louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02755480: Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients
Official title: Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Leukemia
Keywords: bone marrow transplant
infection
computed tomography
radiation dose
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 119
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: Patients with bone marrow cancer are more susceptible to chest infections than healthy adults; marrow ablation treatment further compromises their immune status and increases the risk of fungal opportunistic infection, which is associated with a high fatality rate. Therefore, it is critical to achieve early and accurate diagnosis of fungal infection when these patients become febrile. At the Mount Sinai Hospital (MSH) and the University Health Network (UHN), the standard of care (SOC) to exclude a chest infection in immunocompromised (IC) patients is chest computed tomography (CT) using low dose CT (LDCTT).

Detailed description: As patients may have several febrile episodes during their hospital stay, the cumulative dose from LDCTT scans can be significant and increase the lifetime risk of inducing a second cancer. The aim of this project is to determine whether a 75% reduction in radiation dose for LDCTT in other words, an ultralow dose chest CT (uLDCTT) at a dose comparable to chest X-ray, maintains the diagnostic image quality for detection of fungal chest infection in IC patients. If successful, uLDCTT will be adopted as SOC imaging at Princess Margaret Cancer Center (PM) for these patients.

Eligibility criteria: Inclusion Criteria:

1. All immunocompromised patients clinically referred for LDCTT to the Medical Imaging department at PM
2. 18 years and older

Exclusion Criteria:

1. Patients that cannot follow study procedures

Primary outcomes:
measure: Image acquisition
timeFrame: Study Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, Department of Medical Imaging
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05724680: Effectiveness of Cognitive Behavior Therapy for Persons With Depression
Official title: A Randomized Controlled Trial of the Effectiveness of Cognitive Behavior Therapy for Major Depression in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Rajshahi University
Sponsor class: OTHER
Collaborators: name: University Grants Commission
First posted: 2023-02-13
Enrollment: 148
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: This was a randomized controlled clinical trial (RCT) carried out in three different hospitals in Dhaka city, Bangladesh.

Detailed description: This was a randomized controlled trial, conducted to determine the effectiveness of CBT for depression delivered by trained therapists with an adapted Bengali CBT (BaCBT) manual, as compared to a control group. The main objective of the current study was to examine the efficacy of CBT for persons with major depression in Bangladesh.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Major Depression
* Must be able to take therapeutic session

Exclusion Criteria:

* active suicidal ideation
* a co-morbid serious health condition
* with psychotic features
* currently on medication for depression
* with an intellectual disability

Primary outcomes:
measure: Change in Depression Scale
timeFrame: change from baseline to day 42, a separate outcome from day 42 to day 72
Secondary outcomes:
measure: Change in Anxiety Scale
timeFrame: change from baseline to day 42, a separate outcome from day 42 to day 72
measure: Change in General Health Questionnaire-28
timeFrame: change from baseline to day 42, a separate outcome from day 42 to day 72
measure: Change in Beck Scale for Suicidal Ideation
timeFrame: change from baseline to day 42, a separate outcome from day 42 to day 72
Other outcomes:
Locations:
city: Rājshāhi
country: Bangladesh
facility: Dr. Jesan ara
state: Rajshahi
Study officials:
References:
Clinical trial NCT05836480: Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Official title: Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgical mitral valve repair. Patients of study (Suboptimal) group were discharged with a 2+ or more residual mitral regurgitation, patients in control group (Optimal) were discharged with a 1+ or less residual mitral regurgitation

Brief summary: Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease.

Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+).

The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study


Eligibility criteria: Inclusion Criteria:

* Study group:
* presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
* presence of moderate residual mitral regurgitation at discharge.
* Control group:
* presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
* presence of residual mitral regurgitation of at least mild grade at discharge.

Exclusion Criteria:

* none

Primary outcomes:
measure: Mortality
timeFrame: through study completion, a minimum of 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT02914080: Validation of a Psychological Fragility Questionnary in the Elderly in Isolation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Loneliness
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly people living in isolation , will be tested in different environments : ( i) in rural areas; ( Ii ) in urban areas ; ( Iii) accommodation facility for elderly dependents ( EHPAD)

Brief summary: Social isolation and loneliness of the elderly have become major public health problems, because of the deleterious consequences if not lethal they can generate.

Because of frequent resignation to these phenomena, support must be given to all means of prevention to prevent or at least mitigate their impacts. It appears from the literature that are isolated or living as they have adjustment difficulties which are linked to fragility. If geriatric frailty have been defined to date in somatic and cognitive criteria, psychological fragility criteria have been little discussed outside of psychiatric disorders (depression, anxiety disorders in particular).

This study aims to test in the elderly in isolation psychological fragility questionnaire and to study the statistical qualities and relations with socio-demographic variables, environmental and other known vulnerabilities.


Eligibility criteria: Inclusion Criteria:

* People over 65
* Living alone at home (rural and urban ) or institution ( nursing home , no family member or spouse in the same institution).
* No not refusing to participate in the survey

Exclusion Criteria:

* Overt or decompensated psychiatric pathology: major depressive disorder , bipolar disorder, psychotic disorder, severe personality disorder , primary addiction ( ICD-10 criteria)
* Alzheimer's disease or related illness probable or confirmed (ICD criteria 10)
* Sequel to severe neurological disease , unstabilized somatic pathology and / or may disrupt data collection
* Patients do not have the capacity to understand the objectives of the survey

Primary outcomes:
measure: Psychological scales used to evaluate the elements of fragility in the elderly in isolation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice
Study officials:
References:
Clinical trial NCT02048280: Comparing NAVA Levels in Intubated and Recently Extubated Neonates to Determine Optimal Non-invasive Ventilatory Support
Official title: Comparing NAVA Levels in Intubated and Recently Extubated Neonates to Determine Optimal Non-invasive Ventilatory Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Specified Respiratory Problems in Fetus or Neonate
Lead sponsor: ProMedica Health System
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 23
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount of support provided is determined in part by the NAVA level, where a higher NAVA level will provide higher level of support and unload more of the work of the diaphragm. The purpose of this study is to compare the optimal NAVA level in neonates while on mechanical ventilation while intubated and after being extubated.

Detailed description: Baseline measurements will be taken. The NAVA titration study will then be done. The NAVA level will be set at a starting value of 0.1 cm H2O/mcV and systematically increased by 0.5 cm H2O/mcV every three minutes to a maximum of 3 cmH2O/mcV. Once the NAVA titration study has been completed, the patient will be extubated. There will be a stabilization period following extubation (15-30 minutes), and then the NAVA titration study will be repeated.

Eligibility criteria: Inclusion Criteria:

* Neonates on NAVA ventilation

Exclusion Criteria:

-

Primary outcomes:
measure: Changes in breakpoint in intubated and extubated patients
timeFrame: 20 minute study pre and post extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Promedica Toledo CHildren's Hospital NICU
state: Ohio
Study officials:
affiliation: Promedica Toledo Childrne's Hospital
name: Howard Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04637880: 25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders
Official title: 25- Hydroxyvitamin D Levels in Pregnancy and Effects on Pregnancy Related Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin d Deficiency
Preeclampsia
Preterm Delivery
Gestational Hypertension
Gestational Diabetes
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Ratiopharm GmbH
First posted: 2020-11-20
Enrollment: 249
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy pregnant women

Brief summary: Evaluation of 25- Hydroxyvitamin D levels in pregnant women in Austria and potential related disorders

Hypothesis:

Austrian pregnant women are Vitamin D deficient Present vitamin D supplementation in pregnancy is insufficient Vitamin D deficiency is associated with pregnancy related disorders like preeclampsia


Eligibility criteria: Inclusion Criteria:

* age\> 18 years
* informed consent

Exclusion Criteria:

* chronic hypertension
* kidney disease
* lupus erythematodes
* diabetes mellitus
* malabsorption syndrome
* hyperparathyroidism
* surgery on the thyroid gland

Primary outcomes:
measure: 25- Hydroxyvitamin D and relation to development of preeclampsia
timeFrame: over course of pregnancy
Secondary outcomes:
measure: 25 Hydroxyvitamin D in newborn
timeFrame: once at delivery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Obstetrics and fetomaternal Medicine, Medical University of Vienna
Study officials:
affiliation: MUV
name: Harald Zeisler, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02212080: First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784
Official title: One-center, Randomized, Placebo-controlled, Double Blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (5-1000 mg, Solution) of BAY1214784 Including the Relative Bioavailability of BAY1214784 Administered as Solution With Two Different Concentrations in 56 Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Trials, Phase I as Topic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects
* Age 45 to 65 years
* Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
* Postmenopausal state

Exclusion Criteria:

* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Known or suspected malignant or benign tumors
* Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders
* Regular use of medicines

Primary outcomes:
measure: Number of adverse events
timeFrame: Up to 2 weeks after dosing
measure: Severity of adverse events (mild, moderate, severe)
timeFrame: Up to 2 weeks after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Erfurt
country: Germany
state: Thüringen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02907580: Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric
Official title: Influenza Vaccine Attitudes, Intent, and Receipt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Influenza
Keywords: influenza
vaccination
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate parents and patients, public health entities and physicians give informational handouts in various forms. However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. Few, if any, studies have analyzed the relationship between influenza vaccine attitudes and intention with actual vaccine receipt in the pediatric population. These results will help to understand the relationship between parent's vaccine perception and the intent to vaccinate versus the child's receipt of the influenza vaccine, as well as to optimize educational information given to families regarding the influenza vaccine.


Eligibility criteria: Inclusion Criteria:

* Age at least 6 months

Exclusion Criteria:

* Receipt of influenza vaccination that season

Primary outcomes:
measure: Number of children who receive influenza vaccination on day of intervention
timeFrame: Day 0
Secondary outcomes:
measure: Number of children who receive influenza vaccination during the influenza vaccine season
timeFrame: Up to 7 months
measure: Number of parents who anticipate influenza vaccination during the influenza vaccine season
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scott VP, Opel DJ, Reifler J, Rikin S, Pethe K, Barrett A, Stockwell MS. Office-Based Educational Handout for Influenza Vaccination: A Randomized Controlled Trial. Pediatrics. 2019 Aug;144(2):e20182580. doi: 10.1542/peds.2018-2580. Epub 2019 Jul 10.
Clinical trial NCT06177080: Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy
Official title: Evaluation of the Active Phase of Delivery by Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrapartum
Transperineal Ultrasound
Keywords: head symphysis distance
angle of progression
sonopartograph
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 30 nulliparous and 70 multiparous total 100 singleton pregnant women measured descent angle and head symphysis distances by transperineal ultrasound in the active phase of labor.
Primary purpose: SCREENING

Brief summary: Investigators aimed to determine the progression of the descent angle and head symphysis distance measured by intrapartum transperineal ultrasound as an alternative to vaginal examination and bishop score, according to time and cervical dilatation and to draw a sonopartograph as a new indicator also aimed to evaluate the success of the use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of of delivery.

Detailed description: Descent angle and head symphysis distances by transperineal ultrasound of pregnant women who are in the active phase of labor was measured hourly in the first phase of the active phase (the period from 4 cm to full dilation of the cervical opening); every 15 minutes in the second phase of the active phase (time from full dilation to delivery of the baby) Cervical dilatation and head levels were noted by simultaneous digital vaginal examination. The physician who performed the imaging and the physician who made the vajinal examination worked independently of each other and did not see each other's results.

Eligibility criteria: Inclusion Criteria:

* multiparous pregnancy
* active phase in labor
* vertex position

Exclusion Criteria:

* multiple pregnancy
* BMI over 35
* preterm labor
* congenital anomalies

Primary outcomes:
measure: Transperineal ultrasound instead of digital vaginal examination
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT04956380: Self-assessment Triage in Inflammatory Arthritis
Official title: Self-assessment Triage in Inflammatory Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Arthritis
Keywords: New Referrals
Triage
Self-assessment
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2021-07-09
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial randomized controlled trial
Primary purpose: OTHER

Brief summary: There are benefits to early, intensive treatment of IA. But getting to treatment depends on timeline and accurate case identification. The longest delays occur in persons self-identifying the need to see care for IA, recognition of these cases by primary care providers (PCPs), and appropriate, timely referral to rheumatology. Current methods of improving time to referral and consultation are effective, but costly and unsustainable, so there is need to look for alternatives. One solutions may be the use of patient self-administered tools.

In this study, we will test whether the use of validated, self-administered patient questionnaires (self-assessment) can advance the urgency rating of referrals for people with inflammatory arthritis (IA). If urgency ratings can be advanced then self-assessment may have the potential to reduce wait times to see a rheumatologist.

In Canada, one in every hundred people has IA and hundreds of new patients are diagnosed each year. Wait times to see a rheumatologist are long, so anything that has the potential to reduce these wait times would have a significant impact.


Eligibility criteria: Inclusion Criteria:

* new patient referral

Exclusion Criteria:

* under 18 years of age
* confirmed diagnosis of inflammatory condition
* seen/managed by another rheumatologist within the last five years
* unable to speak English
* on disease modifying antirheumatic drugs.
* referrals from the Emergency Department

Primary outcomes:
measure: Urgency Rating
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Dr. Raheem Kherani
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: