louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01804010: Pharmacokinetic, Pharmacodynamic Profiles and Safety After Oral Administration of Ivabradine in Male Healthy Korean Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Individual
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Institut de Recherches Internationales Servier
First posted: 2013-03-05
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To assess the pharmacokinetic profile of ivabradine (S 16257) and its main active metabolite S 18982 in Korean healthy volunteers after oral administration of ivabradine at the doses of 2.5, 5, 10mg and after repeated oral administrations of ivabradine for 4.5 days at the same doses twice daily versus placebo and to use the study results for bridging with Caucasian data.
2. The pharmacodynamic profile of ivabradine versus placebo by measuring its effects on heart rate after single and then after repeated administrations.
3. Clinical safety of ivabradine versus placebo.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 40 years and Korean
* Nonsmoker or smoke less than 5 cigarettes per day
* normal dietary habits
* BMI ranging from 18 to 25 kg/m2
* good physical and mental status, determined by the investigator
* vital signs in resting condition within range: SBP 100-139 mmHg, DBP 50-89 mmHg
* Normal ECG

Exclusion Criteria:

* Participate any other trial in the last 3 months prior to the study
* History of major psychiatric, medical, surgical disorders
* Acute, or chronic disease
* History of hypersensitivity to at least one drug
* History of alcoholism or positive alcohol breath test
* Positive drug screening results
* known positive serology for HIV1, HIV2, hepatitis B or C
* blood donor within the last 3 month of the study
* regular use of sedatives, hypnotics, tranquillisers

Primary outcomes:
measure: Cmax,tmax, AUC(Area under the time-concentration curve) of ivabradine and metabolite
timeFrame: within 60 days after blood sampling (blood sample analysis)
Secondary outcomes:
measure: pharmacodynamics: The change of heart rate between baseline and over 24-hour, diurnal, nocturnal, awake, and asleep periods after administration of ivabradine
timeFrame: within 10 days after administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00817310: Neurophysiology and Anatomy of Severe Intraventricular Hemorrhage (IVH)
Official title: Influence of Altered Cerebral Spinal Fluid and Arterial Flows on Cerebral Processing Functions in Premature Infants With Severe Intraventricular Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hemorrhages
Prematurity
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 60
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with birthweights below 1500g that are between 1 and 14 days of age

Brief summary: Currently, when premature infants develop severe intraventricular hemorrhage (IVH), a type of intracerebral bleed, there are no proven therapeutic interventions to prevent the devastating consequences of this event. These children will be likely to develop cerebral palsy or severe cognitive delays.

The purpose of our study is to characterize differences in brain physiology, imaging, and function between premature infants with severe IVH and controls. The goals for gathering this information are to generate baseline data, which could facilitate early screening for complications of IVH in premature infants. These baseline data would also allow the design and implementation of early therapeutic interventions to help rehabilitate premature infants with severe IVH.


Eligibility criteria: Inclusion Criteria:

* Birth weight \< 1500 grams for all inborn infants and age less than 14 post-natal days
* Birth weight \< 1500 grams for all outborn infants transferred to the VCH NICU within the first 72 hours after birth and age less than 14 post-natal days
* Parents agree to their infant's participation and give informed written consent.

Exclusion Criteria:

* Unable to obtain informed consent.
* Congenital brain malformations leading to hydrocephalus
* Genetic and metabolic disorders leading to cerebral pathology

Primary outcomes:
measure: neurodevelopmental outcome
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Children's Hospital at Vanderbilt, NICU
state: Tennessee
Study officials:
References:
Clinical trial NCT02378610: Relationship Between the Gut Microbiota and Stress
Official title: Relationship Between the Gut Microbiota and Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Stress
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 59
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Men, 19-35 years old.

Brief summary: The relationship between the gut microbiota and stress is poorly studied in humans. In this study we aim to look for if stressed persons have different levels of key bacterial groups compared to the levels in non-stressed persons.

Detailed description: The gut microbial flora will be analyzed with molecular genetic methods. Stress will be measured with cortisol levels in saliva and with questionnaire.

Eligibility criteria: Inclusion Criteria:

* Healthy man between 19-35 years old

Exclusion Criteria:

* Antibiotic intake
* Gastrointestinal diseases
* Diabetes
* Phsycological diseases
* Tyroid related diseases
* Cardiovascular diseases
* Celiaki
* Cortisone drugs

Primary outcomes:
measure: Markers of the gut microbiota
timeFrame: May 2015-January 2016
Secondary outcomes:
measure: Markers of stress
timeFrame: April 2015-January 2016
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Caroline Linninge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260410: Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics
Official title: Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer Metastatic
Keywords: mCRPC
Lu-PSMA
Prostate Cancer
Radioligand Therapy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 150
Sex: MALE
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: Patients diagnosed with metastatic castration resistant prostate cancer set to receive treatment with Lutetium-177 Prostate Specific Membrane Antigen (Lu-PSMA) as a part of regular clinical care.

Brief summary: This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.


Eligibility criteria: Inclusion Criteria:

* Participants should be at least 18 years old.
* Participants should be able to understand the written information and be able to provide informed consent.
* Participants are planned to start treatment with Lu-PSMA as a part of regular clinical care.

Exclusion Criteria:

None applicable

Primary outcomes:
measure: Overall survival
timeFrame: 44 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 44 months
measure: Heterogeneity of PSMA-positivity
timeFrame: 44 months
measure: Effect of CTC PSMA expression on response to treatment.
timeFrame: 44 months
measure: Effect of biomarkers in blood on response to treatment.
timeFrame: 44 months
measure: PSMA-PET scan data and response to treatment.
timeFrame: 44 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
References:
Clinical trial NCT06898710: z Mini-plate With Lingual Extension Versus Conventional 2 Mini Plates
Official title: Evaluating the Efficacy of Patient Specific Z-shape Mini-plate With Lingual Extension Versus Usual Two Mini-plates in Mandibular Class III Fracture Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mandible Fracture
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The collected patients according to the eligibility criteria will be randomly distributed into one of these groups:

Group I : 10 patients suffering class III mandibular fracture will be managed by patient specific Z shape mini-plate with lingual extension (study group).

Group II : 10 patients suffering class III mandibular fracture will be managed by 2 mini plates at superior and inferior borders (control group).

The allocation sequence will be generated using computerized random numbers and kept in sealed envelopes, which will be opened prior to surgery. All patients will provide the informed consent after declaration the procedures, benefits, and harms


Eligibility criteria: Inclusion Criteria:

* - Class III mandibular fracture
* medically stable patient
* aged above 21 years
* no medical condition affect the bone healing

Exclusion Criteria:

* • absence of other facial trauma, mandibular condylar fracture

  * patient refuse the follow up

Primary outcomes:
measure: inter condylar distance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05086510: Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
Official title: Ablation Targets of Scar-related Ventricular Tachycardia Identified by Dynamic Functional Substrate Mapping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia, Ventricular
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at comparing the recurrence rates of ventricular tachycardia ablated after being mapped by 2 different techniques.

Detailed description: The study participants are patients presented with recurrent ventricular tachycardia.

They will be divided into 2 groups in terms of mapping. The first group will use mapping during sinus rhythm to identify late potentials that may be incriminated in the tachycardia circuit.

The other group will undergo mapping during right ventricular extrastimulus pacing to unmask hidden potentials. The identified potentials will be ablated in both groups.

Eligibility criteria: Inclusion Criteria:

* • Patients with structural heart disease; previous myocardial infarction, left ventricular dilatation/systolic dysfunction, or normal left ventricular diameters/ systolic function with evidence of ventricular scar on contrast enhanced-cardiac magnetic resonance or electroanatomic map.

  * Sustained monomorphic ventricular tachycardia documented by 12-lead ECG or implantable cardioverter defibrillator (electrograms resistant to antiarrhythmic drug treatment or requiring implantable cardioverter defibrillator therapies.

Exclusion Criteria:

* • Patients with ventricular arrhythmias attributed to reversible causes.

Primary outcomes:
measure: Number of Participants With Recurrence of Ventricular Tachycardia
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Who Experience Cardiac Death
timeFrame: 12 months
measure: Number of Participants Who Die From Any Cause (All-cause Mortality)
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university hospitals
Study officials:
affiliation: AinShams university
name: Mohammad G Elewa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04874610: Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
Official title: Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Asthma in Children
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults 2-20 years of age who are admitted to Duke Hospital for primary reason of asthma exacerbation and are treated with methylprednisolone.

Brief summary: Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.

Detailed description: This is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohort. The primary hypothesis is that the obese cohort will have increased methylprednisolone clearance compared to the non-obese cohort. The secondary hypothesis is that the obese cohort will have decreased amounts of 11-β-hydroxysteroid dehydrogenase in the serum which will correlate to abnormalities in steroid clearance. The tertiary hypothesis is that the obese cohort will have increased levels of branched chain amino acids and inflammatory markers which will correlate to disease severity.

Eligibility criteria: Inclusion Criteria:

1. Age between 2 years and 20 years inclusive
2. Written informed consent provided by a parent or legal guardian
3. Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone)
4. BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects

Exclusion Criteria:

1. Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI.
2. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.

Primary outcomes:
measure: Change in Prednisolone concentration levels as measured by ELISA
timeFrame: 0, 24, 48, 72, 96 hours after methylprednisolone dosing
Secondary outcomes:
measure: 11-beta-hydroxysteroid dehydrogenase as measured by ELISA
timeFrame: Up to 72 hours after methylprednisolone dosing
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Caitlin King, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05308810: Postoperative Kidney Functions in Geriatric Major Gynecologic-Oncologic Surgery
Official title: Evaluation of Postoperative Kidney Functions in Geriatric Patients Undergoing Major Gynecologic-Oncologic Surgery: A Retroceptive - Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Geriatrics
Acute Renal Injury
Gynecologic Surgery
Keywords: Geriatrics
Acute Renal Injury
Gynecologic Surgery
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 150
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent major abdominal gynecologic oncologic surgery and followed in the PACU between January 2021 and January 2022 at Ankara City hospital

Brief summary: The increasing number of patients who develop perioperative acute kidney injury (AKI) is partly related to the aging population and the increasing number of individuals with chronic comorbidities, particularly those with premorbid chronic kidney disease. Anesthesiologists and surgeons will increasingly have to deal with such patients who are elderly and have comorbidities and require major surgery.

The aim of this study was to determine the incidence of postoperative acute kidney injury (primary aim) in patients aged 65 and over who underwent elective major gynecological-oncological surgery under general anesthesia in Ankara City Hospital Gynecology-Oncology Operating Room between January 2020-2022 and were followed up in the PACU in the postoperative period. To investigate risk factors and their results in a retrospective manner in line with the KDIGO criteria (secondary purpose).


Eligibility criteria: Inclusion Criteria:

* patients underwent major abdominal gynecologic oncologic surgery between January 2021 and January 2022
* followed in the PACU

Exclusion Criteria:

* Patients with inaccessible data and missing data

Primary outcomes:
measure: the incidence of the patients with AKI STAGE 1
timeFrame: 48 hours after surgery
measure: the incidence of the patients with AKI stage 2
timeFrame: 48 hours after surgery
measure: the incidence of the patients with AKI stage 3
timeFrame: 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Aysun Postaci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02754310: Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation
Official title: Repeated Versus Varied Simulation Scenarios to Teach Medical Students the Management of a Pediatric Asthma Exacerbation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education, Medical
Keywords: Education, medical
Simulation Training
Lead sponsor: Ilumens
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Repeated exposure to simulated cases has been shown to improve performance, but repeating the same scenario may impair the ability of learners to transfer their knowledge and skills to slightly different situations. The objective of this study is to compare the use of repeated versus varied simulation cases for teaching the management of pediatric asthma exacerbation to 3rd year medical students.


Eligibility criteria: Inclusion Criteria:

* Third year medical students from Paris Descartes and Paris Diderot medical faculties.
* Who are not opposed to participated in the study

Exclusion Criteria:

* Opposition to participate in the study

Primary outcomes:
measure: Management Score on Transfer Scenario n°1
timeFrame: One week
Secondary outcomes:
measure: Management Score on Transfer Scenario n°2
timeFrame: One week
measure: Management Score on Evaluation Scenario n°1
timeFrame: One week
measure: Management Score on Evaluation Scenario n°2
timeFrame: One week
measure: Management Score on Transfer Scenario n°3
timeFrame: 4 months
measure: Management Score on Transfer Scenario n°4
timeFrame: 4 months
measure: Management Score on Evaluation Scenario n°1
timeFrame: 4 months
measure: Management Score on Evaluation Scenario n°2
timeFrame: 4 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Département de Simulation iLumens, Université Paris Descartes
Study officials:
affiliation: University Paris René Descartes
name: David Drummond, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tofil NM, Peterson DT, Wheeler JT, Youngblood A, Zinkan JL, Lara D, Jakaitis B, Niebauer J, White ML. Repeated versus varied case selection in pediatric resident simulation. J Grad Med Educ. 2014 Jun;6(2):275-9. doi: 10.4300/JGME-D-13-00099.1.
citation: Cook DA, Hamstra SJ, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hatala R. Comparative effectiveness of instructional design features in simulation-based education: systematic review and meta-analysis. Med Teach. 2013;35(1):e867-98. doi: 10.3109/0142159X.2012.714886. Epub 2012 Sep 3.
Clinical trial NCT04075110: Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus
Official title: Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity; Endocrine; Diabetes Type 2
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).


Eligibility criteria: Inclusion Criteria:

- type 2 diabetic patients who had body mass index (BMI) ≥ 30 kg/m2 , were treated with metformin alone and had ages ranging from 18 to 60 years.

Exclusion Criteria:

* patients who had any other inflammatory disease
* patients with cardiovascular,
* patients with asthma
* patients with severe hepatic
* patients with renal disease,
* patients with epilepsy
* pregnant or lactating females.

Primary outcomes:
measure: Change in HbA1c
timeFrame: From baseline to 12 weeks
measure: Percent change in body weight
timeFrame: From baseline to 12 weeks
measure: BMI
timeFrame: From baseline to 12 weeks
measure: Visceral Adiposity Index
timeFrame: From baseline to 12 weeks
Secondary outcomes:
measure: Adiponectin
timeFrame: At baseline to 12 weeks
measure: TNF-α
timeFrame: At baseline to 12 weeks
measure: IL-6
timeFrame: At baseline to 12 weeks
measure: leukotriene B4
timeFrame: At baseline to 12 weeks
Other outcomes:
Locations:
city: Shebin Elkom
country: Egypt
facility: Faculty of Medicine
Study officials:
References: