louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04603573: Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant
Official title: Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cost Effectiveness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 91
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be randomized, allocation-blinded, two-arm, parallel-group trial. The participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions:

* Resin-based fissure sealant FS.
* Fluoride varnish FV
Primary purpose: PREVENTION

Brief summary: The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.

Detailed description: A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.

This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.

Eligibility criteria: Inclusion Criteria:

* Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).

Exclusion Criteria:

* Teeth will be excluded from the study if they had any of the following:

  * Dental caries in dentine
  * History of pain or swelling. Parents refused their children participate in the trial

Primary outcomes:
measure: Clinical-effectiveness (will be measured with DFS
timeFrame: Through study completion, an average of one year
Secondary outcomes:
measure: Cost-effectiveness (will be measured with Incremental cost effective ratio ICER
timeFrame: through study completion, an average of one year
measure: Time of application (continuous outcome, (minutes) will be measured with stopwatch.
timeFrame: Through application of interventions in treatment visit( baseline)
measure: acceptability will be measured by questionnaire
timeFrame: through study completion, an average of one year
measure: adverse effect will be measured by questionnaire
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Oral and dental medicine Cairo university
Study officials:
References:
Clinical trial NCT01197573: Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy
Official title: Enhancing DCD Utilization With Thrombolytic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Kidney Transplantation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2010-09-09
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Detailed description: The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older
* Subjects willing/able to provide written consent
* Subjects willing/able to comply with study requirements
* Subjects who will receive a solitary organ transplant

Exclusion Criteria:

* Subjects requiring multi-organ transplants
* Women who are pregnant
* Subjects with current severe systemic infection
* Subjects with an active infection

Primary outcomes:
measure: Delayed Kidney Graft Function
timeFrame: 3 months
measure: Number of Participants With Primary Liver Graft Nonfunction
timeFrame: 1 month
Secondary outcomes:
measure: Number of Participants With Liver Ischemic-Type Biliary Strictures
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals / Case medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Bijan Eghtesad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00960973: The Effect of Vitamin K Supplementation on Glucose Metabolism
Official title: The Effect of Vitamin K Supplementation on Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Prediabetic State
Keywords: vitamin K
beta cell
glucose metabolism
insulin resistance
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-08-18
Enrollment: 42
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether vitamin K supplementation has an effect on glucose metabolism in terms of acute beta cell response.

Detailed description: Recently, many studies have reported that vitamin K metabolism is related to glucose metabolism. The suggested mechanisms connecting vitamin K metabolism and glucose metabolism, are inflammation responses and osteocalcin effect on glucose metabolism. Most of the studies have investigated fasting glucose and insulin sensitive index, few have assessed glucose-intake-stimulated responses in regard to vitamin K supplementation. The purpose of this study is to test whether vitamin K supplementation has an effect on glucose metabolism in terms of acute beta cell response using intravenous glucose tolerance test.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer older than 20 years

Exclusion Criteria:

* Subjects with (a history of) diabetes
* Subjects receiving medication related to diabetes or obesity
* Subjects receiving warfarin

Primary outcomes:
measure: AIRg (acute insulin response to glucose) using FSIGT (frequently sampled intravenous glucose tolerance test)
timeFrame: 4 weeks later
Secondary outcomes:
measure: beta-cell function (FSIGT)
timeFrame: 4 weeks later
measure: disposition index (FSIGT)
timeFrame: 4 weeks later
measure: insulin sensitivity (FSIGT)
timeFrame: 4 weeks later
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Medical School
Study officials:
affiliation: Seoul National University Medical School
name: Chan Soo Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01360073: Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death
Official title: Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death - Nested Case Control Analyses in a Cohort of Patients With Acute Serious Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonfatal Myocardial Infarction
Coronary Death
Keywords: MI
low dose aspirin
PPI
epidemiology
Nonfatal MI and coronary death
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 42542
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals aged 50-84 years who from 1 January 2000 to 31 December 2007 had a documented evidence of a hospitalization for a serious acute coronary event (MI, revascularization of coronary arteries or unstable angina) and who were alive 1 month after this event in two primary care clinical practice databases in the UK: General Practice Research Database (GPRD) and The Health Improvement Network (THIN).

Brief summary: The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in patients with serious coronary heart disease using two UK primary care databases.

Detailed description: Number of Anticipated Subjects: In case-control analysis: 10.000-15.000 participants

Eligibility criteria: Inclusion Criteria:

* As above ( study population description).
* All individuals aged 50-84 years with at least one year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study.

Exclusion Criteria:

* Recorded diagnosis of cancer prior to study start.
* Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording

Primary outcomes:
measure: Nonfatal MI or coronary death
timeFrame: Up to eight years from entry into study cohort
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Research Site
city: Molndal
country: Sweden
facility: Research Site
Study officials:
affiliation: CEIFE (Centro Español de Investigación Farmacoepidemiológica)
name: Luis A Garcia Rodriguez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00667173: A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
Official title: A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Lead sponsor: Dow Pharmaceutical Sciences
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.


Eligibility criteria: Inclusion Criteria:

* Presence of facial rosacea
* Presence of inflammatory lesions

Exclusion Criteria:

* Dermatological conditions of the face that could interfere with clinical evaluations
* Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Primary outcomes:
measure: Change from baseline in the number of inflammatory lesions
timeFrame: 12 weeks
measure: Improvement from baseline in global severity
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in erythema
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Vallejo
country: United States
facility: Solano Clinical Research
state: California
city: Denver,
country: United States
facility: Cherry Creek Dermatology Research Inc.
state: Colorado
city: Miami
country: United States
facility: FXM Research Corp.
state: Florida
city: Newnan
country: United States
facility: MedaPhase Inc.
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Cincinnati
country: United States
facility: University Dermatology Consultants, Inc.
state: Ohio
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
References:
Clinical trial NCT06688773: THE EFFECT OF RELAXATION EXERCİSE ON COMFORT AND ANXIETY IN HERNIATED LUMBAR DISC SURGERY
Official title: THE EFFECT OF PROGRESSIVE RELAXATION EXERCISES ON COMFORT AND ANXIETY LEVEL OF PATIENTS WITH LUMBAR DISC HERNIATION SURGERY: CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Anxiety
comfort level
nursing
lumbar disc herniation
progressive relaxation exercises
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 42
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: This study aimed to investigate the effect of progressive relaxation exercises on the comfort and anxiety levels of patients undergoing lumbar disc herniation surgery in the neurosurgery clinic.

Detailed description: This study aimed to investigate the effect of progressive relaxation exercises on the comfort and anxiety levels of patients undergoing lumbar disc herniation surgery in the neurosurgery clinic.The study's data was conducted as experimental study on patients who will undergo surgery in the neurosurgery clinic of the Ministry of Health Muammer Ağım Gemlik State Hospital between March 2023 and July 2023. The sociodemographic Characteristics Questionnaire, Immobilisation Comfort Scale and State Anxiety Scale were used for data collection. The Shapiro-Wilk normality test, the t-test for the same and different groups mean and standard deviation, Pearson correlation analysis were used to evaluate the data.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age, elective surgery,
* Undergoing LDH surgery for the first time,
* Undergoing lumbarmicrodiscectomy surgery,
* ASA 1 and 2 classification,
* Receiving only general anaesthesia under endotracheal intubation,
* Without cognitive impairment, hearing and vision problems,
* Volunteered to participate in the study,
* Patients who did not develop any complications that would affect comfort and anxiety

Exclusion Criteria:

* 18 years of age or younger,
* With psychiatric disorders,

Primary outcomes:
measure: Comfort
timeFrame: Comfort levels of the patients were measured on the morning of the first postoperative day (before mobilisation)
measure: Anxiety
timeFrame: postoperative day 1 before patients are mobilised
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Gemlik Muammer Ağım State Hospital
state: Gemlik
Study officials:
affiliation: Bandırma Onyedi Eylül Üniversity
name: Didem Ayhan, Associate Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01269073: Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz
Official title: Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz In Identification Of Patients At Risk For Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Apnea
Keywords: Obstructive Sleep Apnea
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adults presenting to a sleep center

Brief summary: This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.

The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient population with a high predisposition to sleep apnea presenting to a sleep center.

Detailed description: This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.

400 consecutive adult subjects who have been referred by their doctor to the sleep disorder center and are undergoing a diagnostic sleep study at the OHSU sleep disorders center will be requested to fill out both a Berlin questionnaire and Portland sleep quiz on the night of the initial diagnostic polysomnography. The questionnaires will be collected and scored in a confidential manner. The predictive value of the questionnaires will be compared with the results of overnight polysomnography (Apnea Hypopnea Index).

Eligibility criteria: Inclusion Criteria:

* Adults more than 18 years old

Exclusion Criteria:

* Subjects Unwilling to Complete the Questionnaire

Primary outcomes:
measure: Comparison of 2 questionnaires
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
Clinical trial NCT03580473: Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification
Official title: Phase II, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Inflammation
Cataract
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification


Eligibility criteria: Inclusion Criteria:

* Participants of both sexes, aged 18 years or more;
* Participants presenting the diagnosis of cataract with indication for surgery by the phacoemulsification procedure;
* Participants who undergo surgery in only 1 eye at a time;
* Participants with intraocular pressure (IOP) ≤ 20 mmHg;
* Signed consent.

Exclusion Criteria:

* Used non-steroidal anti-inflammatory drugs or topical steroids or systemic inhalers within 21 days prior to randomization of the clinical trial;
* Performing the surgery for the second time, to correct the previous procedure or to change the lens;
* Decompensated glaucoma or ocular hypertension with IOP above 21 mmHg;
* Active ocular infectious diseases;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History alcohol abuse or illicit drug use;
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Control of ocular inflammation post-phacoemulsification as evaluated though the presence of cells in the anterior chamber
timeFrame: 16 days
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study
timeFrame: 26 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allegisa
state: São Paulo
Study officials:
References:
Clinical trial NCT06281873: Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy
Official title: Outpatient Clinic of Alexandria University Teaching Hospital, Egypt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oroantral Fistula
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis.

Detailed description: This study was conducted on nine eligible patients who complained of OAF with odontogenic sinusitis. Oral fistulectomy was done with proper curettage. Then, EMMA was performed with simultaneous closure of the OAF by application of PRF membrane and covering it with an acrylic splint. Patients were clinically evaluated for closure of the OAF after 14th days postoperatively, relief of the symptoms, and assessment of the pain level. Also, measurement of the size of the bone defect with the aid of computed tomography (CT) preoperatively and 24th weeks postoperatively.

Eligibility criteria: Inclusion Criteria:

1 - Adult patients between the ages of 20-60 years. 2- Patients who were suffering from chronic fistula that occurred after the extraction of upper posterior teeth

Exclusion Criteria:

1. patients who have any systemic disease that contraindicates any intervention under general anesthesia (e.g., coronary artery disease).
2. OAF that occurred as a result of other causes (e.g., cyst,and trauma)

Primary outcomes:
measure: Evaluation of the soft tissue wound's healing
timeFrame: 1st, 7th, and14 days postoperatively
Secondary outcomes:
measure: Secondary radiographic outcomes, assessment of bone formation
timeFrame: 24 weeks postoperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Alexandria University
name: MONA SAMY, PHD
role: STUDY_DIRECTOR
References: