louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04391335: Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
Official title: Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis Obliterans Syndrome
Keywords: Stem cell transplantation
Xenon MRI
Lung
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two groups of participants will be recruited. Group 1 will be participants who meet the screening criteria for the development of BOS according to the NIH criteria. Group 2 will be participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS.

Brief summary: In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.


Eligibility criteria: Inclusion Criteria:

* Male and female participants aged 6 -17.9 years old.
* Received HSCT treatment at least 6 months prior to enrollment in study.
* Participants should have an FEV1%pred value greater than 40%.
* Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
* Participant must be able to perform a breath hold for 16s.
* Participant meets MRI screening criteria

Exclusion Criteria:

* Participant has had a cold or respiratory infection in the last four weeks.
* Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
* Participant is unable to perform spirometry or plethysmography maneuvers.
* Participant is pregnant or lactating.

Primary outcomes:
measure: Assessment of MRI
timeFrame: 24 months
Secondary outcomes:
measure: Correlation
timeFrame: 24 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Giles Santyr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05475535: Can a Self-guided Mobile Phone Application Program Improve Wellbeing in University Students
Official title: Can a Self-guided Cognitive Behavioral-based Mobile Phone Application Program With a Self-Compassion Component Reduce Unhealthy Perfectionism in University Students - a Randomised Controlled Trial (RCT) With a 4-week Follow-up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perfectionism
Shame
Depression, Anxiety
Stress
Self-Compassion
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate and compare the effectiveness of a mobile phone application-based intervention in improving wellbeing in young adults. 400 University students are randomized into 1 of 4 intervention types. Pre, mid and post-intervention outcome measures are compared to determine effectiveness of the various intervention types.


Eligibility criteria: Inclusion Criteria:

* Access to a mobile phone with the following requirements: iPhone 8 and above, or Android 5.2+ (display greater than 5 inches)
* Have scores of greater than or equal to 29 on the 'Concerns over Mistakes' subscale on the FMPS

Exclusion Criteria:

* Participants who do not meet the inclusion criteria
* Currently pregnant
* Undergoing psychological treatment or counselling
* Have any change in psychotropic medication within twelve weeks before starting intervention

Primary outcomes:
measure: Change in maladaptive perfectionism
timeFrame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
measure: Change in shame
timeFrame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
measure: Change in Self-Compassion
timeFrame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Secondary outcomes:
measure: Change in Depression
timeFrame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
measure: Change in Anxiety
timeFrame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
measure: Change in Stress
timeFrame: Day 1, Day 8, Day 14, 4 weeks after completion of treatment
Other outcomes:
Locations:
Study officials:
affiliation: National University of Singapore
name: Marie Tan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03525535: Prevalence Rate of Pulmonary Embolism Among Not Anticoagulated Patients
Official title: MeAsurement of uneXpected Acute Pulmonary embolIsM Among Not Anticoagulated Patients Older Than 75 Years Admitted With Syncope.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Embolism
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 1
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male or female over 75 years old without anticoagulated treatment hospitalized for syncope symptoms.

Brief summary: The purpose of this study is to evaluate the prevalence rate of pulmonary embolism among not anticoagulated patient older than 75 years old admitted with syncope and hospitalised in the Toulon Hospital

Detailed description: This study will be proposed to every patient that correspond to eligibility criteria. Will be included only those who are not opposed to the collection of their data.

The data collected will come from the routine care such as medical history, clinical datas, imaging data... The number of pulmonary imaging will be assessed before the diagnostic strategy proposed by Dr Prandoni and after the application of this strategy thanks to a questionnaire to physicians.

Eligibility criteria: Inclusion Criteria:

* Male or Female over 75 years-old
* Emergency consult resulting on an hospitalization in the geriatric service or in the internal medicine service
* Hospitalised in the Centre Hospitalier Intercommunal de Toulon for syncope, presenting these symptoms:
* Loss of consciousness with quick return to normal (less than one minute)
* Spontaneous resolution

Exclusion Criteria:

* history of syncope
* other loss of consciousness (epilepsy, stroke, head trauma)
* anticoagulated treatment
* patient's objection

Primary outcomes:
measure: Pulmonary embolism prevalence
timeFrame: 24 month
Secondary outcomes:
measure: Assess the impact of the Prandoni's recommendations on the paraclinical evaluations
timeFrame: 24 month
Other outcomes:
Locations:
city: La Seyne-sur-Mer
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Benoit Faucher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04270136: Feasibility of Total Mastectomy in Ambulatory Care
Official title: Feasibility of Total Mastectomy in Ambulatory Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mastectomy
Ambulatory Care
Keywords: Breast Cancer
mastectomy
ambulatory care
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Beauvais
name: Centre Hospitalier de Saint-Quentin
First posted: 2020-02-17
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.

The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.

In France, Ambulatory care is developed as part of the new national health plan.

Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.

Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .


Eligibility criteria: Inclusion Criteria:

* All patient with an indication of breast non conserving surgery

Exclusion Criteria:

* Standard contra-indication for ambulatory care.
* Also bilateral surgery and immediate breast reconstruction.

Primary outcomes:
measure: number of ambulatory care after total mastectomy allowed with PADSS score
timeFrame: day 0= day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: Centre Hospitalier de Beauvais
name: Elodie Demblocque, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de Beauvais
name: Albine Mancaux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH SAINT-QUENTIN
name: Pierrick Theret, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02498236: Target Engagement for Oxytocin: Dose Ranging Study
Official title: Target Engagement for Oxytocin: Response to 8 Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum
Keywords: Psychosis
Schizophrenia
Oxytocin
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two proposed measures of target engagement in brain. The targets are (1) the suppression of a particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially relevant form of motion and (2) pupil dilation will subjects identify faces showing different emotions.

Detailed description: Subjects with schizophrenia spectrum disorders will be randomly assigned to one of 8 doses of oxytocin. After screening and informed consent subjects will receive either their assigned dose or a placebo. Thirty minutes following the drug administration patients will be evaluated on the EEG and pupillometry tasks followed by two tests that evaluate social salience. One week later subjects will have a second challenge in the alternative (drug or placebo) condition.

Eligibility criteria: Inclusion Criteria:

* Schizophrenia, Schizoaffective Disorder, Delusional Disorder
* Able to cooperate with study procedures

Exclusion Criteria:

* Serious medical condition or substance use
* Pregnancy

Primary outcomes:
measure: Mu Suppression on EEG
timeFrame: Baseline, 1 Week
measure: Pupil Dilation While Observing Faces
timeFrame: Baseline, 1 Week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00849836: Novel Biomarkers in Chronic Airway Diseases
Official title: The Study for The Identification of Novel Biomarkers in Chronic Airway Inflammatory Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
COPD
Lead sponsor: Chonbuk National University
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute exacerbation of asthma or COPD, patients with stable status of those disease, and the healthy control subjects

Brief summary: The purpose of this study is:

* To define The differences of bio-chemical phenotypes in chronic airway inflammatory diseases.
* To identify novel biomarkers in chronic airway inflammatory diseases as a screening, diagnostic, or monitoring marker.


Eligibility criteria: Inclusion Criteria:

* \> 18 years olds
* Both sexes
* Asthma or COPD was diagnosed according to the criteria of the American Thoracic Society, GINA, GOLD guideline
* Acute exacerbation was defined by the criteria of the American Thoracic Society, GINA, GOLD guideline
* For stable disease, none of the subjects had received inhaled or oral corticosteroids or any other anti-inflammatory drugs, had an exacerbation history in the previous 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Medical School
Study officials:
References:
Clinical trial NCT01104636: "VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany
Official title: "VIBRATIONS": Varenicline In Patients Ambitioned To Terminate Smoking - A Non-Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-15
Enrollment: 1177
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: Adult smokers who are willing and motivated to stop smoking

Brief summary: The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard 12 week treatment period. Additional information will be gathered regarding prescribing practices in Germany, smoking history, reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the tolerability of varenicline.

Detailed description: Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Eligibility criteria: Inclusion Criteria:

* Legal adult age
* Regular smoker, with main tobacco product smoked being cigarettes, and willing and motivated to stop smoking
* Evidence of a personally signed and dated Informed Consent document.

Exclusion Criteria:

* Any subjects considered unsuitable according to the Summary of product characteristics (SmPC)

Primary outcomes:
measure: Percentage of Participants Who Abstained From Smoking at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Level of Nicotine Dependence Measured by the Fagerstrom Test
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01768936: Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis
Official title: Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Peritonitis After Intestinal Perforation
Keywords: on-demand relaparotomy
PCT
procalcitonin
peritonitis
sepsis
focus index
Lead sponsor: CHIR-Net
Sponsor class: NETWORK
First posted: 2013-01-16
Enrollment: 234
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: consecutive postoperative surgical patients on ICU after intestinal perforation or anastomotic leakage with indication for surgical focus elimination

Brief summary: Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after initial operative focus elimination to investigate the PCT ratio's impact on decision-making for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic peritonitis.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* necessity for operative intervention to eliminate an infectious peritoneal / abdominal focus after organ perforation
* abdominal sepsis according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definition

Exclusion Criteria:

* pregnancy
* immunosuppressive medication

Primary outcomes:
measure: prediction of focus elimination: cured patients versus patients with persisting peritonitis (definitions see below)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TU München
Study officials:
References:
Clinical trial NCT06005636: Post-stroke Delirium in Ischemic Stroke Patients
Official title: Risk Factors and Risk Prediction Model for Post-stroke Delirium in Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Jinan University Guangzhou
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Jinan University
First posted: 2023-08-22
Enrollment: 985
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ischemic stroke patients were recruited from a Grade 3A hospital in Southern China.

Brief summary: This study is to investigate the predictors of post-stroke delirium, develop and validate a nomogram of post-stroke delirium in the ischemic stroke patients.

Detailed description: Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis. Effectively identifying risk factors of PSD and predicting PSD is of essential.

Methods: This is a prospective, single-centered, cohort study.

Eligibility criteria: Inclusion Criteria:

1. aged ≥18 years old;(2) ischemic stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans;(3) patients or their agencies agree to participate in this study.

Exclusion Criteria:

1. brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;(2) history of serious mental illness such as schizophrenia;(3) unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;(4) be in coma \[Glasgow Coma Scale (GCS)≤8 points\] or sedation \[Richmond Agitation Sedation Scale (RASS)\<-3 points\], and do not ameliorate during study;(5) with incomplete data.

Primary outcomes:
measure: post-stroke delirium
timeFrame: The first week of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Jinan University
state: Guangdong
Study officials:
affiliation: Jinan University
name: Fengxia Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01260636: Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries
Official title: A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid, Aortic, Renal or Peripheral Artery Disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2010-12-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries


Eligibility criteria: Inclusion Criteria:

* 18 yrs of age or older
* referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
* Able to provide written informed consent and comply with protocol requirements
* Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol

Exclusion Criteria:

* pregnant or lactating females
* Known allergy to one or more of the ingredients in the products under investigation
* Significant congestive heart failure ( Class IV)
* Moderate to severe chronic kidney disease
* Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
* Vascular stents in vessels of interest
* Received another contrast agent in the 24 hrs preceding or proceeding each exam
* Previously entered into the study
* Contraindications to MRI
* Severe Claustrophobia Undergone DSA between the two exams

Primary outcomes:
measure: Diagnostic Preference
timeFrame: Immediately post dose
Secondary outcomes:
measure: Safety comparison of two diagnostic agents
timeFrame: UP to 24 hours post dose of each contrast agent
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Radiology Department Zhongshan Hospital, Fudan University
Study officials:
References:
citation: Li Y, Li X, Li D, Lu J, Xing X, Yan F, Li Y, Wang X, Iezzi R, De Cobelli F. Multicenter, intraindividual comparison of single-dose gadobenate dimeglumine and double-dose gadopentetate dimeglumine for MR angiography of the supra-aortic arteries (the Supra-Aortic VALUE study). AJNR Am J Neuroradiol. 2013 Apr;34(4):847-54. doi: 10.3174/ajnr.A3298. Epub 2012 Oct 4.