louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00320762: Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Beijing Hospital
Official title: Study of the Safety and Effectiveness of the Ologen (OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Pterygium
Keywords: Glaucoma
Pterygium
collagen matrix
OculusGen
trabeculectomy
Anti scarring
pterygium recurrence
tissue engineering
Aeon Astron
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the OculusGen Collagen Matrix is effective and safe to implant as an aid of glaucoma and pterygium surgeries.

Detailed description: ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that brings a certain pressure press on the top of the scleral flap which makes the dynamic balance for the aqueous system keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or over
* Patient able to cooperate with study procedures and able to perform tests reliably
* Patient willing to sign informed consent
* Patient able and willing to complete postoperative follow-up requirements
* Glaucoma: one/both eye(s) is/are affected by glaucoma
* Pterygium: patient with pterygium

Exclusion Criteria:

* Known allergic reactions to collagen

Primary outcomes:
measure: the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
timeFrame: 180 day
Secondary outcomes:
measure: the safety via the incidence of complications and adverse events.
timeFrame: 180 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
Study officials:
affiliation: Beijing Hospital
name: Hong Dai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
Clinical trial NCT01498562: Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer
Official title: Randomized Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Patients With Advanced Non-small Cell Lung Cancer: Dual-agent Molecular Targeting of EGFR (DATE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer (NSCLC)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Detailed description: Reversible EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, were shown to be effective in patients with non-small cell lung cancer (NSCLC). However, patients almost invariably develop resistance to TKIs and have disease progression. Nimotuzumab is a humanized monoclonal antibody targeting the EGFR.

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent prior to any study specific procedures
* Unresectable non-small cell lung cancer
* ECOG performance status of 0 to 2
* Male or female; ≥ 20 years of age
* Subjects whose disease has progressed after platinum-based chemotherapy
* Subjects with measurable lesion

Exclusion Criteria:

* Inadequate organ functions
* Disease progression after 2 or more previous chemotherapy regimens
* Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab
* Any clinically significant gastrointestinal abnormalities
* Past medical history of interstitial lung disease
* Pregnant or lactating female

Primary outcomes:
measure: Progression free survival rate at 3 months
timeFrame: 3 months after randomization of last patient
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 3 months after randomization of last patient
measure: Overall survival (OS)
timeFrame: 3 months after randomization of last patient
measure: Overall safety profile
timeFrame: 3 months after randomization of last patient
measure: Objective response rate (ORR)
timeFrame: 3 months after randomization of last patient
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital, Yonsei Cancer Center
Study officials:
References:
citation: Kim HR, Jang JS, Sun JM, Ahn MJ, Kim DW, Jung I, Lee KH, Kim JH, Lee DH, Kim SW, Cho BC. A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01). Oncotarget. 2017 Feb 28;8(9):15943-15951. doi: 10.18632/oncotarget.13056.
Clinical trial NCT00520962: Screening for Undiagnosed Type 2 Diabetes in New Classes of Subjects at High Risk
Official title: New Physiopathogenics Mechanisms Susceptible of Pharmacological Developments (Insulin Resistance and Atherosclerosis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: cardiovascular disease
glucose intolerance
type 2 diabetes
endothelial dysfunction
inflammation
Age> 30 years, male and female
Fasting glucose below 126 mg/dl
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2007-08-27
Enrollment: 1997
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at high risk to develop alterations of glucose metabolism and definition of new pathogenic mechanisms of insulin resistance and atherosclerosis.

The following classes of subjects at high risk will be considered:First degree relatives of patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke, patients with heart valve disease. age will be \> 30 years, both gender.

Detailed description: The primary outcome of the study is evaluation of glucose tolerance, insulin sensitivity and insulin secretion before and 2 hours post-glucose load Secondary outcomes are evaluation of endothelial function, of natriuretic peptides and free fatty acids, and inflammation before and 2 hours post-glucose load. New candidate genes will be also evaluated.

Eligibility criteria: Inclusion Criteria:

* Fasting glucose levels \<126 mg/dl
* Age \>30 years
* Both male and female

Exclusion Criteria:

* Type 1 diabetes
* Known type 2 diabetes mellitus
* Pregnancy
* Impaired kidney and liver function
* Previous history of malignancies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Medicine Division, Diabetology, Endocrinology and Metabolic Disease Unit, IRCCS San Raffaele
Study officials:
affiliation: IRCSS San Raffaele
name: PierMarco Piatti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monti LD, Lucotti PC, Setola E, Rossodivita A, Pala MG, Galluccio E, LaCanna G, Castiglioni A, Cannoletta M, Meloni C, Zavaroni I, Bosi E, Alfieri O, Piatti PM. Effects of chronic elevation of atrial natriuretic peptide and free fatty acid levels in the induction of type 2 diabetes mellitus and insulin resistance in patients with mitral valve disease. Nutr Metab Cardiovasc Dis. 2012 Jan;22(1):58-65. doi: 10.1016/j.numecd.2010.04.005. Epub 2010 Aug 14.
Clinical trial NCT02955862: Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report
Official title: Vietnam Cryptococcal Retention in Care Study (CRICS) Federal Financial Report From June 2015 to June 2016
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cryptococcal Meningitis
Keywords: Cryptococcal antigenemia
Cryptococcal meningitis
HIV/AIDS
Lead sponsor: National Hospital for Tropical Diseases, Hanoi, Vietnam
Sponsor class: OTHER_GOV
First posted: 2016-11-04
Enrollment: 1177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: CRICS financial report for the first budget year of the study

Detailed description: Vietnam Cryptococcal Retention in Care Study (CRICS) federal financial report for the first budget year of the study

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* Confirmed HIV infection using National Testing Algorithm
* CD4 ≤100 cells/μL
* Able to provide written informed consent

Exclusion Criteria:

* History of prior CM
* Receipt of systemic antifungal medication for more than 4 consecutive weeks within the past 6 months
* Currently taking ART or history of ART for more than 4 weeks within the past year
* Known to be currently pregnant or planning to become pregnant during the study period

Primary outcomes:
measure: The proportion of patients who have advanced HIV disease (CD4 <100)
timeFrame: 12 months
measure: Prevalence of CrAg-positivity among HIV patients with advanced disease
timeFrame: 12 months
measure: The proportion of patients who have no new opportunistic infections at 12 months
timeFrame: 12 months
measure: Mortality rate among HIV patients with advanced disease
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of patients with advanced HIV disease who retain in HIV care at 6 months and 12 months
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Ham Zong
country: Vietnam
facility: National hospital for tropical diseases
Study officials:
affiliation: NHTD
name: Nguyen V Kinh, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dat VQ, Lyss S, Dung NTH, Hung LM, Pals SL, Anh HTV, Kinh NV, Bateganya M. Prevalence of Advanced HIV Disease, Cryptococcal Antigenemia, and Suboptimal Clinical Outcomes Among Those Enrolled in Care in Vietnam. J Acquir Immune Defic Syndr. 2021 Dec 15;88(5):487-496. doi: 10.1097/QAI.0000000000002786.
Clinical trial NCT02907762: Aorfix Intelliflex First in Human Study
Official title: Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm, Abdominal
Keywords: Endovascular
EVAR
Neck Angulation
Lead sponsor: Lombard Medical
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.

Brief summary: The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.

Exclusion Criteria:

1. Do not comply with the indications for Aorfix™ in the IFU.
2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
3. Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.

Primary outcomes:
measure: Number of participants with Successful Implant Delivery (30d)
timeFrame: 1 Month
measure: Number of participants with Treatment Success (1year)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Auckland, NZ
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956562: Effect of Sinovac on Survival in Intensive Care Unit
Official title: Effect of Inactivated COVID-19 Vaccine, Sinovac on Survival in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival
Intensive Care Unit
Keywords: covid-19 vaccine
sinovac
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 96
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to our institution's intensive care unit (ICU) between 01 April 2021 and 15 May 2021 was enrolled to the study. Exclusion criteria was admissions to ICU due to reasons other than COVID-19, age younger than 18, continued admission at the end of enrolment date.

Brief summary: Effect of Inactivated COVID-19 Vaccine (Sinovac) on survival in intensive care unit, Single Center Experience

Detailed description: Turkey has started vaccinate healthcare professionals at 13 January 2021 by Sinovac vaccine and declared a step by step inclusion schedule The primary aim of the study is to compare clinical, laboratory and survival data of COVID-19 patients who were vaccinated at least 14 days before enrollment to the study with COVID-19 patients not vaccinated although they would have. The secondary aim is to compare age of enrolled patients to ICU due to SARS-CoV-2 infection with patients admitted to ICU before start of vaccination program.

Eligibility criteria: Inclusion Criteria:

* Patients with covid 19 over the age of 65 who were admitted to the intensive care unit between 1 April 2021 and 15 May 2021

Exclusion Criteria:

* admissions to ICU due to reasons other than COVID-19, age younger than 65, continued admission at the end of enrolment date,

Primary outcomes:
measure: survival data
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Research and Training Hospital
Study officials:
References:
citation: Sevinc SA, Metin S, Basi NB, Ling J, Cinar AS, Oba S. Effectiveness of inactivated SARS-CoV-2 vaccine (CoronaVac) on intensive care unit survival. Epidemiol Infect. 2022 Feb 9;150:e35. doi: 10.1017/S0950268822000267.
Clinical trial NCT04427462: Bioenergetic Phenotypes and Cardiometabolic Health
Official title: Linking Bioenergetic Phenotypes in Circulating Cells with Cardiometabolic Health in School-age Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 8-10 year olds

Brief summary: This research study is about how daily activities, behaviors, and fitness affect the health and function of blood cells and their mitochondria, which are the powerhouses of the cells. These small mitochondria inside the cells make energy, and are very important for the health of the body.

Detailed description: Determine the impact of physical activity and obesity status on circulating cells mitochondrial function (e.g., fat vs. carbohydrates combustion capacity, total oxidative capacity, mitochondrial number and proton leak).

Eligibility criteria: Inclusion Criteria:

Ages 8-10 years Boys and girls All ethnicity All BMI

Exclusion Criteria:

severe persistent asthma exercise induced asthma autism spectrum disorder attention deficit hyperactivity disorder attention deficit disorder

* Opposition defiant disorder
* conduct disorder
* epilepsy
* chronic kidney disease
* hormonal disease
* autoimmune diseases
* bleeding disorders
* chronic infections
* mental health disorder
* Type 2 and Type 1 diabetes
* Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest

Primary outcomes:
measure: Platelet mitochondrial respiration and its association with adiposity and peak aerobic capacity in children 8 to 10 years old.
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Elisabet Borsheim, Ph
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189462: A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Official title: A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Otitis Media
Otitis Media
Ear Infection
Keywords: Ear Infections
Otitis Media
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2005-09-19
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Detailed description: Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)

Eligibility criteria: Inclusion Criteria:

* Aged 18 months to 5 years old.
* Diagnosis of current AOM

Exclusion Criteria:

* Presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft palate, anatomic predisposition, major congenital anomaly or syndrome, or severe systemic disease
* Use of:

  * Any investigational medications within the past 30 days, systemic or oral or nasal steroids within the past 30 days
  * Accolate® in the past 7 days
  * Antibiotics within the past week, except for Zithromax®, which will be 21 days
  * Long acting second generation antihistamines (i.e., Claritin®, Clarinex®, Allegra® and Zyrtec®) within the past 72 hours.
* No known allergy to either montelukast or amoxicillin/clavulanate
* Have not responded to Augmentin® in the past

Primary outcomes:
measure: Incidence of Acute Otitis Media
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Bellevue Pediatric Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: David Skoner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05956262: The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students
Official title: The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Augmented reality
dental plaque
schoolchildren
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Sun Yat-sen University
First posted: 2023-07-21
Enrollment: 601
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study An augmented reality (AR) simulation toothbrushing machine was developed to train proper brushing technique for children. The investigators aimed to evaluate the effects of AR brushing machine on knowledge of dental clearing skill, self-efficacy and dental plaque control in elementary schoolchildren in Taiwan.

Detailed description: A quasi-experimental design was conducted; ten intervention schools (AR group) and ten comparison schools were selected from elementary schools. Overall, grade 3-6 students in the AR group (n = 290) and the traditional group (n = 311), respectively. Students in the AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. Students in the CG received traditional classroom-based teaching. Baseline and follow-ups information was collected using dental plaque examinations and questionnaires. The generalized estimating equations(GEE) were used to evaluate the outcomes between two groups over time.

Eligibility criteria: Inclusion Criteria:

* Primary school students 3 to 6 grades

Exclusion Criteria:

* Schoolchildren with disability certification.
* Schoolchildren with congenital severe oral diseases (eg. cleft lip and palate )
* Disability to operate the AR system

Primary outcomes:
measure: Plaque Control Record (PCR)
timeFrame: Change from Baseline at 2-week after intervention
measure: Plaque Control Record (PCR)
timeFrame: Change from Baseline at 4-week after intervention
measure: Self-efficacy
timeFrame: Change from Baseline at 2-week after intervention
measure: Self-efficacy
timeFrame: Change from Baseline at 4-week after intervention
measure: Skill of Toothbrushing
timeFrame: Change from Baseline at 2-week after intervention
measure: Skill of Toothbrushing
timeFrame: Change from Baseline at 4-week after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References: