louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05866666: Cardiac Performance System Data Collection Study
Official title: Cardiac Performance System Data Collection Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Lead sponsor: Sensydia Corporation
Sponsor class: INDUSTRY
Collaborators: name: Orlando Health, Inc.
First posted: 2023-05-19
Enrollment: 115
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac catheterization procedure

Brief summary: Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Detailed description: Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* 22 years of age or older
* Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria:

* Previous Heart Transplant
* Presence of Left Ventricular Assist Device
* Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
* Surgical scars/wounds/bandages/ports at the site of sensor placement

Primary outcomes:
measure: Cardiac Performance System electronic data for Cardiac Output
timeFrame: 10 minutes before cardiac catheterization procedure
measure: Cardiac Performance System electronic data for Pulmonary Artery Pressure
timeFrame: 10 minutes before cardiac catheterization procedure
measure: Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure
timeFrame: 10 minutes before cardiac catheterization procedure
measure: Pulmonary Artery Catheter electronic data for Cardiac Output
timeFrame: 60 minutes during cardiac catheterization procedure
measure: Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure
timeFrame: 60 minutes during cardiac catheterization procedure
measure: Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure
timeFrame: 60 minutes during cardiac catheterization procedure
measure: Echocardiography electronic data for Ejection Fraction
timeFrame: 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Yahaira Ortiz-Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03478566: Transcutaneous CO2 Monitoring at Home for Children With Neuromuscular Disease
Official title: The Diagnostic Accuracy and Reliability of Transcutaneous Carbon Dioxide Monitoring at Home for Nocturnal Hypoventilation Screening in Children With Neuromuscular Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Disorder; Breathing-Related
Central Apnea
Neuromuscular Diseases
Obstructive Sleep Apnea
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 39
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There is an unmet demand for the evaluation of nocturnal hypoventilation in children with NMD. An ambulatory screening tool that can reliably facilitate timely diagnosis and treatment in these children would be invaluable. If an ambulatory, at home, tcCO2 monitoring device is shown to be diagnostically accurate, sleep physicians would be able to triage children on existing waiting lists and optimize screening of nocturnal hypoventilation as recommended by international guidelines.


Eligibility criteria: Inclusion Criteria:

* children with a confirmed diagnosis of NMD that meet criteria for evaluating SDB as per international recommendations
* lives within the greater Toronto area.

Exclusion Criteria:

* known diagnosis of nocturnal hypoventilation
* current ventilatory support
* physician diagnosis of active upper respiratory tract infection (fever, increased cough, rhinorrhea, increased nasal congestion, sore throat, headache, malaise and/or sneezing).

Primary outcomes:
measure: Sensitivity and specificity of ambulatory, at home, transcutaneous CO2 (tcCO2) monitoring to diagnose nocturnal hypoventilation as compared to the gold standard, end tidal CO2 conducted during polysomnogram (PSG).
timeFrame: 9 months
Secondary outcomes:
measure: a) Agreement of tcCO2 monitoring when worn in the ambulatory, at home, setting compared to tcCO2 recorded during a PSG in a hospital based sleep laboratory for diagnosis of nocturnal hypoventilation.
timeFrame: 9 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Staff Physician
name: Reshma Amin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00604266: Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study
Official title: Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cholangiocarcinoma
Keywords: Potentially resectable hilar cholangiocarcinoma as per initial imaging studies.
Able to undergo PET/CT and MRI with Gadolinium
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2008-01-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifteen patients with potentially resectable hilar cholangiocarcinomas, as determined by conventional imaging modalities, will be recruited. In order to minimize false positive uptake of 18F-FDG due to inflammatory changes, patients will be recruited either before biliary stenting, or after biliary stenting if there is no clinical evidence of active cholangitis.

Brief summary: To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of potentially respectable hilar cholangiocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Hilar cholangiocarcinoma assessed by conventional imaging modalities (triphasic CT scan of the liver) and thought to be potentially resectable.

Exclusion Criteria:

* Biliary drain inserted.
* Contraindication for MRI.
* Pregnant or breast-feeding.
* Uncontrolled diabetes (over 9.7 mmol/L).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: UHN - Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: U of Toronto, UHN
name: Ur Metser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917566: Evaluation of Airtraq in Pediatric
Official title: Evaluation of Airtraq in Pediatric Population: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Keywords: Airtraq
Pediatric
Lead sponsor: King Khaled Eye Specialist Hospital
Sponsor class: OTHER_GOV
First posted: 2009-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study indented to evaluate the use of Optical laryngoscope in pediatric

Detailed description: The authors are welling to study how intubation will differ if Airtraq optical laryngoscope used in pediatrics

Eligibility criteria: Inclusion Criteria:

* Healthy children undergoing general anesthesia required tracheal intubation.

Exclusion Criteria:

* History of difficult intubation.
* Risk of aspiration.
* Children with cardiovascular disease.
* Children with respiratory disease.

Primary outcomes:
measure: Duration of intubation
timeFrame: two minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: king Khaled Eye Specialist hospital
Study officials:
affiliation: King Khaled Eye Specialist Hospital
name: Waleed Riad, MD, AB, SB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264666: Postprandial Effect of Chinese Tea Flavor Liquor on Selected CVD Risk Factors
Official title: Phase I Study of Chinese Tea Flavor Liquor on Human Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohols
Cardiovascular Diseases
Keywords: Chinese tea flavor liquor
postprandial
uric acid
high-sensitive C-reactive protein
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Guizhou Meijiao Co., Ltd, China
First posted: 2010-12-22
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Background: human studies of Chinese liquor are sparse. we hypothesis that Chinese Tea Flavor liquor may be beneficial to CVD risk factors postprandially.

Design: three-way crossover design with one week wash time.16 young men were included to consume 60mL Chinese tea flavor liquor(45% alcohol content), Chinese Meijiao liquor 45% alcohol content) or water control.Blood samples were collected fasted, 0.5,1,2,4 hours postprandially.

Tested serum indices: lipids, glucose, insulin, hs-CRP, uric acid, liver function parameters.


Eligibility criteria: Inclusion Criteria:

* no CVD history or liver disease, healthy young men

Exclusion Criteria:

* smokers

Primary outcomes:
measure: serum sample
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Food Science of Nutrition, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03178266: Zip Arthroplasty Patient Satisfaction Evaluation
Official title: Zip Arthroplasty Patient Satisfaction Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty
Lead sponsor: ZipLine Medical Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for knee arthroplasty

Brief summary: This study is a prospective, randomized, single center, study to evaluate Zip Closure Device in subjects undergoing knee arthroplasty. Patients identified as candidates for knee arthroplasty and meet the study selection criteria will be approached and considered for the study. Knee Arthroplasty of 40 subjects will be enrolled where 20 subjects will receive ZipLine and 20 subjects will receive Staples.

Detailed description: Sutures and metal staples are considered standard of care methods for surgical skin closure. The Zip® Surgical Skin Closure device from ZipLine Medical, Inc. (Campbell, CA USA) is a more recent method of skin closure that utilizes skin adhesive and adjustable ratcheting straps to achieve and maintain tension necessary for wound closure and healing. The Zip device was designated Class I, 510(k) Exempt by the US FDA in 2010, and the CE Mark was affixed in 2014.

Limited patient-reported satisfaction data exists for the Zip device as compared to staples and sutures, so this study will attempt to address this need.

The purpose of the study is to evaluate patient satisfaction of closure method used after knee joint arthroplasty. Metal staples and the Zip® Surgical Skin Closure device are approved methods in regular use. Selection of method is generally based on physician preference. This study is to determine what, if any, differences exist in patient satisfaction amongst the two methods

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing primary elective knee arthroplasty.
2. Willing and able to provide informed consent and/or obtain legal guardian authorization
3. Willing and able to comply with the subject-specific requirements outlined in the study protocol

Exclusion Criteria:

1. Patients that do not meet the conditions listed in the wound closure device warnings, precautions, and contraindications (Appendix A)
2. Patients with comorbidities or conditions that the investigator deems to be ineligible for the study
3. Patients without the capacity to give informed consent (e.g., dementia)

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 6 weeks post knee arthroplasty
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 weeks post knee arthroplasty
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Montgomery Orthopaedics Associates
state: Pennsylvania
Study officials:
affiliation: Cheif of Surgery and Orthopaedics
name: Bruce Menkowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02428166: Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
Official title: Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: crosslinking
keratoconus
keratometry
pachymetry
pentacam
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible keratoconus patients aged 18-50 years who underwent unilateral crosslinking treatment in our ophthalmology department and completed a postoperative follow-up of 2-14 months

Brief summary: The purpose of this retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. The corneal measurements obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and ocular surgeries as potential factors involved in treatment outcome are also evaluated.


Eligibility criteria: Inclusion Criteria:

* Keratoconus patients after unilateral crosslinking treatment

Exclusion Criteria:

* Morphological changes of the cornea caused be ocular infection or trauma (e.g. corneal scarring)
* Other pre-existing corneal surgery (e.g. corneal transplantation, implantation of intrastromal corneal ring segments)

Primary outcomes:
measure: Change in maximum keratometry (Kmax) as measured by the Pentacam HR
timeFrame: after completion of data collection based on the measurements preoperatively and 2-14 months postoperative
Secondary outcomes:
measure: Change in corneal thickness as measured by the Pentacam HR
timeFrame: retrospective analysis from preoperatively to 2-14 months postoperatively
measure: Change in visual acuity (VA)
timeFrame: retrospective analysis from preoperatively to 2-14 months postoperatively
measure: Evaluation of pre-existing ocular pathology or/and ocular surgery as potential factors involved in treatment outcome
timeFrame: retrospective analysis from preoperatively to 2-14 months postoperatively
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of ophthalmology, University of Heidelberg
state: Baden-Wuerttemberg
Study officials:
affiliation: Department of ophthalmology, University of Heidelberg
name: Mike P Holzer, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00532766: Evaluating Pharmacokinetics and Pharmacodynamics of Jusline
Official title: Bioequivalence of Jusline Following Subcutaneous Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy subjects
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2007-09-20
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

Detailed description: To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration in the abdominal, and to compare this profile with Humulin insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).

Eligibility criteria: Inclusion Criteria:

* Healthy
* Non-diabetic
* Age 18-35 year
* Normal body mass index (BMI 18-25 kg/m2)

Exclusion Criteria:

* Diabetics
* Overweight/obese
* Anemic, with liver, cardiac, renal or thyroid dysfunction

Primary outcomes:
measure: To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline)
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: University Diabetes Center
Study officials:
affiliation: College of Medicine, King Saud University
name: Khalid A Al-Rubeaan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01272466: Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma
Official title: Vaccination With Peptides Derived From Anti-apoptotic Proteins From the Bcl-2 Family, Administered in Combination With Montanide ISA-51 in Relation to Treatment With Proteasome Inhibitors in Patients With Relapsed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Relapsed Multiple Myeloma
Keywords: multiple myeloma
vaccination
antiapoptotic proteins
proteasome inhibition
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2011-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. Patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory adjuvant. The vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of multiple myeloma
* tissue type of HLA-A1, HLA-A2 or HLA-A3
* Performance status \< 2
* Adequate bone marrow - renal and liver function
* written informed concent

Exclusion Criteria:

* candidate for bone marrow transplantation
* other malignancies than multiple myeloma
* other significant medical disease (heart-, lung or liver disease or diabetes)
* allergy
* active autoimmune disease
* treatment with immunosuppressive drugs
* treatment with other experimental drugs
* uncontrolled hypercalcemia

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Haematology, Odense University Hospital
Study officials:
affiliation: Department of Haematology, Odense University Hospital
name: Lene M Knudsen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00662766: Intervention With Black Currant Seed Press Residues in Healthy Subjects
Official title: Intervention Study on the Health Beneficial Effects of Bread Enriched With Black Currant Seed Press Residues in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Black currant
Berry seed
Press residue
Tocopherol
Fatty acids
Fiber
Total phenols
TEAC
Comet assay
Dihydroxybenzoic acid
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2008-04-21
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was performed to investigate the effects of the consumption of black currant seed press residues, which were baked into bread.

Detailed description: Berry seeds are a by-product of berry fabrication (e. g. to juices or jam). In order to maintain their functionality and long life span, berry seeds need to contain cell stabilizing ingredients such as vitamins and polyphenols. Since it seems to be a valuable source of health beneficial substances in human nutrition, commercial use should be found. Therefore, seeds were pressed (seed press residue), ground and baked into bread for consumption.

Black currant seed press residues are rich in tocopherols and also contain anthocyanins; both act as antioxidants. Additionally there is 50% fibre in the residue, soluble and insoluble fibre in equal shares.

Eligibility criteria: Inclusion Criteria:

* discrimination between smoker (\> 5 cigarets/d) or non-smoker

Exclusion Criteria:

* diet during the study
* serious sport
* diagnosed diseases
* use of nutritional supplements

Primary outcomes:
measure: oxidant/antioxidant status of the test person
timeFrame: after 1, 5, and 9 weeks
Secondary outcomes:
measure: tocopherol intake, tocopherol faecal excretion and serum tocopherol concentration
timeFrame: after 1, 5, and 9 weeks
measure: fiber intake and excretion
timeFrame: after 1, 5, and 9 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Jena, Dept. of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Jena, Dept. of Nutritional Physiology
name: Dorit Helbig, Dipl. troph.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helbig D, Wagner A, Schubert R, Jahreis G. Tocopherol isomer pattern in serum and stool of human following consumption of black currant seed press residue administered in whole grain bread. Clin Nutr. 2009 Dec;28(6):662-7. doi: 10.1016/j.clnu.2009.05.003. Epub 2009 Jun 11.