louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03308526: Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)
Official title: Prevailing Microorganisms Causing Neonatal Sepsis in Neonatal Intensive Care Unit (Prospective Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal SEPSIS
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2017-10-12
Enrollment: 50
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates from age zero to 28 days

Brief summary: Prevailing microorganisms causing neonatal sepsis in neonatal intensive care unit of Assiut University children Hospital Methods prospective study conducted in the neonatal intensive care unit in Assiut university children hospital.

Detailed description: Sepsis remains a leading cause of death in the intensive care units and in all age groups worldwide.sepsis was defined as the host's immune response(systemic inflammatory response syndrome) to injury and/or infectious stimuli in the presence of a known(or strongly suspected) infection .early onset neonatal sepsis occurs in utero or might become infected when exposed to potentially pathogenic bacteria,viruses,or fungi during passage through the birth canal.

Eligibility criteria: Inclusion Criteria:

* both preterm and full term neonates
* both early onset and late onset neonatal sepsis

Exclusion Criteria:

* Genetic diseases immunocompromized neonates
* Neonates of diabetic mothers
* Neonates of HIV mothers

Primary outcomes:
measure: Prevention of neonatal sepsis
timeFrame: From september2017 to september 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06191926: Diagnostic Performance of Shear Wave Dispersive Imaging in Breast Lesions: Comparison With Shear Wave Elastography
Official title: Diagnostic Performance of Shear Wave Dispersive Imaging to Differenciate Benign From Malignant Breast Lesions: Comparison With Shear Wave Elastography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Diseases
Lead sponsor: Korea University Ansan Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 594
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population should fulfill the following criteria as follows:(a) histologically confirmed breast lesions and (b) shear wave elastography and dispersion ultrasound performed before biopsy

Brief summary: Human soft tissue such as breast tissue has viscoelasticity property. However, most ultrasound has only been measured for elasticity and viscosity has been neglected. Shear wave elastography (SWE) is a ultrasound technique that quantifies tissue elasticity. Shear wave dispersion (SWD) imaging is a newly developed ultrasound technique that evaluates the dispersion slope of shear waves, which is related to the viscosity of biological tissues. The goal of this retrospective study was to compare diagnostic performance between SWE and SWD to distinguish benign from malignant breast masses and to investigate additional role of SWD. Using histological diagnosis of breast lesions as a standard reference, quantitative indices of SWE and SWD were evaluated to diagnose breast cancer, and the diagnostic performance of SWE and SWD was compared.

Detailed description: This retrospective study was approved by our institutional review board, which waved the requrement for informed consent. The investigators obtained quantitative parameters of SWE and SWD of solid breast lesions before biopsy. The investigators measured average tumor elasticity and tumor-to-fat elasticity ratio on SWE and average tumor dispersion and tumor-to-fat ratio and on SWD from each breast lesion. Diagnostic performance of SWE and SWD was compared using the area under the curve (AUC), sensitivity, specificity, and accuracy.

Eligibility criteria: Inclusion Criteria:

* patients with histological results

Exclusion Criteria:

* patients without histological results

Primary outcomes:
measure: Elastography and dispersion parameters to determine benign or malignant tumors
timeFrame: baseline, pre-biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Bo Kyoung Seo
Study officials:
affiliation: Korea University
name: Bo Kyoung Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05391126: GENOCARE: a Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Official title: GENOCARE: a Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Pancreatic Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized study designed to compare genotype-guided dosing to usual care in patients with pancreas cancer and colorectal cancer who are UGT1A1 intermediate metabolizers (\*1/\*28) (heterozygotes) and usual UGT metabolizers (\*1/\*1). All patients will be assessed for UGT1A1 genotype at screening and those with intermediate or usual UGT1A1 genotypes (\*1/\*28, \*1/\*1) will be randomized to genotype-guided dosing versus usual care.


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed stage I-IV pancreas or stage III-IV colorectal cancer who are planning to undergo treatment.
* Prior treatment is allowed, specifically surgery and/or radiation and non-irinotecan containing regimens are allowed.
* Age ≥ 18 years.
* ECOG performance status ≤ 1.
* Patients must have adequate organ and marrow function as defined below:
* Measurable or non-measurable disease.

Exclusion Criteria:

* Patients who received prior treatment with irinotecan are excluded.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
* Pregnant women are excluded from this study.
* Patients who are not planned for treatment of their cancer.

Primary outcomes:
measure: Adverse Events Frequency
timeFrame: 6 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Reema A Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00804726: Evaluation of the Safety and Effectiveness of the Akreos MI Five-0 Intraocular Lens.
Official title: A Prospective, Open-label, Monocular Feasibility Clinical Evaluation of the Bausch & Lomb Akreos MI Five-O Accommodating Intraocular Lens.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Keywords: Cataract extraction
Phacoemulsification
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this 12-month clinical investigation is to evaluate the safety and effectiveness of the Bausch \& Lomb Akreos MI Five-O intraocular lens (IOL). Effectiveness will be shown through the demonstration of accurate distance correction and safety will be demonstrated through the monitoring of adverse events.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract.
* Subjects must have clear intraocular media other than cataract.
* Subjects must be undergoing primary in-the-bag intraocular lens implantation for the correction of aphakia following continuous curvilinear anterior capsulotomy and phacoemulsification cataract extraction.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with diagnosis of degenerative visual disorder.
* Subjects who have any inflammation or edema (swelling) of the cornea.
* Subjects with immunodeficiency disorders.
* Subjects who have had previous intraocular surgery in the study eye.
* Subjects with incomplete/damaged zonule, or with conditions associated with increased risk of zonular rupture.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.

Primary outcomes:
measure: Visual acuity
timeFrame: 5 visits up to 420 days
Secondary outcomes:
measure: Visual acuity
timeFrame: 5 visits up to 420 days
Other outcomes:
Locations:
city: Koln
country: Germany
facility: Augenzentrum Maus Wolfsstr 16
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Helmut Allmeier, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06962826: A Study in Healthy People to Test How Empagliflozin is Taken up in the Body When Taken as a Whole Tablet or Dissolved in Water and Mixed With Food
Official title: Relative Bioavailability of Empagliflozin Tablets After Different Administration Modi in Healthy Male and Female Subjects (Randomised, Two-period Crossover Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-05-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted to test how empagliflozin is taken up in the body when taken as a whole tablet or dissolved in water and mixed with food.


Eligibility criteria: Inclusion criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 3 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 3 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 3 days
Other outcomes:
Locations:
city: Biberach/Riß
country: Germany
facility: Humanpharmakologisches Zentrum
Study officials:
References:
Clinical trial NCT01946126: A Retrospective Chart Review to Evaluate Diagnosis and Treatment of Chronic Migraine and Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Headache
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-09-19
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of chronic migraine or other diagnosis of migraine or headache.

Brief summary: This study is a retrospective chart review in patients diagnosed with headache or migraine to evaluate treatment patterns and diagnosis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic migraine or other diagnosis of migraine or headache for a minimum of 15 months
* Eight (8) headache days per month for at least 1 of the preceding 15 months

Exclusion Criteria:

* Not currently diagnosed with chronic migraine, headache or migraine
* History of receiving botulinum toxin injections for the treatment of chronic migraine.

Primary outcomes:
measure: Presence or Absence of Prophylactic Medication for Headache/Migraine
timeFrame: 15 Months
Secondary outcomes:
measure: Number of Unique Prophylactic Medications for Headache/Migraine Reported
timeFrame: 15 Months
measure: Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches
timeFrame: 15 Months
measure: Highest Number of Headache Days Per Month at a Qualifying Visit
timeFrame: 15 Months
measure: Number of Visits for Headache Diagnosis
timeFrame: 15 Months
Other outcomes:
Locations:
city: Raleigh
country: United States
state: North Carolina
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03974126: Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene
Official title: Postprandial Effect of High-starch Meals in Individuals With Low and High Copy Number of the Salivary Amylase Gene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glucose and Insulin Response
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2019-06-04
Enrollment: 23
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants with low and high copy numbers of AMY1 were randomized to either 40 or 80 grams of starch in a crossover design.
Primary purpose: PREVENTION

Brief summary: Individuals with low copy numbers of salivary amylase gene have lower salivary amylase levels and might therefore have decreased capacity to metabolize starch into glucose. We will in a randomized crossover meal study examine the postprandial response of high-starch meals in individuals with either low or high copy number of the salivary amylase gene.


Eligibility criteria: Inclusion Criteria:

* Participant in the Malmö Offspring Study
* Genotyped for AMY1 copy number variation and selected for having either low (2-4) or high (10 or above) copy number of AMY1
* Gender: both males and females
* Completed information on dietary habits

Exclusion Criteria:

* Allergic to wheat, gluten intolerant or on a low-carbohydrate diet
* Inability to eat up to 4 slices of white bread in 15 minutes
* Use of medication known to influence glucose metabolism, appetite or saliva flow
* Diagnosed diabetes or high fasting plasma glucose (above 6.1 mmol/L)
* Smoking

Primary outcomes:
measure: Postprandial glucose
timeFrame: AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)
measure: Postprandial insulin
timeFrame: AUC (0, 7, 15, 30, 45, 60, 90, 120 minutes)
measure: Preabsorptive insulin release
timeFrame: 7 minutes
Secondary outcomes:
measure: subjective satiety
timeFrame: 0, 15, 30, 45, 60, 90, 120 minutes
measure: salivary amylase activity
timeFrame: 0 minutes
Other outcomes:
measure: weight
timeFrame: 0 minutes
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
References:
citation: Farrell M, Ramne S, Gouinguenet P, Brunkwall L, Ericson U, Raben A, Nilsson PM, Orho-Melander M, Granfeldt Y, Tovar J, Sonestedt E. Effect of AMY1 copy number variation and various doses of starch intake on glucose homeostasis: data from a cross-sectional observational study and a crossover meal study. Genes Nutr. 2021 Nov 17;16(1):21. doi: 10.1186/s12263-021-00701-8.
Clinical trial NCT00988026: Safety and Efficacy Comparison of Minocycline Microgranules Versus Lymecycline in the Treatment of Mild to Moderate Acne
Official title: Safety and Efficacy Comparison of Minocycline Microgranules vs Lymecycline in the Treatment of Mild to Moderate Acne. Randomized, Double Blind, Parallel and Prospective Clinical Trial for 8 Weeks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mild to Moderate Acne
Lead sponsor: Darier
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 168
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial to compare the benefits and possible adverse events of two antibiotic treatments for mild to moderate acne. It is expected that minocycline microgranules will be more effective than lymecycline with a better adverse events profile.


Eligibility criteria: Inclusion Criteria:

* Both gender
* 14 to 30 years old
* Mild to moderate acne
* Face localization
* At least 20 non-inflammatory lesions OR
* At least 15 inflammatory lesions OR
* At least 30 total lesions AND
* Less than 5 nodular lesions

Exclusion Criteria:

* Patients younger than 14 or older than 30 years old
* Less than 20 non-inflammatory lesions OR
* Less than 15 inflammatory lesions OR
* Less than 30 total lesions
* Patients with severe acne
* More than 5 nodular lesions OR
* More than 50 inflammatory lesions OR
* More than 125 total lesions
* Pregnant women
* Lactating women

Primary outcomes:
measure: Number of inflammatory and non-inflammatory acne lesions
timeFrame: 8 weeks
Secondary outcomes:
measure: Incidence of local and systemic adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Servicio de Dermatología. Hospital " Dr. José Eleuterio González" de la Universidad Autónoma de Nuevo León
state: Nuevo León
Study officials:
References:
citation: Ocampo-Candiani J, Velazquez-Arenas LL, de la Fuente-Garcia A, Trevino-Gomezharper C, Berber A. Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks. J Drugs Dermatol. 2014 Jun;13(6):671-6.
Clinical trial NCT03334526: Study of the Reaction of the Brain to Various Stimulations
Official title: Corticospinal and Neuromuscular Plasticity Induced by Real and Imaginary Contractions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corticospinal Plasticity
Neuromuscular Plasticity
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: this study is interventional because of it acts on the physical and respiratory capacities of patients
Primary purpose: OTHER

Brief summary: Physical activity is considered a therapeutic strategy in its own right in a vast majority of disabling chronic disorders. It leads to an increase in physical and probably cognitive capacity, thanks to its effects on both metabolism (muscle hypertrophy, improvement in oxidative metabolism) and the nervous system (neuroplasticity). Nonetheless, even though there is a consensus on the positive effects of physical exercise (PE) on cerebral plasticity, the physiological mechanisms by which PE affects neuroplasticity, in particular depending on the mode of muscle contraction, are still hypothetical. Moreover, several recent studies have shown that mental learning (ML) by motor imagery improves motor performance, thus making it of interest in a context of rehabilitation, in particular in situations where PE is transient of definitively impossible. Yet, the mechanisms and brain structures involved in motor learning by ML have not been established so far. Finally, on the basis of clinical observations concerning the key role of sensory input in motor function, the hypothesis that increased demand on this input by electrical stimulation (ES) as a means to improve motor function has been proposed. However, the mechanisms by which this type of stimulation could induce neuroplasticity is still to be elucidated.


Eligibility criteria: Inclusion Criteria:

* persons who have provided written consent
* healthy subjects
* national health insurance cover
* age 18 to 60 years

Exclusion Criteria:

* personal or family history of epilepsy
* pacemakers or other apparatus likely to interfere with the magnetic field
* history of psychiatric disease
* Persons under guardianship or wards of court
* Pregnant or breast-feeding women
* problem perceived during the neurological examination which could bias the results of the study

Primary outcomes:
measure: level of corticospinal excitability
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: