louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06469112: The Effect of Vibration on Pain During Subcutaneous Heparin Injection
Official title: The Effect of Vibration on Pain During Subcutaneous Heparin Injection: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Asthma
Pulmonary Disease
Chest Disorder
Keywords: Subcutaneous heparin injection
pain
non-pharmacological method
vibration
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.

Methods: The patients will randomly assigned to an experimental (vibration) group , a placebo control group, and a nonintervention control group. Participants in the experimental group will give slight vibration to the injection site before the injection will administered; for participants in the placebo group, the device will placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection will administered. The level of pain felt by the participants during the administration of the injection will assess with a visual analog scale.


Eligibility criteria: Inclusion Criteria:

* being over the age of 18
* having a doctor's prescription for subcutaneousheparin 0.6 mL treatment with a ready-to-use syringe and not yet having begun treatment
* having no coagulation disorder
* having no disorder which could affect pain perception,
* having no incision, lipodystrophy or finding of infection at the injection site,
* having no communication problem, and voluntarily agreeing to participate in the research

Exclusion Criteria:

* being under the age of 18
* having diabetes mellitus
* peripheral vascular disease, etc. which could affect the perception of pain
* not being conscious, refusing to participate in the research or opting to leave the study at any point.

Primary outcomes:
measure: pain intensity in mm
timeFrame: 6 months
Secondary outcomes:
measure: weight
timeFrame: 6 months
measure: height
timeFrame: 6 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University Hospital
Study officials:
References:
Clinical trial NCT01235312: Microcirculatory Mapping of the Aging Hand and Foot
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Microcirculation in Vascular Diseases
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both healthy subjects and patients suffering from diabetes mellitus or manifested peripheral arterial occlusive disease

Brief summary: Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to address this highly visible area, although no specific statistics concerning the number of patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above mentioned therapies have been reported in the literature, but still there is a lack of scientific literature about functional microcirculation of the dorsum of the hand.

Furthermore, there is a lack of scientific data about functional microcirculation of the plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation of the functional microcirculation of hands and feet in healthy subjects as well as patients suffering from the above mentioned diseases.


Eligibility criteria: Inclusion Criteria:

* Both healthy subjects and patients suffering from diabetes mellitus or manifested peripheral arterial occlusive disease aged between 18 and 75 years

Exclusion Criteria:

* soft tissue inflammation or osteomyelitis, liver disease, cardiac dysfunction, arterial hypotension

Primary outcomes:
measure: Correlation of microcirculation to age and incidence of vascular diseases
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
Study officials:
References:
Clinical trial NCT05460312: Protein Kinase A in Prostate Cancer Tissue.
Official title: Assessment of the Expression and Activity of Protein Kinase A in Prostate Cancer Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Neoplasm
Inflammation
Benign Hyperplasia of Prostate
Keywords: protein kinase A
immunohistochemistry
prostate cancer
prostate biopsy
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-15
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of 100 consecutive men referred to prostate biopsy due to clinical suspicion of prosatet cancer.

Brief summary: Prostate cancer is the most common malignancy in men. documented risk factors of prostate cancer are age, ethnicity, various genomic mutations and family history of prostate cancer. The cellular mechanisms of malignant transformation are numerous and not completely understood. A possible mechanism is induction of an inflammation resulting in cellular atypia and pre-malignant changes in the affected tissue by inducing a pro-inflammatory response or changes in extra cellular matrix. Protein Kinase A (PKA) is a key stone enzyme in various intra-cellular processes. Various infections' inflammations and malignancies were proved to impact PKA activity. The research hypothesis is that prostate cancer tissue will show a unique profile of PKA activity, regulation and intracellular distribution.

Detailed description: The study will be conducted among men referred to prostate biopsy due to clinical suspicion of malignancy. 100 consecutive patients will undergo prostate biopsies. Biopsies will be taken from both lobes of the prostate (standard protocol) and additional biopsies will be taken according to MRI findings (Fusion biopsies) if relevant. One additional biopsy will be taken from each lobe of the prostate and immediately freezed in -80 Celsius degrees. Routine biopsies will be fixed in formaldehyde and embedded in paraffin and will undergo routine pathological analysis and staining.

Following pathological analysis, paraffin slides will be undergo immunohistochemically staining for PKA, comparing cancerous tissue to normal surrounding tissue. the fresh frozen tissue will undergo western blot analysis for quantitative expression of PKA and its sub units.

Eligibility criteria: Inclusion Criteria:

* Men
* Clinical suspicion of prostate cancer
* Referred for biopsy
* Able to sign informed consent.

Exclusion Criteria:

* Previous prostate irradiation
* Chronic prostatitis
* Previous prostate surgery
* Recent urinary tract infection (3 months prior to biopsy).
* Indwelling urinary catheter

Primary outcomes:
measure: The distribution of PKA in prostate cancer versus benign tissue
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04734912: Evaluation of Transnasal Endoscopy During COVID-19 Pandemic
Official title: Evaluation of Transnasal Endoscopy During COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopy
Keywords: gastroscopy
transnasal
nursing
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients with indication für gastroscopy in transnasal techique are included.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is submitted to the patient.

Detailed description: COVID-19 is transmitted, among other things, by a droplet infection. Conventional gastroscopy through the patient's mouth is therefore considered a high-risk examination for the medical and nursing staff. Alternatively, gastroscopy can also be performed through the patient's nose. An advantage here is that the aerosol formation is naturally significantly reduced and the patient usually does not need sedation, since in transnasal endoscopy no stranglehold occurs. Transnasal endoscopy therefore appears to us, especially during the COVID-19 pandemic, as a safe alternative to conventional gastroscopy.

Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is sumbitted to the patient.

Only patients who have the indication for gastroscopy in transnasal technique are included. A specific risk to patients cannot be foreseen.This study does not interfere with diagnostics or therapy.

Eligibility criteria: Inclusion Criteria:

* Indication for transnasal endoscopy

Exclusion Criteria:

* pregnancy
* breast feeding
* contraindication to transnasal endoscopy
* pronounced blood clotting disorders

Primary outcomes:
measure: Questionnaire
timeFrame: after examination, about 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Hospital Mainz
state: Rhenanie-Palatinate
Study officials:
affiliation: University Medical Center Mainz
name: Helmut Neumann, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107012: Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment
Official title: Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment With QLF Compared to Conventional Fixed Appliances: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Keywords: White spot lesion
QLF
Clear aligners
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 49
Sex: ALL
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)

Detailed description: White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups

Eligibility criteria: Inclusion Criteria:

* Healthy patients from both genders aged (17 - 24 years).
* Class I malocclusion with mild to moderate crowding (≤ 5 mm).
* Non-extraction treatment plan.
* Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis.
* Maximum of 3 restored teeth.
* Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Exclusion Criteria:

-Patients with poor oral hygiene, defective enamel, extensive restorations and salivary glands diseases were excluded.

Primary outcomes:
measure: Delta F
timeFrame: 3 months
measure: Lesion area
timeFrame: 3 months
Secondary outcomes:
measure: Number of new lesions
timeFrame: 3 months
measure: ΔR30
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.
Clinical trial NCT02706912: Virtual Occupational Therapy Application
Official title: Virtual Occupational Therapy Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: Stroke
Hemiparesis
Activities of Daily Living
Virtual World
Occupational Therapy
Lead sponsor: Barron Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
First posted: 2016-03-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Virtual Occupational Therapy Application (VOTA) combines low-cost human motion tracking, commercial game engine technology, and evidence-based Occupational Therapy (OT) practice in a computer-based virtual world in which stroke patients practice activities of daily living (ADLs). The protocol investigates the efficacy of VOTA therapy for Upper Extremity (UE) motor recovery and assesses system usability and user acceptance.


Eligibility criteria: Inclusion Criteria:

* Participant is a hemiparetic stroke survivor;
* Time since last stroke at least 3 months;
* Participant has antigravity strength at the elbow to at least 45 degrees of active flexion in the stroke affected arm;
* Participant has antigravity shoulder strength to at least 30 degrees each in active flexion, abduction/adduction, and 15 degrees in active rotation from an upright seated position in the stroke affected arm;
* Participant has visual acuity with corrective lenses of 20/50 or better;

Exclusion Criteria:

* Existing participation in an upper extremity stroke rehabilitation program or planned participation during the study period;
* Inability to understand and follow verbal directions;
* Determination that participation would result in over exertion or significant discomfort or pain;
* Determination that participation would result in significant agitation or elevated stress;
* Withholding or withdrawal of consent by the participant;
* Visual field deficit in either eye that impairs the ability to view the computer monitor;
* Hemispatial neglect that impairs the ability process and perceive visual stimuli provided through the computer monitor;

Primary outcomes:
measure: Fugl-Meyer upper extremity assessment
timeFrame: Pre-assessment and Post-assessment (8 weeks)
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: Pre-assessment and Post-assessment (8 weeks)
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Pre-assessment and Post-assessment (8 weeks)
measure: Trail Making Test
timeFrame: Pre-assessment and Post-assessment (8 weeks)
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA- HealthSouth Rehabilitation Hospital
state: Virginia
Study officials:
References:
Clinical trial NCT00717912: Determination of the Glycemic Index and the Insulinemic Index of a Sweetener Syrup
Official title: Determination of the Glycemic Index and the Insulinemic Index of a Sweetener
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: BLOOD GLUCOSE
glycemic index
rates of digestion and absorption of food
Lead sponsor: Routin SA
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup

Detailed description: Glycemic index is a measure of how carbohydrate-containing foods affect blood glucose levels. All foods that contain carbohydrates, such as starchy vegetables (potatoes, corn), desserts, fruits, bread, pasta, and rice, can be tested for how they affect blood sugar levels after being eaten. Glycemic index is assessed by having one or more people eat a specific amount of a single food (usually 50 grams of digestible carbohydrate) and then measuring the change in blood sugar levels compared with the levels achieved after they have eaten a control food containing the same amount of digestible carbohydrate, such as white bread or glucose. The average change in blood sugar levels over a set period of time relative to the levels after consumption of the control food, usually white bread or glucose, is the food's glycemic index.

Insulinemic index is measure with the same methodology.

Eligibility criteria: Inclusion Criteria:

* age 18-50 years
* male
* healthy volunteers
* BMI above 25 kg/m²

Exclusion Criteria:

* no medical history of hypercholesterolemia, high pressure blood, diabetes, sugar intolerance
* food allergy
* kidney deficiency
* liver troubles
* gastro-intestinal troubles
* drugs which impair sugar and lipid metabolism

Primary outcomes:
measure: Glycemic Index
timeFrame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
Secondary outcomes:
measure: Insulinemic Index
timeFrame: Every 48 hours (each new intervention), over a 2 hour blood glucose challenge
Other outcomes:
Locations:
city: Nantes
country: France
facility: Biofortis
Study officials:
affiliation: BioFortis
name: Jean-Marc Cazaubiel, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01549912: Results of Rotator Cuff Repair
Official title: Results of Rotator Cuff Repair Following Acute Shoulder Dislocation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Dislocation
Keywords: Rotator Cuff Tears
Dislocation
Shoulder Dislocation
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 2
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will include patients age 35 years and older who have sustained an acute rotator cuff tear following shoulder dislocation who underwent a rotator cuff repair either by open or arthroscopic techniques between January 1, 2001 and June 1, 2011.

Brief summary: The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.

Detailed description: There is a higher risk of rotator cuff tears following dislocation when the individual is greater than 40 years old. Rotator cuff tears after dislocation of the shoulder are more of a challenge to repair particularly if there is a delay in diagnosis. Clinical experience would suggest that rotator cuff repair within the first month of injury allows for better results in acute rotator cuff tears without shoulder dislocation. There are no reported results for rotator cuff repairs following shoulder dislocation and timing of repair. If we find that early repair provides better results this will be important for Primary Care Providers and Emergency Department physicians to refer these patients early for evaluation and subsequently earlier treatment.

Eligibility criteria: Inclusion Criteria:

* age 35 years or older with acute rotator cuff tear following documented shoulder dislocation requiring reduction, subjects sustained acute rotator cuff tear following shoulder dislocation that was treated surgically with open and/or arthroscopic technique between January 1, 2001 and June 1, 2011, surgical intervention within 6 months of dislocation, minimum follow up time of one year from surgery.

Exclusion Criteria:

* rotator cuff tears without shoulder dislocation, known previous rotator cuff disease, history of other trauma to the shoulder, inability to provide informed consent, other suspect pathology (ie: tumor, infection).

Primary outcomes:
measure: Levels of pain, range of motion and strength
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah Orthopaedic
name: Robert Z Tashjian, MD
role: PRINCIPAL_INVESTIGATOR
References: