louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05821179: Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma
Official title: Salivary LINC00657 as a Diagnostic Biomarker for Oral Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Squamous Cell Carcinoma
Keywords: Oral squamous cell carcinoma, oral potentially malignant disorders, saliva, LINC00657, miR-106a.
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - patients recruited from the outpatient clinic of departments of oral diagnosis and medicine and periodontology Fayoum, Beni-Suef and Ahram-Candian universities

Brief summary: This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included.

Detailed description: This study was designed to verify the role of salivary LINC00657 as a diagnostic marker in oral squamous cell carcinoma (OSCC) patients as compared to oral lichen planus (OLP) (as an example of oral potentially malignant lesions) and normal individuals, and to show its relation to miR-106a. A total of 36 participants were included, subdivided into 3 groups: Group I: 12 patients diagnosed with OSCC. Group II: 12 patients diagnosed with OLP. Group III: 12 systemically free individuals with no oral mucosal lesions. statistical analysis and ROC analysis were performed

Eligibility criteria: Inclusion Criteria:

* group I : oral squamous cell carcinoma lesions (OSCC)
* group II: oral lichen planus lesions (OLP)
* group III: systemically healthy volunteers

Exclusion Criteria:

* oral lesions other than OSCC / OLP in group I and II
* any oral lesion in group III
* pregnant females

Primary outcomes:
measure: LINC00657 level in salivary samples from all participants measured using PCR
timeFrame: level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation after diagnosis confirmation
Secondary outcomes:
measure: miR-106a level in salivary samples from the included subjects evaluated by PCR
timeFrame: level of miR-106a is measured after the completion of all salivary sample collection carried at the 1 day of enrollment of subjects in the investigation
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: faculty of dentistry, Fayoum university
Study officials:
affiliation: faculty of dentistry, Fayoum university
name: Nayroz Tarrad, as. professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05497479: Study Evaluating Techniques for Measuring Tear Production
Official title: A Phase 1 Study Evaluating Techniques for Measuring Tear Production
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Disease
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.
Primary purpose: TREATMENT

Brief summary: This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.


Eligibility criteria: Inclusion Criteria:

* Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
* Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
* Within the last year from Visit 1, have documented symptoms of DED
* Corrected Visual Acuity (Snellen) 20/200 or better in both

Exclusion Criteria:

* Use of artificial tears within 2 hours prior to Visit 1
* Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
* Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
* Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
* Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.

Primary outcomes:
measure: Unanesthetized Schirmer test
timeFrame: Day 1
measure: Unanesthetized Schirmer test
timeFrame: Day 1
measure: Unanesthetized Schirmer test
timeFrame: Day 1
measure: Anesthetized Schirmer test
timeFrame: Day 1
measure: Anesthetized Schirmer test
timeFrame: Day 1
measure: Anesthetized Schirmer test
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Aerie Pharmaceuticals
name: Michelle S Senchyna, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00869479: Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis
Official title: Validation of a Questionnaire as a Screening Tool to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrogenic Systemic Fibrosis
Keywords: Nephrogenic Systemic Fibrosis
Screening
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Massachusetts General Hospital Dermatology and Rheumatology clinics

Brief summary: The Primary Aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators believe that there will be difference between subjects with NSF and other skin conditions and normal skin.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18 years of age or older.
2. Willing and able to understand and provide oral informed consent.
3. Able to complete study and comply with study procedures.

Exclusion Criteria:

1. Subject is unable to provide oral consent.
2. Psychiatric or other conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Primary outcomes:
measure: Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases.
timeFrame: 1 day
Secondary outcomes:
measure: Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases.
timeFrame: 1 day
measure: Sensitivity of the questionnaire when applied to NSF subjects.
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jonathan Kay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Todd DJ, Kay J. Nephrogenic systemic fibrosis: an epidemic of gadolinium toxicity. Curr Rheumatol Rep. 2008 Jul;10(3):195-204. doi: 10.1007/s11926-008-0033-6.
citation: Todd DJ, Kagan A, Chibnik LB, Kay J. Cutaneous changes of nephrogenic systemic fibrosis: predictor of early mortality and association with gadolinium exposure. Arthritis Rheum. 2007 Oct;56(10):3433-41. doi: 10.1002/art.22925.
citation: Lima XT, Alora-Palli MB, Kimball AB, Kay J. Validation of a screening instrument for nephrogenic systemic fibrosis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):637-42. doi: 10.1002/acr.21877.
Clinical trial NCT00831779: Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Astra Zeneca, Bristol-Myers Squibb
First posted: 2009-01-29
Enrollment: 116
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit
* Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
* C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
* BMI ≤ 45.0 kg/m2

Exclusion Criteria:

* Urine albumin to creatinine ratio (UACR) \> 1,800 mg/g (203.4 mg/mmol/Cr)
* Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN)
* Alanine aminotransferase (ALT) \> 3X ULN
* Serum Total Bilirubin \> 2 mg/dL (34.2 μmol/l)
* Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Primary outcomes:
measure: Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Va San Diego Healthcare System
state: California
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Philadelphia
country: United States
facility: Temple University General Clinical Research Center
state: Pennsylvania
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02671279: Low Calorie Diet in Morbidly Obese Patients
Official title: Effect of 6 Days Low Calorie Diet Before Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Fonna
First posted: 2016-02-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. On admission and after finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.

Detailed description: The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal.

At the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. Weight will be measured every morning for the study period.

During the operation fatty tissue samples will be taken subcutaneous and from the omentum major.

This study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.

Eligibility criteria: Inclusion Criteria:

* BMI 40-46 kg/m2
* The patients must not conduct a diet before admission.
* Fasting blood glucose \<-7 nmol/l

Exclusion Criteria:

* Diabetes mellitus
* Treatment with antidiabetics
* Allergy for substances in the planned study-diet

Primary outcomes:
measure: Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet
timeFrame: 8 days
Secondary outcomes:
measure: Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet
timeFrame: 8 days
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Hordaland
city: Haugesund
country: Norway
facility: Haugesund Sjukehus, Helse Fonna
Study officials:
affiliation: Haukeland University Hospital
name: Gunnar Mellgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825379: Clinical Evaluation of a Bioactive Material
Official title: Clinical Evaluation of a Bioactive Material
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tooth Disease
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performance of a bioactive composite and a posterior resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a bioactive composite \[Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)\] and a posterior resin composite \[G-ænial Posterior (GC, Tokyo, Japan) (GP)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility criteria: Inclusion Criteria:

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria:

* poor gingival health
* adverse medical history
* potential behavioral problems

Primary outcomes:
measure: Clinical performances of different restorative systems according to FDI criteria
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT04742179: Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.
Official title: Fighting Climate Change: Urban Greennes, Active Mobility and Health Co-benefits.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory and Allergic Symptoms
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 175
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, non-randomized, controlled, interventional study aiming to assess, in a primary school in the city of Palermo, the health effects of a maintenance and care intervention of the school's green areas.

All children of the third, fourth and fifth classes of two school complexes of the same primary school will be selected. One complex will undergo maintenance and care of the green areas and gardens inside the school. The other complex will serve as a control group and will not undergo any intervention.

The study will involve three phases.

1. During the first phase (prior to the intervention) respiratory and allergic symptoms will be assessed through a standardized questionnaire to be administered to students, parents and teachers in both the school complexes.
2. During the second phase, the maintenance and care intervention plan will be implemented in the experimental complex.
3. During the third phase, 1 week after the maintenance intervention, respiratory and allergic symptoms will be re-assessed through a standardized questionnaire to be administered to the same students, parents and teachers in both the school complexes.


Eligibility criteria: Inclusion Criteria:

* male or female gender
* age between 7 and 11 years

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Asthma symptoms at baseline
timeFrame: Before the maintenance intervention
measure: Rhinitis symptoms at baseline
timeFrame: Before the maintenance intervention
measure: Conjunctivitis symptoms at baseline
timeFrame: Before the maintenance intervention
measure: Asthma symptoms at follow-up
timeFrame: 7 days after the maintenance intervention
measure: Rhinitis symptoms at follow-up
timeFrame: 7 days after the maintenance intervention
measure: Conjunctivitis symptoms at follow-up
timeFrame: 7 days after the maintenance intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Translational Pharmacology
Study officials:
References:
Clinical trial NCT03911479: Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric Surgery
Official title: Evaluation of Heart Rate Variability and Endothelial Function Three Months After Bariatric
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Eliete Bouskela
First posted: 2019-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Short-term, non-blinded, non-randomized longitudinal study comparing obese patients undergoing bariatric surgery with those on clinical treatment.
Primary purpose: TREATMENT

Brief summary: Was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

Detailed description: To assess the pathophysiological mechanisms that leads the benefits in cardiovascular risk after bariatric surgery, through the autonomic nervous system and endothelial function, was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment.

The analysis of HRV and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery.

Were also analyzed GLP-1, insulin and glucose at fast, and 30 and 60 minutes. The results were compared in parallel with a control group with clinical treatment for obesity.

Eligibility criteria: Inclusion Criteria:

Patients with obesity grade 3 \[Body Mass Index (BMI) ≥ 40kg/m2\] or grade 2 (BMI 35-39.9kg/m2) with comorbidities

Exclusion Criteria:

Current use of incretin mimetics or inhibitors of dipeptidyl peptidase-4 (DPP4); and history of a previous cardiovascular event (acute myocardial infarction, stroke or peripheral obstructive arterial disease)

Primary outcomes:
measure: Rate variability and endothelial function
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gomide Braga T, das Gracas Coelho de Souza M, Maranhao PA, Menezes M, Dellatorre-Teixeira L, Bouskela E, Le Roux CW, Kraemer-Aguiar LG. Evaluation of Heart Rate Variability and Endothelial Function 3 Months After Bariatric Surgery. Obes Surg. 2020 Jun;30(6):2450-2453. doi: 10.1007/s11695-020-04397-4.
Clinical trial NCT02783079: Insomnia Interventions in Cancer Survivors
Official title: Insomnia Interventions in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Breast Cancer
Prostate Cancer
Colon Cancer
Lung Cancer
Gynecologic Cancer
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at two different interventions used for the treatment of insomnia in survivors of breast, colon, lung, prostate and gynecologic cancer.

Detailed description: The purpose of this study is to evaluate two validated interventions for the treatment of insomnia in cancer survivors of breast, colon, lung and prostate cancer. Moreover, it will provide an opportunity to assess the efficacy of both of these interventions in a group setting in patients of varied ethnic backgrounds including African-Americans, Latinos and Caucasians. The results of this study will help clinicians provide future interventions specific to cancer type and ethnicity in order to better serve the needs of our cancer survivors and improve their quality of life.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* age 18 and over
* diagnosis of breast, colon, lung, prostate or gynecologic cancer that is non metastatic
* receiving treatment at one of the outpatient offices of the MD Anderson Cancer Center at Cooper
* Self reported insomnia
* Not currently taking any medications to treat insomnia
* No medical or psychological condition that would prevent successful protocol completion in the opinion of investigator.

Primary outcomes:
measure: Change in Insomnia Severity Index
timeFrame: Baseline to 6 weeks and 6 weeks to 12 weeks
Secondary outcomes:
measure: Change in Brief Fatigue Inventory (BFI)
timeFrame: Baseline to 6 weeks and 6 weeks to 12 weeks
measure: Change in Depression, Anxiety and Stress Scale 21 (DASS21)
timeFrame: Baseline to 6 weeks and 6 weeks to 12 weeks
measure: Number of patients who respond to CBT vs MBSR based on Ethnicity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Camden
country: United States
facility: MD Anderson Cancer Center at Cooper
state: New Jersey
city: Voorhees
country: United States
facility: MD Anderson Cancer Center at Cooper
state: New Jersey
Study officials:
References: