louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03211741: Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
Official title: Longterm Efficiency and Safety of Intravitreal Injections With Bevacizumab in Patients With Neovascularisation or Macular Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Retinal Neovascularization
Macular Edema
Keywords: Bevacizumab
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although the safety and efficacy of bevacizumab has been established in several phase 3 trials, there is only little documented about the long-term safety and efficacy in the 'real-world practice' in large populations from different regions.

Therefore the investigators evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available. This will allow the investigators to compare the results of their centre with the results of several phase 3 trials from the literature and will guide improvements in their treatment protocols.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years of either gender
2. Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed
3. Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The presence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the ocular coherence tomography.

If both eyes are eligible for the study, both eyes can be included in the study.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (\> 5mIU/mL)
2. Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication
3. Tromboembolic event (CVA or transient ischemic attack, AMI) less than 3 months prior to the intravitreal injection of bevacizumab
4. History of hypersensitivity for bevacizumab.

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: every visit, up to ten years
measure: Slit lamp examination
timeFrame: every visit, up to ten years
measure: Dilated Fundoscopy
timeFrame: every visit, up to ten years
measure: Central Retinal Thickness
timeFrame: annually, up to ten years
measure: Fluorescein Angiography and Ocular Coherence Tomography
timeFrame: annually, up to ten years
Secondary outcomes:
measure: side-effects
timeFrame: annually, up to ten years
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT04272541: Effectiveness of a Psychoeducation Program in Patients With Severe Mental Disorder
Official title: Effectiveness of a Psychoeducation Program on Metabolic Syndrome, Cardiovascular Risk, Independency and Psychopatology in Patients With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Healthy Lifestyle
Keywords: cardiovascular risk
metabolic syndrome
independency
psychopathology
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower than the general population. Among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. The objective of the present study will be to evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for activities of daily living and psychopathological symptoms.

Detailed description: It will be selected sixty patients diagnosed with SMD from a community Mental Health Unit from Spain. It will be implemented a intervention program consisted of psychopharmacology + psychoeducation on healthy living habits during three months. The patients will be evaluated at the beginning, at three months and at six months follow-up for weight, waist circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and psychopathology.

Eligibility criteria: Inclusion Criteria:

* Over 40 years old,
* A body mass index higher than 30
* Psychopathologically stabilized

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: weight
timeFrame: Change from Baseline in weight at 3 and 6 months
Secondary outcomes:
measure: waist circumference
timeFrame: Change from Baseline in waist circumference at 3 and 6 months
measure: waist-hip ratio
timeFrame: Change from Baseline in waist-hip ratio at 3 and 6 months
measure: Framingham scale
timeFrame: Change from Baseline in Framingham scale at 3 and 6 months
measure: Global Assesment of funtioning Scale
timeFrame: Change from Baseline in Global Assesment of funtioning Scale at 3 and 6 months
measure: PANNS
timeFrame: Change from Baseline in PANNS at 3 and 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: José Manuel Pérez Mármol
Study officials:
affiliation: Department of Physiotherapy. Faculty of Health Sciences, University of Granada
name: José Manuel Pérez Mármol, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02719041: Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The tissue and medical history of forty women who underwent surgery for ovarian cancer, at the Hillel Yaffe Medical Center

Brief summary: The main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.


Eligibility criteria: Inclusion Criteria:

* women who underwent surgery for ovarian cancer

Exclusion Criteria:

* None

Primary outcomes:
measure: Responsive to IGF1R therapy
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ilan Bruchim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01997541: Insertion Depth Comparison of Tracheal Tubes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: American Society of Anesthesiologists physical status I, II patients scheduled for elective surgery with general anesthesia

Brief summary: There will be a difference of the insertion depth between the types of the endotracheal tube.


Eligibility criteria: Inclusion Criteria:

* undergoing surgery under general anesthesia -

Exclusion Criteria:

* upper airway or pulmonary problems
* neck and/or chest distortion
* patients at risk for pulmonary aspiration of gastric content -

Primary outcomes:
measure: the distance between endotracheal tube tip and carina
timeFrame: within 1 minute after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
References:
Clinical trial NCT04732741: Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
Official title: Diagnostic Accuracy of Salivary Gamma-synuclein in Oral Malignant and Premalignant Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Cancer
Oral Lichen Planus
Oral Leukoplakia
Premalignant Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: patients with malignant lesions will be diagnosed through clinical and histopathological examination of tissue biopsy.

Group 2: patients with oral potentially malignant lesions will be diagnosed clinically and histopathological examination of tissue biopsy.

Group 3: healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history

Brief summary: Synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (Surguchov et al., 2001). Gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. It is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (Liu et al., 2018). Smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the Gamma-synuclein expression in cancer cells (Hsu et al., 2020a).

Gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (Liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (Liu et al., 2012). It is present in blood, serum, cerebrospinal fluid and saliva. The detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (Surguchov, 2016).

This study aims to identify the diagnostic accuracy of Gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.


Eligibility criteria: Inclusion Criteria:

Group 1: patients with malignant lesions will be diagnosed through clinical and histopathological examination of tissue biopsy.

Group 2: patients with oral potentially malignant lesions will be diagnosed clinically and histopathological examination of tissue biopsy.

Group 3: healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history

Exclusion Criteria:

-

Primary outcomes:
measure: Gamma-synuclein level sensitivity and specificity
timeFrame: At same time as biopsy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01181141: Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
Official title: A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Anticoagulants
Enoxaparin sodium
venous thromboembolism.
thromboembolism
Thrombosis
deep vein thrombosis
DU-176b
Edoxaban
factor Xa
hip fracture surgery
embolism
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Exclusion Criteria:

* Subjects with risks of hemorrhage
* Subjects with thrombolic risks
* Subjects who weigh less than 40 kg
* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Primary outcomes:
measure: The Incidence of Major or Clinically Relevant Non-major Bleeding
timeFrame: 2 weeks
Secondary outcomes:
measure: Proportion of Subjects With Venous Thromboembolism Events.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
affiliation: Osaka Kouseinennkin Hospital
name: Takeshi Fuji
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Kiuchi Y, Abe K, Tachibana S. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res. 2014 Jun;133(6):1016-22. doi: 10.1016/j.thromres.2014.03.009. Epub 2014 Mar 6.
Clinical trial NCT01890941: A Late Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry eye syndromes
Corneal diseases
Conjunctival diseases
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-02
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.


Eligibility criteria: Inclusion Criteria:

* Corneal and conjunctival damage
* Insufficiency of lacrimal secretion
* Ocular symptom

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctual plugs or surgery for occlusion of the lacrimal puncta

Primary outcomes:
measure: Score of the Corneal conjunctival staining
timeFrame: 8weeks
Secondary outcomes:
measure: Incidences of Adverse Events
timeFrame: 8weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
Study officials:
References:
Clinical trial NCT02494219: Pharyngitis,Group A Streptococcal Infection,Rapid Streptococcal Test,Throat Swab Culture
Official title: Comparison of Immunochromatographic Test for Rapid Detection of Group A Streptococcal Antigen With Culture in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharyngitis
Keywords: Group A streptococcal pharyngitis
Rapid streptococcal test
Throat swab culture
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2015-07-10
Enrollment: 906
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of Immunochromatographic Test for rapid detection of group A streptococcal antigen with culture in Pediatric patients.

Detailed description: Throat swabbing by two port germ Amines agar (copan) swabs,then the swabs were randomly labeled as swab A and swab B.Swab A was processed for rapid streptococcal test and swab B was processed for culture in Colombia blood agar.All patients were followed up after 48-72 hours with the final culture results that ultimately determined the need to continue or discontinue treatment.

Eligibility criteria: Inclusion Criteria:

* All patients presenting with the possible diagnosis of Bacterial pharyngitis,between 1-14 years of age.

Exclusion Criteria:

* Patients who received antibiotics within two weeks from presentation

Primary outcomes:
measure: The ratio of true negative rapid immunochromatographic strep test when compared throat culture
timeFrame: upto 48 hours
Secondary outcomes:
measure: The ratio of true positive rapid immunochromatographic strep test when compared to throat culture
timeFrame: upto 48hours
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad medical corporation
Study officials:
References:
Clinical trial NCT00225719: Effect of rHDL on Atherosclerosis - Safety and Efficacy: THE ERASE TRIAL
Official title: Regression of Coronary Atherosclerotic Lesions After rHDL Infusions in Acute Coronary Syndrome Patients as Assessed by Intravascular Ultrasound.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndromes
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently available therapies to treat Acute Coronary Syndromes(ACS) have several limitations including; the relatively long treatment duration required before apparent significant benefit; the inability to achieve reversal of the atherosclerotic process; and poor patient compliance due to chronicity of therapy. This study will assess the effects of rHDL compared with placebo on indices of atherosclerosis progression and regression as assessed with intravascular ultrasound (IVUS) in patients after acute coronary syndromes (ACS).


Eligibility criteria: Inclusion Criteria:

* Male or female 30 - 75 years of age
* Recent acute coronary syndrome, defined as unstable angina, non-Q wave myocardial infarction, or ST elevation indicative of myocardial infarction, within the last 14 days

Exclusion Criteria:

* \>50% stenosis by visual angiographic estimation in the left main artery
* Renal insufficiency
* Severe liver disease
* Congestive heart failure as defined by the NYHA classification as functional Class III or Class IV
* Previous or planned coronary artery bypass surgery

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Jean-Claude Tardif, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tardif JC, Gregoire J, L'Allier PL, Ibrahim R, Lesperance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodes-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. doi: 10.1001/jama.297.15.jpc70004. Epub 2007 Mar 26.
Clinical trial NCT05837819: Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2
Official title: Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Sleep Disturbance
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 135
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score \<25
* Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5

Exclusion Criteria:

* Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
* Obstructing cataracts
* Severe macular degeneration
* Use of sleep medication
* Use of oral melatonin
* untreated moderate to severe sleep apnea
* Severe restless leg syndrome
* Blindness

Primary outcomes:
measure: Sleep Disturbance using the Pittsburgh Sleep Quality Index
timeFrame: up to week 14
Secondary outcomes:
measure: Sleep efficiency using actigraphy
timeFrame: up to week 14
measure: Depression using the Cornell Scale for Depression in Dementia (CSDD)
timeFrame: up to week 14
measure: Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)
timeFrame: up to week 14
measure: Light measurements using the Daysimeter
timeFrame: up to week 14
measure: Cognitive status Using the Montreal Cognitive Assessment (MOCA)
timeFrame: up to week 14
Other outcomes:
Locations:
city: Albany
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00552019: Intraocular Pressure (IOP) Assessed by Dynamic Contour Tonometer (DCT) and Goldman Applanation Tonometry (GAT)
Official title: Inflammatory Changes of Corneal Thickness and Influence on Assessment of Intraocular Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Intraocular Pressure
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2007-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tertiary referral center

Brief summary: The purpose of this study is to evaluate an assessment of the intraocular pressure with the dynamic contour tonometry and the Goldmann applanation tonometry in patients with active anterior uveitis.

Detailed description: Keratoprecipitates are often found in anterior uveitis. Also elevation of the IOP can be seen in these patients. Goldmann applanation tonometry is the standard technique to assess the IOP but depends on the corneal thickness. Therefore IOP is measured by Goldmann and dynamic contour tonometry and corneal thickness is quantified by Orbscan at active uveitis and after the keratoprecipitates have disappeared.

Eligibility criteria: Inclusion Criteria:

* active anterior or panuveitis with keratoprecipitates

Exclusion Criteria:

* corneal endothelial dystrophy

Primary outcomes:
measure: IOP by GAT and DCT
timeFrame: 3 months after treatment start
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Department of Ophthalmology at St.-Franziskus Hospital
Study officials:
affiliation: Department of Ophthalmology at St.-Franziskus Hospital
name: Arnd Heiligenhaus, MD
role: STUDY_DIRECTOR
References: