
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05293106: Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
Official title: Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cardiopulmonary Bypass Surgery
Keywords: Platelet Transfusion
LVDS platelet transfusion
PR platelet transfusion
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 9
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).

Detailed description: This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.

Eligibility criteria: Inclusion Criteria:

* Male or female 0 up to and including 18 years of age
* Undergoing elective cardiopulmonary bypass surgery
* Are planned to have a chest tube placed in the operating room prior to chest closure

Exclusion Criteria:

* \>/=19 years of age
* Preterm infants (less than 38-week gestational age at time of surgery)
* On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
* Family requests limitation of blood products (i.e. Jehovah's Witness)
* Congenital bleeding disorder
* Are planned to require ECMO post-op
* Previously enrolled in the study

Primary outcomes:
measure: Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
timeFrame: Within the first 24 hours post-op.
Secondary outcomes:
measure: Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op
timeFrame: During hospitalization in the first 48 hours (no follow-up visits necessary)
measure: Total Platelet Volume Transfused in the First 48 Hours Post-op
timeFrame: During hospitalization in the first 48 hours (no follow-up visits necessary)
measure: Total Plasma Volume Transfused in the First 48 Hours Post-op
timeFrame: During hospitalization in the first 48 hours (no follow-up visits necessary)
measure: Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.
timeFrame: During hospitalization in the first 48 hours (no follow-up visits necessary)
Other outcomes:
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital at Columbia University
state: New York
city: New York
country: United States
facility: Komansky Children's Hospital at Weill Cornell
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Marianne Nellis, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05098106: PLAIAR-Trial: Platelets in Inflammation and Resolution
Official title: PlaIaR-Trial: Platelets in Inflammation and Resolution.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Platelet Abnormality
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Study Chair and Principal Investigator: Univ.-Prof. Dr. Alexander Zarbock
name: Principal Investigator: Dr. Andreas Margraf
First posted: 2021-10-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perioperative patients

Brief summary: Detection and determination of platelets in bronchoalveolar lavage fluid and blood in ARDS and non-ARDS-patients. Correlation with phenotype and inflammation parameters in blood and outcome parameters.


Eligibility criteria: Inclusion Criteria:

* Routine bronchoscopy
* Patient in perioperative setting
* Age \>=18 years
* Consent

Exclusion Criteria:

* Active or recent (in past 7 days) bleeding in upper airways
* Recent traumatic injury of the lung associated with (micro-)hemorrhage
* Blood aspiration
* Pregnancy
* Age\<18 years
* Acute kidney injury / Chronic kidney failure / Dialysis
* Transplantation
* HIV
* Hematologic diseases
* Immunosuppression
* Anti-Platelet-Therapy

Primary outcomes:
measure: Detectability and changes in platelets in BAL and blood
timeFrame: 5-7 days
measure: Organ failure, survival.
timeFrame: 1 Year
measure: Systemic platelet and leukocyte numbers
timeFrame: 5-7 days
measure: Systemic platelet and leukocyte phenotypes.
timeFrame: 5-7 days
measure: Systemic cytokine profiles.
timeFrame: 5-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Alexander Zarbock, Univ.-Prof. Dr.
role: STUDY_CHAIR
affiliation: University Hospital Muenster
name: Andreas Margraf, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122406: Depression and Anxiety in Rheumatoid Arthritis
Official title: Depression and Anxiety in Rheumatoid Arthritis: Prevalence and Relation With Disease Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Depression
Anxiety
Keywords: Rheumatoid Arthritis
Depression
Anxiety
DAS28
HADS
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with rheumatoid arthritis currently treated with biological drugs.

Brief summary: The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive disorders, and their relationship with disease activity, in patients with rheumatoid arthritis treated with biological drugs

Detailed description: The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* diagnosis of rheumatoid arthritis according to 2010 Classification American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Criteria
* being able to compile questionnaire
* current treatment with biological disease-modifying antirheumatic drug

Exclusion Criteria:

* Current treatment for anxiety or depressive disorder

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 day of enrollement
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS policlinico San Matteo - Reparto di Reumatologia
state: PV
Study officials:
affiliation: University of Pavia
name: Roberto Caporali, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06998706: REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
Official title: REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Interstitial Lung Disease (ILD)
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.


Eligibility criteria: Inclusion Criteria:

1. Age 40-75 years.
2. Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
3. DLCO ≥30% and \<80% predicted.

Exclusion Criteria:

1. Pregnancy, lactation, or plans for pregnancy within 1 year.
2. Active malignancy or history of malignancy.
3. Positive serology for HIV, HBV, HCV, or syphilis.

Primary outcomes:
measure: Change in DLCO from baseline.
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Secondary outcomes:
measure: Change in FVC from baseline
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
measure: Incidence of adverse events and serious adverse events.
timeFrame: Through study completion, an average of 6 months
measure: High-resolution CT (HRCT) imaging scores
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
measure: Quality of life (QoL) assessment via validated respiratory questionnaires
timeFrame: Baseline, 4 weeks post treatment, 24 weeks post treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03755206: Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings
Official title: Sust-AIns: Sustainment of Suicide Prevention Programs in American Indian Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Program Sustainability
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-11-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study is part of the research project for a National Institute of Mental Health K01 grant to Dr. Haroz. The overall research project is focused on understanding how to sustain evidenced-based mental and behavioral health programs in tribal contexts. The aim of this study is to pilot test sustainment strategy interventions across tribal settings using mixed-methods.

Detailed description: Among the most pressing issues in mental health Dissemination and Implementation research (D\&I) is the lack of knowledge about how to sustain mental health prevention and treatment services for which there is substantial evidence of impact. Most D\&I studies focus on adoption and initial implementation, with few studies (\<20) rigorously exploring sustainment. The sustainment of services has been described as "one of the greatest, yet least understood, challenges in the field of implementation science." The gap in knowledge is even greater for low-resource contexts, as few studies have focused on these settings. This project aims to address this gap by developing and testing sustainment strategies for an evidenced-based youth suicide prevention program in a low-resource, American Indian (AI) contexts.

Eligibility criteria: Inclusion Criteria:

* Knowledgeable about the implementation of the suicide prevention program
* Over the age of 18
* Available to participate in required study meetings and assessments
* Fluent in English

Exclusion Criteria:

* Factors identified at baseline that preclude full participation including: being under the influence of a substance; active psychosis or mania; any other condition that makes an individual lack capacity to give consent.

Primary outcomes:
measure: Program Sustainability Assessment Tool
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Online Survey
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Emily E. Haroz, PhD
role: PRINCIPAL_INVESTIGATOR
References: