louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00943891: A Study of Lymphangiogenesis in Colorectal and Nasopharyngeal Cancer
Official title: A Study of Lymphangiogenesis in Colorectal and Nasopharyngeal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Nasopharyngeal Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal and nasopharyngeal cancer.

Brief summary: 1. To determine the association between LVD and clinico-pathologic variables in archived colorectal cancer and Nasopharyngeal carcinoma specimens
2. To determine the association between VEGF-C,-D expression with COX-2 expression and clinico-pathologic variables in colorectal cancer and Nasopharyngeal carcinoma
3. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma Lymphangiogenesis and factors modulating lymphangiogenesis are associated with clinico-pathological outcome in Nasopharyngeal carcinoma and colorectal cancer. Celecoxib down-regulates lymphangiogenesis Archival colorectal cancer and Nasopharyngeal carcinoma tumor specimens will be obtained from the Department of Pathology. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma, the investigators intend to analyze archived specimens collected in a previously conducted study. Colorectal tumor and nodal specimens and Nasopharyngeal carcinoma primary will be examined for MVD, LVD and growth factor expression using established haematoxylin and eosin and immunohistochemical techniques. Quantification of LVD and MVD shall be performed by two pathologists blinded to clinico-pathological variables using standardised methods.


Eligibility criteria: Inclusion Criteria:

* Male and female patients are eligible
* Patients 21 years or older

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Ross Andrew Soo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stacker SA, Caesar C, Baldwin ME, Thornton GE, Williams RA, Prevo R, Jackson DG, Nishikawa S, Kubo H, Achen MG. VEGF-D promotes the metastatic spread of tumor cells via the lymphatics. Nat Med. 2001 Feb;7(2):186-91. doi: 10.1038/84635.
citation: Mandriota SJ, Jussila L, Jeltsch M, Compagni A, Baetens D, Prevo R, Banerji S, Huarte J, Montesano R, Jackson DG, Orci L, Alitalo K, Christofori G, Pepper MS. Vascular endothelial growth factor-C-mediated lymphangiogenesis promotes tumour metastasis. EMBO J. 2001 Feb 15;20(4):672-82. doi: 10.1093/emboj/20.4.672.
Clinical trial NCT03911791: Screening of Helicobacter Pylori in Children of Positive Infected Mothers
Official title: Screening of Helicobacter Pylori Infection in Children of Positive Infected Mothers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: H Pylori Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cross sectional study

Brief summary: Helicobacter pylori is aspiral shaped gram negative organism that colonized the gastric mucosa.it was showen that intra familial infection play role in transmission of H pylori and mother play the key role in transmission .

Detailed description: Prevelance of H pylori infection in children whose mother positive infected is different according to risks factors such as mother education,work out side or not , socioeconomic status, family size and breast feeding or not.H pylori in children can be represent with recurrent abdominal pain ,recurrent diarrhea,repeated vomitting ,pallor ,fulness,non variceal hematemesis,loss of appetite,reterded growth.complication of H pylori include gastric ulcer,duodenal ulcer,gastric atrophy may lead to gastric cancer and intestinal metaplasia.

Eligibility criteria: Inclusion Criteria:

Child with Dyspeptic symptoms

Exclusion Criteria:

malnutrition childs Patient with metabolic disorder

Primary outcomes:
measure: To assess prevelance of H pylori infection in children born of infected positive mother
timeFrame: Period from April 2019 to April 2020
measure: Asse the effect of Helicobacter pylori infection in children with anemia
timeFrame: Period from April 2019 to April 2020
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Warren JR, Marshall B. Unidentified curved bacilli on gastric epithelium in active chronic gastritis. Lancet. 1983 Jun 4;1(8336):1273-5. No abstract available.
citation: Greenberg ER, Chey WD. Defining the role of sequential therapy for H pylori infection. Lancet. 2013 Jan 19;381(9862):180-2. doi: 10.1016/S0140-6736(12)61849-2. Epub 2012 Nov 16. No abstract available.
Clinical trial NCT02031991: A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
Official title: Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06439535 And Bevacizumab Sourced From US And EU Administered To Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Biosimilarity
Similarity
PK
Phase 1
Bevacizumab
Healthy Volunteers
Single-Dose
Oncology
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 102
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to prove that the handling (also referred to as pharmacokinetics) of the following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is similar in healthy male volunteers after receiving a single intravenous dose of either drugs.

During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects 21-55 years old
* Subjects who have previously been exposed to a biologic agent (other than a VEGF \[Vascular Endothelial Growth Factor Receptor\] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50kg (110lbs)

Exclusion Criteria:

* Evidence or history of a clinically significant disease or clinical finding at Screening
* Previous treatment with an anti-VEGF antibody, or any other antibody or protein targeting the VEGF receptor.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 - Day 71
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: Day 1 - Day 71
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: Day 1 - Day 71
Secondary outcomes:
measure: Systemic Clearance (CL)
timeFrame: Day 1 - Day 71
measure: Terminal Disposition Half-Life (t1/2)
timeFrame: Day 1 - Day 71
measure: Volume of Distribution at Steady State (Vss)
timeFrame: Day 1 - Day 71
measure: Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab)
timeFrame: Day 1 - Day 71 or LSLV, whichever occurs later
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01970891: Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients
Official title: Electrical Stimulation for the Relief of Freezing of Gait (FOG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Freezing of Gait
Gait
Comfort
Pain tolerance
Pain
Sensory threshold
Motor threshold
Pain threshold
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: University Hospital of Limerick
First posted: 2013-10-28
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sensory electrical stimulation for the amelioration of FoG through the continuous delivery of stimulation.
Primary purpose: TREATMENT

Brief summary: Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)

Detailed description: The purpose of this study is to investigate the potential for an electrical stimulation intervention to ameliorate Freezing of Gait (FOG) and related gait disturbances in Parkinson's patients.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of idiopathic Parkinson's Disease (PD) (UK, PD Brain Bank Criteria)
* A Hoehn and Yahr stage of 2 - 4
* Exhibiting Freezing of Gait or another gait abnormality in the ON state.
* An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state

Exclusion Criteria:

* A serious cognitive impairment (MMSE\<24)
* Pregnant or currently involved in another clinical trial.
* Pacemakers
* On opioid or neuropathic pain medication

Primary outcomes:
measure: Percentage of Time in FoG PTF
timeFrame: At time of intervention (seconds)
measure: Number of FoG episodes occurring
timeFrame: At time of intervention (seconds)
Secondary outcomes:
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Participants' home in the Mid-West region of Ireland
Study officials:
affiliation: National University of Ireland, Galway
name: Gearóid Ó Laighin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02275091: Children With Diabetes at Risk for Heart Disease.
Official title: Identifying Children With Diabetes Type 1 at High Risk for Cardiovascular Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 1
Diabetes Complications
Keywords: Children
Cholesterol
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Howard University
First posted: 2014-10-27
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with diabetes type 1 and healthy children

Brief summary: Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD so that interventions to prevent heart disease and stroke can be undertaken.

Detailed description: Patients with type 1 diabetes and healthy controls will have evaluation of their lipid profile. Arterial stiffness, heart rate variability and adiposity measurements will be done in patients with type 1 diabetes and healthy controls. Blood pressure and heart rate will be recorded. 50 ml of urine will be collected from patients and controls.

All studies will be performed as a single outpatient visit at Georgetown University.

Eligibility criteria: Inclusion Criteria:

Diabetes type 1 or Healthy

Exclusion Criteria:

Taking medications that lower cholesterol Duration of type 1 diabetes \< 1 year.

Primary outcomes:
measure: small LDL particles
timeFrame: This is an observational cross sectional study. Samples will be collected through study completion, on average of 6 years duration.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown-Howard Universities Center
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Evgenia Gourgari
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gourgari E, Ma J, Playford MP, Mehta NN, Goldman R, Remaley AT, Gordon SM. Proteomic alterations of HDL in youth with type 1 diabetes and their associations with glycemic control: a case-control study. Cardiovasc Diabetol. 2019 Mar 28;18(1):43. doi: 10.1186/s12933-019-0846-9.
citation: Gourgari E, Playford MP, Campia U, Dey AK, Cogen F, Gubb-Weiser S, Mete M, Desale S, Sampson M, Taylor A, Rother KI, Remaley AT, Mehta NN. Low cholesterol efflux capacity and abnormal lipoprotein particles in youth with type 1 diabetes: a case control study. Cardiovasc Diabetol. 2018 Dec 19;17(1):158. doi: 10.1186/s12933-018-0802-0.
Clinical trial NCT01305291: Fibersol-2 Clinical Trials Related to Appetite
Official title: Fibersol-2 Clinical Trials Related to Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Satiety
Keywords: dietary fiber
satiety response
hunger
CCK
PYY
ghrelin
GIP
GLP-1
Lead sponsor: Iowa State University
Sponsor class: OTHER
Collaborators: name: Archer Daniels Midland Co.
First posted: 2011-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut. This research aims to determine whether or not Fibersol-2 may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut.


Eligibility criteria: Inclusion Criteria:

i. No known food allergies

ii. Normal healthy individuals

iii. No food intake abnormalities or abnormal feeding behaviors

iv. Average American BMI (21-28)

Primary outcomes:
measure: Visual analog scale questionnaire subjective satiety responses
timeFrame: 4 hours
measure: serum cholecystokinin (CCK)
timeFrame: 4 hours
measure: serum peptide YY (PYY)
timeFrame: 4 hours
measure: serum glucagon-like peptide-1 (GLP-1)
timeFrame: 4 hours
measure: serum ghrelin
timeFrame: 4 hours
measure: serum gastric inhibitory peptide (GIP)
timeFrame: 4 hours
Secondary outcomes:
measure: serum total cholesterol
timeFrame: 4 hours
measure: serum LDL-cholesterol
timeFrame: 4 hours
measure: serum HDL-cholesterol
timeFrame: 4 hours
measure: serum triglycerides
timeFrame: 4 hours
measure: serum free fatty acids
timeFrame: 4 hours
measure: serum glucose
timeFrame: 2 hours
measure: serum insulin
timeFrame: 2 hours
measure: gastrointestinal symptoms questionnaire
timeFrame: 24 h
Other outcomes:
Locations:
city: Ames
country: United States
facility: Nutrition and Wellness Research Center
state: Iowa
Study officials:
affiliation: Iowa State University
name: Suzanne Hendrich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ye Z, Arumugam V, Haugabrooks E, Williamson P, Hendrich S. Soluble dietary fiber (Fibersol-2) decreased hunger and increased satiety hormones in humans when ingested with a meal. Nutr Res. 2015 May;35(5):393-400. doi: 10.1016/j.nutres.2015.03.004. Epub 2015 Mar 18.
Clinical trial NCT03108391: A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients
Official title: A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supraglottic Airway
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2017-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parellel Assignment
Primary purpose: TREATMENT

Brief summary: The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.

Detailed description: Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Ⅰ-Ⅲ classification
* Patients evaluated as eligible for a LMA
* Body Mass Index ≤35kg/m2

Exclusion Criteria:

* Patients with known or predicted difficult airway
* Active respiratory infection
* Risk of aspiration
* Head and neck surgery
* Emergent surgery

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: Up to 1 minute after the time of confirmed device placement
Secondary outcomes:
measure: Insertion time
timeFrame: Up to 1 minute on each insertion attempt
measure: Ease of insertion
timeFrame: Up to 1 minute on each insertion attempt
measure: Fiberoptic Grade of Laryngeal View
timeFrame: Up to 1 minute after placement of device
measure: Postoperative Complications
timeFrame: 2 hours after removal of the device
Other outcomes:
Locations:
city: Beijing
country: China
facility: ChineseAMS
state: Beijing
Study officials:
affiliation: Plastic Surgery Hospital, ChineseAMS
name: Liu Juhui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023891: Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Official title: Pharmacogenomics of the Variability in the In Vivo Response to Glucocorticoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glucocorticoids Toxicity
Glucose Intolerance
Keywords: glucocorticoids
efficacy
metabolic toxicity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2017-01-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the effect of acute administration of oral prednisone in white blood cells counts and glucose tolerance and the relationship of these measures with changes in gene expression in healthy volunteers. White blood cells counts, glucose tolerance and gene expression will be study before and after prednisone administration.

Detailed description: Prednisone is a potent anti-inflammatory drug that has large variability in its response. The large inter individual variability in the response to prednisone has a genetic component, but the genetic determinants of this variability remain unknown. We propose to use two relevant phenotypes, changes in white blood cell counts and changes in glucose tolerance induced by in vivo administration of prednisone, to characterize gene expression patterns and identify variants that are involved in the in vivo response to prednisone.

Eligibility criteria: Inclusion Criteria:

* 18 to 45 years old (to exclude the effect of age on glucose tolerance);
* BMI between 20 and 25 kg/m2 (to exclude individuals that are likely to have impaired insulin response);
* Normal fasting glucose;
* Stable weight for three months before participation

Exclusion Criteria:

* BMI \>25kg/m2;
* Fasting glucose ≥126 mg/dl
* Shift work or disordered sleep (to exclude individuals with alterations in the hypothalamus-adrenergic axis);
* Any diseases;
* Use of any medication regularly (including over-the-counter);
* Previous exposure to glucocorticoids (within the last year);
* Pregnancy

Primary outcomes:
measure: White Blood Cell Counts
timeFrame: baseline and within 4 and 8 hours after drug administration
measure: Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose
timeFrame: baseline and 4-8 hours after drug administration
measure: Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels
timeFrame: baseline and 4-8 hours after drug administration
measure: Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels
timeFrame: baseline and 4-8 hours after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center -CRC
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Vivian K Kawai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03686891: Prevalence of Sensitization to Legumes in a Region From Southern France (Légumineuses)
Official title: Analyis of the Prevalence of Sensitization to Legumes by Realistic Skin Prick Tests in a Patient Population Consulting at the University Hospital of Montpellier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensitization to Legumes
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. The introduction of legumes into an easily prepared and economical food for a large part of the population will lead to an increase in consumption. The combination of durum wheat semolina and legume flour would benefit from the nutritional qualities of the two raw materials (high protein, slow digestible carbohydrates, fiber, vitamins and minerals), but also of their double wheat-legume allergenicity.


Eligibility criteria: Inclusion Criteria:

* Patients seen in allergy consultation
* The patient (or parents for the under 18 years) must have given their free consent and signed the consent chart
* Men and women are included
* The patient is at least 2 years old

Exclusion Criteria:

* The patient is pregnant
* The patient is breast-feeding
* The patient is unable to stop in antihistamine medication for at least 7 days
* The patient refused or is unable to sign the consent chart
* The patient has a dermographism

Primary outcomes:
measure: Sensitization rate to four cooked legumes in the population consulting in Allergy Unit at the University Hospital of Montpellier
timeFrame: 10 minutes (the average duration of the test will not be significantly increased)
Secondary outcomes:
measure: Describe the population with positive skin prick tests to legumes
timeFrame: 5 years
measure: Associations between symptoms on ingestion of these legumes
timeFrame: 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Service Exploration des allergologies-Hopital Arnaud de Villeneuve-CHU de Montpellier
Study officials:
References: