louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00893854: The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
Official title: The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Uveitis
Cystoid Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-05-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cystoids macular edema (CME) is one of the most common causes of low vision due to uveitis. The treatment for reducing the intra-ocular inflammation can decrease the macular edema. In some patients, CME persists even after inflammation control, and additional treatment is needed for better vision. Oral steroid, periocular and intravitreal Triamcinolone are the principles in treatment, but some complications like cataracts and increased ocular pressure have been seen. Diclophenac is a non-steroid anti-inflammatory drug that improves the vision and decreases the macular thickness by slowing down the prostaglandin E2 (PGE2) ending in vascular endothelial growth factor (VEGF) inhibition. In this study, the investigators are going to compare the therapeutic affect of intravitreal Diclophenac and Triamcinolone in persistent uveitic cystoids macular edema. Since diclophenac is a cheap and accessible drug in all curative centers it could be applied instead of Triamcinolone.


Eligibility criteria: Inclusion Criteria:

* cystoids macular edema which is diagnosed by OCT and flurocein angiography
* 5/200 \< Visual acuity \< 20/50
* resistance to routine treatment (oral treatment, periocular injection)

Exclusion Criteria:

* history of retinal disease cause macular edema like diabetes
* arterial occlusion
* monocular patients
* patients candidate for intra-ocular operation
* history of glaucoma or ocular hypertension
* any cataract that would interfere with OCT

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT00527254: Telemedicine Influence in the Follow up of the Type 2 Diabetes Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Telemedicine
Self Monitoring Blood Glucose
Primary Care
Lead sponsor: Province of Malaga Health Department
Sponsor class: OTHER_GOV
Collaborators: name: Roche Diabetes Care
First posted: 2007-09-10
Enrollment: 328
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the impact of a a real time teleassistance system in the clinical evolution of type 2 diabetic patients on self monitoring blood glucose in the Public National Primary Care System.

Detailed description: The UKPDS study in type 2 diabetes and the DCCT in type 1, showed that intensive blood glucose control and the following HBA1c decrease were associated with a decrease of diabetic complications. Introducing telecontrol elements in the real time follow up of the patients, should help to know continuously patient blood glucose profile and add if necessary immediately therapeutical variations, to maintain HbA1c levels as low as possible.

The study compares type 2 diabetes patients performing self monitoring of blood glucose, followed up by their family doctor in their primary care unit with the extra support of a real time teleassistance system with type 2 diabetes patients performing self monitoring of blood glucose, followed up by their family doctor in their primary care unit.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 Diabetes
* on SMBG al least 6 months before
* age superior of 30 years
* controlled in province of Málaga Primary Care Units

Exclusion Criteria:

* having diabetic complications or other diseases that could make difficult to use the telemedicine system
* patients who need a carer
* not passing the initial training (low cultural level)
* living in an area without mobile phone coverage

Primary outcomes:
measure: HBA1c Glycosylated hemoglobin
timeFrame: one year for every patient
Secondary outcomes:
measure: Blood glucose, Total Cholesterol, HDL Cholesterol,LDL Cholesterol, Triglycerides, BMI, systolic and diastolic blood pressure and system adherence
timeFrame: one year for every patient
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Province of Malaga Health Department
Study officials:
affiliation: Málaga Health Department (Junta de Andalucia)
name: Maria Isabel Rodríguez Idígoras, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Idigoras MI, Sepulveda-Munoz J, Sanchez-Garrido-Escudero R, Martinez-Gonzalez JL, Escolar-Castello JL, Paniagua-Gomez IM, Bernal-Lopez R, Fuentes-Simon MV, Garofano-Serrano D. Telemedicine influence on the follow-up of type 2 diabetes patients. Diabetes Technol Ther. 2009 Jul;11(7):431-7. doi: 10.1089/dia.2008.0114.
Clinical trial NCT05242354: Macrophage Markers in Periodontal and Peri-implant Health and Disease
Official title: CD80, CD163 and CD206 Tissue Levels in Periodontal and Peri-implant Health and Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis
Periodontitis
Lead sponsor: Biruni University
Sponsor class: OTHER
Collaborators: name: University of Turku
First posted: 2022-02-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Otherwise healthy periodontitis, peri-implantitis patients or periodontally healthy individuals who applied to Biruni University Dentistry Faculty for treatment / regular oral examination

Brief summary: Macrophage surface markers (CD80, CD163 and CD206) will be evaluated in periodontally healthy gingiva, healthy peri-implant mucosa, and periodontitis and peri-implantitis lesions.

Detailed description: Soft tissue biopsies obtained from clinically healthy gingiva, healthy peri-implant mucosa, Stage III Grade C periodontitis lesions and peri-implantitis lesions will be evaluated.

Healthy peri-implant samples are obtained from submerged implants during exposure surgery. Healthy gingiva samples are obtained from individuals receiving crown lengthening, gingivectomy or tooth extraction as excess tissue during the corresponding treatment. Samples from peri-implantitis and periodontitis (pocket depth ≥6 mm, bleeding on probing+) are obtained during initial periodontal treatment / debridement procedure with a single stroke at the pocket wall.

The samples will be grinded and ultrasonicated. Western blotting will be used for determination of CD80, CD163 and CD206 in biopsy specimens. ImageJ will be used for intensity analysis of the bands.

Eligibility criteria: Inclusion Criteria:

* diagnosed with generalized Grade C Stage III periodontitis
* diagnosed with peri-implantitis
* periodontally healthy individuals with dental implants in the primary healing period
* periodontally healthy individuals who are in need of crown lengthening / gingivectomy or extraction

Exclusion Criteria:

* systemic disease
* smoking / former smokers
* regular medicine intake
* antibiotic or anti-inflammatory medicine intake in the last 3 months
* pregnancy or lactation

Primary outcomes:
measure: CD80
timeFrame: Baseline
measure: CD163
timeFrame: Baseline
measure: CD206
timeFrame: Baseline
measure: CD80/CD163 Ratio
timeFrame: Baseline
measure: CD80/CD206 Ratio
timeFrame: Baseline
Secondary outcomes:
measure: Probing Depth
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References:
Clinical trial NCT00106054: Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases
Official title: An Open-Label, Multi-Center Phase II Trial of Neoadjuvant Irinotecan in Combination With Infusional 5-FU, Leucovorin (Folfiri) Plus Bevacizumab in Patients With Unresectable Hepatic-Only Metastases of Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Liver Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-03-21
Enrollment: 2
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 study was terminated early due to low enrollment with only 2 subjects enrolled and treated after being open for enrollment for over a year. Therefore, no meaningful efficacy analyses could be performed.

This trial is studying the effects (good and bad) of a combination of drugs, Irinotecan in combination with infusional 5-FU, leucovorin (FOLFIFI) plus Bevacizumab, for cancer of the colon or rectum that has spread to the liver only and is currently not able to be removed by surgery. All of the drugs that will be received in this research study have been approved in the United States for colorectal cancer, that has spread to other areas of the body, including the liver. Another reason for doing this study is to see if the chemotherapy drugs FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so that any tumor remaining can be completely removed with surgery and, if it can be removed whether doing so will prolong the time it takes the cancer to return and/or prolong the life of these patients. This trial is also looking at the genes of people who take part in this study, to see if it is possible to find out characteristics that can help predict whose cancer will respond well or not so well, and who will have more or less side effects to this chemotherapy.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status of 0 or 1
* Histological documentation of adenocarcinoma of the colon or rectum. The primary site must have been confirmed to be in the large bowel

Exclusion Criteria:

* Prior systemic anticancer therapy for mCRC
* Prior hepatic surgery, chemoembolization, hepatic artery infusion, radiofrequency ablation or cryotherapy for liver metastases

Primary outcomes:
measure: To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases
Secondary outcomes:
measure: oTo determine the resectable rate, defined as the number of subjects with R0 resection, pathologically staged CR, or undergoing non-surgical ablative procedures with curative intent divided by the total number of evaluable subjects following treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00312754: A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome
Official title: A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-04-11
Enrollment: 70
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 clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

- Documented Metabolic Syndrome by at least 3 of the following parameters:

* Abdominal obesity, assessed by waist circumference (for men \>103 cm, for women \>88 cm).
* Triglycerides \> 150 mg/dl.
* HDL cholestrol (for men \<40 mg/dl, for women \<50 mg/dl).
* Blood pressure \> or equal to 130/85 mm Hg.
* Fasting serum glucose \> or equal to 110 mg/dl.
* HIV RNA \< 50 copies/mL.
* IP within 3 months prior to selection.

Exclusion Criteria:

-Treated Metabolic Syndrom

Primary outcomes:
measure: To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period.
Secondary outcomes:
measure: The change in FMD from ref. value after a 12-wk ATV/RTV treatment period.
measure: The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period.
measure: The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.-
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Local Institution
city: Le Kremlin Bicetre
country: France
facility: Local Institution
city: Paris Cedex 15
country: France
facility: Local Institution
city: Paris Cedex 20
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
Study officials:
affiliation: 00 33 1 58 83 63 84
name: Yacia Bennai, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04108754: Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack
Official title: Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnosis of TIA
MRI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the neurovascular unit of the Neurological Hospital of Lyon between 01/01/2016 and 30/12/2017 with a probable diagnosis of TIA and having an MRI within 7 days of the TIA.

Brief summary: Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the literature. score ABCD3-I1. Several studies have shown that brain microhemorrhages are associated with the risk of early stroke in patients with TIA. Data on white matter hypersignals on the T2-weighted sequence or FLAIR (FLuid Attenuated Inversion Recovery) are more conflicting. The global microangiopathic load, including the gaps, the hypersignals of the white matter, the perivascular spaces visible on MRI in the basal ganglia, especially when they are very numerous (\> 20) and the gaps, have recently been described as being associated with stroke risk within 2 to 3 years of TIA or ischemic stroke. To date, the predictive value of global microangiopathic burden on early stroke risk in the course of TIA is not known.


Eligibility criteria: Inclusion Criteria:

* Patients with probable TIA with Regression of symptoms within 24 hours (unilateral motor or sensory disorders affecting the face and / or limbs , language disorder, blindness of an eye or amputation of a visual field)
* Patients with possible AIT with 2 of these symptoms associated: fear of heights, diplopia, dysarthria, disorders of swallowing, loss of balance, isolated sensory symptoms affecting only part of a limb or hemiface.
* Patient who have had a brain MRI.
* Patient over 18 year-old.
* Patient who give their non opposition to participate at the study.

Exclusion Criteria:

-

Primary outcomes:
measure: stroke recurrence within 90 days,
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Norbert NIGHOGHOSSIAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00311454: Quaternium-15, Use Test
Official title: An Open Single Centre Evaluation of the Reactivity of the T.R.U.E. Test Quaternium-15 Patch and a Real Use Exposure in Subjects Known to Be Allergic to Quaternium-15
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Allergic Contact Dermatitis Towards Quaternium-15
Lead sponsor: Mekos Laboratories AS
Sponsor class: INDUSTRY
First posted: 2006-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is required by the FDA as part of a post-marketing commitment. The purpose of the study is to compare the reactivity of the TRUE Test quaternium-15 patch and a real use exposure.The subjects will wear the patch test for 48 hours and reading will be performed day 3 or 4. The use test will be applied from day 3 or 4 and untill reaction appears. Reactions from respectively TRUE Test and use test will be compared using the McNemar Change Test.


Eligibility criteria: Inclusion Criteria:

* Sensitivity to quaternium-15
* Age more than 18 years

Exclusion Criteria:

* Topical or systemic treatment with corticosteroids or immunosuppresives.
* Treatment with UV-light
* Widespread active dermatitis or dermatitis on test area

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Amtssygehuset i Gentofte
Study officials:
References:
Clinical trial NCT06678854: First Responder Aphasia Strategy Training
Official title: First Responder Aphasia Strategy Training
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aphasia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to determine the impact of a collaborative approach to training law enforcement officers and first responders about aphasia including their knowledge and confidence in communicating with individuals with aphasia that they may encounter in the field. 75 participants from Madison Police Department will be enrolled and can expect to be on study for up to 6 months.

Detailed description: The investigators will partner with the Madison Police Department to provide training and programming to law enforcement officers and first responders. Training will include direct teaching, aphasia simulations, scenario-based training and a panel with persons with aphasia with the goal of increasing confidence for law enforcement officers and first responders providing services to and communicating with persons with aphasia.

Participants will take 3 surveys over 6 months.

Eligibility criteria: Inclusion Criteria:

* Employed by Madison Police Department as a first responder or law enforcement officer
* willing and able to provide informed consent
* willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Not employed as a first responder or law enforcement officer with Madison Police Department

Primary outcomes:
measure: First Responder Aphasia Training Score
timeFrame: pre-test (baseline), post-test (after 1 day of training)
measure: First Responder Aphasia Training Score
timeFrame: pre-test (baseline), 3 to 6 month follow-up
measure: First Responder Strategies for Aphasia
timeFrame: pre-test (baseline), post-test (after 1 day of training), 3 to 6 month follow-up
measure: First Responder Confidence in Communication Score
timeFrame: pre-test (baseline), post-test (after 1 day of training), 3 to 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kimberly Mueller, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748654: Feasibility of Visual Field Testing With a Virtual Reality Headset
Official title: Feasibility of Visual Field Testing With a Virtual Reality Headset
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aim to determine the feasibility of using a virtual reality (VR) headset (HTC Vive) to test the visual field. The VR headset test will be compared to a conventional visual field test, using the Humphrey Field Analyzer. The investigators will include 10 healthy patients without visual field defect, 10 patients with early glaucomatous visual field defect, and 10 patients with advanced visual field defect. Each patient will perform the conventional test twice and the VR headset test 4 times, divided in 3 visits within a 2 month period. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and VR tests will be similar.


Eligibility criteria: Inclusion Criteria:

* Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, or advanced glaucomatous field damage, according to Canadian Glaucoma Society Guidelines.
* Ability to understand and consent to the study.

Exclusion Criteria:

* Presence of non-glaucomatous pathology that could influence the visual field test, such as media opacities.
* Previous intraocular surgery less than 6 months from inclusion.
* Difficulty to execute a reliable visual field test.
* Potential contra-indications to use of virtual reality headset, including: anxiety disorder, pregnancy, seizure disorder, cardiac pacemaker or other implantable device, severe vertigo or balance disturbance.

Primary outcomes:
measure: Visual field differential light sensitivity threshold
timeFrame: Three weeks
Secondary outcomes:
measure: Reproducibility of sensitivity values
timeFrame: Three weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Victoria General Hopsital - Nova Scotia Health Authority
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Brennan Eadie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: