louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04840524: Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers
Official title: Effect of Preparation Design on the Functional and Esthetic Outcome of CAD/CAM Lithium Disilicate Laminate Veneers (Split Mouth Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Disorders Hard Tissues of Teeth
Tooth Discoloration
Keywords: Laminates
Vertical preparation
veneers
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conservatism is considered the main concern in any treatment plan, the feather edge preparation design of laminate veneers have been introduced yet clinical studies are lacking to evaluate their clinical performance.The aim of this study is to evaluate the effect of the two different preparation designs on the functional and esthetic outcome of laminate veneers in terms of marginal adaptation, retention, fracture, marginal discoloration and patient satisfaction


Eligibility criteria: Inclusion Criteria:

* From 18-60 years old, and able to read and sign the informed consent document.
* Patients with teeth problems indicated for laminate veneers.
* Physically and psychologically able to tolerate conventional restorative procedures.
* Have no active periodontal or pulpal diseases.
* Maintenance of good oral hygiene .
* Willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth.
* Patients with para-functional habits.
* Cases that need modification in the incisal edge.
* Patients with poor oral hygiene and motivation .
* Psychiatric problems or unrealistic expectations.

Primary outcomes:
measure: marginal gap distance
timeFrame: at time of laminate cementation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry - Cairo University
Study officials:
References:
Clinical trial NCT05575024: Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy With oXiris Membrane
Official title: Real-time Monitoring of Hemodynamic Stability in Septic Shock Patients Undergoing Continuous Renal Replacement Therapy: Propensity Score-matched Comparison Between oXiris and Polysulfone Membranes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury Due to Sepsis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have severe acute kidney injury and require continuous renal replacement therapy because of hemodynamic instability.

Brief summary: The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in septic shock patients with severe acute kidney injury, compared with standard membranes. However, its hemodynamic stability or benefits have not been thoroughly evaluated although this is reasonable.

Detailed description: The new adsorbing membrane for continuous renal replacement therapy (CRRT), oXiris, can reduce plasma cytokines and endotoxins in patients with severe acute kidney injury or sepsis, compared with standard membranes. Based on this benefit, the use of oXiris may confer better outcomes than other membranes.

The patient outcomes include cardiovascular, respiratory, renal, and overall survivals, but this information of oXiris are insufficient. Although cytokine and endotoxin removal rates are great in oXiris, the beneficial effects on the hard outcomes are needed to use oXiris in real clinical practice.

The inflammatory and cardiovascular systems have intensive crosstalk, and thus if there are remission in inflammatory process, the patients can have hemodynamic stability. Regarding this, the investigators would like to compare the hemodynamic stability between oXiris and other standard membrane such as polysulfone, using our new real-time monitoring registry.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Sepsis related acute kidney injury requiring continuous renal replacement therapy

Exclusion Criteria:

• No monitoring of blood pressure and ECG

Primary outcomes:
measure: Rate of all-cause mortality
timeFrame: 28 days
measure: Occurrence rates of ventricular tachycardia, intradialytic hypotension
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seung Seok Han, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02353624: Physiological Responses to a Prolonged Cycling Expedition in Older Men
Official title: Physiological Responses to a Prolonged Cycling Expedition in Older Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 6
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older male cyclits particpating in the cycling event

Brief summary: The aim of this study was to test the physiological response to a 2800 km cycling expedition, from Copenhagen, Denmark to Nordkapp, Norway, in a group of older male recreational cyclists.


Eligibility criteria: Inclusion Criteria:

* Participation in the cycling expedition

Exclusion Criteria:

* None

Primary outcomes:
measure: Total daily energy expenditure (Measured using the doubly labeled water technique)
timeFrame: Change from baseline
Secondary outcomes:
measure: Peak fat oxidation (Measured during incremental submaximal exercise)
timeFrame: Change from baseline
Other outcomes:
measure: Energy intake (Measured using selfreported and supervised food logs)
timeFrame: Change from baseline
measure: Body composition
timeFrame: Change from baseline
measure: Energy Balance (Discrepancy between energy expenditure and intake or changes in body composition)
timeFrame: Change from baseline
measure: Cardiac Stress
timeFrame: Change from baseline
Locations:
city: Copenhagen N
country: Denmark
facility: University of Copenhagen, Department of Biomedical Sciences
Study officials:
affiliation: University of Copenhagen
name: Jørn Helge
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenkilde M, Morville T, Andersen PR, Kjaer K, Rasmusen H, Holst JJ, Dela F, Westerterp K, Sjodin A, Helge JW. Inability to match energy intake with energy expenditure at sustained near-maximal rates of energy expenditure in older men during a 14-d cycling expedition. Am J Clin Nutr. 2015 Dec;102(6):1398-405. doi: 10.3945/ajcn.115.109918. Epub 2015 Oct 21.
Clinical trial NCT06264024: Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
Official title: Simultaneous pHototherapeutic Keratectomy and corneAl Collagen cRosslinking in Eyes With Keratoconus: a Randomized Trial (SHARK)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Keratoconus
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 81
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 goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.

The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit.
* Progressive keratoconus with indication for CXL
* Corneal thickness ≥ 420 μm

Exclusion Criteria:

* Other eye disease causing visual impairment

Primary outcomes:
measure: Visual acuity
timeFrame: 1 month after surgery
measure: Risk of progression
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Visual acuity
timeFrame: 3 month after surgery
measure: Visual acuity
timeFrame: 6 month after surgery
measure: Visual acuity
timeFrame: 1 year after surgery
measure: Visual acuity
timeFrame: 2 years after surgery
measure: Visual acuity
timeFrame: 5 years after surgery
measure: Risk of progression
timeFrame: 1 month after surgery
measure: Risk of progression
timeFrame: 3 months after surgery
measure: Risk of progression
timeFrame: 6 months after surgery
measure: Risk of progression
timeFrame: 2 years after surgery
measure: Risk of progression
timeFrame: 5 years after surgery
measure: Depth of demarcation line (OCT)
timeFrame: 1 month after surgery
measure: Depth of demarcation line (confocal microscopy)
timeFrame: 1 month after surgery
measure: Patient reported outcome measure (PROMs)
timeFrame: 1 month after surgery
measure: Patient reported outcome measure (PROMs)
timeFrame: 6 months after surgery
measure: Patient reported outcome measure (PROMs)
timeFrame: 2 years after surgery
measure: Patient reported pain after surgery
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Ophhtalmology, University of Oslo
Study officials:
References:
Clinical trial NCT00867724: Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
Official title: A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Keywords: polyp
Lead sponsor: GI View Ltd.
Sponsor class: INDUSTRY
First posted: 2009-03-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.

Detailed description: Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.

Eligibility criteria: Inclusion Criteria:

* Male or female patients between 18 and 70 years of age
* Patients who are generally healthy and classified as low risk for CRC
* Patients who are ready to undergo standard colonoscopy examination including colon prep.
* Signed informed consent

Exclusion Criteria:

* Patients with any known GI related symptoms complaints or GI diseases
* Patients with cancer or other life threatening diseases or conditions
* Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study).
* Pregnant women
* Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
* Morbid Obesity (BMI \> 40)
* Drug abuse or alcoholism
* Bed-ridden patient
* Inadequate communication with the patient
* Patients under custodial care
* Participation in current clinical study or clinical study within 30 days prior to the procedure

Primary outcomes:
measure: Ability to screen the entire length of the colon to the cecum.
timeFrame: 30 -60 minutes
Secondary outcomes:
measure: Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Erwin M Santo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00723424: Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin
Official title: An Open-label Study to Assess the Effect of AZD5672 at Steady State on the Pharmacokinetics of Digoxin Following Single Dose Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Pharmacokinetics
Keywords: AZD5672
digoxin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).


Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent.
* Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative drug test and negative tests of Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV.

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
* Known allergy to digoxin or previous complications to digoxin therapy.
* Participation in any clinical study involving an investigational product in the 3 months prior to enrolment.

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study periods
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment periods
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Charnwood, UK
name: Rod Hepburn
role: STUDY_DIRECTOR
affiliation: Parexel
name: Rainard Fuhr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02894424: Effect of the Membrane Blue Dual® Dye on the Retinal Sensitivity in Macular Hole Surgery
Official title: Pilot Study of the Effect on the Retinal Sensitivity of the Membrane Blue Dual® Dye Used for Peeling of the Internal Limiting Membrane in Macular Hole Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole Surgery
Keywords: Inner limiting membrane
Microperimetry
surgical's dye
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for macular hole surgery

Brief summary: The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years.

This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery.

This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models.

It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* lower idiopathic macular hole inferior or equal to 600 micron millimeter
* undergoing macular hole surgery

Exclusion Criteria:

* Myopia \> -3 diopters
* pregnant women
* no Health Insurance coverage
* refusal to participate in the study

Primary outcomes:
measure: change in retinal sensitivity
timeFrame: change from baseline sensitivity at 1 month after macular hole surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Yannick Le Mer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05289024: Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy
Official title: Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-pharmacologic Management of Chronic Pain
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2022-03-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic pain patients attending an integrative health center

Brief summary: This is a one group study using a hybrid implementation design.

Detailed description: The proposed pilot study will collect preliminary data to support a larger hybrid effectiveness-implementation study designed to examine the implementation of the evidence-based Mindful Awareness in Body-oriented Therapy (MABT), delivered by massage therapists, on patient and implementation science outcomes in an interdisciplinary chronic pain clinic. The combined foci of this mixed-methods pilot study is expected to provide an indication of implementation success, highlight implementation processes, and show treatment effectiveness on health outcomes.1 MABT is a mind-body therapy designed to teach interoceptive awareness skills for symptom management and emotion regulation. The proposed pilot study uses mixed methods and a single-group repeated measures design to explore MABT implementation and to estimate the effect of MABT to reduce symptomatic distress in the treatment of chronic pain at the Osher Center for Integrative Medicine at Vanderbilt Clinic (OCIM).

Eligibility criteria: Inclusion Criteria:

* Patient attending clinic and who received a referral to MABT

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Total number of referrals to MABT
timeFrame: 24 months
measure: Total number of MABT visits
timeFrame: 24 months
measure: Number of referrals to MABT from a Psychologist
timeFrame: 24 months
measure: Number of referrals to MABT from a Nurse Practitioner
timeFrame: 24 months
measure: Number of referrals to MABT from a Physical Therapist
timeFrame: 24 months
measure: Number of referrals to MABT from a Massage Therapist
timeFrame: 24 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT01025024: Investigation of Genetic Disease Marker Associated With Korean Glaucoma Patients
Official title: Investigation of Genetic Disease Marker Associated With Korean Glaucoma Patients Patients, A Single-nucleotide Polymorphism(SNP)Analysis for Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single-nucleotide Polymorphism (SNP) for Glaucoma
Keywords: SNP
single-nucleotide polymorphism
glaucoma
primary open angle glaucoma
Lead sponsor: Chungnam National University
Sponsor class: OTHER
Collaborators: name: Korea Healthcare Technology R&D Project
name: Korea Advanced Institute of Science and Technology
First posted: 2009-12-03
Enrollment: 1224
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with open angle glaucoma who visited glaocoma clinic of departemtn of Ophtalmology, Chungnam National University Hospital, Daejeon, south Korea

Brief summary: A single-nucleotide polymorphism (SNP) analysis of DNA obtained from peripheral blood of the glaucoma patients and the normal control will be performed to find genetic marker for primary open angle glaucoma.

Detailed description: Unrelated Korean subjects who have primary open angle glaucoma were recruited in the current study. Genotyping for various SNP associated with POAG due to the linkage disequilibrium patterns is to be performed. Genotypes would be statistically compared between patients with primary open angle glaucoma and normal control subjects free of any eye diseases.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary open angle glaucoma

Exclusion Criteria:

* Primary open angle glaucoma combined with congenital ocular disease
* Primary open angel glaucoma combined with other ocular disease
* Significant systemic disease other than systemic hypertension and diabetes

Primary outcomes:
measure: genotyping for the SNP associated with primary open angle glaucoma
timeFrame: one year
Secondary outcomes:
measure: genotyping for rs7961953 and additional SNPs in TMTC2 from other linkage disequilibrium patterns
timeFrame: one year
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Department of Ophthalmology, Chungnam National University Hospital
name: Chang-sik Kim, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea Advanced Institute of Science and Technology
name: Changwon Kang, professor
role: STUDY_CHAIR
affiliation: Department of Biological Sciences, Korea Advanced Institute of Science and Technology
name: Kyunglan Kim
role: STUDY_DIRECTOR
References: