louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05276778: Diabetic Retinopathy Screening in General Practice
Official title: Diabetic Retinopathy Screenings in General Practice for People With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Type2 Diabetes
Keywords: Artificial Intelligence
Diabetic Retinopathy Screening
General practice
Primary care
Type 2 diabetes
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is patients diagnosed with type 2 diabetes treated in general practice within the Region of North Jutland. We are excluding patients above the age of 70 as patients at this age diagnosed with diabetes have a higher risk of developing other eye diseases, such as glaucoma or cataracts, so the general practitioners would still have to advice this patient group to schedule consultations at an ophthalmologist even though they have no sign of retinopathy.

Patients who participate in the project must fulfill all inclusion criteria and cannot fulfill any exclusion criteria listed below.

Brief summary: Diabetic Retinopathy is a microvascular eye complication of diabetes, which can go unnoticed until permanent vision damage has occurred - in worst-case blindness. Timely retinopathy screenings reduce the risk of sight loss since the disease can be treated if detected in time. For people with type 2 diabetes, retinopathy screenings are typically performed by specialist at private ophthalmologists' practices, and individualized screening intervals based on retinopathy level and diabetes regulation are recommended. Unfortunately, 26% of people with type 2 diabetes do not follow their screening interval, and the attendance is too low compared to the national standard of minimum 90% of patients with diabetes who ought to follow the screening program. Consequently, actions must be taken to improve screening attendance in Denmark.

The aim of this study is to investigate patients' acceptance of diabetic retinopathy screenings in general practice. Patients' acceptance is explored through a questionnaire developed for the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Understands Danish
* Age between 18-70

Exclusion Criteria:

* Blindness
* Cannot partake in second screening

Primary outcomes:
measure: Patients' acceptance of diabetic retinopathy screenings in general practice
timeFrame: 1 day (the questionnarie is fufilled one time after the retinopaty screening in general practice)
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Malene Krogh
state: DK
Study officials:
affiliation: Aalborg University
name: Malene Krogh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05746078: Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.
Official title: Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ptosis
Ptosis, Mild
Keywords: Ptosis, Moderate
Lead sponsor: 1st SurgiConcept
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2023-02-27
Enrollment: 99
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.

Brief summary: The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SPRING THREAD® elastic tensor thread. The study will evaluate the outcome of the SPRING THREAD® elastic tensor thread range over a period of 5 years.


Eligibility criteria: Inclusion Criteria:

* Men / women aged 35 to 75 with facial ptosis (cheekbones, jowls) with or without a history of aesthetic treatment (botox, filler, surgical lift).
* Patient able to understand the explanations given.
* Patient informed and not objecting to participate in the study.
* Patient able to comply with protocol requirements, including follow-up visits.
* Patient affiliated to social security.

Exclusion Criteria:

* Patient unable to understand study information and attend study visits.
* Patient did not give consent to participate.
* Patients who have had a previous facial rejuvenation treatment in the 3 months prior to the study.
* Patients treated with long-term systemic corticosteroids.
* Patients with visceral failure, chronic immunological pathology, pregnant or breasfeading women.
* Patient participating or having participated in another clinical trial protocol, drug or medical device within 30 days of inclusion.
* Patient refusing to participate in the clinical investigation.

Primary outcomes:
measure: Investigator Global Aesthetic Improvement Scale (IGAIS)
timeFrame: At 12 months
Secondary outcomes:
measure: Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)
timeFrame: Day 0 to Year 5.
measure: Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)
timeFrame: Day 0 to month 24
measure: Improvement of overall facial appearance
timeFrame: Day 0 to Year 5.
measure: Age of face
timeFrame: Day 0 to year 5.
measure: Safety of SPRING THREAD® Elastic Tensor Thread
timeFrame: Day 0 to month 12.
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet
Study officials:
References:
Clinical trial NCT02051478: Thoracic Manipulation and Mobilization for Neck Pain
Official title: CHANGES IN PRESSURE PAIN SENSITIVITY AND NECK PAIN AFTER THORACIC THRUST MANIPULATION OR NON-THRUST MOBILIZATION IN PATIENTS WITH MECHANICAL NECK PAIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: manipulation
mobilization
spine
pressure pain
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain.


Eligibility criteria: Inclusion Criteria:

* mechanical idiopathic neck pain
* bilateral pain symptoms
* chronic pain (\>3 months of duration)

Exclusion Criteria:

* whiplash injury
* previous spine surgery
* diagnosis of cervical radiculopathy or myelopathy
* diagnosis of fibromyalgia
* having undergone any physical therapy intervention in the previous year
* pregnancy

Primary outcomes:
measure: Change in Pressure pain thresholds
timeFrame: Change between baseline and 1o minutes immediate after the intervention
Secondary outcomes:
measure: Change in Neck pain intensity
timeFrame: Change between baseline and 1o minutes immediate after the intervention
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Jaime Salom.Moreno, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00383578: Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes
Official title: A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
hemoglobin A1c
metformin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-03
Enrollment: 335
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Age from 65 years to the upper age limit recommended by local prescribing information for metformin
* Drug naive patients with type 2 diabetes.
* Body mass index (BMI) in the range of 22-40 kg/m2.
* HbA1c in the range of 7 to 9% inclusive
* FPG \<270 mg/dL (15 mmol/L)

Exclusion Criteria:

* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: after 24 weeks of treatment
Secondary outcomes:
measure: Adverse event profile
timeFrame: after 24 weeks of treatment
measure: Gastrointestinal tolerability
timeFrame: after 24 weeks of treatment
measure: Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%
timeFrame: after 24 weeks of treatment
measure: Change from baseline in fasting plasma glucose
timeFrame: after 24 weeks of treatment
measure: Change from baseline in body weight
timeFrame: after 24 weeks of treatment
Other outcomes:
Locations:
city: Nurnberg
country: Germany
facility: Investigative Centers
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05705778: Plasma Biomarker in Amblyopia Patients
Official title: Prognostic Value of Plasma Biomarkers Among Patients With Amblyopia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amblyopia
Keywords: amblyopia
plasma biomarker
prediction
treatment outcome
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: amblyopia patients

Brief summary: This prospective study aims to observe the predictive effect of peripheral blood plasma biomarker on the outcome of treatment in children with different types of amblyopia. We also investigated the mechanism of neuromodulation in the visual development of amblyopic children.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with amblyopia
* 3-12 years of age
* Able to tolerate amblyopia treatment
* Agree to be involved in this study and agree to have a follow up visit every 3 months.

Exclusion Criteria:

* Have previous treatment history before
* Have pathological ocular anomalies known to cause reduced visual acuity
* Have previous psychiatric, visual or neurological disorders
* Have eccentric fixation and/or abnormal retinal correspondence
* Have attention disorder and learning disability that cannot comprehend psychophysical test instructions given and/or consent for themselves

Primary outcomes:
measure: Plasma protein predictor screening for visual acuity improvement following amblyopia therapy using Tandem Mass Tags proteomics
timeFrame: 2 years after including into this clinical trial
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
Clinical trial NCT01994278: Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth
Official title: Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Control
Lead sponsor: Peri-Swab, LLC
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to observe whether a brushless cleaning device can be equally as effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people an alternative to bristle brush cleaning if they find they are brushing too hard. The hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless methods in conjunction with flossing.


Eligibility criteria: Inclusion Criteria:

* 18 yrs of age
* healthy gingiva

Exclusion Criteria:

* less than 18 yrs old
* patients with braces
* decisionally impaired

Primary outcomes:
measure: Silness Gingival index
timeFrame: June 2013
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04829578: Hypnosis for Chronic Idiopathic Pruritus
Official title: A Prospective Study of Hypnosis for Chronic Idiopathic Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Idiopathic Pruritus
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 12
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: TREATMENT

Brief summary: Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, for which there is no specific treatment. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.

Detailed description: Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, with significative impact on quality of life. At present, there is no specific treatment for CIP. Topical steroids are frequently used, with partial efficacy, and adverse effects. Hypnosis is a specific state of conscience. It differs from waking state, sleeping state, relaxation, or meditation. In this state, the person is highly responsive to suggestion. In medicine, hypnosis can be used to engage the internal resources of the person against unpleasant feelings. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.

Eligibility criteria: Inclusion Criteria:

* Male or female of at least 18 years at screening
* Diagnosis of chronic (at least 6 wks.) idiopathic pruritus
* Pruritus Numeric Rating Scale \> = 4

Exclusion Criteria:

* Pruritus caused by a dermatological or a systemic conditions
* Suicidal crisis, moderate, or severe
* Psychosis (schizophrenia, persistent delusional disorder)
* Bipolar disorder, not stabilized or decompensating
* Personality disorder, decompensated

Primary outcomes:
measure: Change From Baseline in Pruritus Numeric Rating Scale
timeFrame: Day 84
Secondary outcomes:
measure: Change From Baseline in Pruritus Verbal Rating Scale
timeFrame: Day 84
measure: Change From Baseline in Sleeping Scale
timeFrame: Day 84
measure: Change From Baseline in DLQI scale
timeFrame: Day 84
measure: Change From Baseline in HAD scale
timeFrame: Day 84
measure: Change From Baseline in usage of topical steroids
timeFrame: Day 84
measure: Evaluation of tolerance of hypnosis
timeFrame: Day 84
Other outcomes:
Locations:
city: Nice
country: France
facility: Chu de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: BAHADORAN PHILIPPE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01340378: A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
Official title: A Pilot Study of Thrombin Generation Changes in Neonates Undergoing Placement of a Blalock-Taussig Shunt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Coarctation
Keywords: neonatal surgery
Blalock-Taussig shunt
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's healthcare of Atlanta: Cardiac Research Donor Funds
First posted: 2011-04-22
Enrollment: 20
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Full-term neonates (37-42 weeks gestational age)
2. Apgar score of 7 or more at 5 minutes after delivery
3. Surgical placement of BT shunt or repair of an aortic coarctation
4. Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

Brief summary: The primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a Blalock-Taussig (BT) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.

Detailed description: To accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (Antithrombin). The investigators will also measure preoperative and postoperative thrombelastograms (TEG) and preoperative and postoperative thrombin generation curves (TGC).

Eligibility criteria: Inclusion Criteria:

1. Full-term neonates (37-42 weeks gestational age)
2. Apgar score of 7 or more at 5 minutes after delivery
3. Surgical placement of BT shunt or repair of an aortic coarctation
4. Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent

Exclusion Criteria:

1. Preterm neonates (less than 37 weeks gestation)
2. Apgar score of less than 7 at 5 minutes after birth
3. Emergent procedure
4. Surgical procedure other than placement of BT shunt or repair of aortic coarctation
5. Neonates with a known coagulation defect or coagulopathy
6. Mother with a known coagulation defect or coagulopathy
7. Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent

Primary outcomes:
measure: Thrombin generation - peak amount
timeFrame: 2 years
Secondary outcomes:
measure: Thrombin Generation Curve validation in neonates
timeFrame: 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
References:
Clinical trial NCT04407078: Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female
Official title: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Diseases
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the optimal Ce of remifentanil for preventing emergence cough following extubation during general anesthesia in female who are reversed with sugammadex or neostigmine.

Detailed description: Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases the at-risk time during extubation. In addition, cough suppression of remifentanil enables smooth extubation with reduced complications. However, the infusion of remifentanil suppresses the emergence cough effectively in clinical practice, whereas it still delays the awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil during emergence would decrease the adverse events that are associated with remifentanil infusion.

Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* BMI \> 30 kg/m2, respiratory infection, uncontrolled hypertension

Primary outcomes:
measure: optimal Ce of remifentanil
timeFrame: from the ene of surgery until endotracheal extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Gyeonggido
Study officials:
References:
Clinical trial NCT06988878: The Effect of the Flipped Learning Model on Nurses' Evidence-based Practice Competence
Official title: The Effect of the Flipped Learning Model on Nurses' Evidence-based Practice Competence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evidence Based Practice
Flipped Education Model
Keywords: Education, Nursing
evidence-based practice
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-test and post-test single group quasi-experimental
Primary purpose: OTHER

Brief summary: The research is a quasi-experimental (intervention group) study conducted to determine the effect of 'Evidence Based Practice Competency' training based on the reverse learning model on nurses' knowledge, skills, attitudes and competencies related to evidence-based practice.

Detailed description: Purpose: The aim of the research is to determine the effect of Evidence-Based Practice Competence training based on the reverse learning model on nurses' knowledge, skills, attitudes and competencies related to evidence-based practice.

Method: This is a quasi-experimental study with a pre-post intervention group. The research was conducted with 19 charge nurses working in a training and research hospital in Istanbul between 11 September and 18 December 2024. Data were collected using the Evidence-Based Practice Knowledge Test and the Evidence-based Practice Evaluation Competence Questionnaire.

Eligibility criteria: Inclusion Criteria:

* Have at least a bachelor's degree in nursing

Exclusion Criteria:

* Willingness to voluntarily withdraw from the study

Primary outcomes:
measure: Evidence-based Practice Evaluation Competence Questionnaire (EBP-COQ)
timeFrame: two months
measure: Evidence-Based Practice Knowledge Test
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Taşcıoğlu Training and Research Hospital
Study officials:
References:
citation: Ruzafa-Martinez M, Molina-Rodriguez A, Perez-Munoz V, Leal-Costa C, Ramos-Morcillo AJ. Effectiveness of the flipped classroom methodology on the learning of evidence-based practice of nursing students: Quasi-experimental design. Nurse Educ Today. 2023 Sep;128:105878. doi: 10.1016/j.nedt.2023.105878. Epub 2023 Jun 18.