louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04032184: Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
Official title: Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prevention of Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data


Eligibility criteria: Inclusion Criteria:

* Age range 20-50 years
* High caries risk patients defined according to cariogram caries risk assessment model
* On non-cariogenic diet
* High plaque index
* Systematically healthy
* No orthodontic or prosthodontic appliance

Exclusion Criteria:

* Age range less than 20 or more than 50 years
* Low or moderate caries risk patients according to cariogram
* Patients with a compromised medical history
* Cariogenic diet patient
* Participants with a history of allergy to any of the drugs or chemicals used in the study
* Patients on any antibiotics during the past month

Primary outcomes:
measure: Caries Risk Assessment
timeFrame: an average 3 months
Secondary outcomes:
measure: DMF scores
timeFrame: an average of 12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Howaida Fakhry Fouad
state: Other
Study officials:
References:
Clinical trial NCT04548284: Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO
Official title: Periorbitally Injected Glucocorticoids for Mild TAO: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Thyroid Associated Ophthalmopathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.


Eligibility criteria: Inclusion Criteria:

General conditions:

1. clinically diagnosed as thyroid disease;
2. able and willing to participate in clinical trials and ensure regular follow-up.

Eye condition:

1. patients with monocular disease diagnosed by TAO;
2. EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
3. the course of eye disease was less than 12mo and had not been treated in the past.

Exclusion Criteria:

General situation:

1. patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
2. blood pressure still fluctuated \> 180/110mmHg after medication;
3. obvious liver and kidney insufficiency;
4. contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
5. patients with severe abnormal blood coagulation;
6. patients with other systemic immune diseases;
7. any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
8. history of chronic infection;
9. pregnant and lactating women.

Eye conditions:

1. B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
2. moderate to severe TAO, in either eye requiring local or systemic treatment;
3. periorbital infectious diseases, hemorrhagic diseases;
4. uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases.
5. those who studied the eyes who had a history of arbitrary surgery;
6. those who were considered by the researchers to be excluded.

Primary outcomes:
measure: Change of Clinical Activity Score (CAS) score
timeFrame: baseline、3months、6months、9months、12months
measure: Change of NOSPECS score
timeFrame: baseline、3months、6months、9months、12months
Secondary outcomes:
measure: adverse events
timeFrame: baseline、3months、6months、9months、12months
measure: Quality of life questionnaires (GO-QoL)
timeFrame: baseline、3months、6months、9months、12months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT00585884: Following the Use of Gel Prosethetics in Breast Reconstruction
Official title: Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Reconstruction or Revision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Reconstruction, Silicone prostheses
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Mentor Worldwide, LLC
First posted: 2008-01-03
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women over 18 undergoing breast reconstruction

Brief summary: Following placement of silicone breast prosthetics for reconstruction

Detailed description: Patients undergoing breast reconstruction will be followed for outcomes after placement of silicone prostheses

Eligibility criteria: Inclusion Criteria:

* Women undergoing breast surgery

Exclusion Criteria:

* Collagen vascular disease, Scleroderma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: The University of California Irvine
state: California
Study officials:
affiliation: Mentor Worldwide, LLC
name: Jeff Lewis
role: STUDY_CHAIR
References:
Clinical trial NCT06448884: Accuracy of ICCMS Versus Simplified Cariogram
Official title: Accuracy of the Caries Risk Assessment of International Caries Classification and Management System (ICCMS) Versus Simplified Cariogram in the Egyptian Young Adult Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Caries,Dental
Keywords: Risk
Validity
Cariogram
ICCMS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young Adult Egyptians

Brief summary: The study aims to compare the validity of the caries risk assessment regarding the comprehensive ICCMs Caries risk and likelihood matrix versus the simplified Cariogram aiming to see if there is a significant difference in the caries risk levels between both models.

Detailed description: The simplified Cariogram has been already established as a simple computerised efficient way to categorise patients according to their risk of developing new lesions. However, since then, more comprehensive ways such as the ICCMS have risen. Such comprehensive models require much more data to be entered and more time for the assessment to be complete.

This study aims to test whether there is a significant difference between the validity of both models that would justify the extra time, effort, and recordings that have to be taken for the ICCMS.

Eligibility criteria: Inclusion Criteria:

* Age ranging from 18 to 29 years.
* The presence of dental caries or restoration.

Exclusion Criteria:

* Patients with no caries.
* Patients diagnosed of psychiatric disease.
* Patients not willing to be part of the study or ones who refuse to sign the informed consent.

Primary outcomes:
measure: Validity
timeFrame: At baseline Immediately after collecting the data.
Secondary outcomes:
measure: Reproducibility
timeFrame: At baseline Immediately after collecting the data.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03839784: Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Official title: Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Decline
Cognitive Change
Cognitive Impairment
Postoperative Delirium
Anesthesia; Reaction
Anesthesia; Adverse Effect
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stanford Hospital geriatric patients having surgery.

Brief summary: The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.


Eligibility criteria: Inclusion Criteria:

* At least 65 years old (inclusive)
* Non cardiac general elective surgery
* General anesthesia is expected for 2+ hours

Exclusion Criteria:

* Alzheimer's
* Dementia
* Parkinson's
* History of neurodegenerative diseases
* Medication for depression (ie. Benzodiazepines)
* Alcoholism
* Discretion of PI

Primary outcomes:
measure: Postoperative Neurocognitive Disorders
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Medical Center
state: California
Study officials:
affiliation: Stanford University
name: David Drover, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02780284: Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer
Official title: Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Gut Microbiota
Butyrate
Physical activity
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study has 2 aims:

Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Investigators hypothesize that it will be possible to recruit and retain this patient population to a physical activity intervention trial.

Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing the gut microbiome data. Investigators hypothesize that all of these steps are feasible.

Detailed description: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and is the third most common cancer in men and women. CRC risk factors include genetic predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical activity, obesity). There are very limited data on the differences in the gut microbiota among populations at different levels of CRC risk, as well as the effects of behavioral interventions to alter the gut microbiome.

Eligibility criteria: Inclusion Criteria:

1. Fluent in English or Spanish;
2. At high risk of developing colorectal cancer;
3. No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
4. No use of antibiotics in the previous 3 months; or current regular use of antibiotics
5. Access to either smart phone or computer; and
6. Currently physically inactive.

Exclusion Criteria:

Any criterion not met under inclusion.

Primary outcomes:
measure: Percentage of participants retained at the end of study
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of participants with collected, processed, and analyzed stool samples
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Heather Greenlee, ND, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02934984: Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer
Official title: Analysis of Factors Related to Pancreatic Cancer Recurrence Using Circulating Cell-free Tumor DNA(ctDNA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
recurrence
DNA
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive pancreatic cancer patients who received EUS-FNA for diangosis and undergo operation, benign pancreas disease patients who received EUS-FNA for diagnosis, healthy population

Brief summary: The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.

Detailed description: In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.

So in this study, the investigator will collect ctDNA of pancreatic cancer patients, benign pancreatic disease patients, and healthy population. And the investigator will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.

Eligibility criteria: Inclusion Criteria:

* Comparative group : Pancreatic cancer patients who progress endoscopic ultrasonography fine-needle aspiration (EUS-FNA) for pancreatic cancer diagnosis, pancreatic cancer patients who are in operable stage
* Control group : Benign pancreas disease patients who progress EUS-FNA for diagnosis, healthy population

Exclusion Criteria:

* Foreigners
* Pancreatic cancer patients who have other cancer
* Patients who impossible to consent to study by own

Primary outcomes:
measure: Rates of recurrence in pancreatic cancer patients
timeFrame: 36 months
Secondary outcomes:
measure: Rates of death in pancreatic cancer patients
timeFrame: 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02791984: Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness
Official title: Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular System
Keywords: Suprasternal
echography
fluid responsiveness
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 62
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: Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. A threshold value of 12% allowed discrimination between responders and nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is already used to measure cardiac output. The primary endpoint of this study is to determine the predictive value of the respiratory variability in aortic blood velocity measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint is to compare maximum velocity and velocity time integral measured by suprasternal and transthoracic view.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* American Society of Anesthesiologists (ASA) score 1 or 2
* General Anesthesia with mechanical ventilation
* General Surgery

Exclusion Criteria:

* Arrhythmia
* Spontaneous breathing activity
* Significant valvular disease

Primary outcomes:
measure: Percentage of cardiac flow variability
timeFrame: At day 1(before surgery)
Secondary outcomes:
measure: Comparison of percentage of cardiac flow variability between transthoracic and suprasternal views
timeFrame: At day 1(before surgery)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix-Rousse, Hospices Civils de Lyon
Study officials:
affiliation: Hopital de la Croix-Rousse
name: Pauline Devauchelle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876484: Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
Official title: Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Obesity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2016-08-23
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of bile acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Uncomplicated RYGB performed minimum 3 months prior to the study.
* Fasting plasma glucose \< 7,0 mM, HbA1c \< 48 mmol/mol 3 months after RYGB

Exclusion Criteria:

* Fasting plasma glucose \> 7,0 mM, HbA1c \> 48 mmol/mol 3 months after RYGB.
* Dysregulated thyroid diseases, use of antithyroid treatment.
* Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
* Complications to RYGB. Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake).
* Cholecystectomy

Primary outcomes:
measure: GLP-1 secretion (evaluated by iAUC)
timeFrame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal
Secondary outcomes:
measure: Glucose levels
timeFrame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Insulin secretion
timeFrame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: PYY secretion
timeFrame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Bile acids/FGF19 concentrations
timeFrame: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Appetite measurements (VAS-score)
timeFrame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: PCM levels
timeFrame: Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes
measure: C-peptide secretion
timeFrame: Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
measure: Glucagon secretion
timeFrame: Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes
measure: GIP secretion
timeFrame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: CCK secretion
timeFrame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Ghrelin
timeFrame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
measure: Total bile acid secretion
timeFrame: 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References: