louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04774627: Pancytopenia Related to PARP Inhibitors (PancytoRIB)
Official title: Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients treated with PARPi and experiencing pancytopenia.

Brief summary: Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce.

The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Detailed description: Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of pancytopenia related to PARPi.

Eligibility criteria: Inclusion Criteria:

* case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
* patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none) and pamiparib (none).

Exclusion Criteria: chronology not compatible between the PARPi and adverse event.

Primary outcomes:
measure: Pancytopenia reports related to PARPi.
timeFrame: From inception to Feb, 2021
Secondary outcomes:
measure: Description of the latency period since first PARPi exposure.
timeFrame: From inception to Feb, 2021
measure: Description of the fatality rate.
timeFrame: From inception to Feb, 2021
measure: Description of patients who experienced co-reported adverse events
timeFrame: From inception to Feb, 2021
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre Joachim
state: Basse Normandie
Study officials:
References:
Clinical trial NCT06542627: Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes: A Prospective Community-based (Workplace) Cohort Study
Official title: Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Diabetes Mellitus, Type 2
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2024-08-07
Enrollment: 420
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.


Eligibility criteria: Inclusion Criteria:

* Subjects over the age of 19
* Patients with type 2 diabetes

  * Fasting blood glucose ≥ 126 mg/dL or
  * HbA1c ≥ 6.5% or
  * Type 2 diabetes by clinical history and treated with antidiabetic medications or lifestyle Modifications
* Patients with prediabetes

  * Fasting blood glucose 100-125 mg/dL
  * HbA1c 5.7-6.4%
* Willing to participate in the study

Exclusion Criteria:

* Subjects less than 19 years old
* Patients with type 1 diabetes
* Pregnant at the time of screening or planning to become pregnant during the study
* Severe chronic diseases such as cancer, stroke, proliferative retinopathy, myocardial infarction, chronic renal disease, or amputation of a diabetic foot
* Diagnosed with or treated for myocardial infarction, stroke, end-stage renal disease, liver failure, or chronic lung disease within the past year
* Severe liver disease (e.g., cancer, liver cirrhosis, hepatitis B, hepatitis C)
* Diseases of the biliary tract, thyroid disorders, autoimmune disorders, or acute infections
* Planning to be admitted to a hospital within 2 months
* Unable to participate in the mobile intervention study as determined by the investigator

Primary outcomes:
measure: HbA1c
timeFrame: 8weeks after intervention
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: 8weeks after intervention
measure: Lipid profiles
timeFrame: 8weeks after intervention
measure: Body weight
timeFrame: 8weeks after intervention
measure: Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: 8weeks after intervention
measure: Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).
timeFrame: 8weeks after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: cydoctor68@gmail.com
name: Park
role: STUDY_DIRECTOR
References:
Clinical trial NCT02493127: The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness
Official title: The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand and Upper Extremity Illness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 122
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: Objectives:

To determine the association between priming and measurements of hand function such as grip strength

Primary null hypothesis:

There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to patients that complete the positively adjusted PCS.

Secondary null hypotheses:

There is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

There is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

Detailed description: Priming affects all aspects of human behavior. Prior research by the investigators' group determined that completing a positively phrased version of the pain catastrophizing scale (PCS) primed patients to report less disability on average than completing the standard PCS. The influence of priming can be better understood by determining if it also affects direct measurements of hand function such as grip strength measures.

Eligibility criteria: Inclusion Criteria:

* All English-speaking adult patients visiting the Orthopaedic Hand and Upper Extremity Service

Exclusion Criteria:

* Unable to complete enrollment forms due to mental status or language problem

Primary outcomes:
measure: Pain Catastrophizing Scale (PCS)
timeFrame: enrollment
measure: Positive Pain Catastrophizing Scale (PCS)
timeFrame: enrollment
measure: Difference in Grip Strength Measured With Dynamometer
timeFrame: Day 1
measure: Difference in Grip Strength Measured With Dynamometer
timeFrame: Day 1
measure: Difference in Grip Strength Measured With Dynamometer
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David C Ring, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092027: A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Compare the Safety and Tolerability of an Oral Buffered Solution of Alendronate Sodium 70 mg Once-Weekly Versus Placebo for the Treatment of Osteoporosis in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 454
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety and tolerability of MK0217 being evaluated to treat women with postmenopausal osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Women with postmenopausal osteoporosis

Exclusion Criteria:

* High risk for fractures
* Esophageal abnormalities
* Upper gastrointestinal symptoms that are not relieved with medication
* Metabolic bone disease (example - vitamin D deficiency)
* Medications that would affect the breakdown or build-up of bone

Primary outcomes:
measure: To evaluate the upper gastrointestinal (UGI) safety and tolerability of 6 months of treatment with once weekly alendronate 70 mg in an oral buffered solution in comparison to placebo in postmenopausal women with osteoporosis
Secondary outcomes:
measure: To evaluate the overall safety and tolerability of once weekly alendronate 70 mg oral buffered solution versus placebo
measure: To evaluate the mean percent change from baseline in bone markers (BSAP, Urinary NTx) at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Cryer B, Binkley N, Simonelli C, Lewiecki EM, Lanza F, Chen E, Petruschke RA, Mullen C, de Papp AE. A randomized, placebo-controlled, 6-month study of once-weekly alendronate oral solution for postmenopausal osteoporosis. Am J Geriatr Pharmacother. 2005 Sep;3(3):127-36. doi: 10.1016/s1543-5946(05)80019-4.
Clinical trial NCT05143827: Glycemic Index of Pasta From Traditional and Current Wheat Varieties
Official title: Glycemic Index of Pasta From Traditional and Current Wheat Varieties in Patients With Type 2 Diabetes: a Randomized, Cross-over, Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This randomized, cross-over study compares pasta produced with three different wheat varieties (Senatore Cappelli, Korasan, Claudio). Patients with type 2 diabetes with no pharmacological treatment will be randomized to three different sequences, and asked to eat a standard portion of pasta on three different occasions, four days apart. 3-hour post-prandial interstitial glucose profiles will be recorded using trans-cutaneous sensors.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Body Mass Index (BMI) \> 20 kg/m2
* HbA1c \< 58 mmol/mol

Exclusion Criteria:

* Current pharmacological therapy for diabetes (of any kind)
* Pregnancy or lactation

Primary outcomes:
measure: 60-min glucose
timeFrame: 60 minutes
Secondary outcomes:
measure: 30-min glucose
timeFrame: 30 minutes
measure: 90-min glucose
timeFrame: 90 minutes
measure: 120-min glucose
timeFrame: 120 minutes
measure: 150-min glucose
timeFrame: 150 minutes
measure: 180-min glucose
timeFrame: 180 minutes
measure: Area Under the Curve (AUC) glucose 30 min
timeFrame: 30 minutes
measure: AUC glucose 60 min
timeFrame: 60 minutes
measure: AUC glucose 90 min
timeFrame: 90 minutes
measure: AUC glucose 120 min
timeFrame: 120 minutes
measure: AUC glucose 180 min
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Diabetologia AOU Careggi
Study officials:
References:
Clinical trial NCT06837727: Left Ventricular Outflow Tract Mean Velocity in Children: a Strong Alternative to Cardiac Index in Pediatric Intensive Care Unit
Official title: Left Ventricular Outflow Tract Mean Velocity in Children: a Strong Alternative to Cardiac Index in Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock Circulatory
Cardiogenic Shock
Keywords: Cardiac Index
hemodynamic
echocardiography
intensive care unit
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit

Brief summary: Objectives: Noninvasive assessment of cardiac index (CI) in pediatric critical ill patient is crucial. Aortic Velocity Time Integral (VTI) valuable in adults, faces age and heart rate variability challenges in pediatrics, complicating CI interpretation in shocked patients. Measurement errors can complicate CI evaluation, particularly in shocked patients. Considering the proportional relationship between aortic annulus and Body Surface Area (BSA) in children, along with the relatively constant mean aortic velocity, we studied if Left Ventricular Outflow Tract mean-velocity (LVOTmv) reliably estimates bedside CI.

Design : retrospective, observational, single-center study.

Setting : Pediatric Intensive Care Unit (PICU) in a tertiary care hospital.

Patients : one hundred forty-four children in PICU (age 0-17 years, BSA 0.11-1.69 m2) requiring hemodynamic evaluation.

Intervention : Bedside ultrasound by expert cardiologists

Measurements and Main Results : We explored the correlation between LVOTmv (measured in pulse wave doppler from the apical five-chamber view) and standard CI estimation (multiplying aortic VTI, heart rate, and aortic valve area). We excluded arrhythmia and anomalies of the left ventricular outflow tract.


Eligibility criteria: Inclusion Criteria:

* infants, children, and adolescents hospitalized in our Pediatric Intensive Care Unit (PICU) in a non-surgical cardiology unit requiring hemodynamic assessment

Exclusion Criteria:

* documented irregular heart rates (HR) or with congenital heart malformations that could affect aortic measurements or LVOT velocity (such as aortic valve anomalies)

Primary outcomes:
measure: correlation between LVOT mean velocity (LVOTmv) from the traditional apical five-chamber view and standard CI measurements
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: CHRU of Nancy
state: Lorraine
Study officials:
References:
Clinical trial NCT03089827: Biodistribution of [11C]PIB in Patients With Risk Factors for Alzheimer's Disease
Official title: Biodistribution of [11C]PIB in Patients With Risk Factors for Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Keywords: Memory
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 800
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults enrolled with the Alzheimer's Disease Research Center at Wake Forest School of Medicine will be invited to participate,

Brief summary: Participants enrolled at the Alzheimer's Disease Research Center (ADRC) at Wake Forest School of Medicine will be invited to take part in this study. The purpose of this study is to identify and measure the amount of a protein called amyloid in the brain.It is thought that the build up of amyloid may be related to the development of Alzheimer's disease.

Detailed description: Brain amyloid will be measured using PET with \[11C\]PiB. Participation will involve an initial brain scan and possibly a follow-up brain scan two years later.

The data collected in this study will help explain amyloid deposits in several groups of participants including adults with and without signs of memory impairment. The information collected will help find out who is more likely to have brain amyloid and when it increases the risk for developing memory problems. Research studies suggest that people with elevated levels of brain amyloid are at an increased risk for memory decline, but this does not mean that every person with amyloid build up will develop AD.

Eligibility criteria: Inclusion Criteria:

* Enrolled in a study with the Alzheimer's Disease Research Center.

Exclusion Criteria:

-

Primary outcomes:
measure: Amyloid deposition
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne Craft, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982527: Fenoldopam in Pediatric Cardiac Surgery
Official title: Intraoperative Fenoldopam Infusion in Children Requiring Cardiopulmonary Bypass During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Failure, Acute
Keywords: cardiopulmonary bypass
pediatric cardiac surgery
acute renal failure
renal biomarkers
fenoldopam
Focus on optimization of perfusion during pediatric CPB
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.


Eligibility criteria: Inclusion Criteria:

* Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass

Exclusion Criteria:

* Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.

Primary outcomes:
measure: Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls
timeFrame: End of surgery and 12 hours postoperatively
Secondary outcomes:
measure: Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls
timeFrame: End of surgery and 12 hours postoperatively
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Hospital
state: Lazio
Study officials:
affiliation: Bambino Gesu Hospital
name: Zaccaria Ricci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bambino Gesù Hospital
name: Sergio Picardo, MD
role: STUDY_DIRECTOR
References:
citation: Dent CL, Ma Q, Dastrala S, Bennett M, Mitsnefes MM, Barasch J, Devarajan P. Plasma neutrophil gelatinase-associated lipocalin predicts acute kidney injury, morbidity and mortality after pediatric cardiac surgery: a prospective uncontrolled cohort study. Crit Care. 2007;11(6):R127. doi: 10.1186/cc6192.
citation: Ricci Z, Stazi GV, Di Chiara L, Morelli S, Vitale V, Giorni C, Ronco C, Picardo S. Fenoldopam in newborn patients undergoing cardiopulmonary bypass: controlled clinical trial. Interact Cardiovasc Thorac Surg. 2008 Dec;7(6):1049-53. doi: 10.1510/icvts.2008.185025. Epub 2008 Sep 9.
citation: Ricci Z, Luciano R, Favia I, Garisto C, Muraca M, Morelli S, Di Chiara L, Cogo P, Picardo S. High-dose fenoldopam reduces postoperative neutrophil gelatinase-associated lipocaline and cystatin C levels in pediatric cardiac surgery. Crit Care. 2011 Jun 29;15(3):R160. doi: 10.1186/cc10295.
Clinical trial NCT01592227: A Study to Compare Two Paracetamol Formulations.
Official title: A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: healthy volunteer
pharmacokinetics
paracetamol
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent

Primary outcomes:
measure: Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
timeFrame: baseline to 10 hours post dose
Secondary outcomes:
measure: Speed of absorption in fasted and semi-fed states
timeFrame: baseline to 10 hours post dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services ARIZONA
state: Arizona
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: