louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04712773: Comparison of the Nociception Monitoring Devices During Cardiac Surgery.
Official title: Comparison of the Nociception Monitoring Devices During Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: cardiac surgery
pain
nociception
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the values of Surgical Pleth Index (SPI) and Nociception Level Index (NOL) measured simultaneously during cardiac surgery.

Detailed description: Participants are given oral and written information about the course of the trial, associated risks and benefits and about the handling of the personal data on the day before the surgery by one of the investigators. Participants are also given written information about patient's rights and insurance, the aim of the trial and its course. 40 adult cardiac surgery patients will be recruited for the study. NOL and SPI values will be measured during the cardiac surgery procedure. All patients receive oral premedication and standardized anesthesia.

Eligibility criteria: Inclusion Criteria:

* coronary artery disease of heart valve disorder qualified for the surgical treatment
* participant understands the course of the trial and its aim
* participant has given informed written consent

Exclusion Criteria:

* participant has not given consent
* neurological or psychical disorders (psychiatric medication)
* dementia
* alcohol or substance abuse
* central nervous system medication (medication for epilepsy or neuropathic pain)

Primary outcomes:
measure: SPI values measured at several timepoints during cardiac surgery
timeFrame: Values are measured during the course of the cardiac surgery procedure
measure: NOL values measured at several timepoints during cardiac surgery
timeFrame: Values are measured during the course of the cardiac surgery procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital, Department of Anesthesiology and Intensive Care
name: Tadeusz Musialowicz, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01181973: Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
Official title: An Open-label, Randomized, Phase 1, Single-Dose Crossover Study to Evaluate Safety, Tolerability and Relative Bioavailability of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Keywords: Relative bioavailability
pegvisomant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to that of the current approved 15 -mg vials. In addition, the SC injection using the new 30-mg vial is safe and well-tolerated.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females between the ages of 21 and 55 years

Exclusion Criteria:

* Positive urine drug screen
* Excessive use of alcohol or nicotine-containing products
* Pregnant or nursing females

Primary outcomes:
measure: The area under the pegvisomant concentration-time curve from time 0 to infinity hours post dose (AUCinf)
timeFrame: 16 days
measure: The area under the pegvisomant concentration-time curve from time 0 to last observed timepoint (AUClast)
timeFrame: 16 days
Secondary outcomes:
measure: Maximal pegvisomant concentration (Cmax)
timeFrame: 16 days
measure: The timepoint at which Cmax is obtained (Tmax)
timeFrame: 16 days
measure: Elimination half-life of pegvisomant (as data permit)
timeFrame: 16 days
measure: Biomarkers IGF-1 (A few samples will be taken at timepoints around Tmax to observe the pegvisomant effect on IGF-1)
timeFrame: 16 days
measure: Safety laboratory tests (including hematology and serum chemistry parameters) and adverse events (including local site reactions)
timeFrame: 16 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06298773: Spatial Profile of Tumors
Official title: SPATIAL PROFILE OF SUBPOPULATIONS OF CANCER AND IMMUNITARY CELLS IN SEVERAL SOLID TUMORS
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Solid Tumors
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 1000
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: The study population will be 1000 adult male and female patients with primary or metastatic neoplastic pathology of the following types of cancer: lung cancer, colon cancer, salivary gland cancer, hepatocarcinoma, sarcomas, osteosarcomas, breast cancer, glioblastoma, kidney cancer, pancreatic cancer, neck cancer.

The patient samples that will be examined in the study are derived from biopsies that patients have been subjected to according to their treatment plan.

Brief summary: The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®.


Eligibility criteria: Inclusion Criteria:

* male or female subjects aged 18 years
* primary or metastatic tumors Diagnosed by histology and/or radiological evidence, RNM, or endoscopic
* signature of informed consent
* substitute declaration to the consent form where applicable

Exclusion Criteria:

* previous unrelated tumour disease
* significant acute or chronic infections (HIV, HCV and HBV infections) and/or ongoing bacterial and viral infections
* active autoimmune disease
* pregnant or breastfeeding
* patients who do not sign informed consent

Primary outcomes:
measure: Spatial analysis of cancer cells
timeFrame: 7 days
Secondary outcomes:
measure: Comparison of clinical data
timeFrame: 1 day
measure: Identification of therapeutic targets
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Alessandro Sgambato
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05101473: Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
Official title: Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Foot
Wound Healing Disorder
Ulcer Foot
Ulcer Healing
Lead sponsor: Holbaek Sygehus
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The trial is a single-center single-group feasibility trial in outpatient clinical settings.

The trial will be reported with reference to the extended CONSORT guidelines.
Primary purpose: TREATMENT

Brief summary: The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT.

The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or above
* Diabetes mellitus
* Non-surgical ulcer located distal to the malleoli
* Willingness to participate in a 12-week supervised exercise therapy intervention twice a week
* Prescribed with a therapeutic shoe, orthopaedic specialist shoe from the outpatient clinic or a specialized podiatrist.

Exclusion Criteria:

* Dementia or other reasons that cause inability to give informed consent
* People that are wheelchair-bound
* People with a prescribed cast or walker boot
* Unable to understand Danish.
* Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 month
measure: Participant retention
timeFrame: 12-week follow up.
measure: Exercise adherence
timeFrame: 12-week follow up.
measure: Adverse events
timeFrame: 12-week follow up.
measure: Participant and physiotherapist feedback
timeFrame: 12-week follow up.
measure: 30-second chair-stand test
timeFrame: 12-week follow up.
measure: Tandem Test
timeFrame: 12-week follow up.
measure: Ulcer size
timeFrame: 12-week follow up.
measure: Wound-QoL
timeFrame: 12-week follow up.
measure: EC-5D-5L
timeFrame: 12-week follow up.
measure: 4x10-meter fast-paced walk test
timeFrame: 12-week follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: SUH Køge
Study officials:
References:
Clinical trial NCT06725173: Detailed Phenotypic and Genotype Study to Correlate RB1 Mutations Relating to Primary Ocular Tumors and Secondary Extra-ocular Metastasis.
Official title: Genetic Associations of Ocular Cancers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Retinoblastoma Bilateral
Retinoblastoma Unilateral
Retinoblastoma, Extraocular
Retinoblastoma, Recurrent
Retinoblastoma
Keywords: retinoblastoma
parent-of-origin
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2024-12-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with presumed or genetically confirmed retinoblastoma

Brief summary: The goal of this observational study is undertake a detailed phenotypic and genotypic study of patients with ocular and secondary cancers due to mutations in the RB1 gene. Our research sequencing approach will allow advanced insight to for further detailed genotypic understanding of parent-of-origin for valuable insight into the genotype-phenotype relationship of this cancer syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with molecularly proven retinoblastoma due to RB1 or a typical clinical retinoblastoma phenotype with genetic screening pending.
* Able to give consent/parent or guardian able to give consent.

Exclusion Criteria:

* Patients unable or unwilling to undertake consent or clinical testing.
* Patients unwilling to donate a saliva or blood sample in order to establish the genetic cause of their condition.

Primary outcomes:
measure: Epigenomic and genomic profiling of the RB1 gene
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Debarshi Mustafi, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Andrew W Stacey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stacey AW, Nakamichi K, Huey J, Stevens J, Waligorski N, Crotty EE, Van Gelder RN, Mustafi D. Prognostic importance of direct assignment of parent of origin via long-read genome and epigenome sequencing in retinoblastoma. JCI Insight. 2024 Dec 26;10(4):e188216. doi: 10.1172/jci.insight.188216.
citation: Nakamichi K, Stacey A, Mustafi D. Targeted long-read sequencing allows for rapid identification of pathogenic disease-causing variants in retinoblastoma. Ophthalmic Genet. 2022 Dec;43(6):762-770. doi: 10.1080/13816810.2022.2141797. Epub 2022 Nov 3.
Clinical trial NCT03848273: Post Stroke Epileptic Seizures Risk Forecast
Official title: Clinical Diagnostic Criteria of Forecasting Epileptic Seizures in Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Post Stroke Seizure
Post Stroke Epilepsy
Keywords: stroke
epilepsy
seizure
EEG
Lead sponsor: Lviv National Medical University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 120
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: Patient of Lviv Clinical Emergency Hospital

Brief summary: Improve the effectiveness of treatment and prognosis in patients with cerebrovascular accident by early detection of the risk of developing epileptic seizures.


Eligibility criteria: Inclusion Criteria:

* informed consent to participate in the study signed by the patient / relative of the patient / the legal representative of the patient
* age over 18 years
* stroke, confirmed by neuroimaging
* light to moderate stroke (score on National Institutes of Health Stroke Scale).

Exclusion Criteria:

* recanalization therapy
* previous epileptic seizures and history of epilepsy
* psychiatric diseases in history
* previous stroke
* traumatic brain injury
* brain tumors.
* inflammatory and infectious diseases
* decompensated physical illness.
* pregnancy.

Primary outcomes:
measure: First epileptic seizure
timeFrame: 1 year
Secondary outcomes:
measure: Longest seizure-free period
timeFrame: 1 year
Other outcomes:
measure: Death
timeFrame: 1 year
Locations:
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University
Study officials:
affiliation: Danylo Halytsky Lviv National Medical University
name: Anzhelika Payenok, MD, DrMedSc, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03181373: IRM Cognition in Patients With Head Trauma
Official title: Longitudinal Descriptive Study of the Correlation Between Cognitive Functions, White Matter Anatomical Pathways and Functional Magnetic Resonance Imaging Activations in Patients With Moderate to Severe Head Trauma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain-damaged Patients
Keywords: Craniocerebral injury
Mild and severe brain traumatic injury
Neuropsychological abilities
Clinical assessment
Anatomical and functional imaging
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Clementel
name: Maurice Gantchoula
name: LADAPT
name: APF
First posted: 2017-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with traumatic brain injury

Brief summary: Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.

Detailed description: The following data are collected in 3 months, 12 months then 24 months after the accident with followed data collection :

* Clinical, neuropsychological assessments
* Diffusion magnetic resonance imaging (MRI) for the reconstruction of anatomical pathways
* Functional imaging data.

Eligibility criteria: Inclusion Criteria:

* Adult patients, over the age of 18.
* Mild traumatic brain injury (Initial Glasgow score between 9 and 12)
* Severe brain injury (Initial Glasgow score between 3 and 8),
* Diffuse axonal injury and/or focal lesions.

Exclusion Criteria:

* Patients with MRI contraindications,
* Antecedents of brain lesions,
* Important lesions of the lobes and cortex on cerebral CT,
* Anoxic lesions related to cardiorespiratory arrest,
* Must be able to perform neuropsychological tests,
* Visual and auditory impairments.
* Aphasia

Primary outcomes:
measure: Changes in Baseline standardized volume of the white matter fascicles
timeFrame: at 3, 12 and 24 months
Secondary outcomes:
measure: Measure of the volume of activations clusters
timeFrame: at 3, 12 and 24 months
measure: Location of activation clusters
timeFrame: at 3, 12 and 24 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Auvergne
Study officials:
References:
Clinical trial NCT00445276: Symptomatic Efficacy of Diacerein in Knee Osteoarthritis
Official title: Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Knee
Diacerein
Painful osteoarthritis
Clinical trial
Lead sponsor: Laboratoires NEGMA
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 500
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: Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.


Eligibility criteria: Inclusion Criteria:

* Painful primary osteoarthritis (VAS ≥ 40 mm)
* Radiologically proven (Kellgren \& Lawrence grade I to III)
* Requiring the prescription of a symptomatic treatment of pain

Exclusion Criteria:

* Severe associated diseases
* Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
* Other osteoarticular disease

Primary outcomes:
measure: VAS on pain movement, WOMAC A 1.1 section
Secondary outcomes:
measure: WOMAC : total, pain, physical function
measure: Paracetamol consumption
measure: Global assessment of the patient
measure: Responder patients with OMERACT-OARSI criteria
measure: Tolerance
Other outcomes:
Locations:
city: Tours
country: France
facility: Chu Trousseau
Study officials:
affiliation: Unafilliated
name: Jean - Pierre Valat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00459576: Risk of Asthma in Infants With Atopic Dermatitis
Official title: Risk of Asthma in Infants With Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Eczema
Dermatitis, Atopic
Keywords: Asthma
Eczema
Dermatitis, Atopic
Infant
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our population was recruited through primary physician, pediatric practices, and dermatology groups through out Indianapolis Indiana and the surrounding counties. We also ran ads in local newspapers.

Brief summary: Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.

Detailed description: Asthma is a disease characterized by recurrent episodes of wheezing, inflammation of the airways, and airways that are very sensitive to stimulation (hyper-responsiveness). Symptoms of asthma frequently begin in early childhood; however, it has been difficult to identify pre-symptomatic, at-risk infants and toddlers. Family history of asthma and allergy is strongly associated with the early onset and persistence of asthma symptoms, and children with early onset persistent asthma are more likely to demonstrate allergies. The development of allergic disease results from complex interactions between genetic susceptibility and environmental factors; however, infants with atopic dermatitis have a 50% chance of developing asthma by 6 years of age. Airway inflammation and airway hyper-responsiveness are characteristics of asthmatic children. We plan to evaluate whether infants with allergic dermatitis have evidence of airway inflammation and hyper-responsiveness, and whether cells from the blood and the nose are also hyper-responsive to stimulation prior to the onset of clinical symptoms of asthma. In addition we will evaluate whether certain genetic profiles are associated with allergic disease in infants.

Eligibility criteria: Inclusion criteria-

1. Full term infants born greater than 37 weeks
2. History of atopic dermatitis or eczema

Exclusion criteria

1. Heart disease
2. asthma
3. Respiratory illness such as RSV, bronchiolitis or croup
4. Hospitalization for respiratory illness
5. History of wheezing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University
name: Robert S Tepper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: