louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02186054: T2 Weighted Imaging of the Liver With Fast Spin Echo MRI
Official title: Enhancement of T2 Weighted Imaging of the Liver With Fast Spin Echo Magnetic Resonance Imaging (MRI).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Disease
Keywords: Abdominal-Pelvic MRI (magnetic resonance image)
T2W (T2 weighted)
FSE Flex (recently developed MRI pulse sequence)
Enhanced single shot FSE (fast spin echo).
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to test two new MRI (magnetic resonance imaging) sequences to see how they compare to previously used imaging sequences as they may improve the quality of abdominal MRI.

Detailed description: * Approximately 50 patients undergoing routine liver MRI in our practice imaged with one of our 4 clinical scanners will undergo our standard liver MRI protocol with the addition of 2 breath-hold sequences (FSE Flex and eSSFSE) only increasing the scan time by approximately 3 minutes.
* Data will be retrieved from examinations that have been performed from the patient's electronic imaging file stored in our picture archiving and communication system (PACS).
* Images will be completely anonymized. No patient identifiers will be available on the images during the analysis.
* Analyses will include the visual assessment of image quality, presence and severity of imaging artifact and other non-invasive imaging outcomes performed by radiologists blinded to patient information and the type of sequence performed. Data will be presented in a Likert type scale (1=poor, 2=suboptimal, 3=average, 4=above average and 5=excellent) and imaging parameters will be compared using the Wilcoxon sign rank test.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine liver MRI imaged with one of our 4 clinical scanners (MR 750W, General Electric, Milwaukee WI)

Exclusion Criteria:

* Patients not undergoing routine liver MRI

Primary outcomes:
measure: The number of abdominal MRI scans deemed improved quality
timeFrame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
Secondary outcomes:
measure: The number of MRI scans that display severity of imaging artifact
timeFrame: Regular scan time with one of 4 clinical scanners plus 3 additional minutes
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital (Civic Campus)
state: Ontario
Study officials:
affiliation: OHRI
name: Nick Schieda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01647854: Operation of a Mobile Telemedicine System in the EMS
Official title: Introduction and Operation of a Mobile Telemedicine System to Support Paramedics in the Emergency Medical Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehospital Emergency
Teleconsultation
Safety
Keywords: emergency medical service
telemedicine
teleconsultation
safety
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 425
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study is to investigate the safety and efficacy of the operation of a prehospital teleconsultation system in the Emergency Medical Service.

Detailed description: Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. The paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can be transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The safety and efficacy of the introduction and operation of this system should be evaluated.

Eligibility criteria: Inclusion Criteria:

* prehospital emergency
* consent of the patient for teleconsultation was obtained or patient is unable to consent due to the severity of the emergency

Exclusion Criteria:

* patient refuses consent for teleconsultation
* psychiatric emergency

Primary outcomes:
measure: Rate of complications
timeFrame: up to 2 hours
Secondary outcomes:
measure: Time intervals
timeFrame: up to 2 hours
measure: Duration of teleconsultation
timeFrame: up to 2 hours
measure: Requirement of on-scene EMS physician
timeFrame: up to 2 hours
measure: Technical assessments
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
affiliation: University Hospital Aachen, Germany, Department of Anesthesiology
name: Rolf Rossaint, Prof. Dr.
role: STUDY_CHAIR
affiliation: University Hospital Aachen, Germany, Emergency Department
name: Jörg C Brokmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882154: To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions
Official title: A Single Center, Open, Randomized, 2-Way, 2-Period, 2-Sequence Crossover Study of the Bioequivalence of 300 mg Cefdinir (Test Formulation) and Omnicel 300 mg Capsule (Reference Formulation) Each Given as a Single Oral Dose to Twenty-Eight Healthy Male and/or Female Volunteers in the Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SFBC Anapharm
name: Richard Larouche, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02624154: Pancreatic Neuroendocrine Tumor：Factor of Surgery Influencing Survival
Official title: Pancreatic Neuroendocrine Tumor：Factor of Surgery Influencing Survival
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neuroendocrine Tumor
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 2
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Investigators selected the patient who underwent pancreatectomy during the time from 2010 to 2013 at the First Affiliated Hospital of Sun Yat-sen University.

Brief summary: Investigator determined the factor of surgery associated with the survival of pancreatic neuroendocrine tumor.

Detailed description: The variables including clinical characteristics, surgical data and pathological findings are examined by univariate and multivariate analyses.

Eligibility criteria: Inclusion Criteria:

* The patients with pancreatic neuroendocrine tumor underwent pancreatectomy

Exclusion Criteria:

* The patients with pancreatic neuroendocrine tumor did not undergo pancreatectomy

Primary outcomes:
measure: The survival rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Shaowei Gao, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06032754: PortoSinusoidal Vascular Diseases and Systemic Sclerosis
Official title: PortoSinusoidal Vascular Diseases and Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PSVD With or Without SSc
Keywords: Porto-Sinusoidal Vascular Disease
Nodular regenerative hyperplasia
Systemic sclerosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 types of patients : PSVD with SSC, PSVD without SSC, SSC without PSVD will be compared.

Brief summary: Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.

Detailed description: The study aims to compare the outcome of patients with MVPS associated with SSc to patients with MVPS without SSc. This work is a multicenter retrospective study comparing two groups of adult patients, one with MVPS associated with SSc and the other with MVPS without SSc. Patients with MVPS associated with SSc will be recruited from French university hospital departments of Hepatogastroenterology and Internal Medecine. Patients with MVPS without SSc will be recruited from the Beaujon Hospital database dedicated to liver vascular diseases.

Eligibility criteria: Inclusion Criteria:

* PSVD (Valdig criteria)
* SSC (ACR/EULAR 2013 criteria)

Exclusion Criteria:

* Liver cirrhosis
* Limited scleroderma
* Autoimmune hepatitis
* Primary biliary cholangitis

Primary outcomes:
measure: Prognosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Chu de Caen
state: Calvados
Study officials:
References:
Clinical trial NCT01442454: Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis
Official title: Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis: A Prospective Correlation With Intraoperative Findings and Surgical Pathology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pancreatitis
Keywords: chronic pancreatitis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing EUS

Brief summary: The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology.


Eligibility criteria: Patients who are eligible are individuals who have:

* normal pancreas
* suspected chronic pancreatitis
* established chronic pancreatitis (by ERCP, MRI, previous EUS, CT)
* pancreatic cancer

Patients who are not eligible are individuals who have:

• an uncorrectable coagulopathy (platelet \<50,000, INR\>1.5), or bleeding disorder, or are unable to discontinue anticoagulation 5-7 days prior to EUS (aspirin and bridging therapy with lovenox are allowed, clopidogrel is not allowed)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT00177554: Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
Official title: Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin Lymphoma
Keywords: Non-Hodgkin Lymphoma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2005-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma

Detailed description: Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.

Eligibility criteria: Inclusion Criteria:

* Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
* No prior chemotherapy
* No prior monoclonal antibody therapy
* Bulky or symptomatic disease, stage II-IV
* Performance status 0-2

Exclusion Criteria:

* Impaired bone marrow reserve
* Presence of CNS lymphoma
* Serious nonmalignant disease or active infection

Primary outcomes:
measure: Complete response rate
timeFrame: May 2007,May 2008, May2009, May 2010
Secondary outcomes:
measure: PET-CT conversion rate
timeFrame: May2007
measure: Frequency and severity of adverse events
timeFrame: May 2007
measure: Duration of complete response
timeFrame: May 2007,May 2008, May 2009, May 2010
measure: Time to next lymphoma therapy
timeFrame: May 2207,May2008,May2009, May2010
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Samuel A Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacobs SA, Swerdlow SH, Kant J, Foon KA, Jankowitz R, Land SR, DeMonaco N, Joyce J, Osborn JL, Evans TL, Schaefer PM, Luong TM. Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. Clin Cancer Res. 2008 Nov 1;14(21):7088-94. doi: 10.1158/1078-0432.CCR-08-0529.
Clinical trial NCT06699654: "Comparison of Spirulina Gels for Treating Stage II Grade B Periodontitis"
Official title: Comparative Study Between Spirulina Gel and Spirulina Nanoparticles Gel for Treatment of Stage II Grade B Periodontitis: Randomized Control Clinical Study with Radiological and Biochemical Assessment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periodontitis Stage II
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of three arms: Spirulina Gel, Spirulina Nanoparticles Gel, or control. The interventions are administered over a defined period with radiological and biochemical assessments conducted at baseline and post-treatment.
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical study investigates the effectiveness of Spirulina gel and Spirulina nanoparticles gel in treating Stage II Grade B periodontitis. The research aims to compare the two formulations in terms of clinical, radiological, and biochemical outcomes, such as pocket depth reduction, alveolar bone density improvement, and inflammatory marker levels. The study seeks to provide insights into the potential of Spirulina-based therapies for enhancing periodontal health.


Eligibility criteria: Inclusion criteria:

* Patients with good systemic health.
* Patients who can maintain good oral hygiene.
* Attachment loss 3-4 mm and probing pocket depth ≤ 5mm. Exclusion criteria for this study include: ·

  * Any systemic disease that affects the periodontium. ·
  * Pregnant, postmenopausal women. ·
  * People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.
  * People who use mouth washes regularly ·
  * Participation in other clinical trials.

Primary outcomes:
measure: Reduction in Probing Pocket Depth (PPD)
timeFrame: at baseline, 1 month , 3 months, 6 months
Secondary outcomes:
measure: Radiographic Bone Density Improvement
timeFrame: at baseline and after 6 months
measure: Biochemical Marker Levels
timeFrame: Measured at baseline, 1 month ,3 months, and 6 months
Other outcomes:
Locations:
city: El-Sheikh Zayed City
country: Egypt
facility: Doctor Mohamed Samir Periodontal and Implantology Clinic
state: Cairo
Study officials:
affiliation: Kafrelsheikh University
name: Enas Elgendy, Prof.Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04665154: A First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers
Official title: A First-in-human, Randomized, Subject-blinded, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of MAS825 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is conducted to investigate the safety, tolerability and pharmacokinetics of MAS825 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

• Healthy male and female subjects 18 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

Exclusion Criteria:

* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
* A history of ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test
* Fasting LDL \> 160 mg/dL, at screening.
* Subjects in cohorts D1 and D2 (Japanese cohorts) must be of first to third generation Japanese ethnic origin.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: up to day 253
Secondary outcomes:
measure: Concentrations of anti-MAS825 antibodies
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: Maximum Plasma Concentration [Cmax]
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: Time to reach maximum concentration [Tmax]
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: AUClast
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: AUCinf
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: T1/2
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: CL
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: Vz
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: Vz/F
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: Vss
timeFrame: up to day 197
measure: Pharmacokinetic parameters of MAS825: CL/F
timeFrame: up to day 197
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Overland Park
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Mere Way
country: United Kingdom
facility: Novartis Investigative Site
state: Nottingham
Study officials:
References:
Clinical trial NCT06645054: Usability of the Smart Hallway System in Clinical Setting
Official title: Smart Hallway for Gait Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation
Gait Disorders, Neurologic
Keywords: Gait analysis
Computerised assessment
Rehabilitation
Lower limb loss
Prosthetics and orthotics
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after lower limb loss (because of traumatic reason or disease) for the LLL group; patients fitted with lower-limb orthosis because of neurological reasons for the LLO group

Brief summary: The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.

Detailed description: The goal of the study is to use off-the-shelves markerless and contactless technologies and automatically digitise the person's movements as they walk through an institutional hallway. Multi-camera-based technologies can merge 2D-video into 3D-information. With an appropriate software, one can acquire data, perform the kinematic calculations and generate a report, all with minimal or no human intervention. The specific research question are whether pathological gait or walking disorders of the patients can be identified and classified based on the system's output, whether signs of depression can be classified from the the system's output, and whether the results of the 6-minute walk test can be predicted from the the system's output.

Eligibility criteria: Inclusion Criteria:

* ability to walk at least 10 metres without help of a person,
* no severe cognitive problems (able to answer questionnaires),
* native Slovenian speakers,
* wiling to participate (signed informed consent)

Exclusion Criteria:

* severe cognitive impairment,
* not being able to walk with or without a prosthesis or orthosis.

Primary outcomes:
measure: Smart Hallway
timeFrame: Upon admission to rehabilitation
measure: Falls during rehabilitation
timeFrame: Upon discharge from rehabilitation
Secondary outcomes:
measure: World Health Organisation Disability Assessment Schedule
timeFrame: Upon admission to rehabilitation
measure: Activity Specific Balance Confidence Scale
timeFrame: Upon admission to rehabilitation
measure: Hospital Anxiety and Depression Scale
timeFrame: Upon admission to rehabilitation
measure: Six-minute walk test
timeFrame: Upon admission to rehabilitation
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Helena Burger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: