louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04187274: Evaluation of the IKORUS Technology in Patients Undergoing Major Abdominal Surgery
Official title: Evaluation of the Urethral Photoplethysmography-derived Perfusion Device (IKORUS) in Patients Undergoing Major Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Technology
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing major abdominal surgery

Brief summary: The goal of this observational substudy is to evaluate the feasibility, performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new tissue perfusion device using urethral photoplethysmography in patients undergoing major abdominal surgery and in whom an advanced hemodynamic monitoring is placed.

Detailed description: Continuous monitoring of tissue perfusion in patients undergoing major surgery remains challenging because of the lack of tools available. Through using urethral photoplethysmography, the urethral perfusion index (uPI) could allow tissue perfusion monitoring through a modified urinary catheter. The goal of this observational study is to evaluate the feasibility , performance and behavior of the IKORUS (Advanced Perfusion Diagnostics, Villeurbanne, France), a new device in the field. We aimed to assess its performance (duration and signal quality), the uPI variations during hemodynamic events (fluid challenge) in patients undergoing major abdominal surgery and equipped with an advanced hemodynamic monitoring.

Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing major abdominal surgeries and equipped with an advanced hemodynamic monitoring for goal directed therapy

Exclusion Criteria:

* Atrial fibrillation
* Ejection fraction \< 30%

Primary outcomes:
measure: Analysis of uPi evolution during surgery and comparison with Stroke volume
timeFrame: during surgery
Secondary outcomes:
measure: Occurrence of decreased perfusion during surgery
timeFrame: during surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
state: Brussel-hoofdstad
Study officials:
affiliation: ERASME
name: JOOSTEN ALEXANDRE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06901674: Stimulating the Cochlear Apex Without Longer Electrodes
Official title: Stimulating the Cochlear Apex Without Longer Electrodes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deafness With a Cochlear Implant
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2025-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear unstimulated. Providing stimulation over the entire cochlea has the potential to improve speech understanding, sound quality, as well as spectral and temporal representation. Increasing the length of the electrode array to cover a greater portion of the cochlea has many potential issues, including increased damage to the cochlea and probability of incomplete insertions. In this study, a new technique is being investigated that allows stimulation across the entire cochlear extent without increasing the length of the electrode array. The purpose of this study is to evaluate the benefit of the new technique on speech understanding outcomes. Additionally, the study will investigate the new configuration to explore how the auditory system encodes temporal and spectral information.


Eligibility criteria: Inclusion Criteria:

* Participants in this study must have already been evaluated at the NYU cochlear implant center as being eligible for a cochlear implant.
* They must have decided to receive a cochlear implant manufactured by Cochlear Limited and have been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted.
* Individuals who have already been implanted with a cochlear implant manufactured by Cochlear Limited with or without this new approach may also participate in this study.

Exclusion Criteria:

* They are under the age of 18
* They have not been diagnosed with a moderate to profound sensorineural hearing loss in the ear to be implanted
* Have \>15 years of profound deafness
* Have not chosen to receive a cochlear implant manufactured by Cochlear Limited
* Are pregnant or plan to conceive within 6 months of consenting

Primary outcomes:
measure: Upper Limit of Rate Pitch Perception for Cochlear Implant Stimuli
timeFrame: Month 12
measure: Mean pitch rank
timeFrame: Month 12
measure: Percentage of Consonant-Nucleus-Consonant (CNC) words correctly repeated
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David M. Landsberger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04872374: Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults
Official title: Effects of Parmigiano Reggiano on Exercise Induced Muscle Damage in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Old Age; Atrophy
Inflammatory Response
Muscle Soreness
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity.

Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt.

Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect.

Therefore, the central hypothes is that PR consumed during RET can provide more energy substrates and improve muscle recovery. To date, no studies have studied its function on recovery from exercise nor in the elderly.


Eligibility criteria: Inclusion Criteria:

* age \>60 years old or \>18 and \< 30 years old
* BMI \>18 and \<30 kg/m2
* stable body weight in the past 3 months
* valid medical certifacate for practice of physical activity

Exclusion Criteria:

* diabetes or pre-diabetes as for ADA guidelines
* chronic diseases (cardiovascular, liver, respiratory, cancer, etc)
* acute inflammatory status
* regular practice of intense physical activity (\>2 sessions/week)
* treatment with steroids in the past 3 months
* regular use of \>50g/die of Parmigiano Reggiano

Primary outcomes:
measure: maximum volountary contraction (MVC)
timeFrame: Change from baseline to up to 5 days
Secondary outcomes:
measure: reactive Proteinc C
timeFrame: Change from baseline to up to 5 days
measure: Creatin Kinase
timeFrame: Change from baseline to up to 5 days
measure: IL-6
timeFrame: Change from baseline to up to 5 days
measure: delayed onset muscle soreness (DOMS)
timeFrame: Change from baseline to up to 5 days
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
References:
Clinical trial NCT05450874: A Novel MSE Score to Predict rHCC Patients
Official title: A Novel MSE Score to Predict the Postoperative Prognosis of Patients With Ruptured Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 221 patients with rHCC who underwent liver resection from February 2010 to March 2016 at Tongji Hospital and 97 patients with rHCC who underwent hepatectomy at Zhongshan People's Hospital during the same period were included in this study

Brief summary: Develop and validate a novel scoring system based on pathological factors to predict the postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy were recruited from two hospitals.Exploring whether this scoring system is related to prognosis


Eligibility criteria: Inclusion Criteria:

* a diagnosis of ruptured tumor confirmed by enhanced computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI),
* a diagnosis of HCC made by two experienced pathologists

Exclusion Criteria:

* extrahepatic HCC metastasis
* death within 1 month after surgery

Primary outcomes:
measure: overall survival
timeFrame: 2010-2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02313974: Lupus Flares and Histological Renal Activity at the End of the Treatment (LuFla)
Official title: Lupus Flares and Histological Renal Activity at the End of the Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis Treatment
Renal Biopsy in Lupus
Lupus Flare
Lead sponsor: Hospital de Clinicas José de San Martín
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Proliferative Lupus Nephritis confirmed by renal biopsy

Brief summary: At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been determined.

Almost 30 percent of patients in total remission during or after a treatment, will relapse in the first 5 years.

The factors associated to Renal relapses are not completly known. The investigators think that an histological control study performed to patient with complete remission for a year at the end of a 3 years treatment could help us to know which patients are going to relapse.


Eligibility criteria: Inclusion Criteria :

* Patients between 18 and 70 years old with Proliferative Lupus Nephritis
* 3 years treatment with a 6 month induction therapy and 2 years and a half of treatment maintenence

Exclusion Criteria :

* Membranous Nephropaty
* Mesangial Nephropathy
* Less than 3 years treatment
* Less than 1 year of complete remission

Primary outcomes:
measure: Renal Flares
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital de Clinicas
state: Caba
Study officials:
affiliation: Hospital de Clinicas. UBA
name: Marcelo A De Rosa, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Rosa M, Azzato F, Toblli JE, De Rosa G, Fuentes F, Nagaraja HN, Nash R, Rovin BH. A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy. Kidney Int. 2018 Oct;94(4):788-794. doi: 10.1016/j.kint.2018.05.021. Epub 2018 Jul 23.
Clinical trial NCT01973374: Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
Official title: Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes in Pregnancy
Gestational Diabetes
Texting Interventions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. A number of studies in non-pregnant populations have highlighted the feasibility, acceptability and efficacy of text messaging interventions for improving diabetic compliance and control. This study will investigate whether a text messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and whether this intervention can improve compliance with diabetes care, glucose control and pregnancy outcomes. The study will also assess satisfaction with the intervention itself.


Eligibility criteria: Inclusion Criteria:

* Pregnant women aged 18-50 years
* Planned delivery at Hospital of the University of Pennsylvania

Exclusion Criteria:

* Gestational age greater than 34 weeks at initial visit in the Penn Perinatal Diabetes Program
* Women who are unable to read English as all text messages will be in English
* Women who do not have a cellular phone capable of receiving text messages as this is the study intervention

Primary outcomes:
measure: Patient Satisfaction
timeFrame: date of enrollment up to 12 weeks post partum
measure: Compliance with Obstetric and Diabetes Care
timeFrame: OB screening visit through 12 weeks postpartum
Secondary outcomes:
measure: Efficacy measures
timeFrame: Diabetes diagnosis through 12 weeks postpartum
measure: Healthcare Utilization Measures
timeFrame: Screening OB visit through 12 weeks postpartum
measure: Maternal Outcomes
timeFrame: Delivery date through 12 weeks postpartum
measure: Neonatal Outcomes
timeFrame: Neonate delivery through 12 weeks postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06078774: Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls
Official title: Redesigning Pediatric Primary Care Obesity Treatment: Virtual House Calls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Pediatric
Keywords: Obesity
House Calls
Pediatric Primary Care
Virtual
Telehealth
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines a redesign of pediatric primary care overweight/obesity treatment, augmenting typical in-person visits with: (1) direct-to-patient video telehealth to tailor counseling advice to families, (2) that leverages certified health coaches as a part of the care team, and (3) creates skills building in real-time within the home environment.

Detailed description: Investigators will recruit children with an elevated body mass index (BMI) (85th to \<99th percentile) and a parent. Dyads will participate in a 24-week intervention with a total of 26 contact hours. Dyads will participate in weekly education sessions for the first 12 weeks and bi-weekly sessions for the remaining 12 weeks. Additionally, dyads will participate in weekly exercise sessions.

Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3-months and 6-months.

Eligibility criteria: Inclusion Criteria:

Children:

* Ages 9-13 years
* BMI 85th to \<99th percentile
* Must be a patient within Health System Pediatric Primary Care
* Must be English or Spanish speaking

Parent:

-Must be English or Spanish speaking

Exclusion Criteria:

Children:

* Cannot have an emotional, social, or physical disability that would prevent them from participating in the protocol
* Non-English or Non-Spanish speaking
* Cannot have a medical condition resulting in unintentional weight gain (i.e. Prader Willi)
* Females cannot be pregnant
* In addition, children will potentially be excluded from participation if they have a positive screen during an interview led pre-screening eating disorder questionnaire

Parent:

-Non-English or Non-Spanish speaking

Primary outcomes:
measure: Recruitment of participants.
timeFrame: 6 months
measure: Retention of participants
timeFrame: 6 months
measure: Participant satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: BMI
timeFrame: 6 months
measure: Parenting assessed by child
timeFrame: 6 months
measure: Parenting assessed by parent
timeFrame: 6 months
measure: Child diet
timeFrame: 6 months
measure: Physical activity.
timeFrame: 6 months
measure: Sleep.
timeFrame: 6 months
measure: Home food environment.
timeFrame: 6 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth Universiy
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Melanie Bean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05354674: Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Official title: Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Liver Metastases
Keywords: colorectal cancer liver metastasis
bevacizumab
radiomics
multimodal
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initially unresectable CRLM patients with PET/CT images and colonoscopy biopsy specimens before treatment.

Brief summary: Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients

Detailed description: Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.

Eligibility criteria: Inclusion Criteria:

Age 18-75 years; Histologically proven colorectal adenocarcinoma; Simultaneous liver-limited metastases; Initially unresectable liver metastases determined by a local MDT; Life expectancy of \> 3 months; RAS mutation and BRAF V600E wild-type; ECOG 0-1; Available PET/CT imaging before treatment; Available colonoscopy biopsy specimens before treatment

Exclusion Criteria:

Previous systemic treatment for metastatic disease; Previous surgery for metastatic disease; Extrahepatic metastases; Unresectable primary tumor; Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation; Acute or subacute intestinal obstruction; Second primary malignancy within the past 5 years; Drug or alcohol abuse; No legal capacity or limited legal capacity; Pregnant or lactating women; Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; Peripheral neuropathy;

Primary outcomes:
measure: response rate
timeFrame: 6 months
measure: progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05937074: Metabolic Response to Food in Lung Cancer
Official title: Metabolic Response to Food in Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include participants with non-small-cell lung cancer with varying degrees of weight loss.

Brief summary: This goal of this study is to describe how unintentional weight loss influences fasting and post-prandial metabolic flexibility in participants with advanced non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Diagnosis of non-small-cell lung cancer
* Reported weight stability or loss after cancer diagnosis
* Body mass index less than or equal to 35 kilograms per meter squared
* Ability to provide written informed consent
* Willing and able to comply with all scheduled visits, treatment plans, lab tests, and other study procedure
* Allow the collection and storage of biospecimens and data for future use

Exclusion Criteria:

* Prior diagnosis of diabetes mellitus (type 1 or type 2)
* Currently pregnant or breastfeeding
* Contraindication to consuming the liquid mixed meal
* Any medications affecting gastric motility
* Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

Primary outcomes:
measure: Respiratory quotient
timeFrame: Difference between pre- to post-prandial conditions over four hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References: