louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06029088: Risk-adapted Strategy Including Magnetic Resonance Imaging and Prostate-specific Antigen Density in Blood for Biopsy Decision in Patients With Lesions Suspicious for Prostate Cancer
Official title: Risk-adapted Strategy Combining Magnetic Resonance Imaging and Prostate-specific Antigen Density to Individualize Biopsy Decision in Patients With PI-RADS 3 'Gray Zone' Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: Prostate cancer
Risk-adapted strategy
Magnetic resonance imaging
Prostate-specific antigen density
PIRADS
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-08
Enrollment: 616
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care clinic

Brief summary: Recent guidelines now recommend multi parametric magnetic resonance imaging prior to biopsy for all men as an integral part of improved diagnosis of clinical significant prostate cancer. However, magnetic resonance imaging targeted biopsy is a strategy that focuses on maximizing detection of clinical significant prostate cancer, but this procedure has the disadvantage of leading to higher detection of clinically insignificant prostate cancers. One of the risk-stratifications developed to minimize the existing disadvantages and avoid unnecessary biopsy procedures is a strategy in which multi parametric magnetic resonance imaging and prostate-specific antigen density are used in combination. This is especially important in all patients with PI-RADS (Prostate Imaging Reporting and Data System) 3 lesions which are also interpreted as indeterminate mpMRI findings. Current guidelines suggest that biopsy may be omitted in some patient groups with PI-RADS 3 lesions in the risk-adapted strategy involving prostate-specific antigen density. The aim of this study was to evaluate the role of risk-adapted strategies involving prostate-specific antigen density in biopsy decision to avoid unnecessary biopsy vs the risk of missing clinical significant prostate cancer diagnosis in patients with PI-RADS 3 lesions.


Eligibility criteria: Inclusion Criteria:

* Patients who all had undergone multi parametric magnetic resonance imaging at our hospital
* Patients who all had undergone transrectal ultrasonography guided cognitive and fusion targeted biopsies

Exclusion Criteria:

* Magnetic resonance imaging at exterior hospitals
* Insufficient image quality/artifacts
* Previous prostate biopsy and/or prior prostate cancer diagnosis

Primary outcomes:
measure: Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement
timeFrame: 2 weeks from the outpatient clinic admission
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
References:
Clinical trial NCT01575288: Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
Official title: Oral Trehalose Therapy to Reverse Arterial Aging in Middle-Aged and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Aging
Keywords: arterial function
cardiovascular
aging
endothelial function
arterial stiffness
vascular function
Trehalose
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will assess the ability of a naturally occurring sugar to improve the function of arteries with age. Overall, the proposed research project has the long-term potential to influence clinical practice guidelines by establishing a novel, easy to deliver, cost-effective therapy for treating age-associated arterial dysfunction and reducing the risk of cardiovascular disease with age.


Eligibility criteria: Inclusion Criteria:

* women must be postmenopausal
* body mass index (BMI) \<40 kg/m2
* weight stable in the prior 3 months
* absence of clinical disease as determined by medical history, physical examination, blood and urine chemistries, ankle-brachial index, and a graded exercise stress test with monitoring of blood pressure and 12-lead ECG

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 12 weeks
measure: nitric-oxide mediated endothelium-dependent dilation
timeFrame: 12 weeks
Secondary outcomes:
measure: Systemic oxidative stress and inflammation
timeFrame: 12 weeks
measure: Endothelial cell oxidative stress and inflammation
timeFrame: 12 weeks
measure: Insulin sensitivity
timeFrame: 12 weeks
measure: Endothelial cell autophagic flux
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado, Boulder Clinical Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Rachelle E Kaplon, MS
role: STUDY_DIRECTOR
affiliation: University of Colorado, Denver
name: Douglas R Seals, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04298788: Food Intake and Blue Dishware in Residents Living With Dementia
Official title: Food Intake and Blue Dishware in Residents Living With Dementia in Retirement Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Preferences
Eating Behavior
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: participant meals were randomized to blue or white dishware conditions, matched for food choices
Primary purpose: PREVENTION

Brief summary: Blue dishware was alternated with white dishware for lunch and dinner for residents living with dementia. Food consumption occurred in the home dining room and food was weighed before and after consumption to determine proportion consumed. Eating challenges were also noted. Within-participant comparisons were made to determine if food intake and eating challenges improved with the blue dishware condition.


Eligibility criteria: Inclusion Criteria:

* living in a residential care environment with dementia
* informed consent of POA and assent of person living with dementia

Exclusion Criteria:

* did not come to the dining room to eat
* required eating assistance
* did not live on the study unit

Primary outcomes:
measure: Precent of Food consumed of food served (grams consumed/grams provided)
timeFrame: 8 weeks
Secondary outcomes:
measure: Percent of Meals with an Eating challenge based on an Eating challenges Checklist
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Riverside Glen
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Heather Keller
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donnelly R, Wei C, Morrison-Koechl J, Keller H. The effect of blue dishware versus white dishware on food intake and eating challenges among residents living with dementia: a crossover trial. BMC Res Notes. 2020 Jul 23;13(1):353. doi: 10.1186/s13104-020-05195-y.
Clinical trial NCT02695888: Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
Official title: A Pilot Study of a Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent
Accidents, Traffic
Attention
Motor Vehicles
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2016-03-01
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.

Detailed description: This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers. Approximately 20 teens who have been licensed for less than 90 days will be enrolled and evaluated at baseline, \~1 week and \~4 weeks. Participants will complete an intervention after the \~1 week assessment. This study will provide information on the feasibility of the web-based intervention to prevent risky driving and estimation of effect size of the intervention on cell phone use while driving.

Eligibility criteria: Inclusion Criteria:

1. Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
2. Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
3. PA driver's license for 90 days or less at time of teen assent
4. Personal email address and computer and internet access
5. Ability to read and write English
6. Primarily drives one vehicle with the ability to accommodate the DriveID device
7. Parental consent and teen assent

Exclusion Criteria:

1. Participation in a Center for Injury Research and Prevention at CHOP teen driving study within the past 6 months
2. Unable to follow study procedures

Primary outcomes:
measure: Retention of participants
timeFrame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
Secondary outcomes:
measure: In-vehicle cell phone use
timeFrame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
measure: Self-reported driving behaviors
timeFrame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01957488: Investigating the Safety and Performance of Two New 1-piece Ostomy Products Compared With SenSura 1-piece
Official title: Investigating the Safety and Performance of Two New 1-piece Ostomy Products in 180 Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current investigation is to investigate the performance of two new 1-piece ostomy products

Detailed description: The present investigation aims at testing the performance and safety of the two new 1-piece ostomy products

Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and signed letter of authority (mandatory in DK)
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the products themselves
4. Have an ileostomy with a diameter between 10 and 40 mm.
5. Have had their ostomy for at least three months.
6. Have within the last month used a 1-piece flat product with open bag
7. Currently using midi or maxi bags
8. Willing to use minimum 1 product every second day, i.e. maximum 2 days wear time.
9. Be suitable for participation in the investigation
10. Must be able to use custom cut product
11. Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
2. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
3. Are pregnant or breastfeeding
4. Participating in other interventional clinical investigations or have previously participated in this investigation
5. Has participated in the previous explorative Coloplast studies CP236 and CP237
6. Are currently or during the study using ostomy belt
7. Has a stoma below skin surface
8. Currently suffering from peristomal skin problems (i.e.bleeding and/or broken skin)
9. Has known hypersensitivity towards any of the test products

Primary outcomes:
measure: Leakage
timeFrame: 14 +- 1 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Holtedam 3
city: Groningen
country: Netherlands
facility: QPS Nederlands
city: Larvik
country: Norway
facility: Sykepleierklinikken
city: Chorley
country: United Kingdom
facility: Synexus Limited
state: Lancashire
Study officials:
affiliation: Coloplast A/S
name: Birte P Jakobsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224588: KETOR: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
Official title: Effects of Peri Operative Administration of Ketamine on Long Term Post Thoracotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ketamine
Chronic Post Thoracotomy Pain
Thoracotomy
Pain
Neuralgia
Keywords: Ketamine
Chronic post thoracotomy pain
NMDA
Post operative
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Direction Régionale de la Recherche Clinique D'ILE DE FRANCE
name: Clinical Research Unit
name: European Georges Pompidou Hospital
First posted: 2005-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We assessed the effects of the N Methyl aspartate receptor antagonist Ketamine on long-term post thoracotomy pain. We hypothesized that ketamine could prevent supersensitization of the central nervous system involved in this chronic neuropathic pain.

Detailed description: In this clinical, randomized prospective study, peri operative administration of ketamine was compared to placebo on long term post thoracotomy pain after a 2 months follow up period.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for thoracotomy or pneumectomy

Exclusion Criteria:

-

Primary outcomes:
measure: Long term (2 months) post thoracotomy pain was assessed using a french equivalent of the Mc Gill Pain score and pain area measurements in both groups
Secondary outcomes:
measure: Analogic pain scores at rest and after coughing
Other outcomes:
Locations:
city: Paris
country: France
facility: Georges Pompidou European Hospital
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Thierry GUENOUN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
Clinical trial NCT01216709: Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)
Official title: Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Dietary Supplements
Food, Fortified
Keywords: Infant
Dietary Supplements
Food, Fortified
Iron Absorption
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: University of California, Davis
First posted: 2010-10-07
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.


Eligibility criteria: Inclusion Criteria:

* 6-7 months of age at the start of intervention
* healthy at enrollment
* full-term (\>37 gestational weeks at birth)
* birth weight \>2500 g
* predominantly bottle-fed at recruitment

Exclusion Criteria:

* iron deficiency at enrollment
* previous or current use of iron supplements

Primary outcomes:
measure: iron absorption
timeFrame: 1 month after enrollment
Secondary outcomes:
measure: indicators of iron metabolism, growth, and oxidative stress
timeFrame: 1 month and 1.5 months after enrollment
measure: zinc absorption
timeFrame: 1 month after enrollment
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Clinical Sciences, Pediatrics, Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Magnus Domellöf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522509: Preoperative Hepatic Arterial Infusion Chemotherapy
Official title: Preoperative Hepatic Arterial Infusion Chemotherapy in Patients Undergoing Liver Resection for Colorectal Liver Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Liver Metastases
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2007-08-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: To assess the feasibility and results of liver resection after preoperative hepatic artery infusion (HAI) chemotherapy with FUDR.

Detailed description: Between 1995 and 2004, 239 patients with isolated colorectal liver metastases received HAI chemotherapy with neoadjuvant intent. Fifty of these patients underwent subsequent curative liver resection (HAI group).

Postoperative morbidity, liver function tests, and long term outcomes were evaluated. Adverse events related to HAI chemotherapy were also evaluated.

Eligibility criteria: Inclusion Criteria:

* Unresectable liver metastases
* Potentially resectable liver metastases

Exclusion Criteria:

* Extrahepatic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Surgery - Liver Unit, Scientific Institute San Raffaele,
Study officials:
affiliation: Department of Surgery - Liver Unit, Scientific Institute San Raffaele,
name: Luca Aldrighetti, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06460909: Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
Official title: Randomised Study Evaluating the Interest of Psychological Support of Patients Waiting for Hallux Valgus Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallux Valgus Surgery
Keywords: Hallux Valgus Surgery
Psychological Support
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Catastrophizing is a negative evaluation of events. What surgery concerns, pain catastrophizing is one of the main risks of postoperative pain and / or poor functional recovery. The best survey to evaluate pain catastrophizing is the PCS (Pain Catastrophizing Scale). According to the authors, catastrophizers report more negative pain related thoughts, more emotional distress and more pain than non-catastrophizers. The PCS is a significant predictor of pain intensity and so of poor functional recovery.

It is already well known that anxiety and catastrophizing predict postoperative pain.

The actual studies focus mainly on functional recovery of knee and hip arthroplasties, but less on pain and functional recovery of hallux valgus surgery.

According to several authors, adapted psychological support of preoperative catastrophizing could allow a better postoperative evolution.

Our hypothesis is that a preoperative psychological consultation of catastrophizing patients is efficient to lower pain catastrophizing in adult patients undergoing a surgical operation for hallux valgus.

The first objective is to evaluate the impact of a psychological support of preoperative pain catastrophizing during a hallux valgus surgery.The principal evaluation scale is the pain catastrophizing score before and after surgery.

The second objective is to evaluate the pain and functional recovery of pain catastrophizing patients. The criteria of this survey are: anxiety score (usual and actual), pain and function according to the FAOS (Foot and Ankle Outcome Score) pain (Analogic Visual Scale).


Eligibility criteria: Inclusion Criteria:

* Adult over 18
* Independent, living in its own home
* Affiliated at a social security
* Consent signed
* Waiting for a Hallux Valgus surgery.

Exclusion Criteria:

* Not Able to understand french language
* Patient refusal
* Under guardianship
* Under french AME system

Primary outcomes:
measure: Impact of preoperative psychological support on pain catastrophizing
timeFrame: at baseline
Secondary outcomes:
measure: Pain evaluate of catastrophizing patients
timeFrame: at baseline
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Orthopedia and traumatological department
Study officials:
affiliation: Ambroise Paré hospital - APHP
name: Marie-Hélène Sandiford
role: PRINCIPAL_INVESTIGATOR
References: