louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05313828: Effect of Various Treatment Modalities on Dendritic Vial Ulcer
Official title: Effect of Various Treatment Modalities on Dendritic Vial Ulcer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Ulcer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients suffering from epithelial viral keratitis

Brief summary: Eye infection is a prevalent problem in primary care and remains a crucial healthcare concern. According to the American Academy of Ophthalmology (AAO), herpes simplex virus (HSV) keratitis (HSK) is the leading cause of infectious blindness worldwide . HSK is defined as a corneal inflammatory condition caused by the HSV infection . The global incidence of herpetic keratitis is estimated at 1.5 million per year, resulting in 40,000 new cases of severe visual impairment associated with corneal scarring and opacification . HSV type I (HSV-1) is by far the most predominant causative pathogen of eye infections\]. HSV-1 is also known for causing orolabial herpes, HSV folliculitis, herpes gladiatorum, herpetic whitlow, and eczema herpeticum . HSV can be transferred to the eye by touching an active lesion and then the eye. The National Health and Nutrition Evaluation revealed a seroprevalence of HSV-1 in 53.9% of 14-49 year olds, and 90% of adults 50 years or older , indicating that the majority of the population has been exposed to this virus thus are at risk of developing HSK.

In this study we evaluate the efficacy of different treatment modalities on viral keratitis HSK.


Eligibility criteria: Inclusion Criteria:

patients with epithelial viral ulcers

-

Exclusion Criteria:

* patients with stromal keratitis patients with corneal opacity

Primary outcomes:
measure: healing of the epithelium
timeFrame: 10 days follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT00229528: Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
Official title: Dose Ranging Study of the Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* normal volunteers (without heart disease)
* patients with heart disease
* between ages 18 \& 65

Exclusion Criteria:

* children less than 18 years
* adults greater than 65 years
* those who can not keep appointments
* patients within 2 weeks of a coronary catheterization
* patients within 6 months of unstable angina or myocardial infarction
* individuals with allergies to paroxetine or similar medications
* individuals having adverse events to paroxetine or similar medications
* individuals with diagnosis of mania
* individuals with a diagnosis of hypomania
* individuals with a diagnosis of bipolar disorders
* individuals with a diagnosis of depression
* individuals with a diagnosis of panic disorders
* individuals with a diagnosis of seizure disorders
* individuals with a history of suicide attempts
* individuals with a diagnosis of hyponatremia
* individuals with active bleeding disorders
* individuals with a diagnosis of narrow angle glaucoma
* individuals with an estimated creatinine clearance of less that 30 ml/min
* individuals taking potentially interacting medications

Primary outcomes:
measure: To define the percent COAT-platelet and response to Paxil-CR in 5 control subjects.
Secondary outcomes:
measure: To define the percent COAT-platelet and response to Paxil-CR in 20 patients with Coronary Artery Disease.
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: The University of Oklahoma College of Pharmacy
name: Stephen F. Hamilton, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03974828: Telemedicine Notifications With Machine Learning for Postoperative Care
Official title: Telemedicine Notifications With Machine Learning for Postoperative Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery--Complications
Perioperative/Postoperative Complications
Acute Kidney Injury
Hospital Mortality
Keywords: Telemedicine
Anesthesia Control Tower
Machine Learning
Forecasting Algorithms
Randomized Controlled Trial
PACU
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 3375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 randomization between standard of care (no contact), postoperative contact (brief), postoperative contact (long).
Primary purpose: OTHER

Brief summary: The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay.

Detailed description: This will be a single center, randomized, controlled, pragmatic clinical trial. The investigators will screen surgical patients enrolled in TECTONICS (NCT03923699) and randomized to intraoperative contact. Near the end of the operation, the investigators will calculate the same machine learning risk forecasts of major complications as TECTONICS, and enroll patients if all of the following are true: (1) No ICU admission is intended (2) ML mortality risk forecast is in top 15% of historical PACU patients.

Patients will be randomized 1:1:1 to no contact, brief contact, and full contact. The postoperative provider (PACU physician, anesthesiologist, ward clinician) will be notified before arrival of the risk forecast in the contact groups, and in the full contact group an additional set of explanatory ML outputs will be provided. The intention-to-treat principle will be followed for all analyses.

Eligibility criteria: Inclusion Criteria:

* Enrolled in TECTONICS Study (ID 201903026, NCT03923699), in OR randomized to contact
* workweek hours
* preoperative assessment completed
* estimated risk of mortality in top 15% of historical PACU patients

Exclusion Criteria:

* Not enrolled in TECTONICS Study
* Operating room randomized to non-contact in TECTONICS
* Planned ICU admission

Primary outcomes:
measure: Unplanned ICU admission
timeFrame: 7 days post-op
Secondary outcomes:
measure: Acute Kidney Injury
timeFrame: 7 days post-op
measure: Hospital length of stay
timeFrame: 30 days post-op
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Christopher R King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109628: Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People
Official title: Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia
frail elderly
protein drink
skeletal muscle mass
muscle mass in elderly
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Top Institute Food and Nutrition
First posted: 2010-04-23
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.


Eligibility criteria: Inclusion Criteria:

* Frail elderly individuals
* Able to understand and perform the study procedures

Exclusion Criteria:

* Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)
* No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)
* Use of anti-coagulation medication (except of Acetyl Salicyl acid)
* Renal insufficiency (eGFR \<60 mL/min/1.73 m2)
* Allergic or sensitive for milk proteins

Primary outcomes:
measure: Change in skeletal muscle mass
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Physical performance
timeFrame: Baseline, 3 months and 6 months
measure: Blood parameters related to the outcome measures
timeFrame: Baseline, 3 months and 6 months
measure: Dietary intake
timeFrame: Baseline, 3 months and 6 months
measure: Physical activity
timeFrame: Baseline, 3 months and 6 months
measure: Cognitive performance
timeFrame: Baseline and 6 months
measure: Blood pressure
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
References:
citation: van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.
citation: van der Zwaluw NL, van de Rest O, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. The impact of protein supplementation on cognitive performance in frail elderly. Eur J Nutr. 2014 Apr;53(3):803-12. doi: 10.1007/s00394-013-0584-9. Epub 2013 Sep 18.
citation: Tieland M, van de Rest O, Dirks ML, van der Zwaluw N, Mensink M, van Loon LJ, de Groot LC. Protein supplementation improves physical performance in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):720-6. doi: 10.1016/j.jamda.2012.07.005. Epub 2012 Aug 11.
Clinical trial NCT02505828: ARTEMIS Synovial Markers in Arthritis Childhood
Official title: ARTEMIS Synovial Markers in Arthritis Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Arthritis
Juvenile Idiopathic Arthritis
Keywords: Arthritis
septic
Juvenile idiopathic arthritis
diagnosis
proteomic
cytokine
monocytes
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.


Eligibility criteria: Inclusion Criteria:

* Septic arthritis with bacteriological identification
* Juvenile idiopathic arthritis beyond the ILAR definition
* Having acute arthritis requiring an articular draining
* Child benefiting from a national insurance scheme
* Collection of the consent of the parents or the legal representative

Exclusion Criteria:

* Contraindication in an articular draining: platelet 50 000 / mm3, Rate of prothrombins lower than 70 %, activated partial thromboplastin times (APTT)\> 1,5
* Treatment by biotherapy, corticoids or other immuno suppressor in the month preceding the articular draining.
* Treatment by antibiotic begun more than 24 hours before the draining.

Primary outcomes:
measure: Qualitative analysis of new biological markers (proteic, cytokine or cellular) that discriminate inflammatory and infectious arthritis.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
Study officials:
affiliation: Montpellier University Hospital
name: Eric EJ JEZIORSKI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nziza N, Jeziorski E, Delpont M, Cren M, Chevassus H, Carbasse A, Mahe P, Abassi H, Joly-Monrigal P, Schordan E, Mange A, Jorgensen C, Apparailly F, Duroux-Richard I. Synovial-Fluid miRNA Signature for Diagnosis of Juvenile Idiopathic Arthritis. Cells. 2019 Nov 26;8(12):1521. doi: 10.3390/cells8121521.
citation: Cren M, Nziza N, Carbasse A, Mahe P, Dufourcq-Lopez E, Delpont M, Chevassus H, Khalil M, Mura T, Duroux-Richard I, Apparailly F, Jeziorski E, Louis-Plence P. Differential Accumulation and Activation of Monocyte and Dendritic Cell Subsets in Inflamed Synovial Fluid Discriminates Between Juvenile Idiopathic Arthritis and Septic Arthritis. Front Immunol. 2020 Jul 31;11:1716. doi: 10.3389/fimmu.2020.01716. eCollection 2020.
Clinical trial NCT00579228: Vascular Risk Progression in Normal and Diabetic Control Subjects.
Official title: Vascular Risk Progression in Normal and Diabetes Control Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Inflammation
Keywords: Diabetes
Vascular risk
Inflammation
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with diabetes or healthy individuals

Brief summary: The purpose of this study is to look at the progression of cardiovascular disease (CVD) in normal control individuals and in patients with controlled diabetes.

Detailed description: Cardiovascular disease remains the greatest cause of mortality in people with diabetes mellitus. This observation study will evaluate non-traditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over 1 year. This study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intimal medical thickness.

Eligibility criteria: Inclusion Criteria:

* 19 years old or more and willing to return for annual testing for 2 years.
* Those with Diabetes need to have the condition for at least 5 years.
* Normal controls need to have no diabetes, kidney disease, or chronic disease.

Exclusion Criteria:

* Estimated GFR \<60 (mL/min/1.73m2)
* Any condition that would change weight dramatically in the near future such as malabsorption, pregnancy, malignancy
* For Normal: BMI\>30, BP \> 140/90 , LDL \> 130.
* For Diabetes: BP\> 135/85, A1C\> 8%. LDL \> 100.

Primary outcomes:
measure: Carotid intima media measurement change
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jennifer Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926328: Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Official title: Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Keywords: Gingivitis and Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.


Eligibility criteria: Inclusion Criteria:

* Availability for the six-month duration of the study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form.

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of
* periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Use of antibiotics any time during the one month prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry
* into the study.
* Pregnant women or women who are breast feeding.
* Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
* History of allergic to personal care/consumer products or their ingredients.
* Taking any prescription medicines. That might interfere with the study outcome.
* Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.

Primary outcomes:
measure: Gingivitis Index
timeFrame: 6 months
measure: Plaque Index
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dr. Fernando Autran
Study officials:
affiliation: Dental Research Associates
name: Augusto E Boneta, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01539928: Dual PET/CT Imaging in Lung Cancer
Official title: Dual PET/CT Imaging in Lung Cancer (Danish Title: En og Tre Timers FDG-PET/CT Ved Lungecancer)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Dual time PET/CT
glucose-6-phosphatase
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pt. referred to The Department of Pulmonary Medicine, Odense University Hospital or The Department of Medicine, Hospital of Southern Denmark, Sønderborg with suspicion of lung cancer

Brief summary: The purpose of this study is to compare conventional PET/CT scan performed 1 hour after injection of the radioactive tracer FDG (PET/CT\[1\]) with PET/CT performed after 3 hours (PET/CT\[3\]) in a group of patients with biopsy verified lung cancer or high suspicion of lung cancer after initial work-up (chest x-ray and CT of thorax/upper abdomen), who are potentially operable.

Detailed description: The investigators also want to:

* To find the sensitivity, specificity and accuracy in PET/CT 1h and 3 h in the staging of lung cancer (N-/M-stage). Our gold standard is pathology, when not possible - follow-up (se Gold Standard 6.1.1)
* To compare SUVmax with the expression of GLUT1 and G-6-Pase in tumors
* To compare the expression of GLUT1 with the activity of G6Pase
* To compare SUVmax, RI, tumor/liver ratio, GLUT1 and G-6-Pase with the occurrence of relapse within a year after curative surgery

Eligibility criteria: Inclusion Criteria:

* Cytologic/histologic-verified lung cancer or high suspicion of lung cancer after initial work up
* Candidate to curative intended surgery after initial work up (usually chest x-ray, CT of chest/upper abdomen and if needed spirometry).

Exclusion Criteria:

* Former lung cancer
* Contraindications for PET/CT: Pregnancy, recent chemoradiotherapy
* Diabetes mellitus.

Primary outcomes:
measure: Sensitivity, specificity and accuracy
timeFrame: After staging or 1 year of follow up
Secondary outcomes:
measure: Occurence of relapse
timeFrame: 1 year follow up after surgery
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Pulmonary Medicine
state: Fünen
Study officials:
affiliation: Odense University Hospital
name: Mie H Vilstrup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847028: Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
Official title: Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Newborn
Pain
glucose solution
venipuncture
non-pharmacologic pain relief.
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 304
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.

Detailed description: This double-blind clinical trial is conducted on a maternity and newborn (N\*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale).

Eligibility criteria: Inclusion criteria

* Neonates were included if they had to undergo a venipuncture as part of routine medical care.

Exclusion criteria

* Unstable neonates with respiratory support as well as neonates with a proven neurological abnormality were excluded.
* Newborns who had been administered sedatives, analgesics or naloxone during the past 48 hours were excluded along with premature infants younger than 32 weeks post menstrual age.

Primary outcomes:
measure: Pain after venipuncture measured by the Leuven pain scale for newborns
timeFrame: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring
Secondary outcomes:
measure: difference in heart rhythm
timeFrame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement
Other outcomes:
Locations:
city: Mol
country: Belgium
facility: H Hart ziekenhuis
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen + Heilig Hart ziekenhuis Mol
name: Ben Dilen, MSN
role: PRINCIPAL_INVESTIGATOR
References: