louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01795820: Platelet Aggregation During the Shift From Clopidogrel to Ticagrelor
Official title: Platelet Aggregation During Pharmacological Shift From Clopidogrel to Ticagrelor in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: ticagrelor
clopidogrel
platelet aggregation
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Antiplatelet therapy with ticagrelor is currently indicated for treatment of patients presenting with acute coronary syndrome. Such therapy is started with the administration of a loading dose in patients which are not yet under treatment with P2Y12 inhibitors (antiplatelet agents). However it is unknown whether a loading dose is needed to maintain a satisfactory inhibition of platelet aggregation in patients who are already treated with a previous generation P2Y12 inhibitor (clopidogrel) during the passage to the newer compound ticagrelor. For this reason aim of the present study is to evaluate the levels of platelet aggregation during the pharmacological shift from clopidogrel to ticagrelor performed with or without a loading starting dose of the newer drug.


Eligibility criteria: Inclusion Criteria:

* Acute Coronary Syndrome
* Current dual anti platelet treatment with ASA and Clopidogrel

Exclusion Criteria:

* No coronary revascularization within the previous six months
* Ongoing therapy with ticagrelor, prasugrel or ticlopidine before enrollment
* No treatment with glycoprotein IIb/IIIa inhibitors within the previous 6 days
* Patients which are known to be no responders to Clopidogrel
* Known neoplastic or autoimmune disease
* Liver cirrhosis
* Severe pulmonary disease
* Known disorder of Haemostasis
* Previous Stroke
* Ongoing pregnancy
* Therapy with any inhibitor of P450 Cytochrome until 15 days before enrollment
* Low platelet count or Hb\<10 g/dl

Primary outcomes:
measure: Platelet aggregation
timeFrame: 2 hours
Secondary outcomes:
measure: 30-days clinical events
timeFrame: 30 days
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Magna Graecia University
state: Calabria
Study officials:
affiliation: Magna Graecia University
name: Ciro Indolfi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caiazzo G, De Rosa S, Torella D, Spaccarotella C, Mongiardo A, Giampa S, Micieli M, Palella E, Gulletta E, Indolfi C. Administration of a loading dose has no additive effect on platelet aggregation during the switch from ongoing clopidogrel treatment to ticagrelor in patients with acute coronary syndrome. Circ Cardiovasc Interv. 2014 Feb;7(1):104-12. doi: 10.1161/CIRCINTERVENTIONS.113.000512. Epub 2014 Jan 21.
Clinical trial NCT03085420: Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
Official title: Cardiac Arrhythmias and Dysfunction in the Pediatric Burn Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Dysfunction
Keywords: Burns
Pediatrics
Cardiac Arrhythmia
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 10
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to collect information about how often an abnormal heart beat happens in children who have been burned.

Detailed description: The investigators hope to learn the following:

* If heart arrhythmias are more common in children with a large burn injury than in children with a small burn injury.
* The difference in development of a heart arrhythmia after a large burn injury by comparing information from children with large burns who do and do not develop a heart arrhythmia.
* A better understanding of the length of a hospital stay, the number of operations, and the number of care complications in patients with heart arrhythmias after a burn injury.

Eligibility criteria: Inclusion Criteria:

Pediatric burn patients from age 0 - 18 who have sustained a burn injury will be eligible for this study.

Group 1 will consist of patients with ≥30% TBSA burn injury. Group 2 will consist of patients with \<30% TBSA burn injury who develop a cardiac abnormality.

Exclusion Criteria:

Patients with pre-existing cardiac disorder, desquamative skin disorders and electrical injury.

Primary outcomes:
measure: Frequency of cardiac dysfunction in pediatric burn patients
timeFrame: Through study completion up to 4 years after hospital discharge.
Secondary outcomes:
measure: Acute care hospital length of stay
timeFrame: Hospital admission to discharge (average of 1 day per %TBSA burn - example 30 days for a 30% TBSA burn injury).
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospitals for Children
state: Ohio
Study officials:
affiliation: Shriners Hospitals for Children
name: Ivan Wilmot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shriners Hospitals for Children
name: Petra M Warner, MD
role: STUDY_DIRECTOR
References:
citation: Mak GZ, Hardy AR, Meyer RA, Kagan RJ. Reversible cardiomyopathy after severe burn injury. J Burn Care Res. 2006 Jul-Aug;27(4):482-6. doi: 10.1097/01.BCR.0000226018.30433.ED.
citation: Howard TS, Hermann DG, McQuitty AL, Woodson LC, Kramer GC, Herndon DN, Ford PM, Kinsky MP. Burn-induced cardiac dysfunction increases length of stay in pediatric burn patients. J Burn Care Res. 2013 Jul-Aug;34(4):413-9. doi: 10.1097/BCR.0b013e3182685e11.
citation: Guillory AN, Clayton RP, Herndon DN, Finnerty CC. Cardiovascular Dysfunction Following Burn Injury: What We Have Learned from Rat and Mouse Models. Int J Mol Sci. 2016 Jan 2;17(1):53. doi: 10.3390/ijms17010053.
Clinical trial NCT00170820: Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
Official title: A Single Arm, Prospective, Open-label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal transplantation, maintenance, switch, everolimus, CNI-free
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.


Eligibility criteria: Inclusion Criteria:

* First or second renal transplantation (1 to 10 years post-transplant)
* Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin

Exclusion Criteria

* Treatment with a CNI or azathioprine
* Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
* Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply

Primary outcomes:
measure: Renal function at M6 (glomerular filtration and tubular function).
Secondary outcomes:
measure: Renal function (other tubular function parameters)
measure: Incidence of biopsy-proven acute rejections and CMV infections
measure: Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH
measure: Mucous and cutaneous disorders
measure: Adverse events and serious adverse events, premature study treatment discontinuations.
measure: Monitoring of everolimus trough levels.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Kamar N, Jaafar A, Esposito L, Ribes D, Durand D, Di-Giambattista F, Tack I, Rostaing L. Conversion from sirolimus to everolimus in maintenance renal transplant recipients within a calcineurin inhibitor-free regimen: results of a 6-month pilot study. Clin Nephrol. 2008 Aug;70(2):118-25. doi: 10.5414/cnp70118.
Clinical trial NCT05910320: Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Official title: Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease in Children
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary objective of this study is to evaluate the feasibility of the use of an investigational wearable vital sign monitoring device in infants.

Detailed description: Vital sign monitoring of infants outside of a traditional healthcare setting has already been shown to significantly decrease mortality for children with single ventricle congenital heart disease (1V CHD), a fragile group of patients with congenital heart disease (CHD). Therefore, there is a critical need to develop an accurate, at-home vital sign monitoring system for infants to expand the benefits of remote monitoring to further patient populations. The investigators believe that allowing for continuous monitoring at a clinical standard with interpretations and alerts built into the technology will result in an even greater decline in mortality for infants with 1V CHD, improved clinical outcomes for all infants with CHD, and increased well-being for healthy infants.

To achieve this goal, the investigators are developing a health monitoring system that collects numerical data and physiological waveforms describing heart rate (HR), respiratory rate (RR), pulse oximetry (SpO2), regional oxygen saturation, temperature, and infant motion.

Eligibility criteria: Inclusion Criteria:

* Patient admitted to either the newborn nursery, pediatric cardiac intensive care unit (PCICU), or pediatric care unit (PCU)
* Parent provided written informed consent

Exclusion Criteria:

* Foster or ward of the state

Primary outcomes:
measure: Signal morphology of wearable monitoring device
timeFrame: From device placement to removal, up to 1 hour
measure: Signal-to-noise ratio of wearable monitoring device
timeFrame: From device placement to removal, up to 1 hour
measure: Signal-to-noise ratio of reusable electrodes
timeFrame: From electrode placement to removal, up to 15 minutes
measure: Percent error of wearable monitoring device compared to clinical bedside monitors
timeFrame: From device placement to removal, up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Danielle Gottlieb Sen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05231720: Mannheim Register of Sepsis and Septic Shock
Official title: Mannheim Register of Sepsis and Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Sepsis
Septic Shock
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes internal medicine patients presenting sepsis and septic shock at the ICU irrespective of the septic focus.

Brief summary: The study aims to investigate clinically and prognostically relevant parameters in patients with sepsis and septic shock within a monocentric observational clinical register.

Detailed description: All consecutive septic patients at the internists intensive care Unit (ICU) at the University of Mannheim are included in the register and follow up during ICU stay and after that. Data of patients' admission status, septic focus, baseline parameters, and comorbidities are collected. Extensive information about echocardiography, electrocardiography, and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2,3, 5,7, and 10). Standard scores for critically ill patients were calculated for the day before admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality, and septic patients' 1-year mortality.

Eligibility criteria: Inclusion Criteria:

* Sepsis and septic shock according to current guidelines

Exclusion Criteria:

* other forms of shock not associated with an infection

Primary outcomes:
measure: all-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: all-cause mortality
timeFrame: in hospital
measure: all-cause mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
state: Baden Württemberg
city: Mannheim
country: Germany
facility: First Department of Medicine, University Medical Centre Mannheim
Study officials:
References:
Clinical trial NCT06549920: Danish Breast Cancer Group Internal Mammary Node Study
Official title: Danish Breast Cancer Group Internal Mammary Node Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Internal mammary node irradiation
Node-positive breast cancer
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 7630
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The DBCG IMN study is a nationwide prospective population-based cohort study allocating node-positive breast cancer patients with right-sided tumors to internal mammary node irradiation (IMNI) and patients with left-sided tumors to no IMNI.


Eligibility criteria: Inclusion Criteria:

* Patients with macrometastatic node-positive breast cancer treated with loco-regional radiotherapy.

Exclusion Criteria:

* Prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.

Primary outcomes:
measure: Overall survival
timeFrame: 15-years.
Secondary outcomes:
measure: Breast cancer mortality
timeFrame: 15-years.
measure: Distant recurrences
timeFrame: 15-years.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02893020: Emotional Experience and Burnout in Physician
Official title: National Study of the Psychological Consequences Resulting From the Practice of Invasive Therapeutic Interventions: Mixed Evaluation, Qualitative and Quantitative, of Burn Out Among Digestive Surgeons, Gastroenterologists and Radiologists
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emotional Experience and Burnout in Physicians
Keywords: Emotional experience and burnout in physicians
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 3390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Digestive surgeon, Gastroenterologist, Radiologist

Brief summary: Recent studies have highlighted a high incidence of burnout among surgeons. The aim of this study is in particular to investigate if this is the consequence of performing surgery (i.e. invasive procedures) or whether it is related to the cultural background of surgeons.

Detailed description: A mixed method approach (qualitative approach and quantitative approach) will be used to investigate surgeons, as well as gastroenterologists and radiologists who perform invasive procedures and gastroenterologists and radiologists who do not perform invasive procedures. The qualitative approach will rely on face-to face interviews with purposively sampled physicians of the 5 groups and will be continued until saturation. The quantitative approach will rely on a questionnaire that will be sent to physicians of the 5 groups.

Eligibility criteria: Inclusion Criteria:

* Digestive surgeon, Gastroenterologist, Radiologist

Exclusion Criteria:

* None

Primary outcomes:
measure: incidence of burnout
timeFrame: quantitative approach 27 months
Secondary outcomes:
measure: physicians understanding of the Maslach Burnout Inventory (MBI) questionnaire will be reported by interview
timeFrame: quantitative approach 27 months
measure: physician's emotions will be reported by interview and MBI questionnaire
timeFrame: quantitative approach 27 months
measure: Correlation score depending on the specialty and professional experience
timeFrame: quantitative approach 27 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier Farges, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sibeoni J, Bellon-Champel L, Verneuil L, Siaugues C, Revah-Levy A, Farges O. Workplace environment around physicians' burnout: A qualitative study in French hospitals. Scand J Work Environ Health. 2021 Oct 1;47(7):521-530. doi: 10.5271/sjweh.3977. Epub 2021 Aug 7.
Clinical trial NCT03322020: Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Prostate Cancer
Official title: Androgen Deprivation Therapy, External Beam Radiotherapy and Stereotactic Radiosurgery Boost for Men With Intermediate- or High-risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasm, Prostate
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For the treatment for intermediate- and high-risk prostate cancer, Cyberknife boost will be used after 4 weeks of intensity modulated radiotherapy to pelvis. The boost doses are 18 Gy and 21 Gy in 3 fractions, respectively. The investigators plan to evaluate the toxicity of two dose groups and decide the appropriate dose for Cyberknife boost. Also, PSA control will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed intermediate- or high-risk prostate cancer within 6 months after enrollment
* ECOG performance status 0-1
* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
* Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
* Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value

Exclusion Criteria:

* Presence of distant metastasis
* Presence of pelvic LN metastasis
* History of androgen deprivation therapy within 6 months after enrollment
* History of definitive treatment for prostate cancer (e.g., radical prostatectomy)
* History of pelvic irradiation
* Double primary cancer other than skin/thyroid cancer

Primary outcomes:
measure: Acute toxicity assessment for 18 Gy and 21 Gy arm
timeFrame: 3 months
Secondary outcomes:
measure: Biochemical control free survival
timeFrame: 3 years
measure: Late toxicity assessment for 18 Gy and 21 Gy arm
timeFrame: average 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young Seok Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YJ, Ahn H, Kim CS, Kim YS. Phase I/IIa trial of androgen deprivation therapy, external beam radiotherapy, and stereotactic body radiotherapy boost for high-risk prostate cancer (ADEBAR). Radiat Oncol. 2020 Oct 8;15(1):234. doi: 10.1186/s13014-020-01665-6.
citation: Kim YJ, Ahn H, Kim CS, Lee JL, Kim YS. Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate- or high-risk prostate cancer: a study protocol for a randomized controlled, pilot trial. Trials. 2018 Apr 2;19(1):212. doi: 10.1186/s13063-018-2574-y.