louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01514305: Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
Official title: Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that fit the inclusion criteria will be chosen from the general population

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing.

Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values.

Safety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older;
2. Have been diagnosed with insulin-requiring diabetes
3. Abstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
4. Insert sensors on their own and wear 2 systems simultaneously;
5. Use only the blood glucose meter provided for all blood glucose measurements performed during sensor wear and not allow others to use this meter during the study;
6. Participate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session;
7. Have an intravenous catheter inserted for 4 blood draws per hour
8. Willing to perform SMBG during home use with the meter provided;
9. Refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
10. Speak, read, and write English;
11. Willing and able to be compliant with provisions laid out in this protocol.

Exclusion Criteria:

1. Have extensive skin changes/diseases that preclude wearing devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
2. Allergy to medical-grade adhesives;
3. Pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
4. Dialysis treatment;
5. Hematocrit that is outside the range of 30-55% at screening visit;

Primary outcomes:
measure: Absolute Relative Difference (%) to Reference Standard
timeFrame: one time measure (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
Study officials:
affiliation: DexCom, Inc.
name: David Price, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02633605: Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results
Official title: Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: First Sense Medical, LLC
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 358
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is comprised of adult women who are having a diagnostic or screening mammogram.

Brief summary: First Sense Medical®, LLC is a medical device company developing a novel breast cancer screening tester called the First Sense Breast Exam® Tester. This radiation free tester is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. When the tester is in production, a test will take approximately 7 minutes and will be performed in a doctor's office.

Detailed description: This study is designed to evaluate the First Sense Breast Exam® test and the analysis by Therma-Scan. The First Sense Breast Exam® test is an adjunct to a mammogram. Currently, mammography is the standard of care in screening for breast cancer, and manual thermology is an adjunctive screening method. All of the study costs will be incurred by the sponsor and the subject will incur no costs to participate in the study. The First Sense Tester is a non-significant risk device where the tester's imaging camera makes no contact with the subjects during the entire procedure.

Eligibility criteria: Inclusion Criteria:

* Female, over the age of 18 years of age.
* Asymptomatic women and women who are being screened for breast abnormality.
* Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
* Not pregnant or breast feeding.
* Signed Informed consent.

Exclusion Criteria:

* Subject does not meet inclusion criteria, noted above.
* Use of niacin or niacin patch.
* Use of nitroglycerin.
* Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
* Patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.).
* History of breast cancer

Primary outcomes:
measure: Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Eleanor N. Dana Cancer Center
state: Ohio
Study officials:
References:
Clinical trial NCT01864005: A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
Official title: A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-ST or ST Elevation Acute Coronary Syndromes
Keywords: Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 60
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: The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.


Eligibility criteria: Inclusion Criteria:

* 1. Provision of informed consent prior to any study specific procedures
* 2. Female or male aged at least 18 years
* 3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
* 4. Index event of non-ST or ST segment elevation ACS.

Exclusion Criteria:

* 1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
* 2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
* 3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
* 4. Requires dialysis
* 5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped

Primary outcomes:
measure: the Percentage Inhibition of the P2Y12 Receptor
timeFrame: at 2 hours after first dose of study drug
Secondary outcomes:
measure: the Percentage Inhibition of the P2Y12 Receptor
timeFrame: at 0.5 hour after first dose of study drug
measure: the Percentage Inhibition of the P2Y12 Receptor
timeFrame: at 8 hours after first dose of study drug
measure: the Percentage Inhibition of the P2Y12 Receptor
timeFrame: at 24 hours after first dose of study drug
measure: the Percentage Inhibition of the P2Y12 Receptor
timeFrame: at 6 weeks after first dose of study drug
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
Study officials:
affiliation: The General Hospital of People's Liberation Army
name: Yundai Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01173705: Factors Involved in Obesity-related Inflammation and Insulin Resistance
Official title: Genetic and Nutritional Factors Involved in Obesity-related Inflammation and Insulin Resistance
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Insulin Resistance
Inflammation
Keywords: Obesity
Insulin Resistance
Inflammation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal weight and obese subjects who are undergoing elective bariatric or abdominal surgery

Brief summary: In this project, we propose to recruit lean and obese subjects with different ethnic background (African Americans and Caucasians) to study the alterations of lipid and carbohydrate metabolism and determine whether these disturbances are linked to genetic, inflammatory, oxidative stress, and/or nutritional factors. Because systemic inflammation and insulin resistance are frequent features of obesity, we postulate that an unbalanced diet with high saturated- and low omega 3-fatty acids is linked to obesity-related inflammation and insulin resistance. We propose to investigate fatty acid metabolism and determine the links between fatty acid composition and oxidative stress in tissues of lean and obese subjects. We propose the following aims:

Specific Aim 1: Evaluate nutrient intake in lean and obese subjects using the standard NHANES Food Questionnaire.

Specific Aim 2: Evaluate the fatty acid composition, including omega-3, in adipose tissue depots, blood monocytes and skeletal muscle, and examine the relationship between omega-3 content and inflammatory and oxidative stress markers.

Specific Aim 3: Compare the effects of omega-3 and saturated FA supplementation on inflammatory and oxidative stress markers in vitro in adipose tissue explants, preadipocytes and monocyte culture.


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* Undergoing elective abdominal or bariatric surgery

Exclusion Criteria:

* Intercurrent infections
* Active cancer diagnosis within 5 years
* Use of medications for diabetes or hyperlipidemia
* Use of glucocorticoids or anti-inflammatory drugs

Primary outcomes:
measure: Examine the relationship between omega-3 content and inflammatory and oxidative stress markers
timeFrame: 5 years
Secondary outcomes:
measure: Evaluate nutrient intake
timeFrame: 5 years
measure: Compare effects of omega-3 and saturated fatty acid supplementation on inflammatory and oxidative stress markers (in vitro)
timeFrame: 5 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Robyn Tamboli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Naji N Abumrad, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06265805: Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients
Official title: A Randomized Controlled Trial to Explore the Effect of Different Feeding Modes on Psychological Condition and Experience in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

Detailed description: The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences on Psychological Condition and Experience in ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare Psychological Condition and Experience of two groups.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.

Primary outcomes:
measure: Generalized Anxiety Disorder 7
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: day 1 and day 15
measure: Self-made questionnaire
timeFrame: day 1 and day 15
Other outcomes:
Locations:
city: Xinzhu
country: Taiwan
facility: Hsinchu Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT03117205: The Effect of Kinesio Taping® on Motor Control in Patients With Patellofemoral Pain Syndrome
Official title: The Effect of Kinesio Taping® on Motor Control in Patients With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Pain Syndrome
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Recently, several professionals are using the Kinesio Taping® in the treatment of pathologies related to the knee, aiming to improve the motor control, increase the response of muscle activation and promoting better joint stability.

Purpose: The objective of this study is to evaluate the effect of the application of Kinesio Taping® in motor control of patients with patellofemoral pain syndrome.

Methods: This is a 2-arm, randomized with a blinded assessor. We selected 40 women with patellofemoral pain (age 25.2±4,years) were randomly assigned to one of two groups: placebo group (n= 20) and the Kinesio Taping® group (n=20). The placebo group received the application of a non-stretchable tape (Micropore) crosswise on the thigh and the Kinesio Taping® group followed all the criteria of the method in placing the bandage. All patients received the evaluation of the motor control banding pre and post a patch, by means of the method Y balance test.


Eligibility criteria: Inclusion Criteria:

* Patellofemoral pain syndrome diagnoses
* Aged 18-40 years
* Kujala questionnaire above

Exclusion Criteria:

* Neurological disorders
* BMI indicating obesity (BMI\> 30kg / m²)
* High-performance athletes
* History of surgeries in lower limbs
* In treatment of any underlying pathology

Primary outcomes:
measure: Method Y balance test
timeFrame: Evaluation was performed after 30 minutes of applying the bandage
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02658305: Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prognathism
Retrognathia
Jaw Abnormalities
Keywords: transoral approach
transbuccal approach
postoperative complications
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 509
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All orthognathic patients operated in the lower jaw between January 2010 and December 2012 at the Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Belgium

Brief summary: Bicortical screws have been widely used for mandibular osteosynthesis during orthognathic surgery.Transoral placement of bicortical screws is a rigid fixation method in orthognathic surgery, which is less often used.

The aim of this study was to compare postoperative outcome of transoral versus transbuccal bicortical screw placement during orthognathic surgery.

This study comprises an academic, retrospective, monocentric study in which the charts of orthognathic patients operated between January 2010 and December 2012 were retrospectively reviewed. Postoperative complications were registered. Demographic, dental and surgical parameters are examined as potential risk factors for the occurence of postoperative complications.


Eligibility criteria: Inclusion Criteria:

* patients of all ages
* patients of all genders
* patients who had undergone a bimaxillary osteotomy, a bilateral sagittal split ramus osteotomy (BSSO), a BSSO with a chin osteotomy or a trimaxillary osteotomy

Exclusion Criteria:

* patients where cement had been used at the osteotomy sites
* patients who had undergone a multisegmented mandibular osteotomy
* patients who had undergone an osteosynthesis with plates
* patients where the postoperative orthopantomogram was unavailable
* patients where data regarding the type of screw placement was unavailable

Primary outcomes:
measure: Postoperative complications (rate of screw removal and/or infection)
timeFrame: within 4 weeks postoperative
Secondary outcomes:
measure: The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications
timeFrame: within 4 weeks postoperative
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: General Hospital Saint-John Bruges
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06934005: Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
Official title: Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2025-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Following a cross-over design in Part I of the study, two of the four initial Baseplates, is tested for longer wear time (35 days) in this Part II of the study.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this clinical investigation is to test the safety and performance of one short- and one long-term Baseplate constructed with different types of biocompatible adhesives.

Detailed description: This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S.

The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates.

This study is Part II of the protocol. Part I is registered: NCT05111847

Eligibility criteria: Inclusion Criteria:

* Informed consent obtained, and letter of authority signed before any study related activities
* Are at least 18 years of age and have full legal capacity
* Healthy skin behind the ear

Exclusion Criteria:

* Pregnant or breastfeeding
* Known allergic responses to the adhesives
* Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
* Subject is unable or does not have the necessary assistance to properly operate the device system

Primary outcomes:
measure: Trans epidermal water loss (TEWL) to measure skin-friendliness
timeFrame: 35 days
Secondary outcomes:
Other outcomes:
Locations:
city: København NV
country: Denmark
facility: Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Tonny Karlsmark, Dr.
role: STUDY_CHAIR
References: