louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06832800: Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH
Official title: Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Neonatal Hyperbilirubinemia
Keywords: ETCOc
neonatal hemolysis
neonatal hyperbilirubinemia
modified
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 250
Sex: ALL
Minimum age (years): 4
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are:

* Does MDT lower the possibilities participants have brain damage before the age of one?
* How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN.

Participants will:

* Take MDT or a control method in the management of sNH
* Assess if there's brain damage before discharge and at the year of one
* Record how many times of abnormalities in cranial MRI is detected before the age of one


Eligibility criteria: Inclusion Criteria: Inclusion Criteria:

Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams

* Infants with severe neonatal hyperbilirubinemia, including those whose serum total
* bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB \> (threshold - 2) mg/dL).

Exclusion Criteria:

* Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.

Primary outcomes:
measure: neural damage confirmed by professional assessments such as Bayley Scales
timeFrame: at the age of 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06013800: Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
Official title: Volume Status Analysis by Point-of-care Ultrasound: a Cohort Study in Hyponatremia in Internal Medicine
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hyponatremia
Water-Electrolyte Imbalance
Keywords: hyponatremia
water-electrolyte imbalance
POCUS
Point-of-care ultrasound
Lead sponsor: Universidad Veracruzana
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 80
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: Patients with hypotonic hyponatremia

Brief summary: This observational study aims to analyze the time of correction of hyponatremia in patients within an internal medicine ward. The researchers will assess volume status using both clinical evaluation and point-of-care ultrasound. Patients will be categorized based on whether they have the same volume status determined clinically and by ultrasound or a different status between the two methods. By tracking sodium levels daily until normalization, the study will compare the time of hyponatremia correction between the two groups.

Detailed description: The main question it aims to answer are What is the time of correction of hyponatremia by assessing the volume status clinically or by point of care of ultrasound?.

Participants will be asked to participate in the study and they will be receive a volume status by a portable ultrasound. If they have the same volume status clinically and by point of care ultrasound they will be referred as group 1. If they have a different volume status clinically or by point of care ultrasound they will be referred as group 2.

Researchers will follow the patients by measuring the sodium levels daily until they reach normal sodium levels ( \>135mEq/L) and will compare group 1 and group 2 with a survival analysis.

Eligibility criteria: Inclusion Criteria:

* Age greater or equal to 18 years
* Hypotonic hyponatremia (less than 275mosm/kg) calculated by the following formula (2 Na+Glucose/ 18)

Exclusion Criteria:

* Patients who are critically ill with ventilatory support.
* Patients with clinical signs suggestive of hypovolemia and have a documented history of aortic insufficiency or show mitral insufficiency during POCUS (Point-of-Care Ultrasound).

Primary outcomes:
measure: Rate of participants with sodium level >135mEq/L
timeFrame: Baseline, everyday up to 30 days
Secondary outcomes:
measure: Assessment of clinical variables associated with corrected sodium levels
timeFrame: Baseline, up to 30 days
Other outcomes:
Locations:
city: Veracruz
country: Mexico
facility: Hospital Regional B Veracruz Alta Especialidad
Study officials:
affiliation: Universidad Veracruzana
name: Alejandro Martínez Carreón, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01645800: Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
Official title: Effects of Lysozyme On Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: Lysozyme hydrochloride
COPD
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 408
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.


Eligibility criteria: Inclusion criteria;

* Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year.

Exclusion criteria;

* Patients with egg allergy
* Patients with domiciliary oxygen therapy
* Patients with pneumonia or pulmonary tuberculosis
* Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder.
* Patients with cancer.

Primary outcomes:
measure: Acute exacerbation of COPD
timeFrame: 52 weeks
Secondary outcomes:
measure: Yearly reduction in FEV1 and QOL assessed by CAT
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nishio
country: Japan
state: Aichi
city: Noda
country: Japan
state: Chiba
city: Kasuga
country: Japan
state: Fukuoka
city: Kyoto-gun
country: Japan
state: Fukuoka
city: Yanagawa
country: Japan
state: Fukuoka
city: Mabashi
country: Japan
state: Gunma
city: Takasaki
country: Japan
state: Gunma
city: Kitahiroshima
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Himeji
country: Japan
state: Hyogo
city: Takamatsu
country: Japan
state: Kagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokosuka
country: Japan
state: Kanagawa
city: Nagaoka
country: Japan
state: Niigata
city: Okayama
country: Japan
state: Okyama
city: Suita
country: Japan
state: Osaka
city: Chuo-ku
country: Japan
state: Tokyo
city: Edogawa-ku
country: Japan
state: Tokyo
city: Higashikurume
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: Drug Fostering and evolution Coodination Department, Corporate Regulattory Compliance, Safety and Quality Assurance Headquaters, Eisai Co., Ltd., Japan
name: Yukinori Sakata
role: STUDY_DIRECTOR
References:
Clinical trial NCT01781000: Cerebral Reorganization in Schizophrenia
Official title: Training-induced Cerebral Reorganization in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Cognitive Training
Neuroplasticity
MEG
MATRICS
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia

Detailed description: Impairment in cognitive functions is one of the main symptoms in schizophrenia and is currently one of the challenges in the treatment of the disease. In this study we compare effects of two computer-aided training programs. One focused on auditory perception and processing as a basic ability underlying higher order information processing. The other training focus on facial affect discrimination and working memory. Both trainings are computer-aided and time-intensive, including up to twenty sessions within four weeks.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia and disorders with psychotic features
* Intact auditory perception
* Intact visual perception

Exclusion Criteria:

* Mental retardation
* Age over 60
* Insufficient German language knowledge

Primary outcomes:
measure: change from baseline at post-intervention (4-weeks) and 3-months in each to the primary outcome measures: neuropsychological test scores (MCCB), MEG alpha oscillations
timeFrame: baseline, post-intervention (after 4 weeks), 3-months follow-up
Secondary outcomes:
measure: change from baseline in global functioning (GAF score) at 4 weeks and 3 months
timeFrame: baseline, post-intervention, 3-months follow-up
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz
state: Baden Württemberg
Study officials:
affiliation: University Konstanz
name: Brigitte Rockstroh, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Popova P, Popov TG, Wienbruch C, Carolus AM, Miller GA, Rockstroh BS. Changing facial affect recognition in schizophrenia: effects of training on brain dynamics. Neuroimage Clin. 2014 Sep 4;6:156-65. doi: 10.1016/j.nicl.2014.08.026. eCollection 2014.
Clinical trial NCT00560300: Regulation of Bone Formation in Renal Osteodystrophy
Official title: Regulation of Bone Formation in Renal Osteodystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Renal Osteodystrophy
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2007-11-19
Enrollment: 61
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure

Detailed description: Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.

Eligibility criteria: Inclusion Criteria:

* Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,
* Biochemical evidence of secondary hyperparathyroidism (PTH\>400 pg/ml) with bone biopsy evidence of high turnover bone disease

Exclusion Criteria:

* History of parathyroidectomy
* Growth hormone
* Prednisone, or other immunosuppressant medication within the past year.
* Recent history of medication non-compliance.

Primary outcomes:
measure: Bone Formation Rate
timeFrame: 8 months
Secondary outcomes:
measure: Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose)
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Isidro B Salusky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03251300: Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing
Official title: Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder Syndrome
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to elucidate whether night-time dosing of mirebegron can improve nocturia, compared with daytime dosing of mirabegron.

Detailed description: Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to elucidate whether night-time dosing can improve nocturia, compared with daytime dosing.

Patients and Methods: The investigators will perform a prospective randomized controlled trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron. All enrolled OAB women will be allocated to two groups (group A and B). The women in group A will receive daytime dosing of mirabegron treatment; and the women in group B will receive nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron treatment. STATA software is used for statistical analyses.

Possible Results: The investigators can answer whether night-time dosing of mirabegron can improve nocturia, compared with daytime dosing.

Eligibility criteria: Inclusion Criteria:

* OAB symptoms for at least one month
* \>20 years

Exclusion Criteria:

* Allergy to mirabegron, urinary tract infections, unstable hypertension

Primary outcomes:
measure: Nocturia episodes
timeFrame: 12 weeks
Secondary outcomes:
measure: Severity of nocturia
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
citation: Tsai KH, Hsiao SM, Lin HH. Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia. J Obstet Gynaecol Res. 2017 Nov;43(11):1719-1725. doi: 10.1111/jog.13438. Epub 2017 Jul 16.
Clinical trial NCT06812000: Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy
Official title: Investigation of Incidence Rate of Post-stroke Seizure and Post-stroke Epilepsy in Patients Under Treatment With Alteplase and Correlated Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-stroke Seizure
Post-stroke Epilepsy
Thrombolytic (t-PA) Treatment
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke who were admitted between 2016 and 2023 in Bu Ali Sina hospital

Brief summary: This retrospective cohort study was conducted by reviewing the records of consecutive patients referred to Bu Ali Sina Hospital from 2016 to 2023, who were hospitalized with a diagnosis of ischemic stroke. The records of all patients treated with intravenous alteplase during the above period were extracted, and the relevant characteristics were recorded in a questionnaire. In each year, patients with ischemic stroke who were not treated with alteplase but were hospitalized at the Bu Ali Center were selected in a similar number to patients who received alteplase in the same year, and the relevant information was extracted from their records and recorded in a questionnaire. The incidence of post-stroke seizures and epilepsy was determined in both groups, and the factors associated with their incidence were studied and compared.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ischemic stroke
* Treatment with IV alteplase

Exclusion Criteria:

* History of epilepsy
* Taking antiseizure medications
* Unavailable patients
* Unreliability of recorded patients' files

Primary outcomes:
measure: Incidence rate of post-stroke seizure
timeFrame: within 7 days following ischemic stroke onset
measure: Incidence rate of post-stroke epilepsy
timeFrame: 1 to 7 years following ischemic stroke onset
Secondary outcomes:
measure: Factors related to post-stroke seizure occurrence
timeFrame: within 7 days following ischemic stroke onset
measure: Factors related to post-stroke epilepsy occurrence
timeFrame: 1 to 7 years following ischemic stroke onset
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Mazandaran University of Medical Sciences
state: Mazandaran
Study officials:
References:
Clinical trial NCT02354300: Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization
Official title: A Prospective Study of the Treatment of Intracranial Aneurysms Using Pipeline Flow-Diverter Embolization in Conjunction With Transcranial Dopplers (TCD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Aneurysm, Intracranial
Giant Intracranial Aneurysm
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 2
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: Outpatient clinic

Brief summary: Flow diverters have been approved since 2012 for the treatment of large, wide neck intracranial aneurysms. These devices have been associated with embolic events which cause blockage in a blood vessel and can result in long term complications. One possible cause of these events is the formation of small emboli during placement of the device.

Detailed description: Flow diverters have been developed to treat intracranial aneurysms. Embolisms have occurred in a small percentage of patients which can result in long term complications including stroke, hemorrhage, and even death.

The formation of microemboli during the insertion of the device has not been evaluated. During insertion, there is significant disruption of blood flow and this may be a source of intracranial microemboli.

This study will use transcranial doppler ultrasound (TCD) to evaluate the blood flow during the placement of flow diverters to try to determine why these embolic events occur.

Eligibility criteria: Inclusion Criteria:

* Adult subjects 18 years of age and older
* Non-pregnant
* Diagnosis of intracranial aneurysm that will be clinically treated with a flow diverter

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: Occurence of microemboli
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Spiros Blackburn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466400: Fermentation Rate of Infant Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: health benefits of infant formula
Lead sponsor: Father Flanagan's Boys' Home
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2011-11-08
Enrollment: 13
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy infants.

Brief summary: It is hypothesized that there will be no difference in the breath hydrogen excretion between the 2 different prebiotic formulas.

Detailed description: This pilot study is looking at how a formula with one of two different prebiotic blends may alter the hydrogen level in an infant's exhalations in the hours after feeding. Higher levels for a longer period may signal higher levels of short chain fatty acids and bifidobacteria, both beneficial for gastrointestinal health. The higher levels may be the result of the formula undergoing a slower digestion, producing more fermentation.

The study will compare a formula, similar to one currently on the market, with added prebiotics using a special breathing mask designed to be held to the infant's mouth and nose long enough to capture the infant's exhaled breath which will then be tested for Hydrogen content.

Eligibility criteria: Inclusion Criteria:

* 2-6 months of age,
* healthy,receiving standard cow-milk based infant formula weight,
* greater than 5th percentile

Exclusion Criteria:

* on no antibiotics,
* breastfed,
* on solid foods

Primary outcomes:
measure: Hydrogen content of breath
timeFrame: six hours
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
Study officials:
affiliation: Father Flanagan's Boys' Home
name: Laurel Prestridge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Father Flanagan's Boys' Home
name: Sharad Kunnath, MD
role: PRINCIPAL_INVESTIGATOR
References: