louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04271761: Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
Official title: A Prospective, Single-centre Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Impairment
Keywords: cochlear implantation
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current adult recipient of a Cochlear Carina System.

Brief summary: This investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the Cochlear Carina System.

Detailed description: The totally implanted Carina System is an active middle ear implant where all components are implanted under the skin. Placing a microphone under the skin affects its acoustic sensitivity and vibration sensitivity. Software is now available to enable non-intrusive microphone measurements in existing patients with the Carina device, through a wireless link to the implant. Detailed knowledge of the acoustic sensitivity of the implanted microphone and objectively measured maximum stable gain, and its inter-individual variability, will allow more accurate calculation of overall system performance, and thereby more accurate prediction of clinical outcomes.

Subjects will attend one scheduled study visit to be assessed; several objective acoustic measurements will be performed that do not require active participation from the subject. No data monitoring committee will be used for this clinical investigation.

Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older at the time of enrolment in the study
* Current recipient of a Cochlear Carina System.

Exclusion Criteria:

- Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.

Primary outcomes:
measure: Acoustic Sensitivity of Implanted Carina Microphone
timeFrame: from date of enrolment through to study visit, an average of 1 month
measure: Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation
timeFrame: from date of enrolment through to study visit, an average of 1 month
measure: Carina Maximum Stable Gain
timeFrame: from date of enrolment through to study visit, an average of 1 month
measure: Carina Microphone Impulse Response for Acoustic and Actuator Stimulation
timeFrame: from date of enrolment through to study visit, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: CUF Porto Hospital
Study officials:
affiliation: CUF Porto
name: Victor Correia da Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06419361: [68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients
Official title: [68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Stimulator of Interferon Gene
Cancer
Positron Emission Tomography
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Stimulator of interferon gene (STING) protein plays a vital role in the immune surveillance of tumor microenvironment. Monitoring STING expression in tumors benefits the relevant STING therapy. This study will investigate the safety, biodistribution and potential usefulness of a novel 68Ga-labeled agonist (\[68Ga\]Ga-Sa-DABI-4) for noninvasive positron emission tomography (PET) imaging of STING expression in the tumor microenvironment.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously malignant disease.

Exclusion Criteria:

1. Patients with non-malignant disease.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to \[68Ga\]Ga-Sa-DABI-4 or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT01215461: Factors Associated With Mortality in Neonates
Official title: Evaluation of Factors Associated With Mortality in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Mortality
Keywords: Neonatal mortality
Preterm birth
Low gestational age
VLBW
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 645
Sex: ALL
Minimum age (years): 22
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates for whom healthcare was provided.

Brief summary: The purpose of this study is to better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. As a result, an improved neonatal mortality classification system may be defined.


Eligibility criteria: Inclusion Criteria:

* Neonates for whom healthcare was provided
* Born alive
* Neonate greater than or equal to 22 0/7 weeks estimated gestational age

Exclusion Criteria:

* Stillborn
* Fetal demise
* Neonates less than or equal to 21 6/7 weeks estimated gestational age

Primary outcomes:
measure: To better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care.
timeFrame: neonatal outcomes
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
Study officials:
References:
Clinical trial NCT02904161: Detection of Circulating Tumor Cells in Peripheral Blood From Healthy Volunteers and Patients With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulating Tumor Cells (CTCs)
Lead sponsor: MiCareo Taiwan Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 137
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers and breast cancer patients

Brief summary: To address the challenges of isolating and analyzing rare cells, this study aims to validate technical diagnostic instrumentation, tests, protocols and analysis to correlate the number of circulating tumor cells present in whole blood for predicting cancer prognosis and treatment efficacy. Investigators propose to enroll and follow cohorts of cancer patients. Blood samples will be collected from these patients at regular intervals as determined by their doctors. The patient's disease progression will be monitored over the lifetime of this study. The specific aims are to isolate, enumerate and analyze the number of circulating tumor cells (CTCs) in patient blood using chip-based sorting, filtration and imaging techniques. Investigators will also use this study to optimize diagnostic instrumentation, test protocols and downstream CTC analysis. Investigators may also correlate the results of these tests with the prognosis of the patients as well as any clinical evidence (e.g. from radiological imaging scans). While investigators focus on prognosis in this study, these correlated tests potentially may also be valuable in future studies for early diagnosis and monitoring of cancer.


Eligibility criteria: Inclusion Criteria:

For inclusion in the first stage of the study, subjects must fulfill all of the following criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Patients diagnosed with stage 4 breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts.

For inclusion in the second stage of the study, subjects must fulfill all of the following criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Patients diagnosed with breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts.

Exclusion Criteria:

The following is regarded as a criterion for exclusion from the study and applicable to both 2 stages :

1. Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the study.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References:
Clinical trial NCT03767361: Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Official title: Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Blood Transfusion Complication
Oxidative Stress
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.

Detailed description: Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.

Eligibility criteria: Inclusion Criteria:

* Premature neonates ≤36 weeks in need for blood transfusion.

Exclusion Criteria:

* Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)
* Extremely low birth weight neonates(\<1000gm birth weight )
* Recipient of blood transfusion before enrollment in the study.
* Neonates planned for exchange transfusion .

Primary outcomes:
measure: malondialdehyde
timeFrame: 2-3 hours posttransfusion
measure: total antioxidant capacity
timeFrame: 2-3 hours posttransfusion
measure: serum Copper
timeFrame: 2-3 hours posttransfusion
measure: serum Zinc
timeFrame: 2-3 hours posttransfusion
measure: serum magnesium
timeFrame: 2-3 hours posttransfusion
measure: serum iron
timeFrame: 2-3 hours posttransfusion
measure: serum Calcium
timeFrame: 2-3 hours posttransfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Rania Farrash
Study officials:
affiliation: Ain Shams University
name: Rania A. El-Farrash, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04964661: Incidence of MRI Sacro-Iliac (SI) Joint Anomalies in Women With Spondyloarthritis (SpA)
Official title: Incidence of Sacro-iliac (SI) Joint Anomalies on MRI: Differentiation Criteria in Women With Spondyloarthritis (SpA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spondylarthritis
Keywords: Diagnostic Imaging
Magnetic Resonance Imaging
Sacroiliac Joint anomalies
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 530
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 to 50 years old Affected by spondyloarthritis Performed sacroiliac joint MRI

Brief summary: Retrospective study comparing the incidence of inflammatory and structural lesions seen on MRI of the sacro-iliac (SI) joints in a population of women affected by spondyloarthritis (SpA) and control women population (MISIA study NCT02956824).

A previous study (MISIA) demonstrate SpA may be misdiagnosed on MRI in postpartum women due to increased stress on the joint following pregnancy and childbirth, as MRI of the SI joints may show lesions that could mimics SpA.

The primary objective of this study is to compare the incidence and pattern of MRI inflammatory and structural lesions of the SI joints between SpA and control women, and determine differentiation criteria in SpA women.


Eligibility criteria: Inclusion criteria:

* Women aged 18 to 50 years old
* SpA diagnosed
* Pelvis MRI performed

Exclusion criteria:

- Pelvis MRI unavailable

Primary outcomes:
measure: Rate of MRI inflammatory of the sacroiliac joints
timeFrame: day 1
Secondary outcomes:
measure: Rate of structural lesions of the sacroiliac joints
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Catherine CYTEVAL, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06549361: A Retrospective Study on Extranodal DLBCL
Official title: The Retrospective Clinical Study of Extranodal Diffuse Large B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Extranodal Lymphoma
Diffuse Large B Cell Lymphoma
Keywords: Lymphoma
Extranodal
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 5023
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement or non-Hodgkin lymphoma of rare pathological types attending participating centres.

Brief summary: The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.

Detailed description: DLBCL is a highly common aggressive non-Hodgkin's lymphoma. For specific extranodal sites of DLBCL, traditional chemotherapy protocols often cannot provide satisfactory results for patients. The aim of this study is to prospectively collect clinical information of patients with extranodal DLBCL, including the distribution of involved sites (such as central nervous system, testes, skin, breast, gastrointestinal tract, etc.), prognosis of diffuse large B-cell lymphoma with involvement of different extranodal sites, genetic mutation characteristics, correlation with molecular subtypes, impact of different treatment regimens on efficacy, assess the effectiveness of treatment for extranodal DLBCL in the real world, and explore the optimal treatment strategies in real-world populations.

Eligibility criteria: Inclusion Criteria:

* 1. ≥ 18 years (including 18 years).
* 2. Pathologically diagnosed with diffuse large B-cell lymphoma according to the 2016 WHO classification, including non-specific types and various special subtypes.
* 3. Newly diagnosed DLBCL with involvement of extranodal organs.
* 4. Patients who have received clinical treatment for lymphoma.
* 5.Patients with measurable lesions, including at least one effective efficacy assessment.

Exclusion Criteria:

* 1. Patients receiving supportive care only.
* 2. Patients who cannot obtain effective efficacy assessment data.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Time Frame: Baseline up to data cut-off (up to approximately 1 year)
measure: Progression Free Survival (PFS)
timeFrame: Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Secondary outcomes:
measure: Clinical characteristics form
timeFrame: Baseline up to data cut-off (up to approximately 1 year)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT03079661: Impact of Air Quality on Exacerbations of COPD in the Somme
Official title: Impact of Air Quality on Exacerbations of COPD in the Somme
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Exacerbation Copd
Keywords: pollution
ozone
Copd
particles
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary endpoint is the number of exacerbations of COPD corresponding to the variable of interest to be explained. The other variables are the explanatory variables (air quality data PM2.5, PM10, NO2, O3 as well as pollen data, seasonal variations, influenza epidemic and olfactory nuisance). The final diagnosis will also be collected.

Brief summary: All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect for each patient the home address and the work address. The duration of 1 year was chosen to take into account seasonal variations. In parallel, a daily report of the rate of ozone, particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO Picardie.


Eligibility criteria: Inclusion Criteria:

* All COPD patients with a diagnosis of acute exacerbation of COPD in the emergency room. The definition of COPD and acute exacerbation are the official definition of the Société de Pneumologie en Langue Française.

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: exacerbation rate : variable to be explicated with explicative variable : ozone, particles, dioxide nitrogen, but also pollens corresponding to each patient home address for period of exacerbation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT02163161: AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects
Official title: A Phase 1, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Open Label
Single dose
Crossover
Bioavailability
Fasting
Fed
PF-04965842
Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
* Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.

Primary outcomes:
measure: Area Under the Curve from Time Zero to infinity (AUC inf)
timeFrame: 15 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 15 days
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 15 days
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 15 days
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 15 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wojciechowski J, Malhotra BK, Wang X, Fostvedt L, Valdez H, Nicholas T. Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis. Clin Pharmacokinet. 2022 May;61(5):709-723. doi: 10.1007/s40262-021-01104-z. Epub 2022 Jan 21.