louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03874286: The TOGETHER Project - Liver
Official title: The Together Project-Transplant Organ Genomics to Help Prevent Rejection in Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant Rejection
Keywords: Liver Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult liver transplant recipients with diverse demographics (e.g. recipient race and donor type) and treatment strategies (induction, steroid-free, etc.).

Brief summary: To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

Detailed description: The study is a prospective, observational study utilizing peripheral blood assays that will be collected at time points that are considered standard of care at most institutions. 100 participants will be enrolled in study. Participants will have peripheral blood collected at 4 months and 12 months after liver transplant, as well as any for cause time points. Participants will also have liver biopsies collected at these time points. The results from the liver biopsies will be used in correlation with the results from the peripheral blood assays.

Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
* Patients with increased risk of rejection. Patients must meet at least one of the following criteria:

  1. Autoimmune etiology of the original liver disease (autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis)
  2. Recipients of donation-after-cardiac death (DCD) donors
  3. Recipients of simultaneous liver-kidney transplantation
  4. Positive crossmatch liver transplant (T cell flow crossmatch or B cell flow crossmatch).

     Exclusion Criteria:
* Adult ( ≥ = 18 years) renal transplant recipient.

Primary outcomes:
measure: To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
timeFrame: 3 years
Secondary outcomes:
measure: To validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.
timeFrame: 3 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Stegall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00482586: Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy
Official title: Outcomes Following Image-Guided Therapy for Hepatic Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Metastatic Cancer
Keywords: adult primary liver cancer
liver metastases
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-05
Enrollment: 137
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: Patients with hepatic neoplasms who undergo Image-guided Therapy

Brief summary: RATIONALE: Gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy may help the study of cancer in the future.

PURPOSE: This clinical trial is gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy.

Detailed description: OBJECTIVES:

* Develop a data repository for clinical and health-related quality of life outcome measures in patients with hepatic malignancies treated with image-guided therapies.

OUTLINE: This is a pilot, prospective, longitudinal study.

Patients complete a standard questionnaire assessing health-related quality of life at baseline, during routine follow-up care after image-guided therapy, and then annually thereafter. Health and disease status and the development of other illnesses are assessed by medical record review.

PROJECTED ACCRUAL: Not specified

Eligibility criteria: DISEASE CHARACTERISTICS:

* Undergoing concurrent image-guided therapy for hepatic malignancies using any of the following imaging techniques:

  * X-ray
  * Ultrasound
  * MRI
  * CT scan
  * Nuclear medicine imaging

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Development of a data repository for clinical outcome measures by conducting a medical record review at baseline, during routine follow-up after image-guided therapy, and then annually thereafter
timeFrame: one year
measure: Development of a data repository for health-related quality of life outcome measures by administering the Medical Outcomes Study Short Form questionnaire at baseline, during routine follow-up after image-guided therapy, and then annually thereafter
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Steven G. Meranze, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03072186: Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery
Official title: Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skull Base Neoplasms
Skull Neoplasms
Bone Neoplasm
Neoplasms
Bone Diseases
Musculoskeletal Disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.


Eligibility criteria: Inclusion Criteria:

* 18 years and above
* Patients undergoing an an EEA for cranial base pathology that will require any of the following will be eligible for the study: optic canal decompression, intradural tumor dissection, dissection of tumor around the internal carotid artery.

Exclusion Criteria:

* Less than 18 years of age
* History of sulfa, iodide, or penicillin allergy
* Previous anaphylactic reaction to ICG
* Women currently pregnant or nursing

Primary outcomes:
measure: ICG Fluorescence Ratio
timeFrame: Before intradural dissection and during tumor dissection.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Daniel Prevedello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04611386: The Effect of Contrast Agents on the Anticoagulant Properties of Oral Factor Xa Inhibitors
Official title: Bursa Postgraduate Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Agents and Oral Factor Xa Inhibitor
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study prospectively included 65 people who underwent contrast computerized tomography (CT). The CT indications were thoracic aortic dilatation, chronic obstructive pulmonary disease, abdominal aortic dilatation, chronic abdominal pain.

Brief summary: The aim of this study is to evaluate the effect of iohexol as a contrast agent on the anticoagulant activity of oral factor Xa inhibitors.

Detailed description: The study included 65 people who underwent contrast computerized tomography (CT). The study patients were divided into 4 groups. Patients in group 1 were using rivaroxaban (20 patients), patients in group 2 were using apixaban (20 patients), patients in group 3 were using edoxaban (20 patients), and group 4 was the control group (5 volunteers). Iohexol (60 ml) was used as a contrast agent. Two tubes were used to collect 2 ml of blood from the patients at 4 hours after the drug dose (rivaroxaban, apixaban, or edoxaban) and 1 hour after the contrast CT (CT was performed 3 hours after the drug was taken). In the control group, at any time and 1 hour after contrast CT, 2 tubes of 2 ml of blood were collected. The anticoagulant properties of rivaroxaban, apixaban, and edoxaban were evaluated using anti-factor Xa levels.

Eligibility criteria: Inclusion Criteria:

1. the use of oral factor Xa inhibitors (patients with nonvalvular AF and CHA2DS2-VASc Score ≥2),
2. age of 21-80 years,
3. no contraindications for anticoagulation use,
4. GFR greater than 30,
5. volunteering to participate in the study, and
6. patients who needed to use contrast agent (iohexol) for CT examination. -

Exclusion Criteria:

1. coagulopathy,
2. severe hepatic insufficiency,
3. chronic systemic or inflammatory diseases,
4. patients lighter than 60 kg,
5. malignancy,
6. creatinine value above 1.5 mg/dl, and
7. not providing consent to participate in the study -

Primary outcomes:
measure: Anti Factor Xa level
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
References:
citation: Cavlan B, Ari S, Ari H, Camci S, Melek M, Bozat T. The effect of contrast agents on the anticoagulant properties of oral factor Xa inhibitors. Acta Radiol. 2023 Feb;64(2):588-595. doi: 10.1177/02841851221081474. Epub 2022 Mar 16.
Clinical trial NCT00888186: Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
Official title: Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Dyskinesias
Keywords: Dyskinesias
Duodenal levodopa infusion
Dose optimization
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Swedish Parkinson's Disease Foundation
name: Swedish Society for Medical Research
First posted: 2009-04-27
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
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 study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.

Detailed description: By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized dose will be used. Motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Ongoing treatment with Duodopa
* Occurrence of dyskinesias, difficult to manage
* Age 30-90 years
* Hoehn \& Yahr stage 3-5 at worst

Exclusion Criteria:

* Treatment with dopamine agonist or glutamate antagonist
* Dementia
* Psychosis
* Treatment with typical neuroleptics

Primary outcomes:
measure: Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
timeFrame: 3 days
Secondary outcomes:
measure: Correlation between choreatic dyskinesia, dystonia, and parkinsonism.
timeFrame: 3 days
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
References:
citation: Nyholm D, Nilsson Remahl AI, Dizdar N, Constantinescu R, Holmberg B, Jansson R, Aquilonius SM, Askmark H. Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease. Neurology. 2005 Jan 25;64(2):216-23. doi: 10.1212/01.WNL.0000149637.70961.4C.
Clinical trial NCT02693886: Effect of Single Colonoscopy on Colorectal Adenomas Detection
Official title: Clinical Study That Effect of Individualized Intervention of Single Colonoscopy on Colorectal Adenomas Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Polyps
Lead sponsor: Wuxi People's Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 10000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. greater than the age of 40;
2. Pathology and endoscopic data recorded available and detailed;
3. Whole bowel staining endoscopy is not done.

Brief summary: Individualized colonoscopy withdrawal time is determined based on the different grade of physician experience and quality of bowel preparation.


Eligibility criteria: Inclusion Criteria:

1. Greater than the age of 40;
2. Pathology and endoscopic data recorded available and detailed;
3. Whole bowel staining endoscopy is not done.

Exclusion Criteria:

1. Not reach the ileocecal junction;
2. Colorectal cancer;
3. Familial adenomatous polyposis;
4. Inflammatory bowel disease;
5. Part of the bowel resection.

Primary outcomes:
measure: Detection rate of polyps in different withdraw time
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Detection rate of polyps in different experiment levels of examiners
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06219486: The Safe Fast Track Study
Official title: Use of D-dimers in the Emergency Department to Identify Adult Patients at Very Low Risk of Mortality for Fast-track Treatment - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergency Department
Non-specific Complaints
Keywords: D-dimer
Fast track
emergency
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Slagelse Sygehus
name: Holbaek Sygehus
name: Esbjerg Hospital - University Hospital of Southern Denmark
First posted: 2024-01-23
Enrollment: 1538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Emergency departments (ED) internationally are treating an increasing number of patients.

Most require hospital services but some could be better cared for on alternative pathways.

D-dimer has some unique properties. It is non-specific and is elevated in many acute condi- tions; but conversely remains normal in the absence of significant disease. Previous studies have shown that having a normal D-dimer on arrival to the emergency department is associated with a very low risk of 30-day all-cause mortality.

The investigators propose a multicenter randomized controlled trial using D-dimer to identify patients at low risk and test if providing this information will change time to discharge disposition by the treating physician.


Eligibility criteria: Inclusion Criteria:

* Age 18 or above
* Able to provide oral and written informed consent in Danish
* Blood tests ordered on arrival as part of standard of care
* Ambulatory on arrival or walking to the ambulance (i.e., stable independent gait)
* Normal vital signs (i.e., National Early Warning Score \&lt; 3)

Exclusion Criteria:

* Unstable condition requiring immediate care in the resuscitation area
* Triage level red (i.e., the most urgent patients)
* Trauma (minor and major) patients
* High likelihood of requiring a D-dimer analysis on clinical indications during the current hospital contact (e.g., suspected venous thromboembolic disease) that will be ordered on arrival regardless of this study
* Previous participation in the study

Primary outcomes:
measure: Length of stay
timeFrame: From arrival to physician decision within 4 hours of arrival
Secondary outcomes:
measure: 7- and 30-day all-cause mortality from arrival
timeFrame: From arrival until 30-days later
measure: Hospital length of stay
timeFrame: From arrival until final discharge within 1 month
measure: Re-contacts to the emergency department within 30 days from arrival for any reason
timeFrame: From arrival until 30-days later
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital
state: Syd
city: Odense
country: Denmark
facility: Odense University Hospital
state: Syd
Study officials:
References:
Clinical trial NCT01032486: Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's Disease
Official title: An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Rasagiline
Sleep
Sleepiness
Parkinson's Disease Sleep Scale
Epworth Sleepiness Scale
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 120
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: This is a sample of participants with Parkinson's disease who will be prescribed Azilect® treatment as per Canadian product monograph in order to observe changes in sleep behaviour.

Brief summary: The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.


Eligibility criteria: Inclusion Criteria:

* idiopathic Parkinson's disease.
* eligible to Azilect® treatment as per Canadian product monograph

Exclusion Criteria:

* exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the Canadian product monograph.
* investigational drug within 30 days prior to study
* use of Azilect® or selegiline within 60 days prior to study
* significant medical condition

Primary outcomes:
measure: Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: André Barbeau Movement Disorders Unit, Centre Hospitalier Université de Montréal (CHUM)
name: Michel Panisset, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02666586: Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
Official title: Effects of Faba Bean Fractions as Ingredients in Novel Food Products on Glycemia, Appetite and Metabolic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Faba Bean
Post-prandial Blood Glucose
Appetite
Satiety Hormones
Insulin
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To describe the effect and mechanisms of action faba bean powder and fractions (protein, starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic regulation in young adults (18 to 30 years).

Detailed description: The overall objective is to describe the effect and mechanisms of action of faba bean powder and fractions (protein, starch and fiber) on glucose and insulin homeostasis, food intake, satiety and metabolic regulation in young adults (18 to 30 years). The specific objectives are to test the acute effects of different faba bean ingredient smoothie on: 1) post-prandial blood glucose, appetite, satiety hormone and insulin for 200 minutes, and 2) food intake 120 minutes following consumption of the faba bean smoothie. Two short-term acute studies will be conducted to meet these objectives. Both acute studies will follow a randomized, double blinded, balanced, repeated measures design and the same protocol; except one will have an ad libitum pizza meal (study 1), while the other will have a fixed pizza meal (study 2) at 120 minutes. Half the participants will have blood drawn by IV and the other half will be finger prick.

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking males
* aged 20-30 years (min/max age)
* a body mass index between 20 and 25 kg/m2 (the range generally accepted as ideal/healthy by Health and Welfare Canada)

Exclusion Criteria:

* individuals diagnosed with diabetes
* those on medication
* breakfast skippers
* on an energy restricted diet
* this study excludes females because appetite and blood glucose during the female menstruation cycle changes due to fluctuations in hormones

Primary outcomes:
measure: blood glucose
timeFrame: 0-200 minutes
Secondary outcomes:
measure: appetite
timeFrame: 0-200 minutes
measure: satiety hormones
timeFrame: 0- 200mins
measure: insulin
timeFrame: 0-200mins
measure: food intake
timeFrame: 120 minutes following consumption of the faba bean smoothie
measure: physical comfort
timeFrame: 0-200 minutes
measure: energy/fatigue
timeFrame: 0-200 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
References: