louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01406262: Albiglutide Thorough ECG Study in Healthy Volunteers
Official title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: albiglutide
QT interval
cardiac repolarization
ECG study
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

Detailed description: This is a Phase I, randomized, double-blind study designed to investigate the effect of treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.

Eligibility criteria: Inclusion Criteria:

* Healthy male or nonpregnant, nonlactating female
* Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values
* BMI is ≥18 kg/m2 and ≤30 kg/m2
* Nonsmoker

Exclusion Criteria:

* Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
* History of arrythmia or use of antiarrhythmic agents
* History of any anaphylactic reaction to any drug
* History of significant cardiovascular or pulmonary dysfunction
* Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis
* History of alcohol or substance abuse
* History of GI surgery that could influence gastric emptying
* Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy
* History of pancreatitis

Primary outcomes:
measure: QTc interval
timeFrame: 6 weeks
Secondary outcomes:
measure: QTc interval
timeFrame: Day 4
measure: QT interval
timeFrame: Day -1 and Day 40
measure: Number of participants with adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
Clinical trial NCT00840762: A Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
Official title: A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV-1
HIV Infections
Keywords: HIV-1
HIV
HIV Genotypic testing
resistance
Lead sponsor: Ruth M. Rothstein CORE Center
Sponsor class: OTHER
Collaborators: name: Virco
First posted: 2009-02-10
Enrollment: 756
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing

Detailed description: Patients having some documented genotypic HIV resistance but having more than one fully active medication will be randomized to either local review or algorithmic review by VircoType HIV-1.

Eligibility criteria: Inclusion Criteria:

* HIV resistance testing that demonstrates resistance to at least one drug
* Patients of the CORE Center, Chicago Illinois

Exclusion Criteria:

* Wild type HIV on resistance testing or less than or equal to one active antiretroviral medication

Primary outcomes:
measure: Proportion of patients with viral load <1000 60days after HIV regimen change
timeFrame: 60 days
measure: Proportion of patients with viral load <1000 180 days after HIV regimen change
timeFrame: 180 days
Secondary outcomes:
measure: Proportion of patients with undetectable viral load 60days after HIV regimen change
timeFrame: 60 days
measure: Proportion of patients with undetectable viral load 180days after HIV regimen change
timeFrame: 180 days
measure: CD4 Cell count change in each arm at 60 and 180 days
timeFrame: 60 and 180 days
measure: Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days
timeFrame: 180 and 360 days
measure: Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed
timeFrame: 180 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The Ruth M. Rothstein CORE Center
state: Illinois
Study officials:
affiliation: Ruth M. Rothstein CORE Center
name: David E Barker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badri SM, Adeyemi OM, Max BE, Zagorski BM, Barker DE. How does expert advice impact genotypic resistance testing in clinical practice? Clin Infect Dis. 2003 Sep 1;37(5):708-13. doi: 10.1086/377266. Epub 2003 Aug 15.
Clinical trial NCT00905762: Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
Official title: A Single-Center, Randomized, Masked Study Comparing the Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After a Single Topical Instillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-05-21
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.


Eligibility criteria: Inclusion Criteria:

* Willing to avoid all disallowed medications for the appropriate washout periods.
* Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.

Exclusion Criteria:

* Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial.
* Monocular.
* Have previously participated in a conjunctival biopsy study.
* Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study.
* have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Primary outcomes:
measure: Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.
timeFrame: Biopsies collected at specified time points from 15 minutes to 24 hours
Secondary outcomes:
measure: Visual acuity
timeFrame: Day -14 through Day 6(+/-1)
measure: Slit Lamp Biomicroscopy
timeFrame: Day -14 through Day 6 (+/-)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Timothy Comstock, OD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03426462: Time to Peak Effect of Propofol in Children
Official title: Time to Peak Effect of Propofol in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Propofol
Child
Keywords: Pharmacodynamic
Permutation Entropy
EEG
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Age groups 1-6 years will be compared with 8-13 years whilst undergoing propofol anesthesia to detect whether there is indeed a difference in the speed of onset of the hypnotic effect of the drug.
Primary purpose: OTHER

Brief summary: In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will enable investigators to quantify the difference with age in the hypnotic effect of propofol.


Eligibility criteria: Inclusion Criteria:

* The study population will be healthy children in the ranges of 1-6 and 8-13 years of age having surgery with American Society of Anaesthesia (ASA) grades I-II (ie. no prior functional limitation due to comorbidities) that fulfil the following points:
* parental written consent obtained at least a day prior to begin of the subject's study episode; and
* the child is appropriate for induction and maintenance of anaesthesia with propofol.

Exclusion Criteria:

* Any significant subject co-morbidity (ASA III or IV);
* Withdrawal of consent/assent at any point in the study;
* Failure to cannulate a peripheral vein prior to induction after two attempts;
* Any other reason making IV induction with propofol impossible;
* Allergy to propofol (or its emulsion carrier), Eutectic Mixture of Local Anesthetics (EMLA) cream or Nitrous Oxide (N2O);
* previous enrolment in the study;
* Any anaesthetic problem that would take precedence over completion of the study protocol.

Primary outcomes:
measure: Time to peak effect of a propofol bolus
timeFrame: up to 20 minutes from baseline until peak effect following second bolus administration
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäts Kinderspital beider Basel
Study officials:
affiliation: Universitäts Kinderspital beider Basel (UKBB)
name: Gil Gavel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01969162: Tear Collection in Adult Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult volunteers without ocular disease.

Brief summary: This exploratory study will collect tear samples from adult volunteers for determining and quantifying tear composition profiles. No investigational drug will be administered in this study.


Eligibility criteria: Inclusion Criteria:

-Adult volunteers without ocular disease.

Exclusion Criteria:

* Systemic medications that could affect eye health taken within 1 month of enrollment
* Eye infection or inflammation in either eye 3 months prior to screening
* History of herpes in either eye
* Diagnosis of dry eye or meibomian gland dysfunction
* Diagnosis of glaucoma
* Allergic conjunctivitis
* Use of rigid contact lenses within 1 year of screening
* Use of soft contact lenses within 1 week of enrollment.

Primary outcomes:
measure: Tear Lipid Composition Profile
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
state: New South Wales
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06347562: Optical Genome Mapping for the Diagnosis of Neurodevelopmental Disorders
Official title: Next Generation Cytogenetics: Impact of New Technologies in the Genetic Diagnosis of Neurodevelopmental Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurodevelopmental Disorder (Diagnosis)
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: to evaluate the ability of the Optical genome Mapping (OGM) approach to detect simple and complex constitutional chromosomal aberrations of clinical relevance, which had previously been identified with standard diagnostic approaches (karyotyping, FISH, CNV-microarray) in the context of neurodevelopmental disorders (NDDs) with/wo congenital anomalies (CA)


Eligibility criteria: Inclusion Criteria:

* subjects with neurodevelopmental disorders carrying a structural variant identified by standard cytogenetic analyses (Karyotyping/FISH/Chromosomal Microarray Analysis)

Exclusion Criteria:

* none

Primary outcomes:
measure: Diagnostic concordance rate
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute E. Medea
state: Lecco
Study officials:
References:
Clinical trial NCT01443962: The Effect of Positive End Expiratory Pressure (PEEP) During Laparoscopic Cholecystectomy
Official title: The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Ischemia
Keywords: laparoscopic cholecystectomy
PEEP
rSO2
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2)

Detailed description: During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain due to increased intracranial pressure, central venous pressure and make worse to respiratory parameters. Positive end expiratory pressure could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional oxygen saturation of brain during the pneumoperitoneum during the laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* ASA I or II,
* 20-65 year,
* patient who undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* cerebrovascular disease,
* coronary artery disease,
* morbid obesity (BMI \> 30)
* propofol allergy,
* addictive

Primary outcomes:
measure: change in regional brain oxygen saturation
timeFrame: from baseline record rSO2 every 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Hyun Jeong Kwak
Study officials:
affiliation: Gachon University Gil Medical Center
name: Kyung Chon Lee, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06961162: The Accuracy of Ultrasonic Viscoelastic Imaging in Evaluating the Severity of Chronic Kidney Diseases
Official title: A Prospective, Single-Center Study: Evaluation of Chronic Kidney Disease Severity Using Ultrasonic Viscoelastic Parameters Combined With Clinical Indicators-With Histopathological Results as Gold Standard
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease(CKD)
Keywords: chronic kidney disease
sonoelastogrphy
fibrosis
inflammation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 47
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: CKD patients who underwent renal biopsy at Peking University Third Hospital based on clinical requirements

Brief summary: The goal of this observational study is to learn about the role of ultrasonic viscoelastic parameters in the assessing the severity of chronic kidney disease. The main question it aims to answer is:

The accuracy of ultrasonic viscoelastic parameters in evaluating the degree of renal fibrosis and inflammation.


Eligibility criteria: Inclusion Criteria:

* (1) fulfilled the diagnostic criteria for CKD (disease course \> 3months); (2) underwent renal biopsy, (3) a prior 2D-SWE evaluation preceding the renal biopsy, and (4) obtained informed written consent.

Exclusion Criteria:

* (1) the presence of multiple renal cysts, calculi, hydronephrosis, or masses that could potentially interfere with the analysis conducted through 2D-SWE: (2) unsuccessful 2D-SWE measurements ;(3) biopsy specimens deemed inadequate due to insufficient length (less than 10 mm) or fewer than 10 glomeruli, and (4) incomplete clinical data.

Primary outcomes:
measure: renal fibrosis degree
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Ultrasound, Peking University Third Hospital
state: Beiing
Study officials:
affiliation: Department of Ultrasound, Peking University Third Hospital
name: Ligang Cui, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02665962: Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
Official title: Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obese
Endometrial Cancer
Keywords: newly diagnosed patients
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 80% of endometrial cancer patients are overweight or obese. Preclinical and clinical data have shown that caloric restriction (CR) protects against organ injury and decreases perioperative morbidity. This is a feasibility trial to evaluate the effect of a 6 week perioperative CR on surgical and patient-reported outcomes in 20 obese newly diagnosed endometrial cancer patients. The intervention will provide individualized CR program, meal replacement products and nutritional counselling sessions.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with Endometrial Cancer
* BMI30 kg/m2
* 18 year of age or older
* Scheduled for definitive surgical intervention (hysterectomy, bilateral salpingoopherectomy with or without lymphadenectomy) in the following 2-3 weeks as part of the standard of care
* Have ECOG performance status of 0-1
* Have a life expectancy of at least 1 year

Exclusion Criteria:

* Inability to communicate in English
* BMI30 kg/m2
* Age18
* Have any uncontrolled serious medical or psychiatric conditions that would affect their ability to participate in an intervention study, (e.g., severe/uncontrolled diabetes mellitus, severe cardiac and/or pulmonary disease and/or depression)
* Diagnosed with any other invasive malignancy currently, in the last five years or expected to undergo active treatment with either cytotoxic chemotherapy or radiation during the 6 week caloric restriction period

Primary outcomes:
measure: Number of completed perioperative caloric restriction program in obese newly diagnosed endometrial cancer patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Nawar Abdul Latif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02994862: E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent
Official title: One Year Clinical Evaluation of E. Max Laminate Veneers With and Without Using Galla Chinnesis as Natural Cross Linking and Remineralizing Agent Before Bonding to Teeth With Amelogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amelogenesis Imperfecta
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In teeth requiring laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method

Detailed description: one year Clinical evaluation of laminate veneers with amelogenesis imperfecta Will application of galla chinensis before Bonding of laminate veneers with adhesive resin cement provide better survival rate than conventional Bonding method

Eligibility criteria: Inclusion Criteria:

All subjects are required to be:

* From 18-60 years old, and able to read and sign the informed consent document.
* Physically and psychologically able to tolerate conventional restorative procedures
* Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ....)
* Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth
* Patient with fractured teeth of more than 50% enamel loss
* Patients with poor oral hygiene and motivation
* Pregnant women
* Psychiatric problems or unrealistic expectations
* Lack of opposite occluding dentition in the area intended for restoration

Primary outcomes:
measure: marginal adaptation assessed by clinical evaluation using dental mirror and probe
timeFrame: 1 year
Secondary outcomes:
measure: Patient satisfaction assessed using a Questionnaire
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
References:
citation: Cheng L, ten Cate JM. Effect of Galla chinensis on the in vitro remineralization of advanced enamel lesions. Int J Oral Sci. 2010 Mar;2(1):15-20. doi: 10.4248/IJOS10019.