louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01280383: Non-invasive Neurally Adjusted Ventilatory Assist
Official title: Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Respiratory Failure
Keywords: non-invasive ventilation
diaphragm
electrical activity
neurally adjusted ventilatory assist
critically ill patients
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.

Detailed description: To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients

Eligibility criteria: Inclusion Criteria:

* Age 18 - 85 years
* History of chronic obstructive lung disease
* Invasive mechanical ventilation for more than 12 hours
* Planned extubation according to the weaning protocol of our clinic
* Informed consent obtained from a next of kin
* Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient

Exclusion Criteria:

* Tracheostomy
* Facial or cranial trauma or surgery
* Oral, esophageal, diaphragmatic or gastric trauma or surgery
* Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
* Uncooperative state and combativeness not responding to low levels of sedatives
* Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
* Next of kin refuses informed consent
* Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.

Primary outcomes:
measure: patient-ventilator synchrony
timeFrame: outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes
Secondary outcomes:
measure: changes in respiratory pattern
timeFrame: study duration
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital (Inselspital) and University of Bern
name: Lukas Brander, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.
Clinical trial NCT06060561: Genetic Testing to Improve Management of Patients Undergoing Breast Biopsy
Official title: Genetic Testing to Improve Management of Patients Undergoing Breast Biopsy
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred for a radiologically guided breast biopsy.

Brief summary: This study evaluates genetic testing to improve risk assessment and advance efforts to develop precision management for breast cancer by studying saliva samples for genotyping and evaluate associations with pathologic diagnoses and detailed pathologic and radiologic features.

Detailed description: PRIMARY OBJECTIVES:

I. To collect saliva from 500 consenting women undergoing a clinically indicated breast biopsy, perform genotyping, and then assess the associations of polygenic risk score (PRS) (and related single nucleotide polymorphisms \[SNPs\]) to final diagnosis of ductal carcinoma in situ (DCIS), invasive breast cancer or benign breast disease (BBD); BBD severity; specific BBD lesions; and features of background benign lobules from which these lesions arise.

II. To relate PRS (and related SNPs) to radiologic features, including breast density and sentinel lesions, such as masses, densities, calcifications, and asymmetries.

III. To relate PRS (and related SNPs) to molecular markers in pathologic lesions and background tissues, including associations with breast cancer (BC) molecular subtypes (e.g., luminal, triple-negative (basal) and human epidermal growth factor receptor 2 \[HER2\] overexpressing) and biomarkers in BBD and lobules.

OUTLINE: This is an observational study.

Patients undergo saliva sample collection and complete questionnaires on study. Patients' medical records are reviewed.

Eligibility criteria: Inclusion Criteria:

* \* Women over the age of 18 years

  * Able to provide informed consent
  * Referred for a radiologically guided breast biopsy

Exclusion Criteria:

* \* Men

  * Women under the age of 18 years
  * Unable to provide informed consent

Primary outcomes:
measure: Number of subjects consented per month
timeFrame: Baseline; Up to study completion (approximately 5 years)
measure: Deoxyribonucleic acid (DNA) quantity
timeFrame: Up to study completion (approximately 5 years)
measure: Deoxyribonucleic acid (DNA) quality
timeFrame: Up to study completion (approximately 5 years)
measure: Ability to perform genotyping using collected sample
timeFrame: Up to study completion (approximately 5 years)
measure: Success in estimation of polygenic risk score (PRS)
timeFrame: Up to study completion (approximately 5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Mark E. Sherman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03589261: Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects.
Official title: Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects: a Prospective Monocentric Study. PORTEAU Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Flow Changes
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. During fluid challenge in intensive care unit, fluid challenge is often administered to improve hepatic perfusion. That observation is not demonstrated. The aim of the study is to test buffer response and portal flow during fluid challenge.

Detailed description: Prospective monocentric study at Amiens Hospital University. 20 volunteers subjects will be include after providing informed consent. Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.

Eligibility criteria: Inclusion Criteria:

* Fasting for the last 12 hours.

Exclusion Criteria:

* Claustrophobia
* Any previous medical history disease;
* Any abdominal surgical disease
* Pregnancy or breastfeeding

Primary outcomes:
measure: Portal blood flow measure before and after fluid challenge
timeFrame: Two hours: the difference in hepatic portal flow before and after a volume expansion of 500 ml NaCl 0.9%.
Secondary outcomes:
measure: Hepatic artery blood flow measure before and after fluid challenge
timeFrame: Two hours
Other outcomes:
measure: Flow ratio of portal flow on hepatic artery flow
timeFrame: Two hours
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT02710461: Grape and Pomegranate Polyphenols in Postprandial Glucose and Related Parameters
Official title: Acute Effects of Grape and Pomegranate Polyphenols as Modulators of Metabolic Syndrome in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects With Abdominal Obesity
Keywords: Polyphenols
Grape
Pomegranate
Metabolic syndrome
Abdominal obesity
Postprandial glucose
Insulin resistance
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2016-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this is study is to evaluate the acute effect of grape and pomegranate polyphenols in the modulation of markers of metabolic syndrome. Most of the previous works about polyphenols have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a consequence, an important amount of dietary polyphenols, the so-called non-extractable polyphenols are ignored. In contrast, the effect of both extractable and non-extractable polyphenols will be considered in this study. Furthermore, the effect of both polyphenols as present in the food matrix and metabolites derived from microbial fermentation will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Abdominal perimeter ≥102 cm. for male participants and ≥88 cm for female participants.
* Subjects presenting some or several of these characteristics will be prioritized:

Fasting glucose values between 110-128 mg/dL. Triglycerides = 150-195 mg/dL. HDL-cholesterol: \< 50 mg/dL men, \< 40 mg/dL women. Blood pressure: systolic \> 130 mm Hg; diastolic \> 85 mm Hg.

Exclusion Criteria:

* Subjects taking drugs for hyperglycaemia, hypertension or hypercholesterolaemia.
* Volunteers participating in other studies or weight loss plans.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Postprandial glucose
timeFrame: 0-120 min.
Secondary outcomes:
measure: Postprandial insulin
timeFrame: 0-120 min.
measure: Postprandial uric acid
timeFrame: 0-120 min.
measure: Polyphenol metabolites
timeFrame: 0-180 min.
measure: Urinary uric acid
timeFrame: 0-180 min.
measure: Satiety
timeFrame: 120 min.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
Study officials:
References:
Clinical trial NCT01904383: PMS of Trazenta on the Long-term Use as Add-on Therapy
Official title: Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2013-07-22
Enrollment: 4057
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3000 patients with type 2 Diabetes Mellitus

Brief summary: Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion criteria:

Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included.

Exclusion criteria:

None

Primary outcomes:
measure: Percentage of Participants With Drug Related Adverse Events
timeFrame: From first drug administration until last drug administration, up to approximately 156 weeks.
Secondary outcomes:
measure: The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)
timeFrame: Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks.
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Ito T, Naito Y, Shimmoto N, Ochiai K, Hayashi N, Okamura T. Long-term safety and effectiveness of linagliptin as add-on therapy in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance. Expert Opin Drug Saf. 2021 Mar;20(3):363-372. doi: 10.1080/14740338.2021.1859477. Epub 2020 Dec 27.
Clinical trial NCT03820583: Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
Official title: Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whipple Procedure
Keywords: Whipple procedure, pancreatic carcinoma, biliary stenting,
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2019-01-29
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergoing Whipple procedure due to pancreatic tumor were included in the study
Primary purpose: TREATMENT

Brief summary: The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple procedure were studied by compiling demographic details of the patients, common presenting symptoms, various indications for Whipple's procedure, the cofactors which affect the procedures outcome and morbidity and mortality of the patients.

Detailed description: This study was performed by collecting data through predesigned questionnaire about patients undergoing Whipple's procedure from operation theatres and medical record section. Those patients, whose tumor was unresectable and undergone palliative surgical procedures were excluded from the study.

Eligibility criteria: Inclusion Criteria:

* patients of both sexes with age ranging from 20 years to 70 years
* patients with pancreatic tumors
* patients with adequate cardiorespiratory reserves to be fit for prolong general anesthesia

Exclusion Criteria:

* unresectable tumors
* unfit for surgery

Primary outcomes:
measure: Percentage of patients developing pancreatic fistula
timeFrame: 4 weeks
measure: Percentage of patients developing hemorrhage
timeFrame: 2 weeks
measure: Percentage of patients developing wound infection
timeFrame: 4 weeks
measure: Mortality rate
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT05901883: First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects
Official title: A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CEL383 When Administered Intravenously to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Celsius Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-13
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CEL383 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy, adult, male or female (of nonchildbearing potential only), 19-64 years of age, inclusive, at screening visit
* Willingness of men of reproductive potential to agree to use a condom with spermicide or abstain from heterosexual intercourse from dosing until at least 90 days after dosing
* Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening visit
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs

Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to dosing
* History or presence of any known primary or secondary immunodeficiency disorder
* History or presence of any signs, symptoms, or diagnosis of infection, including nausea, vomiting, fever, rash, confusion, muscle aches, cough, nasal congestion, or shortness of breath, in the 4 weeks prior to screening or during the screening period.
* History or presence of any known clotting or hemostasis disorder
* Female subject of childbearing potential

Primary outcomes:
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: Through the Day 85 study visit
Secondary outcomes:
measure: Cmax
timeFrame: Day 1 through Day 85
measure: Tmax
timeFrame: Day 1 through Day 85
measure: t1/2
timeFrame: Day 1 through Day 85
measure: AUC
timeFrame: Day 1 through Day 85
measure: ADA
timeFrame: Day 1 through Day 85
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Celsius Therapeutics, Inc.
name: Sarah Grant, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04038983: Risk for Short-term Adverse Events in Older Users in the Emergency Department
Official title: Risk for Short-term Adverse Events in Older Users in the Emergency Department: An Observational Cohort Study on Evaluation of PRISMA-7
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Old Age
Medical Care
Survey
Keywords: Emergency, Old patients , Survey Questionnaire
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 10000
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are two survey questionnaires that will be fill out by nurses when a patient who are 75 years old and over arrives: Prisma-7 ( Program of Research on Integration of Services for the Maintenances of Autonomy) and ER2 ( Emergency Room Evaluation and Recommendation).

Brief summary: The study evaluates the performance criteria of abnormal PRISMA-7 score, length of stay in Emergency department and in hospital, and hospital admission in older Emergency department users.

Detailed description: In Quebec, Canada, the "Program of Research on Integration of services for the Maintenance of Autonomy" (PRISMA-7) is the Ministry of Health and Social Services' reference tool for the frailty assessment of older Emergency department users. This tool has been initially developed and validated to assess disabilities in older community dwellers with the aim to quickly identify older individuals at risk for disabilities and who should undergo a comprehensive assessment. PRISMA-7 has a high sensitivity for identifying frailty in older community dwellers but its performance criteria for this goal has never been examined in older Emergency Department users. Recently, a systematic review underscored that PRISMA-7 has all characteristics for being a usable clinical tool in Emergency department because it is a brief (i.e., \<5 min), simple and multidimensionality assessment. PRISMA-7 is composed of 7 questions assessing health and functionality of older adults and stratifies risk for disability in two levels: low versus high. PRISMA-7 is a prognostic tool for disabilities.

Eligibility criteria: Inclusion Criteria:

* Being enrolled in the ER2 study( Emergency Room Evaluation and Recommendation)
* Having a score test of Prisma 7( Program of Research on Integration of Services for the Maintenances of Autonomy) at Emergency.

Exclusion Criteria:

* Never being enrolled in the ER2 study( Emergency Room Evaluation and Recommendation)
* Never having a score test of Prisma 7( Program of Research on Integration of Services for the Maintenance of Autonomy) at Emergency

Primary outcomes:
measure: Length of hospital stay
timeFrame: around 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06871683: ClotTriever® Thrombectomy System Use-Result Survey in Japan
Official title: ClotTriever® Thrombectomy System Use-Result Survey in Japan
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Deep Vein Thrombosis
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
Collaborators: name: Vorpal Technologies
First posted: 2025-03-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with deep vein thrombosis with acute severe symptoms (excluding postthrombotic syndrome) for whom the ClotTriever® Thrombectomy System was used. Patients will be enrolled until at least 100 subjects complete the follow-up period through 6 months.

Brief summary: The objective of this survey is to determine the safety and efficacy of the ClotTriever Thrombectomy System under daily clinical practice after marketing approval in Japan.

This device was designated as a subject of use results evaluation at the time of application for manufacturing and marketing approval.


Eligibility criteria: This is an all-comers survey of all patients treated with ClotTriever® Thrombectomy System in Japan.

Primary outcomes:
measure: Rate of Major Adverse Events
timeFrame: Through 30 days post index procedure.
measure: Technical Success
timeFrame: During the index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chuo
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Ota
country: Japan
facility: Ota Memorial Hospital
state: Gunma
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Kyoto
country: Japan
facility: Kyoto Katsura Hospital
Study officials:
References: