louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02325583: Intraoral 30% Glucose Effect In Newborns
Official title: Baskent University Institutional Review Board
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Hydrocephaly
Keywords: Intraoral 30% glucose, newborn, MRI
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Newborn often sedated during MRI but sedation itself creates adverse events and management is more challenging in the MR environment. The investigators describe the investigators initial experience with oral 30% glucose administration through a pacifier during MRI for imaging of newborns. Using this technique, majority of newborns can complete MRI examination without the need for sedation and also offers the availability of administering sedatives to unsuccessful patients.

Detailed description: 19 consecutive newborns over 10 months period were assessed retrospectively. 0.5-1 mL 30% glucose solution was administered orally and after suckling, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added. After 2 consecutive oral glucose administration the newborns who did not keep motionless or sleep and had motion artefacts sedated with midazolam. The outcome measure was the success of the procedure which was determined by providing qualitative images appropriate for interpretation following 30% glucose administration. The routine blood glucose level measurement of the newborns after imaging procedures in the ICU was also performed for each patient.

Eligibility criteria: Inclusion Criteria:

* Newborns admitted from newborn intensive care unit for MR imaging

Exclusion Criteria:

* Intubated newborns

Primary outcomes:
measure: Number of newborn provided qualitative images for MRI following oral glucose administration
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Skogsdal Y, Eriksson M, Schollin J. Analgesia in newborns given oral glucose. Acta Paediatr. 1997 Feb;86(2):217-20. doi: 10.1111/j.1651-2227.1997.tb08872.x.
Clinical trial NCT06369883: How Often and What Type of Deformity is Detected in All Spine Radiographs?
Official title: Medical Doctor, Physiatrist
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Scoliosis
Kyphosis
Radiography
Keywords: scoliosis,kyphosis,radiography
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-17
Enrollment: 632
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 and under, those who were requested to have spinal radiographs for scoliosis and kyphosis

Brief summary: The study will be done retrospectively.The aim of this study is to retrospectively examine the spinal pathologies of patients with a prediagnosis of spinal deformity and for whom spinal radiography is requested and to evaluate the clinical features of these patients.

Detailed description: Spinal radiography for scoliosis is the gold standard in the diagnosis, treatment and follow-up of spinal diseases. There are studies showing that unnecessary and repetitive radiographs of patients increase the risk of cancer in older ages. Patients should be thoroughly examined before a spine radiograph is taken. Adam's test should be applied to the patient with scoliosis findings in the physical examination. Spinal radiography for Scoliosis should be requested from those whose trunk rotation angle is 5 degrees or more during Adam's test. The diagnosis of scoliosis is made when the Cobb angle measured on posterior-anterior radiographs is greater than 10 degrees. The diagnosis of kyphosis is made when the Cobb angle measured on lateral radiographs is greater than 50 degrees. Patients with a prediagnosis of spinal deformity and spinal radiographs taken between January 2019 and September 2019 in the Radiology clinic of our hospital will be included in the study. Demographic characteristics of the patients, presence and degree of scoliosis on posterior-anterior radiographs, if present, degree of kyphosis on lateral radiographs, structural pathologies in the spine and clinical features will be investigated.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 and under
2. Those who requested spine radiographs for scoliosis and kyphosis

Exclusion Criteria:

1. Having a history of previous spinal surgery or trauma
2. Repeated radiographs in the same patient

Primary outcomes:
measure: Who should have full spine radiographs?
timeFrame: 3 month
Secondary outcomes:
measure: We aimed to determine the frequency of kyphosis, types and percentages of scoliosis detected on the radiographs.
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01043783: Preliminary Data for Breath Biofeedback of Dietary Compliance
Official title: Preliminary Data for Breath Biofeedback of Dietary Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators ultimate goal is to test the hypothesis that immediate feedback of dietary adherence will enhance compliance to a weight loss program. This study deals directly with gathering the needed preliminary data for a grant submission.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females age 18 or older

Exclusion Criteria:

* Chronic disease

Primary outcomes:
measure: Breath CO2, ketones, aldehydes, alcohols
timeFrame: Daily for 5-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References:
Clinical trial NCT01037283: Interpersonal and Social Rhythm Therapy Enter the Brief Title for Protocol IRB 09-003781>
Official title: Feasibility of Interpersonal and Social Rhythm Therapy for Outpatients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder, Depressed
Keywords: Bipolar
Depressed
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-12-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients with bipolar disorder referred for psychotherapy, is interpersonal and social rhythm therapy delivered in a group psychotherapy format over 2-3 weeks feasible? This project will help determine if interpersonal social rhythm therapy can be delivered in the programmatic format being considered for the outpatient mood program.


Eligibility criteria: Adult patients with a confirmed diagnosis of Bipolar disorder in a depressed phase.

Referral for Interpersonal and Social Rhythm Therapy

Primary outcomes:
measure: Symptom improvement and patient satisfaction with group and programmatic format in the delivery of interpersonal and social rhythm therapy.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Astrid Hoberg, RN, CNS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04653883: Prognostic Impact of Sleep Disorders in Patients : Pro-TSIC Study
Official title: Prognostic Impact of Sleep Disorders in Patients With Heart
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Sleep Disorder
Insomnia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 115
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included in this study are the patients followed in the Cardiology Department of the Montpellier University Hospital and diagnosed with heart failure according to the 2016 criteria of the European Society of Cardiology.

Brief summary: Heart failure (HF) is a common and progressive condition associated with significant morbidity and mortality. Only 25-35% of patients survive 5 years after diagnosis.Sleep disorders are frequently found in this population with up to 94% of patients complaining of sleep disorders. Of these, insomnia and sleep disorders are the most common. The frequency of restless legs syndrome (RLS) varies between 4 and 40% depending on the studies. Patients with HF frequently experience poor sleep quality which is associated with deterioration in quality of life, alertness, and mood.

Few studies have examined the prognostic impact of sleep disturbances in this population. A greater morbidity and mortality is observed in the event of poor quality sleep or in the presence of sleep breathing disorders .

The investigators therefore propose to evaluate the sleep disorders of patients with HF by self-administered questionnaires, hypothesizing that complaints of poor sleep are linked to a poorer cardiovascular prognosis.


Eligibility criteria: Inclusion criteria:

- heart failure according to the 2016 criteria of the European Society of Cardiology.

Exclusion criteria:

- age less than 30 years

Primary outcomes:
measure: To study the occurrence of cardiovascular events, whether fatal or not, according to the presence or absence of sleep or wakefulness disorders
timeFrame: 1 day
Secondary outcomes:
measure: Evaluate the occurrence of fatal events according to the presence or absence of sleep or wakefulness disorders
timeFrame: 1 day
measure: Evaluate the occurrence of cardiovascular non-fatal major adverse cardiovascular events according to the presence or absence of sleep or wakefulness disorders
timeFrame: 1 day
measure: Evaluate the occurrence of fatal or non-fatal major adverse cardiovascular events depending on whether or not medication is taken for sleep disorders
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: François BUGHIN, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06164483: Auditory Functions in Patients With Multiple Sclerosis
Official title: Electrophysiological Studies of Auditory Functions and CSF Analyses in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Hearing Disorders
Lead sponsor: University of Catania
Sponsor class: OTHER
Collaborators: name: Hannover Medical School
First posted: 2023-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy patients and patients with RRMS

Brief summary: The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers.

The results of DPOAE and CSF will be correlated to identify statistically significant correlation.

Detailed description: Case-Control study

Tools for patients' selection and inclusion in the study

STEP one

* Full medical records detailed for neurological diseases
* Brain and spinal cord MRI performed 12 months (n1) before and most recent one (n2)
* Lumbar puncture
* Blood test
* Questionnaire for screening hearing disorders
* App for screening hearing loss

STEP two

* Pure Tone Auditory test + Tympanometry and Stapedial Reflex
* Speech Perception test
* In case of tinnitus: tinnitus questionnaire and acuphenometry
* DPOAEs
* ABR

STEP three in case of Hearing impairment

- MRI Tractography

Eligibility criteria: Inclusion Criteria

* age \>18 and \<50,
* no history of hearing loss,
* no psychiatric condition
* no familial history of otosclerosis/deafness/genetic hearing loss
* patients with PD and/or MS.

Exclusion Criteria

* Conductive hearing loss
* stroke \< 2 years
* cardiovascular disease non under control
* diabetes
* hypotensive disorders
* alcohol abuse
* recreational drug consumption
* epilepsy

Primary outcomes:
measure: Auditory functions and correlation with CSF findings
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Arianna Di Stadio
state: Sicily
Study officials:
References:
Clinical trial NCT00358683: A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease
Official title: Open Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: certolizunab pegol
long term safety follow-up
Chrohn's disease
infliximab failures patients
Greek population
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is allow the patients suffering from Crohn's disease , who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizumab pegol until the drug is available for the Crohn's disease indication in Greece.


Eligibility criteria: Inclusion Criteria:

* Crohn's disease diagnosis
* Patients having completed the treatment period of study C87055 (previously treated with infliximab) and benefited from the study treatment, as per investigatior's discretion.

Exclusion Criteria:

* Subject withdrawn prematurely from C87055 study.
* Subject who received treatment other than certolizumab pegol and other than medications permitted in C87055 study.
* Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration.

Primary outcomes:
measure: For ethical reasons, provide the opportunity for patients > 18 years suffering from Crohn's disease who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizum
Secondary outcomes:
measure: Incidence of adverse events reported by the patients during the long-term treatment period of the study.
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: George Syrmalis, M.D. M.Sc. Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02428283: Scalp Nerve Block on Emergence Agitation
Official title: The Effect of Scalp Nerve Block on the Emergence Agitation in Children Undergoing Nevus Surgery During Sevoflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.

Detailed description: Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled. Anesthesia was induced with thiopental sodium and rocuronium, and maintained with sevoflurane. Patients were randomly assigned two groups: the control group received IV remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine 2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and Watcha behavior scale for emergence agitation were assessed.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for nevus surgery

Exclusion Criteria:

* developmental disorder
* neurologic disorder
* coaguloparthy
* allergy to local anesthetics

Primary outcomes:
measure: change of Watcha behavior scale for emergence agitation (4 point)
timeFrame: from immediately after PACU arrival to 10 min, 20 min, and 30 min after arrival
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeongki-do
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06343883: Investigation of Low-intensity Focused Ultrasound Pressure
Official title: Investigation of Low-intensity Focused Ultrasound Pressure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Somatic Pain
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Primary cohort (safety) will be collected prior to full study collection. Primary collection will involve highest pressure application and follow-up safety scans (MRI) to be reviewed by a Neuroradiologist. Once cleared - parallel design will be utilized for eeg and fMRI cohorts. Both cohorts will receive 3 LIFU pressures randomized over 3 study visits. Electrical stimulations will be applied pre and post LIFU administration to induce somatosensory evoked potentials (SEPs).
Primary purpose: BASIC_SCIENCE

Brief summary: Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.

Detailed description: Study aims to determine safety and efficacy of variable pressures of low-intensity focused ultrasound using an electrical stimulation to create a somatosensory evoked potential and record eeg and fMRI outcome measures. A primary safety study will be conducted prior to 'full scale' data collection.

Eligibility criteria: Inclusion Criteria:

Understand and speak English

Exclusion Criteria:

1. Claustrophobia (scanning environment may be uncomfortable).
2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
3. Contraindications to CT: pregnancy
4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
6. History of head injury resulting in loss of consciousness for \>10 minutes.
7. History of alcohol or drug dependence (through self-report).

Primary outcomes:
measure: Report of Symptoms Questionnaire
timeFrame: pre/post intervention and 1 week post intervention.
measure: MRI
timeFrame: pre and post intervention in cohort 1
Secondary outcomes:
measure: EEG
timeFrame: throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).
measure: fMRI
timeFrame: throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at VTC
state: Virginia
Study officials:
References:
Clinical trial NCT02225483: Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function
Official title: Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: CancerCare Manitoba
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Novo Nordisk A/S
First posted: 2014-08-26
Enrollment: 42
Sex: MALE
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Boys with severe Hemophilia A, Factor VIII coagulant activity less than or equal to 1%

Brief summary: The is study will examine whether variation in clinical bleeding frequency and severity among boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in laboratory measurements of platelet activity.


Eligibility criteria: Inclusion Criteria:

* documented circulating FVIII level of ≤1%
* age 3 - 20 years
* may be on primary or secondary prophylaxis
* granting of informed consent

Exclusion Criteria:

* measurable inhibitor level at the time of enrollment
* ingestion of aspirin/supplement known to influence platelet function within 14 days of blood sampling, or ibuprofen within 3 days

Primary outcomes:
measure: Procoagulant platelet-derived microparticle formation
timeFrame: At time of enrollment
measure: Platelet aggregation
timeFrame: At time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: