louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03597542: Examining the Relationship Between Acute Meal Intake and Inflammation in Children
Official title: Examining the Relationship Between Acute Meal Intake and Inflammation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Inflammation
Keywords: Children
Inflammation
Obesity
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Egg Nutrition Center
First posted: 2018-07-24
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind randomized cross-over design
Primary purpose: BASIC_SCIENCE

Brief summary: Recent evidence has shown that obese and overweight children exhibit states of chronic inflammation. In obese adults, a high carbohydrate meal induces an inflammatory response; however, the effects of a high carbohydrate meal on biomarkers of inflammation has not previously been examined in children. The purpose of this research project is to characterize the inflammatory response to a high carbohydrate versus a low carbohydrate meal in healthy weight, overweight, and obese children (age 7-17 years). After completing informed consent/assent, a Dual-energy X-ray Absorptiometry (DXA) scan, and baseline blood draw on experimental day 1, children will then return to the lab two times to ingest either a high or low carbohydrate beverage followed by post-meal blood collection for a total of 3 blood draws. Biomarkers of inflammation will be analyzed by flow cytometry and enzyme-linked immunosorbent assay (ELISA). Participants will be recruited through various studies through the Neurocognitive Kinesiology Lab/Body Composition and Nutritional Neuroscience Labs as well as through the local Champaign-Urbana community. Data from this project will provide a better understanding of the inflammatory response to different meals in healthy weight, overweight, and obese children.


Eligibility criteria: Inclusion Criteria:

• Between the ages of 7-17

Exclusion Criteria:

* Younger than 7 years and older than 17 years
* Presence of allergies to eggs and/or sugar substitutes
* Presence of heart or respiratory disease
* Presence of uncontrolled hypertension, diabetes
* Use of anti-inflammatory medications
* Presence of cancer or metabolic disease

Primary outcomes:
measure: Effects of egg or maltodextrin on inflammatory cytokines (Tumor necrosis factor-alpha, C-reactive protein, and Interleukin-6)
timeFrame: 3 weeks.
Secondary outcomes:
measure: Effects of egg or maltodextrin on inflammatory monocyte cells with and without expression of Toll-like receptor 4 and C-C Chemokine receptor-2.
timeFrame: 3 weeks.
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References:
citation: Niemiro GM, Chiarlitti NA, Khan NA, De Lisio M. A Carbohydrate Beverage Reduces Monocytes Expressing TLR4 in Children with Overweight or Obesity. J Nutr. 2020 Mar 1;150(3):616-622. doi: 10.1093/jn/nxz294.
Clinical trial NCT00573742: Efficacy Observational Study of Candesartan Cilexetil on Hypertensive Patients
Official title: Non-interventional Study on Uncontrolled Hypertensive Patients for Evaluating Efficacy of Candesartan Cilexetil as Monotherapy or add-on Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hypertension
Keywords: hypertension
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-12-14
Enrollment: 1940
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hypertensive patients not at BP target (according to ESC Guideline for the management of hypertension, 2003), already treated with candesartan cilexetil 16 mg/day

Brief summary: The purpose of this study is to observe treatment with candesartan cilexetil 16mg for 8 weeks, in uncontrolled hypertensive patients, in improvement of achieving of treatment goals and impact on blood pressure level in patients with uncontrolled hypertension treated with candesartan cilexetil.


Eligibility criteria: Inclusion Criteria:

* diagnosis of essential hypertension (mild or moderate as defined in European Guidelines of Hypertension, 2003), that are treated already with candesartan cilexetil 16mg o.d. within last 2 weeks or more, according to Romanian approved Atacand SPC. Written informed consent to allow access and use(analysis) of data collected

Exclusion Criteria:

* Patients not to be included in the programme: patients who have any contraindication to the product as detailed in Romanian approved Atacand SPC. Use of specific concomitant medication known to present a potential safety concern according to Romanian approved SPC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bacau
country: Romania
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Ghiroda
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Lugoj
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Mihai Isvoranu
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Gabriela Teodorescu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03848442: 'Uptime' Participation Intervention in Girls and Women With Rett Syndrome
Official title: Feasibility and Effectiveness of an Individualized 12-week 'Uptime' Participation Intervention (U-PART) in Girls and Women With Rett Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rett Syndrome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 14
Sex: FEMALE
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the feasibility and health-related effects of an individualized 12wk 'uptime' participation intervention in girls and women with Rett syndrome. Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation will be included. Each individual program focuses on participation in enjoyable activities to promote 'uptime' in home, school/day center and community settings. Primary outcomes are sedentary time and daily steps. Secondary outcomes are gross motor skills, walking capacity, quality of life and participation-level goals. Outcomes are evaluated on four occasions: at baseline and after a 6-week interval, immediately following the 12-week intervention program and 12 weeks after the intervention program.


Eligibility criteria: Inclusion Criteria:

* Girls and women above 5 years of age with Rett syndrome and a confirmed MECP2 mutation
* Hoffer ambulation scale levels I-IV

Exclusion Criteria:

* Girls and women who have undergone orthopedic surgery in the lower extremities within the last 6 months
* Girls and women who have undergone spinal fusion within the last 12 months

Primary outcomes:
measure: ActivPAL
timeFrame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
measure: Stepwatch Activity Monitor
timeFrame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
Secondary outcomes:
measure: Rett Syndrome Gross Motor Scale
timeFrame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
measure: 2 minute walk test
timeFrame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
measure: Quality of Life Inventory - Disability, questionnaire
timeFrame: Assessed four times; twice at baseline; once after the 12 week intervention and once after a further 12 week follow-up
measure: Goal attainment scaling
timeFrame: Assessed twice; at baseline and after the 12 week intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Rett syndrome, Department of Paediatrics and Adolescents Medicine
state: København Ø
Study officials:
References:
Clinical trial NCT01972542: The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk
Official title: The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk in Healthy People, Impaired Glucose Tolerance and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Prediabetes
Keywords: Postprandial period
triglyceride
Diabetes mellitus, type 2
Prediabetic state
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The hypertriglyceridemia at fasting status has been known to be an important risk factor for cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an attention as a superior predictor of CVD because of non-fasting state for more than 12 hours and importance of triglyceride-rich lipoprotein.

We aim to investigate the relationship of postprandial triglyceride after fat tolerance test and intima-medial thickness and to suggest normal reference of postprandial triglyceride after fat tolerance test. In addition, we evaluate the correlation of postprandial triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate clinical importance of postprandial triglyceride in assessment of cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* age : 19 \~ 70 yrs
* Type 2 diabetes : HbA1c \<10%
* Prediabetic state : HbA1c 5.7\~6.4%

Exclusion Criteria:

* Type 1 diabetes, secondary diabetes
* dipeptidyl peptidase-4 -inhibitor, glucagon-like peptide-1 agonist, thiazolidinediones users
* Thyroid disease with abnormal thyroid function test
* Liver disease with abnormal liver function test
* severe kidney disease
* pregnant or lactating women
* current smoker
* severe obesity

Primary outcomes:
measure: Changes of Triglyceride
timeFrame: 8 hours
Secondary outcomes:
measure: Changes of incretin
timeFrame: 8 hours
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890642: The Use of Jet Injection Lidocaine for Blood Draws in Young Children
Official title: Use Of The Needle Free Jet-Injection System With Buffered Lidocaine (J-Tip) For The Treatment Of Pain During Venipuncture For Blood Draws In Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Children
Venipuncture
J tip
Lidocaine
video observation
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 205
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at the use of Jet Injection Lidocaine (J tip) for pain during blood draws in children ages 6 and younger. The investigators will use video observation of patients to asses their pain during lab draws using either 1) Jet Injected lidocaine ( J tip) 2) Pain Ease spray 3) Pain Ease spray plus the J tip noise.

Detailed description: No change since last report.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 months-6 years seen in the Children's Hospital of Wisconsin outpatient laboratory that have an order for venipuncture for a blood draw

Exclusion Criteria:

* Previous adverse reaction to lidocaine or Pain Ease spray
* Pre-existing skin lesion at site of blood draw
* Needle stick for IV insertion or lab draw that has already occurred at current hospital visit
* Patients who are physically unable to move their arms or legs
* Patients who are unable to cry
* Patients with connective tissue disorders that predispose to easy bruising
* Patients with bleeding disorders

Primary outcomes:
measure: Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture
timeFrame: 3 min
Secondary outcomes:
measure: Pain Score
timeFrame: At venipuncture (3 minutes)
measure: Fist Attempt Success
timeFrame: up to 3 minutes
measure: Change in Pain Score From Baseline
timeFrame: 3 min
measure: Pain at J-tip Deployment
timeFrame: 1 minute
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Maren Lunoe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Amy Drendel, DO, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lunoe MM, Bolin AE, Drendel AL. An Evaluation of High Preprocedural Anxiety and Venipuncture Pain Experienced by Young Children. Pediatr Emerg Care. 2021 Oct 1;37(10):e621-e624. doi: 10.1097/PEC.0000000000002424.
Clinical trial NCT00963742: Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol
Official title: Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract surgery
IOL
Intraocular lens
Lead sponsor: Lenstec Incorporated
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 390
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.

Detailed description: The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.

Eligibility criteria: Inclusion Criteria:

* Cataract requiring cataract extraction
* Study IOL to only be implanted in 1 eye
* Distance BCVA 20/40 or worse or glare acuity worse than 20/30
* Ability to comply with study follow-up requirements

Exclusion Criteria:

* Patients with serious corneal disease, previous surgery or serious systemic disease
* Ocular condition that could impact vision after cataract surgery
* Pregnant or lactating women
* Use of ocular or systemic medications that could impact vision

Primary outcomes:
measure: Distance Best Corrected Visual Acuity
timeFrame: 1 year
Secondary outcomes:
measure: FDA IOL Grid Adverse Events
timeFrame: through 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Center for Clinical Research
name: Donald R Sanders, M.D. Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04777942: Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)
Official title: Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With High-risk Barcelona Clinic Liver Cancer (BCLC) A Stage: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. However, the clinical value is still undertermined. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for BCLC A stage patients with high-risk factors is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years;
* BCLC A stage with high-recurrence risk factor;
* Patients with resectable primary hepatocellular carcinoma;
* Child-Pugh A or B (7 score) liver function;
* The volume of residual liver more than 30%

Exclusion Criteria:

* • With unresectable HCC

  * Pregnant woman or sucking period;
  * With other malignant cancer;
  * Received anti-HCC therapy before this study

Primary outcomes:
measure: Progression-free survival, PFS
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival, OS
timeFrame: 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02469142: Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
Official title: Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Incarcerated Inguinal Hernia
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.

Detailed description: observation indicator:

1. recurrence rate after operation
2. incidence rate of complications
3. postoperative hospital stay
4. hospitalization costs
5. Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of incarcerated hernia
* randomly select patch agreed by patients and family members

Exclusion Criteria:

* severe organ dysfunction
* No-tolerate anesthesia
* No-suitable for operation
* glucocorticoid with long-term use
* Sever intraperitoneal adhesion existed
* spirit disease patients
* automatically exit

Primary outcomes:
measure: the recurrence rate after operation
timeFrame: ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: xiaonan liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04672642: Evaluation of the SpyGlass DS for Detection of Residual Pancreatic Calculations
Official title: Evaluation of the SpyGlass DS vs Standard Method for Detection of Residual Pancreatic Calculations After Endoscopic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis, Chronic
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to assess the efficacy of the SpyGlass DS for the detection of residual pancreatic calculations after endoscopic treatment.


Eligibility criteria: Inclusion Criteria:

* aged 18 and over;
* with chronic calcifying pancreatitis;
* having already received endoscopic treatment for pancreatic pain related to stenosis and / or pancreatic stones;
* having given free, informed and written consent;
* being affiliated to a social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* contraindications to performing an upper digestive endoscopy;
* haemorrhagic disease, haemostasis and coagulation disorder (PR \<60%, PTT\> 40 s and platelets \<60,000 / mm3;
* pregnant or breastfeeding woman;
* adult patient protected (guardianship or curatorship), or deprived of liberty by a judicial or administrative decision;
* person subject to a safeguard measure.

Primary outcomes:
measure: Residual pancreatic stones detected by the Spyglass DS
timeFrame: baseline
Secondary outcomes:
measure: Residual pancreatic stones extracted by the SpyGlass DS accessory (the SpyGlass Basket)
timeFrame: baseline
measure: VAS score for pancreatic pain
timeFrame: preoperative, 1 month, 6 months and 12 months
measure: Analgesic consumption
timeFrame: preoperative, 1 month, 6 months and 12 months
measure: Analgesic consumption
timeFrame: preoperative, 1 month, 6 months and 12 months
measure: Rate of patients hospitalized for pancreatic pain
timeFrame: 12 months
measure: Rate of operated patients requiring partial / total pancreatectomy, or pancreas-jejunal shunts for pancreatic pain
timeFrame: 12 months
measure: Rate of patients requiring endoscopic treatment (placement of pancreatic-duct stent, extraction of pancreatic stones)
timeFrame: 12 months
measure: Self-administered quality of life questionnaire score
timeFrame: preoperative, 1 month, 6 months and 12 months
measure: AE rate and type
timeFrame: during and immediately after the operation, 7 days, 1 month, 6 months and 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Jospeh Marseille
Study officials:
References: