louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03613376: Compression And Functional Ability After Endovenous Varicose Vein Treatment
Official title: Compression And Functional Ability After Endovenous Varicose Vein Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins of Lower Limb
Varicose Veins
Keywords: Varicose veins
Compression stockings
Sclerotherapy
Radiofrequency ablation
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)


Eligibility criteria: Inclusion Criteria:

* Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
* Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
* Distal varicose vein insufficiency suitable for sclerotherapy
* Patient willingness to participate

Exclusion Criteria:

* History of pulmonary embolism or deep venous thrombosis
* Large (\>12mm) truncal vein diameter
* CEAP C5-C6
* Antithrombotic medication (ASA accepted)

Primary outcomes:
measure: Post-operative pain
timeFrame: 10days recorded daily
Secondary outcomes:
measure: Functional ability, other than pain
timeFrame: 10 days recorded daily
measure: Aberdeen Varicose Veins Questionnaire (AVVQ)
timeFrame: Assessed preoperatively and at 2 months
measure: Visual appearance of varicose veins, patient assessment
timeFrame: Preoperatively and at 2 months
measure: Signs of deep venous thrombosis hematoma
timeFrame: Assessed at 2 months and earlier if necessary
measure: Time required returning to normal activity
timeFrame: 14 days
measure: Time required returning to full activity
timeFrame: 14 days
measure: Postoperative pigmentation
timeFrame: at 2 months
measure: Visual appearance of varicose veins, expert assessment
timeFrame: Preoperatively and at 2 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital, Vascular Department
Study officials:
References:
Clinical trial NCT01013376: A Pilot Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Dry AMD
Official title: A Pilot, Single-Center, Open-Label Study of the Safety of MC-1101 in Both Normal Volunteers and Patients With Early Non-exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
Lead sponsor: MacuCLEAR, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The safety and comfort of repeated administrations of a topically-administered ophthalmic formulation of MC-1101 will be established through investigator assessments and subject reporting over a 3 day period. Safety assessments will be performed on both normal, healthy subjects as well as those with the signs and symptoms of early non-exudative age-related macular degeneration (dry AMD).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of dry AMD or;
* Normal, healthy volunteer

Exclusion Criteria:

* Uncontrolled systemic disease
* Women who are pregnant, nursing, or planning a pregnancy during the study's duration

Primary outcomes:
measure: Ocular safety
timeFrame: 3 days
Secondary outcomes:
measure: Choroidal blood flow assessment
timeFrame: 3 days
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail L Torkildsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739076: Pain Control After Trauma
Official title: Pain Control After Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2008-08-21
Enrollment: 184
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using Virtual Reality as a form of pain control for trauma patients.

Detailed description: The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' pain from trauma.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 12 years
* Compliant and able to complete questionnaires
* Hospitalization for internal injuries requiring a laparotomy or for orthopedic injuries (closed long bone or calcaneus fractures).
* A minimum of 3 days hospitalization
* No history of psychiatric (DSM-IV-R Axis I) disorder
* Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
* Able to communicate verbally
* Able to take oral medications
* Baseline pain level of \>=5/10
* English-speaking

Exclusion Criteria:

* Age less than 12 years
* Not capable of indicating pain intensity
* Not capable of filling out study measures
* Hospitalization of less than 3 days
* Evidence of traumatic brain injury
* History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes.
* Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems.
* Unable to communicate orally.
* Unable to take oral medications
* History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment
* Receiving prophylaxis for alcohol or drug withdrawal
* Developmental disability
* Mini-mental status score of greater than 20 in patients older than 80 years or suspected of cognitive deficits
* Non-English Speaking
* Extreme susceptibility to motion sickness
* Seizure history

Primary outcomes:
measure: Pain and Anxiety
timeFrame: up to 3 times a day
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington; Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: David R Patterson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00668876: Effects of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy
Official title: Effects of Immunonutrition on Surgical Site Infection and Th1/Th2/Th17 Differentiation in Patients Undergoing Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreaticoduodenectomy
Keywords: immunonutrition
pancreaticoduodenectomy
Th1
Th2
Th17
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2008-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether immunonutrition is effective on surgical site infection and Th1/Th2/Th17 differentiation in patients undergoing pancreaticoduodenectomy

Detailed description: Perioperative immunonutrition is reported to improve the incidence of postoperative infectious complication in patients with gastrointestinal surgery. It has also been recognized that Th1/Th2 balance shifts toward Th2 by surgical stress. On the other hand, the change of Th17 status after surgery has not been established. Furthermore, The change of Th1/Th2 balance and Th17 status with immunonutrition on pancreaticoduodenectomy have not been reported yet.

Objective of this study is to investigate the effects of perioperative immunonutrition on incidence of postoperative infectious complication, Th1/Th2 balance and Th17 status after pancreaticoduodenectomy.

Eligibility criteria: Inclusion Criteria:

* patients underwent pancreaticoduodenectomy

Exclusion Criteria:

* age younger than 18 years or older than 75 years
* preoperative chemotherapy or radiation
* ongoing infection
* diabetes mellitus
* gastrointestinal obstruction
* respiratory dysfunction
* cardiac dysfunction
* hepatic dysfunction
* renal failure
* history of recent immunosuppressive or immunological diseases
* preoperative evidence of widespread metastatic disease

Primary outcomes:
measure: surgical site infection after surgery
timeFrame: 30days
Secondary outcomes:
measure: plasma IL-6, CRP, Th1/Th2 balance, Th17 status
timeFrame: 14 days
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University
Study officials:
affiliation: Chiba University
name: Daisuke Suzuki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05686876: FAPI-PET/CT in Psoriatic Arthritis
Official title: Fibroblast Activation Protein-Targeted PET/CT With 68Ga-FAPI for Imaging Psoriatic Arthritis: Comparison to 18F-NAF PET/CT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Psoriatic Arthritis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 20
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: SCREENING

Brief summary: 68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation, such as IgG4-related disease. Therefore, this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.

Detailed description: Psoriatic arthritis (PsA) is a chronic inflammatory disease that develops in up to 30% of patients with psoriasis and characterized by diverse clinical features including peripheral and axial arthritis, enthesitis, dactylitis and nail dystrophy, leading to impaired function and reduced quality of life. Positron emission tomography (PET) allows for highly sensitive depiction of targets at the molecular level and can be used to specifically visualize immune cells of interest through the use of specific tracers. In this study, we used two tracers: 68Ga-fibroblast activation protein inhibitor (FAPI) and 18F-sodium fluoride (18F-NaF) to evaluate both joint inflammation and bone metabolism in patients with PsA. And the study is going to investigate whether 68Ga-FAPI PET/CT may be superior for disease activity assessment and follow-up of psoriatic arthritis than 18F-NAF PET/CT.

Eligibility criteria: Inclusion Criteria:

* fulfilled the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR)
* 18F-NAF PET/CT within two weeks
* signed written consent.

Exclusion Criteria:

* pregnancy
* breast feeding
* known allergy against FAPI
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Diagnostic value
timeFrame: Through study completion, an average of 3months
Secondary outcomes:
measure: Disease activity assessment
timeFrame: Through study completion, an average of 3months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT06930976: Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells
Official title: Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glucose
Metabolism
Isotope Labeling
Immune System and Related Disorders
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand how cells of the immune system use the common sugar glucose to fuel energy production and as a building block within the cell. Investigators will intravenously infuse a non-radioactive glucose tracer into participants over a few hours and collect immune cells from the blood to track uptake and usage of this glucose within these immune cells.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 or older

Exclusion Criteria:

* Pregnant
* Prisoner or in police custody
* Uncontrolled hyperglycemia/diabetes
* Current participation in another study where the total volume of blood drawn, when added to this study blood draw volume, exceeds 500cc in an 8 week period
* Any medical issue or pharmacologic exposure which, in the opinion of the study investigator, that might interfere with the study objectives
* Any reason which, in the opinion of the study investigator, adds additional risk to the participant

Primary outcomes:
measure: 13C6-glucose uptake in immune cells
timeFrame: Up to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Jeffrey C Rathmell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06700876: Evaluation of IGRA, Symptoms and Chest Radiograph for Subclinical TB Detection in ESRD and KT
Official title: Evaluation of Interferon-gamma Release Assays, Symptom Screening and Chest Radiograph for Detection of Subclinical Tuberculosis of End-stage Kidney Disease and Kidney Transplant Recipients in Thailand
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis (TB)
End-Stage Kidney Disease
Keywords: Subclinical Tuberculosis
Interferon gamma release assays
End-stage Kidney Disease
Detection of Subclinical Tuberculosis
Tuberculosis
IGRAs
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2024-11-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: End-stage renal disease on renal replacement therapy (hemodialysis or peritoneal dialysis) or status-post-living donor or deceased donor kidney transplantation aged more than or equal 18 years

Brief summary: This is an observational study among approximately 160 end-stage renal disease patients on renal replacement therapy and post-living donor or deceased donor kidney transplant recipients. Investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.

Detailed description: Patients with chronic kidney disease and end-stage kidney disease (ESKD) are at risk of developing tuberculosis and are often delayed in diagnosis. Herein, investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.

Eligibility criteria: Inclusion Criteria:

1. End-stage renal disease on renal replacement therapy (hemodialysis or peritoneal dialysis) or status-post-living donor or deceased donor kidney transplantation
2. Aged more than or equal 18 years

Exclusion Criteria:

1. Positive PPD test or a previously documented positive PPD
2. Active pulmonary or extrapulmonary tuberculosis

Primary outcomes:
measure: 1.The number of participants with positive IGRAs among end-stage kidney disease and kidney transplant patients
timeFrame: A prospective cohort study with following up period 2 years
measure: 2. The number of participants with latent TB and active TB among end-stage kidney disease and kidney transplant patients during the 2-year follow-up defined by:
timeFrame: A prospective cohort study with following up period 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Study officials:
affiliation: Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
name: Punnee Pitisuttithum, Prof. E.
role: STUDY_CHAIR
References:
Clinical trial NCT05383976: A Feasibility Study to Improve Colorectal Cancer Screening Among Racially Diverse Zip Codes in a Persistent Poverty County Using Navigation and Machine Learning Predictive Algorithms
Official title: A Feasibility Study to Improve Colorectal Cancer Screening Among Racially Diverse Zip Codes in a Persistent Poverty County Using Navigation and Machine Learning Predictive Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 201
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will consist of patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices. Patients will have had a colonoscopy order placed in the past 6 months and have not scheduled, cancelled, or no-showed to their colonoscopy.

Brief summary: The overarching goals of the "PCSNaP" Research Study is to support the Abramson Cancer Center (ACC) of the University of Pennsylvania in carrying out its mission to increase colorectal cancer (CRC) screening completion among high-risk individuals living in a persistent poverty county by designing, conducting, disseminating and evaluating an electronic health record-based automated identification program to target effective, culturally-sensitive CRC screening navigation to individuals who have not completed an ordered colonoscopy or fecal immunochemical test (FIT).


Eligibility criteria: Inclusion Criteria:

* Patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices
* Patients who have had a colonoscopy order placed in the past 6 months and have not scheduled, cancelled, or no-showed to their colonoscopy

Primary outcomes:
measure: Enrollment in Navigator Program (Feasibility)
timeFrame: During the three month enrollment period
measure: Completion of Colorectal Cancer Screening
timeFrame: Within the three month enrollment period and three month follow-up period
measure: Adenoma Detection Rate
timeFrame: Within the three month enrollment period and three month follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Carmen Guerra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611376: Impedance Cardiography During Major Abdominal Surgery
Official title: Comparison of Cardiac Output Derived From Flotrac/Vigileo and Impedance Cardiography During Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Surgery
Keywords: impedance cardiography
Flotrac/Vigileo
cardiac output
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators validated ICG's(impedance cardiography) usefulness during the abdominal surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)

Detailed description: Intrathoracic structures have relatively constant resistance except the influence of changing diameter of aorta. Great vessels in thorax has the lowest resistance, and their diameter changes by the beats of the heart. As their diameter increases, their resistance decreases. ICG measures the difference between the resistances caused by heartbeats, and calculates cardiac output.

But during the surgery, there are many interfering electrical currents made by electro cautery, patient positioning, and internal organ handling. Therefore, it has been thought that ICG is not a valid tool for measuring cardiac output during the surgery.

The investigators validated ICG's usefulness during the surgery, by comparing it with Floctac/Vigileo.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing open gastrectomy with arterial line
* ASA 1 \& 2

Exclusion Criteria:

* severe valve disease
* severe lung disease

Primary outcomes:
measure: Cardiac output
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Ilsan Paik hospital
state: Gyeonggi-do
Study officials:
affiliation: Ilsan-Paik Hospital
name: Won Joo Choe
role: STUDY_CHAIR
affiliation: Ilsan-Paik Hospital
name: Jun Hyun Kim
role: STUDY_DIRECTOR
affiliation: Ilsan-Paik Hospital
name: Kyung woo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JY, Kim BR, Lee KH, Kim KW, Kim JH, Lee SI, Kim KT, Choe WJ, Park JS, Kim JW. Comparison of cardiac output derived from FloTrac/Vigileo and impedance cardiography during major abdominal surgery. J Int Med Res. 2013 Aug;41(4):1342-9. doi: 10.1177/0300060513487649. Epub 2013 Jun 26.