louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02876744: Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes
Official title: Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes, requiring follow-up with fluorescein angiography.

Brief summary: The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus.

This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* diabetes type I or type II
* follow-up with fluorescein angiography

Exclusion Criteria:

* known allergy to fluorescein
* contra-indication to fluorescein angiography
* pregnant or breast-feeding patient
* technical impossibility to analyse retinal ischemic areas on fluorescein angiography or OCT-A.

Primary outcomes:
measure: Detection and measure of ischemic territories in central and peripheral retina
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Opthalmologique A de Rothschild
Study officials:
affiliation: Fondation ophtalmologique de Rothschild
name: Martine MAUGET FAYSSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00358644: Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
Official title: A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
AML
Decitabine
Dacogen
MGI PHARMA, INC.
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 55
Sex: ALL
Minimum age (years): 60
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 estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
2. Ineligible to receive intensive chemotherapy for their disease.
3. Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.

Exclusion Criteria:

1. Received previous treatment for AML.
2. Previously received Vidaza.
3. Received any other investigational agents within 30 days of first dose of study drug.
4. Uncontrolled intercurrent illness.
5. Had radiotherapy within 14 days prior to study enrollment.

Primary outcomes:
measure: Complete Response = Morphologic Complete Remission (mCR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: St. Louis
country: United States
state: Missouri
Study officials:
affiliation: Eisai Inc.
name: Eisai US Medical Services
role: STUDY_DIRECTOR
References:
Clinical trial NCT01623544: Asthma Comparative Effectiveness Study
Official title: A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Comparative Effectiveness
Symbicort
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 6086
Sex: ALL
Minimum age (years): 12
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health plan members with asthma aged 12 to 64 years receiving two or more prescriptions for BFC or FSC during 6/1/2007-9/30/2010 who are naive to ICS/LABA combination therapy.

Brief summary: The objective of this study is to compare the real-world effectiveness of BFC and FSC in asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan enrollees.

Detailed description: A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients

Eligibility criteria: Inclusion Criteria:

* Continuous health plan enrollment for 12 months before and after index Rx
* At least two prescription fills for BFC or FSC within 12 months
* Asthma claims diagnosis, and 12 to 64 years of age at the time of first prescription

Exclusion Criteria:

* Evidence of COPD
* Claims diagnosis of any of inflammatory diseases or cancer
* Presence of Rx for more than one type of ICS/LABA combination on index date
* Chronic steroid use or Xolair use prior to ICS/LABA index treatment

Primary outcomes:
measure: Rate of asthma exacerbations
timeFrame: 12 months
measure: Asthma Related Inpatient Hospitalizations
timeFrame: 12 months
measure: Asthma Related Emergency Department visits
timeFrame: 12 months
measure: Use of Oral Corticosteroids (OCS)
timeFrame: 12 months
Secondary outcomes:
measure: Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)
timeFrame: 12 months
measure: Asthma Related Healthcare Utilization
timeFrame: 12 months
measure: Asthma Related Healthcare costs
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Tunceli O, Williams SA, Kern DM, Elhefni H, Pethick N, Wessman C, Zhou S, Trudo F. Comparative effectiveness of budesonide-formoterol combination and fluticasone-salmeterol combination for asthma management: a United States retrospective database analysis. J Allergy Clin Immunol Pract. 2014 Nov-Dec;2(6):719-26. doi: 10.1016/j.jaip.2014.07.016. Epub 2014 Oct 3.
Clinical trial NCT01159444: What do built-in Softwares in Home Ventilators Tell us?
Official title: What do built-in Softwares in Home Ventilators Tell us? An Observational Study of 150 Patients on Home Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation
Keywords: noninvasive ventilation
ventilator software
ventilator settings
domiciliary ventilation
Lead sponsor: Ligue Pulmonaire Genevoise
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated for at least 3 months in the Geneva Canton Area, followed by the Division of Pulmonary Diseases of Geneva University Hospital, under home ventilation with bi-level positive pressure home ventilators with integrated software for data recording, in stable clinical condition

Brief summary: Home bi-level positive pressure ventilators are equipped with built-in softwares which measure and record specific items such as tidal volume, total ventilation, leaks, respiratory rate, cycles triggered by the patient. These items have not to date been described in a large group of patients under home mechanical ventilation.

Detailed description: Observational study of patients under home positive pressure mechanical ventilation, in a stable condition.

Data recorded by ventilator software is downloaded by specialized nurses during elective home visits, as well as spirometry, results of recent pulse oximetry, ventilator settings, diagnosis, and basic anthropometric data.

Items recorded by ventilator software are: tidal volume, total ventilation, apnea and hypopnea index, leaks, percentage of inspiratory cycles triggered by ventilator, spontaneous and back-up respiratory rates.

Results are reported by diagnostic group. Statistical analysis (univariate and multivariate) aims to determine which variables are related to unintentional leaks, and whether ventilator settings differ significantly between diagnostic groups.

Eligibility criteria: Inclusion Criteria: - All patients with home noninvasive ventilation with bi-level positive pressure home ventilators with integrated software

Exclusion Criteria:

* Hospitalisation or acute exacerbation;
* Ventilation with a device not equipped with built-in software,
* Ventilation with servo-assisted ventilator
* Invasive ventilation (tracheostomy)

Primary outcomes:
measure: Analysis of data downloaded from ventilator software by diagnostic category
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva 14
country: Switzerland
facility: Division of Pulmonary Diseases; Geneva University Hospital
state: Geneva
Study officials:
affiliation: Division of Pulmonary Diseases; Geneva University Hospital
name: Jean-Paul Janssens, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03758144: Rifaximin Improves Gut Dysbiosis in Insulin Resistance and Type 2 Diabetes
Official title: Rifaximin Improves Insulin Resistance in Metabolic Syndrome and Reduces Insulin Requirement in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes
Keywords: gut dysbiosis
rifaximin
insulin resistance
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-11-29
Enrollment: 80
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: Gut Dysbiosis had been involved in some way in the pathogenesis of some extra-intestinal disorders including metabolic syndrome, cardiovascular disease, and obesity.

Detailed description: Accumulating evidence had linked metabolic syndrome and diabetes to dysequilibrium in gut microbiota, which are a critical regulator of host metabolism and immune responses. gut microbiota interacts with host signaling pathways, leading to modulation of the endocrine system, immune responses. gut microbial metabolites, in particular, short-chain fatty acids, have been significantly associated with liability to diabetes. patients with positive fecal short-chain fatty acids will be given rifaximin

Eligibility criteria: Inclusion Criteria:

* diabetes with gut dysbiosis

Exclusion Criteria:

* recent antibiotic use
* pregnancy
* diabetogenic drugs

Primary outcomes:
measure: change in glycemic control
timeFrame: 3 months
Secondary outcomes:
measure: Gastrointestinal symptom questionnaire
timeFrame: 1 month
Other outcomes:
measure: change in weight
timeFrame: 6 months
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
state: Sharkia
Study officials:
References:
Clinical trial NCT02582944: Electromagnetic Navigation for Peripheral Pulmonary Lesions
Official title: Electromagnetic Navigation for Peripheral Pulmonary Lesions Using a Tip Tracked Steerable Catheter and Optical Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Lung Lesions
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. The potential advantages of catheter based techniques include the ability to utilize instruments smaller than the diameter of a conventional bronchoscope, thereby allowing better access to the lung periphery. The drawbacks of a catheter based approach include the relative inability to steer a conventional catheter, and the inability to perform direct visualization and airway inspection through a conventional catheter. This study will evaluate a novel steerable catheter system with optical capabilities and pair this with electromagnetic navigation bronchoscopy to biopsy peripheral pulmonary lesions.


Eligibility criteria: Inclusion Criteria:

* Patients with peripheral lung lesions 1-7cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
* Are at least 18 years old
* Are able to provide informed consent

Exclusion Criteria:

* Patients who refuse to participate
* Are less than 18 years of age
* Are pregnant
* Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
* Are unable to provide informed consent

Primary outcomes:
measure: Diagnostic yield of peripheral bronchoscopy using the tip tracked steerable catheter with removable optics and electromagnetic navigation guidance
timeFrame: At the time of procedure (1 day)
Secondary outcomes:
measure: Confirmation of successful navigation by using radial probe endobronchial ultrasound
timeFrame: At the time of procedure (1 day)
measure: Safety as measured by adverse event rates
timeFrame: At the time of procedure (1 day)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alexander Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813644: A Study of Flexible Ureteroscopy Proficiency After Training on the Uromentor Simulator
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopic Skills
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-12-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: urologists

Brief summary: The development of virtual reality (VR) simulators is changing surgical endoscopic education. The translation of VR skills into clinical endoscopic proficiency has been shown by M.PEARLE. The improvement in performing endoscopic tasks after VR training was evaluated on a cadaver. Our goal is to evaluate the performance of novice endoscopists at the operating room by a randomized controlled study comparing subjects randomized to train on a the "UroMentor" simulator to those without VR training.


Eligibility criteria: Inclusion Criteria:

* novice urologists without endo-urological experience

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center, Beilinson hospital
Study officials:
References:
Clinical trial NCT06742944: Draw-10: A Weekly Blood Draw Study to Understand the Biological Variability of Plasma pTau-217
Official title: Draw-10: A Weekly Blood Draw Study to Understand the Biological Variability of Plasma pTau-217
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Keywords: plasma pTau217
Lead sponsor: Banner Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Arizona residents

Brief summary: This is an observational study that will serially collect 10 plasma samples over the course of 9 weeks from the same individuals to assess fluctuations in blood biomarker results.

Detailed description: Blood biomarkers offer a less invasive and cheaper method for identifying Alzheimer's disease (AD)-related changes. Already, blood biomarkers for AD are being adopted by clinical practice and their use will only expand in coming years. However, blood biomarkers are susceptible to fluctuations not yet well characterized. Such fluctuations, although rarely observed in current research settings, may influence the biological evaluation of dementia once implemented into routine settings. The study at present aims to identify how blood biomarkers fluctuate over a short period of time in the same individual and assess drivers of these fluctuations.

Eligibility criteria: Inclusion Criteria:

* able and wiling to provide informed consent
* Aged 50-80 years old at the time of signing study consent; participants aged 50-59 years will be no more than 20% of the total study population
* Has normal cognition or mild impairment at screening MoCA by a score of greater than or equal to 18; participants with a Montreal Cognitive Assessment (MoCA Test) score between 18-25 will be no more than 20% of the total study population
* able and wiling to fully comply with study procedures defined in the protocol
* Written and spoken fluency in English

Exclusion Criteria:

* Plans to begin any new treatment or is having surgery during the 9-week draw timeframe
* Currently enrolled in a clinical trial using an investigational drug

Primary outcomes:
measure: Fluctuations in plasma pTau217 biomarker results
timeFrame: 9 weeks
measure: Frequency of large unknown biomarkers spike
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Tucson
country: United States
facility: Banner Alzheimer's Institute Tucson
state: Arizona
Study officials:
affiliation: Banner Alzheimer's Institute
name: Jessica B Langbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04579744: Postoperative Quality of Life in Treated Patients With Human Adjuvant Disease
Official title: Postoperative Quality of Life in Surgically Treated Patients With Human Adjuvant Disease: Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Granuloma, Foreign-Body
Keywords: human adjuvant disease
quality of life
Reconstructive surgery
Lead sponsor: Hospital Angeles del Pedregal
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with history of injection of foreign substances as mineral oil or paraffin for cosmetic purposes and who developed human adjuvant disease, characterized for chronic fatigue, myalgias, arthralgias, fever, chronic pain and skin trophic changes due to this foreign substances.

Brief summary: This study aims to describe the quality of life in patients submitted to surgical excision of the adjuvants and injured surrounding tissue. For this purpose, the EuroQol questionnaire (EQ-5d) facilitates to obtain values of health in the physical, psychological, and social dimensions. It is a standardized non-disease specific instrument to describe and value the health-related quality of life. Although there are only five domains, it has been found to cover the most critical dimensions of quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of human adjuvant disease due to foreign substances injection
* Treated surgically to remove foreign substance
* In a private practice setting and treated all by plastic surgeon senior author.

Exclusion Criteria:

* History of antidepressant use during the follow up

Primary outcomes:
measure: Quality of life: EuroQuality Of Life-5Dimensions
timeFrame: 31.09 months (range 6 - 96)
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Angeles Pedregal
state: Cdmx
Study officials:
References:
Clinical trial NCT05215444: Evaluation of Some Prognostic Factors in Acute Aluminum Phosphide Intoxicated Cases
Official title: Evaluation of Some Prognostic Factors in Acute Aluminum Phosphide Intoxicated Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aluminum Phosphide Poisoning
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-01-31
Enrollment: 42
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the mode of toxicity is suicidal by ingestion of AlP tablet

Brief summary: study of some laboratory and clinical findings which may show the severity of aluminium phosphide toxicity and the need of the cases to be admitted to ICU

Detailed description: aluminium phosphide poisoning is a major cause of death in intoxicated and suicidal cases since there is no antidote and there is no specific investigation for it so there is a need for further study to identify the cause of death and the most specific investigation in the case of AlP toxicity

Eligibility criteria: Inclusion Criteria:

1. History of exposure or intake of Aluminum phosphide.
2. Clinical picture of Acute Aluminum phosphide poisoning including severe vomiting, hypotension, abdominal pain, cardio-pulmonary distress.
3. Cases of the age of 15 to 45 years old

Exclusion Criteria:

- 1. Cases with an unclear history. 2. History of co-morbidities or systemic diseases because of the possibility of misleading laboratory results.

3. History of co-ingestion of drugs or another poison.

Primary outcomes:
measure: prognosis
timeFrame: the first 24 post poisoning
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine Zagazig University
state: Sharkia
Study officials:
References: