louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02010320: Computer Guided Doing of Tacrolimus in Renal Transplantation
Official title: Prospective Testing of Pharmacokinetic Population Models for Dosing of Transplanted Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: population model
pharmacokinetic
tacrolimus
therapeutic drug monitoring
individualized dosing
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
Collaborators: name: Rikshospitalet University Hospital
First posted: 2013-12-12
Enrollment: 80
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: Dosing of tacrolimus is challenging due to the large inter-individual variation in its pharmacokinetics. The investigators have developed a pharmacokinetics population model that can be used to estimate individual doses of tacrolimus in renal transplant recipients. The model will be prospective tested in a randomized clinical trial.

The hypothesis is that the computer model is superior to experienced transplant physicians in reaching and keeping the patients in the target range of tacrolimus.

Detailed description: Patients will be randomized to either computer or standard dosing strategies at time of transplantation or as early after transplantation as possible in case of deceased donor transplants.

For patients in the computer arm the model will calculate the dose with the highest probability to reach the specified concentration target.

For all concentrations a predictive error will be calculated and this will be the primary endpoint that the statistics will be calculated on.

All patients will be followed for between 8 to 12 weeks post-transplant, according to center praxis.

Eligibility criteria: Inclusion Criteria:

* renal transplant recipients using tacrolimus as part of their immunosuppression
* above 18 years
* signed informed consent

Exclusion Criteria:

* no specific

Primary outcomes:
measure: Predictive error (Cpred-Cobs)
timeFrame: 8 to 12 weeks
measure: Reaching the target concentration
timeFrame: 8 to 12 weeks post-transplant
Secondary outcomes:
Other outcomes:
measure: Influence of CYP3A5 genotyping
timeFrame: 8 to 12 weeks post-transplant
Locations:
city: Oslo
country: Norway
facility: Olso university hospital - Rikshospitalet
Study officials:
affiliation: OUS-Rikshospitalet and University of Oslo
name: Anders Åsberg, PhD
role: STUDY_CHAIR
References:
citation: Storset E, Asberg A, Skauby M, Neely M, Bergan S, Bremer S, Midtvedt K. Improved Tacrolimus Target Concentration Achievement Using Computerized Dosing in Renal Transplant Recipients--A Prospective, Randomized Study. Transplantation. 2015 Oct;99(10):2158-66. doi: 10.1097/TP.0000000000000708.
Clinical trial NCT05929820: Impact of Protect Your Colon™ on CRC Screening
Official title: Pilot Randomized Controlled Trial Assessing the Impact of Protect Your Colon™ on Colorectal Cancer Screening Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Decision aid
Stool test
Colonoscopy
CT scan
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-03
Enrollment: 184
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.


Eligibility criteria: Inclusion Criteria:

* Individuals 45 to 75 years old
* No prior CRC screening or not up-to-date with CRC screening
* Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC)

Exclusion Criteria:

* Does not speak English
* Does not have internet access
* Any records flagged "break the glass" or "research opt out."

Primary outcomes:
measure: Rate of completion of a CRC screening test
timeFrame: 6 months post visit
Secondary outcomes:
measure: Qualitative feedback on details of CRC screening test
timeFrame: 1 day post visit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Christopher V Almario, MD, MSHPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05413720: Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
Official title: Study of the Innate Immune Response to the Acute Phase of Human Leptospirosis - IMMUNOLEPTO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leptospirosis
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The research hypothesis is based on a suspected strong involvement of the immune system in the genesis of serious manifestations of the disease (hepatitis, renal failure, thrombocytopenia, intra-alveolar hemorrhage). The question asked is that of the state of the immune system (quantitative and qualitative: activation markers, production of cytokines) evaluated by the study of circulating innate immune cells (monocytes, neutrophils, dendritic cells, lymphocytes, platelets).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 4 years;
* Weight ≥ 11 kg;
* with ongoing symptoms compatible with a clinical diagnosis of leptospirosis.
* AND having a diagnosis of leptospirosis confirmed according to standard care procedures: preferably by Polymerase Chain Reaction (PCR) (blood or urine) or, failing that, serology indicating a recent infection (positive Immunoglobulin M (IgM) or Microscopic Agglutination Test (MAT) technique with titer \>1/400 for a pathogenic serogroup)
* AND affiliated to a Social Security scheme

Exclusion Criteria:

* Refusal of participation by the patient or his entourage if the patient is physically unable to give his opinion (coma, resuscitation, etc.).
* Not affiliated with social security
* Immunosuppression that may interfere with the interpretation of the results: chemotherapy in progress, immunosuppressants in progress for organ transplantation or autoimmune disease
* Patient under legal protection (Guardianship, Curators)

Primary outcomes:
measure: proportion of activated monocyte cells (CD14+CD16+ phenotype) within monocytes
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Benoît
country: Réunion
facility: GHER
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
city: Saint-Paul
country: Réunion
facility: CHOR
city: Saint-Pierre
country: Réunion
facility: CHU de la Réunion
Study officials:
References:
Clinical trial NCT03897920: Doppler Ultrasound Renal Arterial Resistive Indices As Predictor Of Multiorgan Failure In Patients With Acute Hypoxic Respiratory Failure Admitted To Respiratory Intensive Care Unit (Cryptic Shock Index- RICU)
Official title: Doppler Ultrasound Renal Arterial Resistive Indices As Predictor Of Multiorgan Failure In Patients With Acute Hypoxic Respiratory Failure Admitted To Respiratory Intensive Care Unit (Cryptic Shock Index CSI- RICU)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Multi Organ Failure
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with de novo respiratory failure admitted to the respiratory intensive care unit of the university hospital of Modena without any other organ failure

Brief summary: Patients with de novo respiratory failure undergoing non invasive ventilation (NIV) present failure rates of mechanical ventilation ranging from 4 to 50%. Causes for NIV treatment failure are various but the onset of septic shock and subsequent multi-organ failure (MOF) seem play a critical role. Recent data show that the 37% of patients admitted to intensive care unit for de novo respiratory failure without any other organ failure experience multiple organ failure within the first days from admission. Early identification of hypoxic patients at major risk for MOF seems critical. Physiological studies have demonstrated that the underlying mechanisms for organ damage preceding MOF are those involved in the oxygen consumption (VO2)/oxygen delivery (DO2) mismatch. Doppler ultrasound indices of renal arteria resistance are directly correlated tot he VO2/DO2 mismatch. With this study we aim at investigating the correlation between Doppler ultrasound indices of renal arteria resistance in patients with de novo respiratory failure admitted to ICU and the onset of MOF within the first 7 days form admission.


Eligibility criteria: Inclusion Criteria:

* patients with de novo respiratory failure admitted to the respiratory intensive care unit of the university hospital of Modena

Exclusion Criteria:

* age lower than 18 or higher than 85
* presence of organ failure apart form lung failure at the time of admission in the respiratory intensive care unit
* pregnancy
* difficult or unreliable ultrasound window for renal arterial resistive index assessment

Primary outcomes:
measure: Onset of shock
timeFrame: 7 days from Respiratory Intensive Care Unit admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05017220: Nature-based Sensory Stimulation on Pain Levels
Official title: The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Nature-based activities
Pain dimensions
Multisensory stimulation
Quantitative sensory testing
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia

Detailed description: All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia syndrome (ACR criteria 2016).
* Chronic widespread musculoskeletal pain symptoms (\>1 location using the Widespread Pain Index).
* High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months.
* If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment
* Over 18 and less than 65 years old (labour active).
* Ability to speak and understand English or Spanish.

Exclusion Criteria:

* Acute or temporal pain
* Severe cognitive impairment, detected by the Mini-Mental State Examination (score \<24 out of 30 points)
* Severe mental disorders in acute phase or symptomatic phase
* Behavioural alterations as this may interfere in their participation
* Severe intellectual disability
* Other severe or medically unstable diseases interfering with the project participation
* Co-occurrence of neuropathic pain
* Other disorders that may cause pain
* Pregnant or breast-feeding
* Drug abuse within the past year.

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline pain intensity after 30 minutes
measure: Cold pain thresholds
timeFrame: Change from baseline cold pain thresholds after 30 minutes
measure: Punctate mechanical hyperalgesia
timeFrame: Change from baseline mechanical hyperalgesia after 30 minutes
measure: Wind-up phenomenon
timeFrame: Change from baseline temporal summation of pain perception after 30 minutes
measure: Pressure pain thresholds
timeFrame: Change from baseline pressure pain thresholds after 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
References:
Clinical trial NCT05001620: Implementation of a Telehealth Palliative Care Model for Persons With Dementia
Official title: Implementation of a Telehealth Palliative Care Model for Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Dementia
Keywords: Dementia
Palliative Care
Telehealth
Nursing Homes
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-08-12
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Grounded in the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Model, this study will assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention for persons living with dementia (PLWD) and their care-partners newly admitted to nursing homes (NHs) for post-acute care.

Detailed description: This single arm embedded pragmatic pilot clinical trial will provide data to assess the implementation outcomes of the Nurse Practitioner (NP) delivered telehealth Palliative Care Consultation in Post-Acute Care (PCC-PAC) intervention among 30 persons living with dementia (PLWD) and their care-partners newly admitted to one nursing homes (NH) for post-acute care.

Eligibility criteria: Inclusion Criteria:

Stakeholders:

* (1) PC provider
* (2) Social Work (SW) NH champions
* (3) post-acute care unit nursing staff and providers (including medical directors)
* (4) NH leadership, information technology staff
* (5) PLWD and their care partner(s).

Person Living with Dementia (PLWD)

* documented dementia diagnosis
* admitted for post-acute care
* age ≥ 60 years
* if unable to participate in a conversation or lacking capacity to make healthcare decisions as determined by the NH staff/providers, a care partner who can act as a surrogate decision maker in the PCC-PAC.

Exclusion Criteria:

Stakeholders:

-PLWD who receives the intervention

PLWD:

* planned discharge within 48 hours of screening
* currently receiving hospice care

Primary outcomes:
measure: Adherence to Skilled Nursing Facility (SNF)-PCC Recommendations
timeFrame: 30 days post admission
Secondary outcomes:
measure: Number of Hospitalizations
timeFrame: 30 days post admission
Other outcomes:
measure: Number of Participants With Completed Stakeholder Interviews/Focus Groups
timeFrame: 1 year
Locations:
city: Rockville
country: United States
facility: Collingswood Rehabilitation and Healthcare Center
state: Maryland
Study officials:
References:
Clinical trial NCT06916520: Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)
Official title: Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 300
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: Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.

Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).

Study design: Open-label, single-centre, randomized controlled trial pilot.

Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.

Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.

Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.


Eligibility criteria: Inclusion Criteria:

* Acute Coronary Syndrome
* Chronic Coronary Syndrome
* Successful PCI

Exclusion Criteria:

* Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)
* Current indication for oral anticoagulant therapy (OAC)
* Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
* Pregnancy or breast-feeding women
* Participation in another trial with an investigational drug or device
* Recent or ongoing strong CYP3A4 inhibitor or inducer therapy (e.g. clarithromycin, ketoconazole, carbamazepine or rifampicin)

Primary outcomes:
measure: NACE (Net Adverse Clinical Events)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03453320: Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects
Official title: Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Edema Secondary
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.

One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.

In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.

Detailed description: Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.

Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.

Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.

After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).

During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.

Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.

Eligibility criteria: Inclusion Criteria:

- Healthy, without allergies and with the age 18 years or above

Exclusion Criteria:

* Heart failure
* Signs of kidney injury/failure
* Severe allergies
* Pregnancy

Primary outcomes:
measure: Plasma volume
timeFrame: 6 hours
Secondary outcomes:
measure: Colloid osmotic pressure
timeFrame: 6 hours
measure: Fluid recruitment from tissues
timeFrame: 6 hours
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Intensive Care Unit, University Hospital
Study officials:
affiliation: University Hospital, Linkoeping
name: Joachim Zdolsek, MD, PhD,Assoc prof
role: PRINCIPAL_INVESTIGATOR
References: