louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01368744: Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology
Official title: Intraoperative Examination of Sentinel Lymph Nodes: Comparison of the OSNA Breast Cancer System to Extensive Frozen Section Histopathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Breast Diseases
Keywords: Breast Neoplasms
Breast Diseases
Lead sponsor: Sysmex America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 150
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 with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

Brief summary: The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female;
* 18 years of age or older;
* Diagnosed pre-surgically with T1 or T2 breast cancer without clinical evidence of axillary lymph node involvement and scheduled for surgery including sentinel lymph node dissection;
* Subjects (or the subjects' legal representatives) who have read, understood to the best of their ability and signed the informed consent form.

Exclusion Criteria:

* Subjects diagnosed pre-surgically with large or locally advanced (T3 \& T4) breast cancer;
* Pregnant subjects, confirmed by interview with either subject or treating physician;
* Subjects diagnosed with inflammatory breast cancer;
* Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done;
* Subjects with clinically suspicious, palpable axillary lymph nodes;
* Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma; Subjects with non-invasive carcinoma of the Cervix may also be included in this study.
* Subjects who have received pre-operative systemic therapy;
* Subjects who are incapable of providing written informed consent;
* Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
* Subjects participating in other clinical studies where the SLN evaluation will be negatively impacted by this study.

Primary outcomes:
measure: Prospectively assess the concordance and performance of the OSNA Breast Cancer System with an extensive intraoperative frozen section protocol for SLNs removed using standard SLN biopsy procedures from breast cancer subjects.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Milan School of Medicine
Study officials:
References:
Clinical trial NCT05786144: Vestibular Schwannoma Organoids
Official title: Vestibular Schwannoma Stem Cell Organoids
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vestibular Schwannoma
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2023-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a supsicion for vestibular schwannoma on an MRI for which surgery was indicated (approximately 10 per year in Maastricht).

Brief summary: In standard of care regularly planned surgery, tissue will be obtained from patients who are suspicious for having vestibular Schwannoma (on MRI). The tissue that remains after the pathologist gathered sufficient for analysis, the remaining tissue is used for creating tumour stem cell organoids.

Detailed description: This project constitutes scientific research since the presence of tumor stem cells has not been shown in schwannoma before. Secondly the organoid model has not yet been described for VSs. The correlation between effect in schwannoma organoids and in patients has to be evaluated but can proof to be very valuable since it has been shown in a number of tumors. The tumor tissue will be acquired during regularly planned surgery. The tissue that is used is what is left after sufficient material has been sent to the pathologist to make the diagnosis. So the tissue that is used is removed routinely during surgery, but instead of banking it at the pathology department, it is used for the research project. Blood samples that can be used to compare normal DNA to tumor cells DNA will be acquired from central lines that are routinely placed during these procedures, so no additional interventions will be done in acquiring the tissue and blood for this study.

Eligibility criteria: Inclusion Criteria:

* MRI with suspicion for vestibular schwannoma
* Indication for surgery in the skull base committee
* 18 years or older

Exclusion Criteria:

* Refusal to participate
* Younger than 18 years
* Incapacitated

Primary outcomes:
measure: Feasibility
timeFrame: 10 years
Secondary outcomes:
measure: Phenotype
timeFrame: 10 years
measure: Genetic
timeFrame: 10 years
measure: Epigenetic
timeFrame: 10 years
measure: Proteomic
timeFrame: 10 years
measure: Transcriptomic
timeFrame: 10 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastro
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Koos Hovinga
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastro
name: Marc Vooijs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02140944: IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence
Official title: IMPAACT P1107: Cord Blood Transplantation With CCR5Δ32 Donor Cells in HIV-1 Infected Subjects Who Require Bone Marrow Transplantation for Any Indication and Its Observed Effects on HIV-1 Persistence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: Cord blood transplantation
CCR5Δ32
HIV cure
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-05-16
Enrollment: 2
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected children and adults who undergo cord blood stem cell transplantation for treatment of cancer, hematopoietic disease, or other underlying disease

Brief summary: IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older, who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer, hematopoietic disease, or other underlying disease.


Eligibility criteria: Inclusion Criteria:

* Confirmed HIV-1 infection
* 12 months of age or older
* Willing to provide written informed consent
* Pre-Transplant Cohort: Underlying disease appropriate for stem cell transplant, as determined by the transplant team as part of standard of care.
* Pre-Transplant Cohort: Availability of an appropriately matched (as determined by the transplant center) CCR5Δ32 cord blood unit (homozygous or heterozygous) and intention to proceed with transplantation. NOTE: Double cord transplants are allowed. If a double cord is used, at least one cord blood unit should be CCR5∆32 (homozygous or heterozygous).
* Pre-Transplant Cohort: Received a CCR5Δ32 homozygous cord blood or bone marrow transplant within the last two years.

Exclusion Criteria:

• Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant.

Primary outcomes:
measure: Survival
timeFrame: Through 5 years post-transplant
measure: Graft versus host disease
timeFrame: Through 5 years post-transplant
measure: Engraftment
timeFrame: Through 5 years post-transplant
measure: HIV DNA level
timeFrame: Through 5 years post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Uptown Clinical Research Site (7803)
state: New York
Study officials:
affiliation: University of California, Los Angeles
name: Yvonne Bryson, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00557544: Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
Official title: Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Migraine
Keywords: migraine
metoclopramide
ketoprofen
child
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:

* metoclopramide 0,15 mg/kg + placebo
* metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg
* ketoprofen 1 mg/Kg + placebo

Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min.

The main objective is the evaluation of healing times from pain in the 3 groups


Eligibility criteria: Inclusion Criteria:

* Children 6-17 years old with migraine presenting in emergency room

Exclusion Criteria:

* Informed consensus not obtained
* Occurring migraine still treated
* Hemiplegic migraine

Primary outcomes:
measure: evaluation of healing times from pain in the 3 groups
timeFrame: 2 hours
Secondary outcomes:
measure: comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial
timeFrame: 2 and 24 hours respectively
measure: need of a rescue drug for lack of effect in every arms of the trial
timeFrame: 2 hours and 24 hours for relapses
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Edoardo Guglia
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Edoardo Guglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04133844: Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation
Official title: Evaluation of Antithrombin Deficiency in Patients of Intensive Care Unit Placed on Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Cardiac Insufficiency
Keywords: extracorporeal membrane oxygenation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with cardiac insifficiency placed on extracorporeal membrane oxygenation (ECMO)

Brief summary: Prospective, monocentric, non-interventional study in patients placed on extracorporeal membrane oxygenation (ECMO)

Detailed description: Our hypothesis is that ECMO initiation is responsible for a severe decrease of antithrombin level in a high proportion of patients who develop heparin resistance.

Eligibility criteria: Inclusion Criteria:

* Any ICU patient of receiving veno-arterial extracorporeal membrane oxygenation
* Patients who have not expressed opposition to participate

Exclusion Criteria:

* Arterial thrombosis or progressive venous thrombosis
* Contraindication to heparin
* Constitutional deficiency in antithrombin
* Patient refusal
* Minor patient
* Protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty

Primary outcomes:
measure: To study antithrombin level from during the first 24h after ECMO initiation
timeFrame: Day 7
Secondary outcomes:
measure: To study antithrombin level 24h after initialization of ECMO
timeFrame: Hour 24
measure: To study the prevalence of antithrombin (AT) deficiency (≤70%) at each time point (from H0 to day 7)
timeFrame: Day 7
measure: To study relationship between antithrombin level and heparin resistance
timeFrame: Day 7
measure: To study relationship between antithrombin level and thrombin generation test
timeFrame: Day 7
measure: To study clinical factors associated with AT deficiency
timeFrame: Day 7
measure: To describe clinical evolution of patients according to initial AT level
timeFrame: Hour 0
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
References:
Clinical trial NCT06840444: Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep
Official title: The Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Insomnia
Adolescent
Digital Health
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth with self-reported insomnia symptoms, aged 13-18.

Brief summary: The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.

Detailed description: The aims of this study are to: 1) form a Teen Advisory Board (TAB) of teens with self-reported insomnia symptoms, 2) co-design a functional app prototype for sleep with TAB, 3) conduct two rounds of beta-testing to inform the iterative refinement of the app prototype. Participants will include 40 youth and their parents; 10 youth will participate in the TAB and first round 1 of beta-testing, and a separate cohort of 30 youth will participate in a second round of beta-testing. Youth will be ages 13-18 years and will have self-reported insomnia symptoms.

Eligibility criteria: Inclusion Criteria:

* 13-18 years old
* Self-reported insomnia symptoms

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Program Completion Percentage
timeFrame: Immediately post-treatment
Secondary outcomes:
measure: Treatment Acceptability Ratings
timeFrame: Immediately post-treatment
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT06372444: Mechanisms of Acute Kidney Injury in Severe Infections
Official title: Mechanisms of Acute Kidney Injury in Severe Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
AKI - Acute Kidney Injury
Positron Emission Tomography (PET)
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with sepsis and AKI and healthy volunteers

Brief summary: Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations.

Detailed description: To study renal perfusion and neutrophil-mediated inflammation 10 critically ill patients with sepsis and acute kidney injury (AKI) and 5 healthy volunteers as controls will be recruited and examined at one time with marked water followed by neutrophil elastase tracer. At the same time, a CT scan is performed for anatomy. Plasma levels of inflammatory mediators will be measured. Clinical data will be collected. The endpoints are changes in renal perfusion and increased presence of neutrophil elastase in the renal parenchyma.

Eligibility criteria: Inclusion Criteria:

Patients with sepsis and AKI

* \> 30 years
* At least AKI stage 1 according to KDIGO where the last plasma creatinine is measured within 24 hours of the examination

Healthy volunteers

* \> 30 years
* No previously known kidney disease
* Normal plasma creatinine value

Exclusion Criteria:

* Chronic renal failure (CKD stage \>3a) or dialysis
* Instability in vital functions that makes PET-CT examination unsuitable
* Claustrophobia or other reasons that make the patient unable to lie still during the examination.
* Pregnancy and breastfeeding

Primary outcomes:
measure: Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET)
timeFrame: PET performed within 10 days of AKI
measure: Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET)
timeFrame: PET performed within days of AKI
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university hospital
Study officials:
References:
Clinical trial NCT03966144: RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
Official title: RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Impairment
Deafness
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will undergo computer based testing using the device to determine the number of haptic stimuli that are correctly interpreted as phenomes.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Pilot study to test the feasibility of translating the English language into haptics (touch sensations)

Detailed description: An adaptive pilot trial of RoboHear™ hardware and software to test the feasibility of learning to understand language using a haptic (touch) device installed in the stem of a pair of glasses. These tests are not meant to be exhaustive but will validate the hardware and software and provide an informal test platform for learning to 'hear' or interpret sounds and words using haptic technology.

Eligibility criteria: Inclusion Criteria:

* Participants need to understand English.
* Participants must be able to sit at a computer for the training and evaluation session. The session may range from one hour to up to 4 hours in length (with breaks provided as needed).

Exclusion Criteria:

* Inability to understand English

Primary outcomes:
measure: Haptic Interpretation Test
timeFrame: at end of training session (1-3 hours), Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: John L Dornhoffer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01909544: Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD
Official title: Muscle Oxygenation and Metabolism in Response to a Localized Fatigue-inducing Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Muscle fatigue
Energy metabolism
Muscle oxygenation
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Lung Association
First posted: 2013-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether a localized exercise, in which cardiorespiratory demand is reduced, will result in greater limb muscle fatigue in patients with COPD as a consequence of muscle oxygenation and muscle metabolism disturbances.


Eligibility criteria: Inclusion Criteria:

* COPD (FEV1/FVC \< 0.70 and FEV1 \< 0.80 predicted
* Healthy subjects: no evidence of airways obstruction (FEV1/FVC \> 0.70 and FEV1 \> 0.80 predicted)
* Smoking history \> 15 pack-years

Exclusion Criteria:

* Chronic hypoxemia and/or hypercapnia (PaO2 \< 60 mmHg or SpO2 \< 88% at rest and/or PaCO2 \> 45 mmHg)
* Recent exacerbation (\< 3 months)
* Recent cancer (\< 3 years)
* Diabetes
* Myopathy, neuromuscular or articular disease
* Unstable cardiac disease
* Absolute contraindications to exercise testing
* Regular physical activity or exercise training program in the last 2 months
* Physical activity score \> 9 in the Voorips questionnaire
* Thigh skinfold thickness \> 15 mm
* BMI \> 30

Primary outcomes:
measure: Muscle deoxygenation
timeFrame: 45 seconds post-exercise (knee-extension repetitions)
measure: Muscle metabolism
timeFrame: 45 seconds post-exercise (knee extension repetitions)
Secondary outcomes:
measure: Ventilatory response
timeFrame: Baseline, beginning and end of each serie of knee extensions (fatiguing exercise)
measure: Quadriceps muscle fatigue
timeFrame: baseline, 15 min and 40 min after the fatigue-inducing exercise
measure: total muscle work
timeFrame: end of fatiguing exercise
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: François Maltais, MD
role: PRINCIPAL_INVESTIGATOR
References: