louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02816307: Etiology of Endocarditis in Negative Blood Cultures
Official title: Etiology of Endocarditis in Negative Blood Cultures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infective Endocarditis (IE)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 3033
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Infective endocarditis remains a serious disease that requires fast and specialized support in 2012. However, 24% of endocarditis unanswered etiology. The systematic use of new policy diagnosis, including (i) a systematic use of specific PCR techniques and (ii) the search for markers of inflammatory and tumoral diseases, should increase the number of positive etiological diagnosis of culture-negative samples.

Secondly, because of the seriousness of the disease, the investigators were led to develop a new score: score for admission. This score, realized in less than 4 hours from the admission of the suspected patient with endocarditis, should allow for immediate probabilistic antibiotic treatment after completion of the diagnostic kit. The modified Duke score give its results in 4 to 7 days. With the score of admission thus diagnostic processes are accelerated and, where appropriate, empirical antibiotic therapy started.

Primary: Evaluate the effectiveness of the new diagnostic strategy on etiological identification of endocarditis.

Secondary: Validate the "admission" score compared to the modified Duke score.


Eligibility criteria: Inclusion Criteria:

* Patient with endocarditis diagnostic kit prescribed
* Patient is more than 18 years old
* Patient who freely signed written informed consent.
* Patient affiliated to a health assurance

Exclusion Criteria:

* Minor patient (\<18 years)
* Patient pregnant or breastfeeding
* Patient incapable or unable to consent
* Private patient of liberty or under court order
* Patient refusing to participate in the research

Primary outcomes:
measure: The percentage of patients with an etiological diagnosis of endocarditis
timeFrame: 6 years
Secondary outcomes:
measure: The "admission" score
timeFrame: 1 day
measure: the Duke score
timeFrame: 1day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assitance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: URIELLE DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hopitaux De Marseille
name: JEAN PAUL CASALTA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06959407: Efficacy Of Oral Dexamethasone Versus Parenteral Dexamethasone In The Management Of Mild To Moderate Croup
Official title: Efficacy Of Oral Dexamethasone Versus Parenteral Dexamethasone In The Management Of Mild To Moderate Croup
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laryngotracheobronchitis
Croup
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 192
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Croup (laryngotracheobronchitis) is a viral infection of the upper airway that causes throat swelling, leading to a barking cough, stridor, and hoarseness. It mainly affects children aged 6 months to 12 years, peaking at around 2 years. Most cases are mild and self-limiting. Emergency treatments include cool mist, nebulized epinephrine, and steroids. Steroid therapy, particularly dexamethasone (oral or intramuscular), is commonly used, with recent studies suggesting intramuscular dexamethasone may be more effective. However, most research has focused on hospitalized patients, and there is a lack of local data for mild cases. This study aims to address that gap and improve patient counseling and future research


Eligibility criteria: Inclusion Criteria:

* Patient age 2 to 12 years
* Both genders
* Diagnosed with croup as operational definitions

Exclusion Criteria:

* Patients with chronic pulmonary disease like tuberculosis,
* Allergy or contraindication of corticosteroid (history of tuberous sclerosis, history of varicella infection during the past three weeks), to corticosteroids,
* history of corticosteroid administration during the last four weeks,
* foreign body
* patients with immunodeficiency disorder

Primary outcomes:
measure: Settlement of symptoms of Croup
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: KPK
Study officials:
References:
citation: Smith DK, McDermott AJ, Sullivan JF. Croup: Diagnosis and Management. Am Fam Physician. 2018 May 1;97(9):575-580.
citation: Parker CM, Cooper MN. Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial. Pediatrics. 2019 Sep;144(3):e20183772. doi: 10.1542/peds.2018-3772. Epub 2019 Aug 15.
citation: Lin SC, Lin HW, Chiang BL. Association of croup with asthma in children: A cohort study. Medicine (Baltimore). 2017 Sep;96(35):e7667. doi: 10.1097/MD.0000000000007667.
citation: Peltz A, Wu CL, White ML, Wilson KM, Lorch SA, Thurm C, Hall M, Berry JG. Characteristics of Rural Children Admitted to Pediatric Hospitals. Pediatrics. 2016 May;137(5):e20153156. doi: 10.1542/peds.2015-3156. Epub 2016 Apr 11.
citation: Parikh K, Hall M, Mittal V, Montalbano A, Gold J, Mahant S, Wilson KM, Shah SS. Comparative Effectiveness of Dexamethasone versus Prednisone in Children Hospitalized with Asthma. J Pediatr. 2015 Sep;167(3):639-44.e1. doi: 10.1016/j.jpeds.2015.06.038.
Clinical trial NCT04018807: MVP RCT: Mind and Voice Project Randomized Control Trial
Official title: MVP RCT: Mind and Voice Project Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Health
Mental Health
Alcohol; Use, Problem
Interpersonal Violence
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-07-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study seeks to learn more about the health behaviors of young adults. Health behaviors include relationships, physical and mental health, alcohol use, and conflicts with others. The purpose of this study is to improve prevention and intervention programs for young adults.


Eligibility criteria: Inclusion Criteria:

* Prior Alcohol Use
* Interpersonal Violence

Exclusion Criteria:

* Person does not understand/speak English
* Prisoner or person being taken into custody/under house arrest
* Person or parent/guardian unable to give consent due to insufficient cognitive orientation due to unknown reasons
* Person unable to give consent due to insufficient cognitive orientation due to drug or alcohol use/ accidental overdose; given pain medications (fails MMSE)
* Person diagnosed with schizophrenia
* Person is actively suicidal or being treated for self-harm (includes overdose with the intent to harm self - not accidental)
* Person being treated for child abuse situation
* Deaf or visually impaired/illiterate/can't speak
* Screened within last month or already in study
* Combative
* Patient died
* Too sick in emergency department to approach (e.g. - never stabilizes, in trauma bay, intubated, on ventilator, or a Level 1 trauma)
* Person has already refused 2 times

Primary outcomes:
measure: Feasibility, as Measured by Number of Sessions Completed
timeFrame: 12 weeks
measure: Acceptability, as Measured by Client Satisfaction
timeFrame: 12 weeks
measure: Usability, as Measured by a Modified Systems Usability Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Quyen Ngo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00273507: Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3
Official title: Neoadjuvant Chemotherapy in Resectable NSCLC Stages IB, IIA, IIB, and IIIA/T3 But Not IIIA/N2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small cell lung cancer
neoadjuvant
resection
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-01-09
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Detailed description: Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Eligibility criteria: Inclusion Criteria:

* NSCLC
* Stages IB, IIA, IIB, IIIA/T3
* Lung function test allowing surgery
* Age 18-75 years

Exclusion Criteria:

* Poor lung function
* Performance status 3-4
* Mediastinal lymph node involvement

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: Time to progression
measure: Complete resection rate
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. Oncology, Rigshospitalet
Study officials:
affiliation: Dept. Oncology, Rigshospitalet
name: Jens B. Sorensen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01769807: Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)
Official title: Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep apnea
CPAP treatment
Plasma nitrate
Urinary norepinephrine
Blood pressure
Lead sponsor: University of Lisbon
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 67
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have been described in severe obstructive sleep apnea (OSA), and are reverted by continuous positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on these biomarkers in mild-moderate OSA.

Detailed description: The investigators aimed to compare NOx and U-NE levels and blood pressure (BP) between male patients with mild-moderate and severe OSA and determine the impact of 1 month of CPAP therapy on these parameters.

The investigators undertook a prospective study of 67 consecutive OSA patients (36 mild-moderate, 31 severe). Measurements of plasma NOx at 11 pm, 4 am and 7 am, 24-h U-NE and ambulatory BP were obtained at baseline and after 1 month of CPAP.

Eligibility criteria: Inclusion Criteria:

- Diagnosis of obstructive sleep apnea

Exclusion Criteria:

* current smoker
* respiratory disease
* cardiac disease (except for arterial hypertension)
* renal disorder
* hepatic disorder
* psychiatric disorder
* diabetes mellitus
* dyslipidemia
* rhinitis
* sinusitis
* acute illness
* daytime hypoxemia or hypercapnia
* therapy with oral nitrates
* therapy with angiotensin-converting enzyme inhibitors
* therapy with beta-blockers
* therapy with statins
* therapy with non-steroidal anti-inflammatory drugs
* presence of central respiratory events
* previous CPAP therapy
* previous uvulopalatopharyngoplasty

Primary outcomes:
measure: Plasma nitrate (NOx) levels
timeFrame: one month
Secondary outcomes:
measure: 24 h Blood pressure
timeFrame: one month after CPAP
measure: Urinary norepinephrine (U-NE) levels
timeFrame: One month
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Hospital Pulido Valente
Study officials:
affiliation: University of Lisbon
name: Paula G Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinto P, Barbara C, Montserrat JM, Patarrao RS, Guarino MP, Carmo MM, Macedo MP, Martinho C, Dias R, Gomes MJ. Effects of CPAP on nitrate and norepinephrine levels in severe and mild-moderate sleep apnea. BMC Pulm Med. 2013 Mar 13;13:13. doi: 10.1186/1471-2466-13-13.
Clinical trial NCT02799407: Electronic Consent of Numerous Subjects Employing Novel Techniques Trial
Official title: Electronic Consent of Numerous Subjects Employing Novel Techniques Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Informed Consent
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 0
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: The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.

Detailed description: The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Able to read and understand study materials which are presented in English
* Owns or has access to a smartphone or other smart device such as a tablet or iPod

Exclusion Criteria:

* Any physical limitations which prevent the participant from using mobile and/or touch screen technologies
* Employed in a research position, clinical care position, or position which has regular exposure to clinical research

Primary outcomes:
measure: Participant comprehension, as measured by Qualtrics survey
timeFrame: at study conclusion, an average of 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke Health
name: David Tanaka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04222907: The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel
Official title: The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 54759
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Full-term pregnancies were defined as gestational age 37 weeks and above. Pregnancies were identified by a pregnancy code accessed by the primary physician indicating that the patient is pregnant, open pregnancy record in the medical record or child linked to the mother's id. Gestational age was defined by last menstrual period (LMP) or first obstetric ultrasound if LMP was unknown.We identified and excluded repeat pregnancies occurring in the same woman during the time period, multiple pregnancies, gestational age greater than 42 weeks due to probability of data inaccuracy and women with missing information.

Brief summary: Determination of GBS colonization rates in Pregnant Women insured with Maccabi Health Services, Doctors' Compliance Rates for Referral for Testing, test execution rates, and Early-onset GBS Disease (EOGBSD) Rates in Israel. Determine the relationship between conducting a GBS test in pregnant women and EOGBSD in Israel.

Detailed description: There have been few studies in recent years, which has prompted us to undertake this study. Our aim was to examine the current colonization rates and attack rates in the Israeli population. Our secondary aim was to evaluate the need to readjust recommendations towards universal screening.

Eligibility criteria: Inclusion Criteria:

* All women with term pregnancies from 2015 to 2016 (until 20/9/16) insured by Maccabi Healthcare Services (MHS)

Exclusion Criteria:

* repeat pregnancies occurring in the same woman during the time period
* multiple pregnancies
* gestational age greater than 42 weeks due to probability of data inaccuracy
* women with missing information

Primary outcomes:
measure: Attack rate of early-onset GBS disease (EOGBSD)
timeFrame: 2015-2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02557607: Quantification of Cerebral Blood Flow by Arterial Spin Labeling in Vasospasm in Subarachnoid Haemorrhage
Official title: Quantification of Cerebral Blood Flow by Arterial Spin Labeling in the Screening and Monitoring of Vasospasm in Subarachnoid Haemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subarachnoid Hemorrhage
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-09-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume

Detailed description: The subarachnoid hemorrhage (SAH) is a relatively severe disease whose prognosis is particularly related to the early onset of arterial vasospasm, maximum between the 5th and 14th day after SAH. Many obstacles make it difficult screening and monitoring of such complication. The challenge is to be able to demonstrate a reduction in regional cerebral blood flow before the onset of irreversible parenchymal sequelae, responsible for the majority of long-term morbidity among survivors. In clinical routine, screening vasospasm is achieved by Doppler intracranial arteries (DTC). However, its sensitivity is poor with regard to the middle and anterior cerebral arteries. The gold standard for diagnosis is cerebral arteriography. However, vasospasm in arteriography or trans-cranial Doppler does not prejudice the appearance of a delayed ischemic deficit.

A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume

Eligibility criteria: Inclusion Criteria:

* Adults.
* Who have given their written consent.
* Affiliated to a social security system.
* Any patient hospitalized at the University Hospital of Angers in neurosurgical intensive care unit for supervision by ASL and DTC a subarachnoid hemorrhage from all etiologies (excluding traumatic).

Exclusion Criteria:

* Contraindications to MRI
* patient hospitalized at the University Hospital of Angers in surgical intensive care for monitoring a subarachnoid hemorrhage.
* patient hospitalized at the University Hospital of Angers for monitoring a subarachnoid hemorrhage traumatic.

Primary outcomes:
measure: exploitation of raw images provided with the waning of the acquisition of the sequence ASL.
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: UH ANGERS
name: Aram TER MINASSIAN, Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01066507: Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections
Official title: Concordance Study for Amplification Detection of Her2 FISH in Breast Tissue Sections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Her2
FISH
Breast cancer
Amplification
Lead sponsor: Applied Spectral Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 126
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The breast samples were taken from female patients after cut biopsies. Paraffin embedded blocks were prepared and the secssion slides were stained with the PathVysion prove for Her2 FISH applification detection

Brief summary: The purpose of the study is the identification of amplification level in human breast tissue. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of Her2 FISH stained tissue samples.


Eligibility criteria: Inclusion Criteria:

* Well stained breast tissue slides with bright Her2 signals

Exclusion Criteria:

* Very old slides that were already bleached

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: PLUS Diagnostics
state: New Jersey
city: Temple
country: United States
facility: Scott & White Hospital, Texas
state: Texas
city: Tel Aviv
country: Israel
facility: Sheba Medical Center, Pathology Dep.
Study officials:
affiliation: Section Chief, Cytogenetics
name: Sheila Dobin, Ph.D.
role: STUDY_DIRECTOR
References: