louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01276483: Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients
Official title: Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Neoplasms
Gastrointestinal Tract
Keywords: GIST
Response Monitoring
Functional Magnetic Imaging
Positron Emission Tomography
Computer Tomography
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 40
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: GIST patients suitable for medical treatment with targeted therapies.

Brief summary: The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.


Eligibility criteria: Inclusion Criteria:

* Metastatic GIST patients suitable for TKI treatment
* GIST patients pursuing preoperative neoadjuvant TKI treatment

Exclusion Criteria:

* Patients with contraindications to MRI and/or TKI treatment. For patients with renal failure, CT without intravenous contrast will be performed according to clinical practice.
* Patients who do not sign the consent paper for any reason or do not accept the study premises or patients who wish to withdraw for any reason during the study

Primary outcomes:
measure: Radiologic-pathologic correlation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hosptal
Study officials:
affiliation: Oslo University Hospital, Dept of Nuclear Medicine
name: Mona-Elisabeth Revheim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital, Institute for Cancer Research
name: Therese Seierstad, PhD
role: STUDY_CHAIR
affiliation: Oslo University Hospital, Dept of Oncology, The Norwegian Radium Hospital
name: Øyvind S Bruland, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital, Department of Diagnostic Radiology
name: Knut Håkon Hole, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital, Department of Diagnostic Radiology
name: Lars Julsrud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Revheim ME, Hole KH, Bruland OS, Reitan E, Bjerkehagen B, Julsrud L, Seierstad T. Multimodal functional imaging for early response assessment in GIST patients treated with imatinib. Acta Oncol. 2014 Jan;53(1):143-8. doi: 10.3109/0284186X.2013.798428. Epub 2013 May 28. No abstract available.
Clinical trial NCT06547983: Effectiviteit en Beleving Van FooDIYou
Official title: Effectiviteit en Beleving Van FooDIYou
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Digital studies
Personalized nutrition
Lead sponsor: TNO
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 180
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies have shown that personalized nutrition advice is more effective compared to generic nutrition advice for weight loss purposes. However, since decentralization of clinical trials is on the rise, it of interest to test whether personalized nutrition advice is as effective when provided fully digitally. In the current study the investigators compare the effects of generic vs. personal nutritional interventions in a fully digital study. Three groups are included, a control group receiving generic nutritional advice, an intervention group receiving personalized nutrition advice and an intervention plus group receiving personalized nutrition advice plus personalized meals. The trial takes six weeks. Anthropometric data are collected every two weeks and data on changes in nutritional diet are collected at the beginning and end of the intervention. In addition, the opinion of the participants on trial participation is asked as well every two weeks during the trial.


Eligibility criteria: Inclusion Criteria:

* Age between 25-60 years
* BMI between 25 and 40
* Motivated to lose weight
* Can fill in a digital questionnaire
* Posses a smartphone, computer, weighing scale and measuring tape to perform anthropometric measurements.

Exclusion Criteria:

* Any food allergy
* Chronic diseases influencing food intake (e.g., IBD)
* Participating in another intervention study
* Females in menopausal transition
* Follow a specific diet

Primary outcomes:
measure: Body weight in kilograms
timeFrame: 6 weeks
Secondary outcomes:
measure: Body height in meters
timeFrame: 6 weeks
measure: BMI as calculated by combining body weight and height (kg/m^2)
timeFrame: 6 weeks
measure: Hip circumference in centimeters
timeFrame: 6 weeks
measure: Waist circumference in centimeters
timeFrame: 6 weeks
measure: Neck circumference in centimeters
timeFrame: 6 weeks
measure: Wrist circumference in centimeters
timeFrame: 6 weeks
measure: Dietary habits as measured using the Nutri+ Module
timeFrame: 6 weeks
measure: Opinion on digital intervention as measured using an online questionnaire.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: TNO
state: South-Holland
Study officials:
affiliation: TNO
name: Femke Hoevenaars, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02625883: Out-of-Hospital Resuscitation in Winterthur - an Outcome Study
Official title: Out-of-Hospital Resuscitation in an Urban Setting in Switzerland - an Outcome Study and Cost Effectiveness Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resuscitation
Keywords: Resuscitation, quality of life
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were resuscitated out-of-hospital in the year 2013 by the emergency medical team from the Kantonsspital Winterthur.

Brief summary: The investigators will retrospectively examine all patients with out-of-hospital resuscitation by the emergency medical Team (EMT) from the Kantonsspital Winterthur in the year 2013 with a two year follow-up and a structured interview about Quality of life. Furthermore, the costs generated by the local health system are analysed.

Detailed description: The Primary objective of this study is to evaluate the Quality of out-of-Hospital resuscitation by the ambulance Service from the Kantonsspital Winterthur including a 2-year follow-up of the survivors. In this follow-up we evaluate the Quality of life by a validated questionnaire.

The following endpoints will be retrospectively analysed:

time-to-Response Interval; Initial cardiac rhythm; medications given; number of Defibrillations; return of spontaneous circulation, Overall costs for the local health System

Furthermore length of hospital-stay, survival until Hospital discharge, one-year survival, Quality of life two years after resuscitation and total costs will be analysed.

Eligibility criteria: Inclusion Criteria:

* Patients with out-of-hospital resuscitation in Winterthur in the year 2013 and treatment by the emergency medical team from the Kantonsspital Winterthur
* Written informed consent of patients for structured interview

Exclusion Criteria:

* Patients with resuscitation but death on Scene
* no written informed consent from patients for structured interview

Primary outcomes:
measure: Survival after prehospital cardiac Arrest until discharge of Hospital and a one-year follow-up
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of direct costs of local health care system
timeFrame: 1 year
measure: Quality of life one year after resuscitation
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: sponsor and principal investigator
name: Michael Ganter, director
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruch R, Stoessel L, Stein P, Ganter MT, Button DA. Outcome, quality of life and direct costs after out-of-hospital cardiac arrest in an urban region of Switzerland. Scand J Trauma Resusc Emerg Med. 2019 Nov 27;27(1):106. doi: 10.1186/s13049-019-0682-7.
Clinical trial NCT00963183: AZD5423 Single Ascending Dose Study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD5423 After Single Ascending Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety
Tolerability
Healthy
Inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
* Use of any prescribed or non-prescribed medication

Primary outcomes:
measure: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab), lung function and physical examination
timeFrame: Frequent sampling occasions during study days
Secondary outcomes:
measure: Pharmacokinetics - Maximum plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve from zero to the time of the last measurable concentration [AUC(0-t)] and from zero to infinity (AUC)
timeFrame: Frequent sampling occasions during study days
measure: Add'l pharmacokinetics - Terminal rate constant (λz); terminal half-life (t½λz), Apparent plasma clearance (CL/F), apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT).
timeFrame: Frequent sampling occasions during study days
measure: Pharmacodynamics - Plasma cortisol concentrations
timeFrame: Frequent sampling occasions during study days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Jorup Carin
role: STUDY_DIRECTOR
affiliation: Guy's Drug Research Unit, Quintiles Ltd, London, UK
name: Darren Wilbraham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03877783: DEMAND - Multifactorial Study to Reduce Dementia in People With Type 2 Diabetes
Official title: Diet, Physical Exercise and Metabolic Control (DEMAND) Intervention to Reduce the Incidence of Major Neurocognitive Disorders Among Individuals With Type 2 Diabetes Combined With Mild Neurocognitive Impairment - a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Mild Cognitive Impairment
Keywords: mediterranean diet
physical fitness
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the DEMAND pilot study, we will recruit and randomize 80 participants at two study sites (Umeå and Uppsala) for a one-year intervention. The primary objectives are to study the inclusion rate, the adherence rate, and the acceptability of the intervention. The secondary objectives are to examine the effect of the intervention on intermediate outcomes, including metabolic control (i.e., blood glucose and lipids), body weight, blood pressure, physical fitness, and cognitive function. Third, the investigators will perform focus group interviews to explore the participants views on the intervention to assess the acceptability. The interventions include (a) Mediterranean diet (b) an individualized physical training program and (c) pharmacological treatment for type 2 diabetes (T2D) aimed to achieve individualized optimal goals, according to national guidelines, taking into account the risk of hypoglycaemia. This multi-component intervention is more comprehensive than usual care, and it specifically focuses on vascular domains.

Detailed description: To be inserted.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes diagnosed in the last year
* age \>=65 years
* signed consent form
* Mild cognitive impairment

Exclusion Criteria:

* diagnosis type 1 diabetes
* major neurocognitive degeneration
* serious illness with live expectancy less than 3 years
* drug- or alcohol-abuse or other neurological / psychiatric illness which affects the outcome
* depressive syndrome
* predicted inability to conduct the study because of drug abuse, serious illness, language issues
* documented episodes of hypoglycemia where help of a third part was needed
* Allergy to fish or nuts
* Angina pectoris
* Heart failure (NYHA 3-4)

Primary outcomes:
measure: inclusion rate
timeFrame: 4 months
measure: adherence rate
timeFrame: 1 year
measure: retention rate
timeFrame: 1 year
Secondary outcomes:
measure: Metabolic change
timeFrame: 1 year
measure: Memory function
timeFrame: 1 year
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Olov Rolandsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04872283: Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion
Official title: Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ketorolac
Joint Fusion
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing.

When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications.

The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 undergoing outpatient primary 1st MTPJ fusion by a fellowship-trained foot and ankle orthopaedic surgeon at the Rothman Orthopaedic Institute

Exclusion Criteria:

* Patients undergoing revision 1st MTPJ fusion;
* Patients with any allergies to any study medication;
* Patients with documented chronic narcotic use;
* Patients with renal insufficiency, as defined by history and preoperative creatinine level (Cr ≥ 2.1 mg/dl);
* Patients who are pregnant;
* Patients undergoing inpatient procedure.

Primary outcomes:
measure: Postoperative Pain
timeFrame: 7 days
measure: Satisfaction with pain management
timeFrame: 7 days
measure: Participant Perception of Pain
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02407483: Laparoscopic Training With Laser Guidance Trial
Official title: Laparoscopic Simulator Training With or Without Laser Visual Guidance -A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depth Perception
Keywords: Laparoscopy
Training Programs
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: "Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.

Detailed description: Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.

Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.

Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.

Outcomes:

Primary outcome: Motor skills performance parameters-movement-time:

Cumulative instrument movement-time for both the right and left instrument for the test session,

Secondary outcome: 2) The overall composite score.

Exploratory outcomes: 3) The NASA Task Load index (NASA-TLX).

Eligibility criteria: Inclusion Criteria:

* Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
* Participants are required to provide informed consent before inclusion.

Exclusion Criteria:

* Participation in prior studies involving laparoscopic training.
* Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
* No informed consent.
* Does not speak Danish on a conversational level.

Primary outcomes:
measure: Motor skills performance parameters (Cumulative Instrument movement-time)
timeFrame: 3 hours
Secondary outcomes:
measure: The composite performance score (errors)
timeFrame: 3 hours
Other outcomes:
measure: The NASA Task Load index (NASA-TLX).
timeFrame: 3 hours
Locations:
city: Copenhagen
country: Denmark
facility: Centre for Clinical Education
state: Cooenhagen Ø
Study officials:
affiliation: Center for Clinical Education, Rigshospitalet,
name: Lars Konge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06237283: Effects of Early Postoperative Showering After Coronary Artery Bypass Grafting Using Bilateral Internal Thoracic Artery
Official title: Effects of Early Postoperative Showering After Coronary Artery Bypass Grafting Using Bilateral Internal Thoracic Artery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wounds and Injuries
Wound Infection
Lead sponsor: Sejong General Hospital
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study to evaluate effects of early postoperative showering after coronary artery bypass grafting using bilateral internal thoracic artery


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Patients who underwent coronary bypass grafting with bilateral internal thoracic artery through median sternotomy
* Patients whose all drains or pacing wires are removed

Exclusion Criteria:

* Concomitant operation
* Redo-surgery
* prolonged intensive care unit stay (more than 4 days) due to serious complications after surgery
* open wounds
* active infection
* prolonged drains

Primary outcomes:
measure: Rate of deep sternal wound infection
timeFrame: until 1 months after discharge
measure: Rate of superficial sternal wound infection
timeFrame: until 1 months after discharge
measure: Rate of wound dehiscence
timeFrame: until 1 months after discharge
Secondary outcomes:
measure: Patient satisfaction
timeFrame: at 1st outpatient clinic visit
measure: Rate of mortality
timeFrame: until 1 months after discharge
measure: Rate of stroke
timeFrame: until 1 months after discharge
measure: Rate of respiratory complications
timeFrame: until 1 months after discharge
measure: Rate of bleeding requiring reoperation
timeFrame: until 1 months after discharge
measure: Rate of low cardiac output syndrome
timeFrame: until 1 months after discharge
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
state: Gyeonggi-do
Study officials:
References: