louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06698081: The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients
Official title: The Effect of Using Multimedia During the Informed Consent Process on the Anxiety of Parents of Orchiopexy Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Undescended Testis
Anxiety State
Keywords: undescended testis
anxiety state
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.

Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.

The main question it aims to answer is:

• Does the use of multimedia during the preoperative consent process affect the anxiety level of parents of patients undergoing orchiopexy surgery?

Detailed description: Aim: The goal of this randomized controlled trial is to detect the effect of using multimedia during the informed consent process on the anxiety of parents of orchiopexy patients.

Parents (primary caregivers) of the patients who underwent orchiopexy surgery are included in the study.

The patient's age, gender, known diseases, previous hospital admissions, and whether they have undergone surgery before will be recorded. The primary caregiver's age, gender, known diseases, educational status, occupation, number of children, and any additional illnesses in other children will be noted.

Patients will be randomized into 2 groups with the help of (https://www.randomizer.org/ ). The first group will be informed of the Standard Consent Form and Verbal Information during the preoperative process. In contrast, the second group will be informed of the Standard Consent Form, Verbal Information, and Multimedia. Both groups will fill out the Hospital Anxiety and Depression Scale(HADS), BECK Anxiety Inventory(BAI), and The State-Trait Anxiety Inventory (STAI) Form Tx 1-2 forms one day before the surgery and on the 7th day after the surgery to determine their anxiety levels.

Eligibility criteria: Inclusion Criteria:

* parents of orchiopexy patients

Exclusion Criteria:

* history of previous orchiopexy surgery
* orchiopexy with other surgical procedures ( f.e. Hypospadias repair)

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week
measure: Beck Anxiety Inventory
timeFrame: 1 week
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Department of Urology
Study officials:
affiliation: Marmara University
name: Cagri Akin Sekerci
role: STUDY_DIRECTOR
References:
Clinical trial NCT04402281: Use of suPAR Algorithm for the ED Decision Making
Official title: Use of Algorithm for Safer and More Efficient Decision Making in the ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: ED
Critical illness
Decision making
POC test
suPAR
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2020-05-26
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 104
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients during the study period who signed the consent

Brief summary: Will the use of a clinical decision algorithm in the ED improve discharge or admission decisions.

Detailed description: Background Crowding and readmissions are common challenges in Emergency departments across Europe. The decision whether to admit or discharge the patient is challenging and is often based on clinical signs and symptoms e.g. blood pressure, pulse, respiratory rate, oxygen saturation and temperature. But some patients are unnecessarily admitted and may have been better off if sent home. Other patients may be discharged without - and one out of five patients are readmitted within a month raising the question whether the patient should have been admitted at first presentation in the ED. suPAR is a strong prognostic biomarker measured routinely in acute medical patients in some emergency department (ED) settings.suPAR is a broadly applicable biomarker of risk, and it has been developed an algorithm for simple interpretation of suPAR in clinical decisions for the study.

Objective To evaluate the use of a clinical decision algorithm in the ED with the aim of improving discharge or admission decisions.

Eligibility criteria: Inclusion Criteria:

* All patients above 18 years
* who are having blood taken for biochemical analysis when attending the ED

Exclusion Criteria:

* Acute medical patients that do not have blood drawn for routine biochemical testing.
* Pregnant
* Under 18 years old
* Terminally ill patients.

Primary outcomes:
measure: Discharges
timeFrame: 30 days
Secondary outcomes:
measure: Admissions
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Readmissions
timeFrame: 1,7 and 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
measure: Economical savings
timeFrame: 30 days
Locations:
city: Helsinki
country: Finland
facility: Department of Emergency Medicine and Services, Helsinki University Hospital and Helsinki University, Helsinki, Finland
state: Helsinki Usimaa
Study officials:
affiliation: Professor
name: Maaret Castrén, Docent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00530881: Randomized, Double-Blind, Placebo-Controlled, With PHX1149 in Patients With Type 2 Diabetes Mellitus
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Establish Proof of Concept With PHX1149 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Phenomix
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a 4-week, multicenter, randomized, double-blind, parallel group, placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2 diabetes ) or placebo. The drug is a "DPP4 inhibitor"


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus treatment with metformin +/- TZD

Exclusion Criteria:

* Type 1 diabetes mellitus

Primary outcomes:
measure: postprandial blood glucose
Secondary outcomes:
measure: fasting blood glucose, HbA1c, safety
Other outcomes:
Locations:
city: san Diego
country: United States
facility: Multiple Sites
state: California
Study officials:
affiliation: Phenomix Corp.
name: Hans-Peter Guler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02203981: TopQ Cut-off Determination Study For 3D-OCT 1 Maestro and 3D OCT-2000
Official title: TopQ Cut-off Determination Study For 3D-OCT 1 Maestro and 3D OCT-2000
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: normal Eyes
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that have no known ocular pathologies

Brief summary: To determine optimal cut-off value for the TopQ cut-off on the Maestro and 3D OCT-2000.


Eligibility criteria: Inclusion Criteria:

* No known ocular pathologies

Exclusion Criteria:

* Any known ocular pathologies

Primary outcomes:
measure: Retinal Thickness
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Medical Systems, Inc.
state: New Jersey
Study officials:
affiliation: Topcon Corporation
name: Sunni Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00747981: Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.
Official title: Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspirated Foreign Body of Lower Respiratory Tract
Keywords: CT Scan
Endoscopy
Aspiration
Foreign Bodies
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 311
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To access CT Scan as a diagnostic tool for foreign bodies aspiration.

Detailed description: Comparison with gold standard diagnostic tool, the endoscopy

Eligibility criteria: Inclusion Criteria:

* age between 6 months and 16 years
* suspicion of a foreign body aspiration
* health care assurance
* information of parents

Exclusion Criteria:

* emergency situation
* certainly of foreign body presence
* delay for CT Scan realization longer than 24 hours
* no speaking French parents
* parents refusal.

Primary outcomes:
measure: Comparison between CT Scan and endoscopy results
timeFrame: 12 HOURS
Secondary outcomes:
measure: X Ray radiation induced by CT Scan
timeFrame: TWO YEARS
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris V University & Assistance Publique Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yves MANACH, MD, HDR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06821581: Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR
Official title: Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aseptic Loosening
Arthropathy of Knee
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The analysis will be conducted on implants performed in the Emilia-Romagna region from 2003 to 2022 and on implants performed at the II Orthopedic and Traumatological Clinic of the Rizzoli Orthopedic Institute during the same period

Brief summary: The increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (TKA), and, consequently, an increase in the number of revisions. The main cause of TKA failure is aseptic mobilization, which is described as the loss of integration between the prosthetic component and the bone in the absence of infection. This represents a significant impact on professional and economic resources for the Italian healthcare system. Aseptic mobilization can be caused by inadequate initial fixation of the implant and/or mechanical or biological loss of fixation over time, factors that often occur simultaneously. A careful, methodical evaluation of post-operative radiographs of TKAs remains an important diagnostic tool. The analysis of the causes of aseptic mobilization of TKAs and the associated economic impact in the Emilia Romagna region is useful for providing an estimate of the problem and identifying potential areas for improvement.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing knee prosthesis revision for aseptic mobilization
* Follow-up ≥ 2 years
* Willingness to participate in the study
* Both sexes
* Patients ≥ 18 years old

Exclusion Criteria:

* Patient refusal to participate in the study and sign the informed consent
* Simultaneous participation in other studies

Primary outcomes:
measure: Demographic data
timeFrame: 24 months
Secondary outcomes:
measure: Healthcare expenses
timeFrame: 24 months
measure: Radiographic analysis
timeFrame: 24 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT00612781: Yellow Versus White Study
Official title: Influence of Blue-Light-Filter IOLs on Color Perception and Contrast Acuity. A Randomized, Double-Masked Study With Intraindividual Comparison.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: intraocular lens
blue-light filtering intraocular lens
contrast acuity
color vision
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2008-02-12
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Blue-light-filtering IOLs are implanted increasingly often in cataract surgery. Several studies examined the effect of blue-light-filters on contrast and colour vision. However, the study outcomes were varying. The present study investigated the effect of a blue-light-filtering IOL on colour perception and contrast acuity using highly sensitive measurement methods.


Eligibility criteria: Inclusion Criteria:

* bilateral age-related cataract
* age 55 to 80 years
* expected postoperative visual acuity of at least 1.0

Exclusion Criteria:

* amblyopia
* corneal scars
* diabetes
* arterial hypertonia
* pseudoexfoliation-syndrome
* earlier ocular surgeries or laser treatments
* intraocular tumors
* color abnormalities
* expected postoperative visual acuity lower 1.0

Primary outcomes:
measure: contrast sensitivity
timeFrame: 3 month after surgery
measure: color vision
timeFrame: 3 month after surgery
Secondary outcomes:
measure: visual acuity
timeFrame: 3 month after surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology, Hietzing Hospital
Study officials:
affiliation: Dept of Ophthalmology, Hietzing Hospital, Vienna, Austria
name: Matthias G Wirtitsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02139410: IGF-1, Sarcopenia and Mortality: a Cohort Study in Patient With Cognitive Impairment
Official title: Insulin Like Growth Factor 1 and Risks of Sarcopenia and Mortality in Patients With Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Insulin-like Growth Factor 1
Keywords: sarcopenia
mortality
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 589
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients were enrolled from orthopedics clinic (IRCCS Galeazzi Milan) and geriatric day service (Sapienza University of Rome)

Brief summary: Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation of this hormone has been reported to influence the genesis of cognitive impairment and dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cognitive impairment (MMSE \< 24)
* Age \> 65 ys

Exclusion Criteria:

* Diagnosis of pancreatic disorders
* Diagnosis of acromegaly
* Diagnosis of GH-related disorders
* Recent bone fractures or immobility before the enrollment (3 months)
* Cancer

Primary outcomes:
measure: IGF-1 reduction in patients with sarcopenia
timeFrame: baseline, 24 months, 48 months
Secondary outcomes:
measure: IGF-1 reduction and mortality in patients with cognitive impairment
timeFrame: baseline, 24 months, 48 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
affiliation: University of Roma La Sapienza
name: Vincenzo Gianturco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04298710: Effects of Arm Cycling and Leg Cycling on Postprandial Blood Glucose Levels in Healthy Persons
Official title: A Comparison Between the Effects of Different Muscle Groups on Blood Glucose Levels at the Postprandial Status in College Students
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hyperglycemia, Postprandial
Lead sponsor: Franklin Pierce University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The literature has shown that exercise is effective in decreasing blood glucose levels. However, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. The purpose of this study is to examine the differences in blood-glucose level changes in response to exercise that involves different muscle groups.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy persons
* Age 18 years or above

Exclusion Criteria:

* Cardiovascular diseases
* Pulmonary diseases
* Metabolic diseases
* Other contraindications to exercise

Primary outcomes:
measure: Postprandial glucose levels
timeFrame: one hour after the carbohydrates intake
Secondary outcomes:
Other outcomes:
Locations:
city: Rindge
country: United States
facility: Franklin Pierce University
state: New Hampshire
Study officials:
affiliation: Franklin Pierce University
name: Tongyu Ma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03937310: NGS for Non-unions
Official title: What is the Role of Next-generation Sequencing in Non-union of Orthopaedic Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonunion of Fracture
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients will be chosen based on intervention planned. This is not an interventional study, just an observational study

Brief summary: The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.


Eligibility criteria: Investigational group:

Inclusion:

1. Patients undergoing open biopsy / surgical intervention for nonunion following a traumatic (open or closed) long bone fracture (femur shaft, tibia, humerus) which was initially treated operatively.Inclusion Criteria:
2. Nonunions will be defined as a failure to progress towards expected union within an anticipated timeframe, and this judgment will be made by the attending caring for each patient. No specific timeframe or arbitrary cut points will be defined to allow for the considerable variation in fracture healing and different anatomical sites.
3. Presumed Septic and Aseptic nonunions
4. \>18 years old and able to provide informed consent

Exclusion Criteria:

Exclusion:

1. Pathological fractures at index injury
2. Patients on antibiotic therapy \<2 weeks prior to surgery

INCLUSION/ EXCLUSION CRITERIA FOR CONTROL GROUP:

Inclusion:

1. Patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus)
2. \>18 years old and able to provide informed consent

Exclusion:

1. Pathological fractures at index injury
2. Patients on antibiotic therapy \<2 weeks prior to surgery

Primary outcomes:
measure: Treatment failure
timeFrame: 6 months post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01846910: Prepare to Quit - A Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting
Official title: Prepare to Quit - A Randomized Clinical Trial to Help People Quit Smoking in a Community Dental Clinic Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: Cessation
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of this study are:

1. To determine the effect that an intensive, community dental clinic centered, stop-smoking program using a motivational interviewing approach has upon cessation rates for interested, smoking inner-city dental patients.
2. To determine the effect that providing a tooth whitening incentive, in a community dental clinic stop-smoking program, has upon cessation rates for interested, smoking inner-city dental patients.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* current smoker
* dental clinic patient
* interested in quitting smoking

Exclusion Criteria:

* minors
* those unable to provide own consent

Primary outcomes:
measure: Smoking Cessation
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Access Downtown Dental Clinic
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Douglas J Brothwell, DMD MSc
role: PRINCIPAL_INVESTIGATOR
References: