louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05602103: Cancer Therapy-related Cardiac Dysfunction Occuring in Children Treated by Anticancer Drugs for Malignancies
Official title: Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction Reporting in Pediatrics - Analysis of the WHO Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Malignancies
Cardiovascular Diseases
Children, Only
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to children and reported, or not, cancer therapy-related cardiac dysfunction

Brief summary: Little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs.


Eligibility criteria: Inclusion Criteria:

* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
* related to children
* and reported, or not, cancer therapy-related cardiac dysfunction

Exclusion Criteria:

* cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients

Primary outcomes:
measure: cancer therapy-related cardiac dysfunction associated with anticancer drugs
timeFrame: from inception to the April 31, 2024
Secondary outcomes:
measure: Association between cancer therapy-related cardiac dysfunction and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase)
timeFrame: from inception to the April 31, 2024
measure: Description of the malignancies for which the incriminated drugs have been prescribed
timeFrame: from inception to the April 31, 2024
Other outcomes:
Locations:
Study officials:
affiliation: Caen Normandy University Hospital, France
name: Joachim Alexandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663803: Live Your Life Without Diabetes
Official title: Effectiveness of a Brief Theory-based Health Promotion Intervention Among Adults at High Risk of Type 2 Diabetes: One-year Results From a Randomised Trial in a Community Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim: To examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among Danish adults at high risk of diabetes.

Methods: A randomised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose: 6.1-6.9 mmol/l and/or HbA1c : 6.0-\<6.5% (42- \< 48 mmol/mol) recruited from general practice in Holstebro, Denmark. Participants were randomised to a control group or to receive the intervention delivered over four 2 h group sessions during five weeks, and two further sessions after one and six months. Questionnaire data and clinical measures were collected at baseline, three months and one year after intervention.


Eligibility criteria: Inclusion Criteria:

* resident in the Municipality of Holstebro
* aged \<70 years
* a measurement of fasting plasma glucose: 6.1-6.9 mmol/l (the thresholds for Impaired Fasting Glucose according to clinical guidelines) and/or HbA1c : 6.0-\<6.5% (42- \<48 mmol/mol) within the previous six months.

Exclusion Criteria:

* none

Primary outcomes:
measure: weight
timeFrame: baseline to one-year follow-up
measure: total-fat intake <30% of energy intake
timeFrame: change from baseline to one-year follow-up
measure: saturated-fat intake <10% of energy intake
timeFrame: change from baseline to one-year follow-up
measure: fibre-intake ≥15g/1000kcal changes in physical activity level.
timeFrame: change from baseline to one-year follow-up
measure: changes in physical activity.
timeFrame: change from baseline to one-year follow-up
Secondary outcomes:
measure: patient activation
timeFrame: change from baseline to one-year follow-up
measure: waist circumference
timeFrame: change from baseline to one-year follow-up
measure: total energy intake
timeFrame: change from baseline to one-year follow-up
measure: blood pressure, systolic and diastolic
timeFrame: change from baseline to one-year follow-up
measure: HbA1c
timeFrame: change from baseline to one-year follow-up
measure: cholesterol
timeFrame: change from baseline to one-year follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02129803: Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Official title: Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of CF
* Hospital admission for acute pulmonary exacerbation of CF (using Fuchs criteria 4/10)
* 10 years of age and older
* Subject is able to comply with the procedures scheduled in the protocol
* Signed informed consent form

Exclusion Criteria:

* Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
* Subject had ear, nose, and throat (ENT) surgery, nasal bleeding, or nasal polyps within 6 months prior to study
* Subject is unlikely to comply with the procedures scheduled in the protocol
* Inability to give informed consent
* Subject requires supplemental oxygen
* History of obstructive sleep apnea
* History of pressure headaches requiring therapy within one month of enrollment
* Any other medical or psychological condition in which the study doctor(s) believe(s) would inhibit the individual from being an appropriate study subject.

Primary outcomes:
measure: Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: Day 0 to Day 6 or upon discharge from the hospital, whichever comes first
Secondary outcomes:
measure: Sputum Collection
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Bruce K Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01197703: European Cardio Computer Tomography Registry
Official title: European Cardio CT Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical Indications
Keywords: Clinical Practice Cardiac CT
Clinical Implications Coronary CT Angiography
Radiation Exposure of Coronary CT Angiography
Registry
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 7115
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: All consecutive patients that are studies by computed tomography of the heart for clinical indications

Brief summary: The European Cardiac CT Registry has the unique potential to provide important data that will help to clarify the clinical role of cardiac computed tomography (CT), to create guidelines and recommendations for its use, and to identify the most important areas that require specific further research.


Eligibility criteria: Inclusion Criteria:

* Inclusion of all consecutive patients with accomplished or attempted CT imaging of the heart (whether imaging of the coronary arteries or other structures of the heart)
* Informed consent to be entered in the registry.
* Inclusion of all consecutive patients with accomplished or attempted coronary CT angiography.
* Inclusion of all patients who undergo coronary CT angiography for clinical indications, with separate analysis of patients with suspected coronary artery disease and previously known coronary artery disease.

Exclusion Criteria:

- Besides the absence of informed consent, and cardiac CT studies performed as part of a research protocol, no exclusion criteria exist.

Primary outcomes:
measure: collect data
timeFrame: June 2009-
Secondary outcomes:
measure: effect of coronary CT angiography
timeFrame: June 2009-
measure: analysis of radiation exposure during coronary CT angiography
timeFrame: June 2009-
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik GmbH
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Göppingen
country: Germany
facility: Klinik am Eichert
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: München
country: Germany
facility: Herzzentrum Bogenhausen
city: Traunstein
country: Germany
facility: Klinikum Traunstein
Study officials:
affiliation: Universitätsklinikum Erlangen
name: Stephan Achenbach, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02912403: Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
Official title: Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Normotensive Postpartum Cesarean Section Patients
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: postpartum women

Brief summary: Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period. Investigators will use a home blood pressure monitor that stays on the arm, and takes blood pressures hourly. Participants will record any symptoms that they feel are attributed to high blood pressure and pain medication use.

Detailed description: Participants will be screened postpartum for inclusion. Only women with cesarean deliveries will be included as they are kept for 3 days in the hospital as opposed to 2 days for vaginal deliveries. If they meet inclusion criteria they will be asked to participate in the study, and consented. Each patient will receive routine postpartum care. The ambulatory blood pressure cuff will be introduced and validated on the particpant prior to discharge. Particpants will then be given specific instructions on when to place the cuff on their am and when to remove it. The ambulatory cuff will take blood pressure measurements every hour. The Particpant will be asked to keep a log of actives, symptoms, and pain medication use for the 72 hour period that her blood pressures are being recorded. The BP device will be returned to the department of OB/GYN at St. Mary's after completion of her 72 hours of monitoring. This will occur at her first post op visit. Particpants will be asked to complete a survey about comfort of device and return with the device. Information pertaining to their pregnancy and delivery will be collected while the patient is in the hospital. Particpants are not responsible for damage or loss of equipment.

All of these procedures are part of the study.

Eligibility criteria: Inclusion Criteria:

* Normotensive postpartum women
* Singleton pregnancy
* Cesarean delivery

Exclusion Criteria:

* Chronic medical conditions that would put the patient at increased risk for hypertension (diabetes, lupus, renal disease)
* Current diagnosis of hypertensive disease
* Skin rash in location of cuff placement
* Tobacco user
* Chronic narcotic user
* Vaginal delivery
* cognitively impaired persons

Primary outcomes:
measure: blood pressure changes on days 3 to 6 of the postpartum period
timeFrame: days 3 to 6 of the postpartum period
Secondary outcomes:
Other outcomes:
Locations:
city: St Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Jennifer Goldkamp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03403803: Prognosis and Therapeutic Biomarkers for Glioblastoma Patients
Official title: Prognosis and Therapeutic Biomarkers for Glioblastoma Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma
Keywords: Glioblastoma
Brain Tumor
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with GBM or diagnosed with other neurological disorder that requires a lumbar puncture.

Brief summary: The purpose of this study is to investigate if the potential biomarkers identified could be used for facilitating the diagnosis and prognosis of patients with glioblastoma (GBM).

Detailed description: The objective of this proposed study is to determine the expression levels of a panel of markers including CD133, CD44, ABCC3, TNFRSF1A, AKT1, IDH2, and MGMT in GBM tissues and the CSF, blood, and saliva from patients with GBM receiving different types of treatment (Optune only or Optune with TMZ) and the non-brain tumor patients (controls). Our aims are: 1) To compare the differences of CD44 between the control group and the combined cancer groups at baseline; and 2) To compare the levels of CD44 and other markers among the 3 different groups such as control vs. GBM patients and Optune vs. Optune + TMZ after 8 weeks of treatment. Exploratory analysis of all other markers will be performed.

Eligibility criteria: Inclusion Criteria:

* 22 years old
* Control Group (only patients evaluated for neurological disorders whose evaluation require a lumbar puncture)
* Non-Control Group - Diagnosed with GBM (Glioblastoma)

Exclusion Criteria:

* Pregnancy
* Infectious Disease to include cold, flu, HIV, etc.
* Blood Disorder (example:low platelets, anemia, thrombosis)
* Vascular Malformations

Primary outcomes:
measure: Primary Outcome - CD44 expression in cerebrospinal fluid (CSF), blood and saliva
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Temple
country: United States
facility: Baylor Scott and White Medical Center
state: Texas
Study officials:
affiliation: Baylor Scott and White Medical Center, Temple, TX
name: Ekokobe Fonkem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02703103: Chest Compression During Resuscitation
Official title: Use of a New Mechanical Chest Compression Machine LifeLine ARM for Cardiopulmonary Resuscitation by Paramedics: a Randomized, Crossover, Manikin Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Keywords: cardiopulmonary resuscitation
chest compression
adult
simulation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the new mechanical chest compression machine LifeLine ARM in healthcare professionals in simulated model of cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* minimum 10 clinical resuscitations
* paramedics

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
* pregnancy

Primary outcomes:
measure: chest compressions effectiveness
timeFrame: 1 day
Secondary outcomes:
measure: Depth
timeFrame: 1 day
measure: Pressure point
timeFrame: 1 day
measure: Complete pressure release
timeFrame: 1 day
measure: Rate of chest compressions
timeFrame: 1 day
measure: hands-off time
timeFrame: 1 day
measure: tidal volume
timeFrame: 1 day
measure: ventilation rate
timeFrame: 1 day
measure: minute-volume
timeFrame: 1 day
measure: number of gastric inflations
timeFrame: 1 day
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Łukasz Szarpak
Study officials:
References:
citation: Truszewski Z, Szarpak L, Kurowski A, Evrin T, Zasko P, Bogdanski L, Czyzewski L. Randomized trial of the chest compressions effectiveness comparing 3 feedback CPR devices and standard basic life support by nurses. Am J Emerg Med. 2016 Mar;34(3):381-5. doi: 10.1016/j.ajem.2015.11.003. Epub 2015 Nov 4.
citation: Kurowski A, Czyzewski L, Bogdanski L, Zasko P, Karczewska K, Szarpak L. Quality of chest compression with CardioPump CPR compared to single rescuer standard BLS. Am J Emerg Med. 2015 Jan;33(1):114-5. doi: 10.1016/j.ajem.2014.10.027. Epub 2014 Oct 20. No abstract available.
Clinical trial NCT03923803: Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Official title: Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acutely exacerbated chronic obstructive pulmonary disease

Brief summary: Chronic obstructive pulmonary disease is a serious disease . Exacerbations of Chronic obstructive pulmonary disease is an acute worsening condition of Chronic obstructive pulmonary disease, which always accompanied by clinical symptoms such as, shortness of breath and increased production of sputum. Respiratory infection (bacteria or viruses or mixed) is thought to be the main cause in most exacerbations.


Eligibility criteria: Inclusion Criteria:

- Patients admitted to the hospital

Exclusion Criteria:

* patients with malignancies
* patients with other systemic infection

Primary outcomes:
measure: The level of C-reactive protein between Infection and Non-infectious inflammatory response in acute exacerbations of Chronic obstructive pulmonary disease patients
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00004443: Study of NTBC for Tyrosinemia I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tyrosinemia I
Keywords: inborn errors of metabolism
rare disease
tyrosinemia I
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Assess the safety and efficacy of NTBC in children with tyrosinemia I.

II. Evaluate the effects of NTBC on survival, rate of neurologic crises, improvement in renal tubular damage, reduction in the need for liver transplantation, and reduction in the development of hepatocarcinoma in these patients.

Detailed description: PROTOCOL OUTLINE: Patients are stratified according to age at onset of symptoms (0-2 months vs 2-6 months vs greater than 6 months).

Patients receive oral NTBC twice a day. Treatment continues in the absence of unacceptable toxicity.

Patients are followed once a month for 6 months, then every 3 months thereafter.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: * Confirmed diagnosis of tyrosinemia Detected through newborn screening before the onset of symptoms OR Diagnosed on the basis of symptoms (liver disease, neurological crises, growth failure) and succinylacetone in urine or blood and/or fumarylacetoacetate dehydratase deficiency in cultured fibroblasts or liver biopsy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Montreal
country: Canada
facility: Hopital Sainte Justine
state: Quebec
Study officials:
affiliation: University of Washington
name: C. Ronald Scott
role: STUDY_CHAIR
References: