louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01543841: Laboratory Testing for Tie-2 Expressing Monocytes (TEMs) in Blood
Official title: A Laboratory Evaluation of Tie-2 Expressing Monocytes (TEMs) in Healthy Volunteers and Patients With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Healthy
Keywords: advanced cancer
healthy
blood sample
TEM
TIE-2 expressing monocytes
ANG1
ANG2
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced cancer attending the Phase I clinic and healthy staff at the Princess Margaret Hospital

Brief summary: Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in healthy individuals and in people with cancer. These cells may play a role in the growth of blood vessels (veins/arteries), and may be particularly important in the growth of blood vessels that supply tumours. Understanding how these cells work may therefore help researchers to develop cancer treatments that starve tumors of their blood supply.

This research study involves an analysis of the behaviour of blood cells in response to different drugs in a test tube. The goal is to develop tests that can then be used to monitor patients treated with drugs that target blood vessel growth.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

  * Ability to understand and the willingness to sign a written informed consent document.
* Patients with advancer cancer

  * Participants must have histologically confirmed metastatic or unresectable solid tumors.
  * Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Healthy volunteers

  * History of cancer within the past 5 years
  * Major medical condition undergoing active therapy
* Patients with advancer cancer

  * Active hematologic malignancy (leukemia, lymphoma, myeloproliferative disorder).
  * Active treatment on a Phase I clinical trial

Primary outcomes:
measure: Characterize the in vitro response of circulating myeloid cells to angiopoeitins-1 and 2 (ANG1 and 2) in the presence or absence of pharmacologic inhibitors
timeFrame: 1 year
Secondary outcomes:
measure: Develop and optimize flow cytometry analyses
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Lillian Siu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06479941: Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota
Official title: Antibiotic Exposure During Pregnancy Affects Infant Gut Microbiota
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antibiotics Affecting Newborn Gut Microbiota
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 450
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant woman registered in Peking University People's Hospital will plan to give birth in the hospital.

Brief summary: Based on a prospective birth cohort, the investigators will collect biological samples from participants including pregnant women and newborns, to measure the gut microbial diversity and metabolites of newborns. These results systematically evaluate the effects of antibiotic exposure on the structure and function of gut microbiota. The project can reveal the effects of antibiotic exposure on the growth and development of gut microbiota in early life.


Eligibility criteria: Inclusion Criteria:

1. Pregnant woman

   * aged 20-40 years old
   * natural conception
   * single pregnancy
   * gestational age ≥36 weeks
2. Newborn

   * normal Apgar score
   * no serious congenital diseases

Exclusion Criteria:

-

Primary outcomes:
measure: Infant gut microbiome
timeFrame: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
Secondary outcomes:
measure: Antibiotic treatment
timeFrame: Pregnancy (12, 24, 37 weeks) and infants (born, 1 week, and 1, 3, 6, 12 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Peking University People's Hospital
Study officials:
References:
Clinical trial NCT02043041: Evaluation of the Quality of Self-collected Blood Spot Specimens for Laboratory HIV Testing - An InvolveMENt Sub Study
Official title: Explaining the Differences in HIV Prevalence and Incidence Between Black and White Men Who Have Sex With Men in Atlanta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2014-01-23
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled or previously enrolled in the InvolveMENt Study through Emory University. They will be assesed for study interest either at the end of their scheduled appointment with InvolveMENt, or will be contacted if consent to contact them for future studies was previously obtained through InvolveMENt.

Brief summary: We will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection.

Detailed description: Participants will be recruited to this one-time assessment during their follow-up visits. After completing a consent procedure specific to this study component, participants will be provided with instructions on how to fully self-administer the procedure of a finger stick and also blotting to collect a blood specimen using a 1, 3 or 5 blood spot specimen collection card. These specimens will be labeled with the participant's unique identification number, and no other identifying information. The dried blood spots will be evaluated by a laboratorian to assess quality, but will not be tested for HIV. This evaluation will help determine what number of self-collected dried blood spots yields the highest usable quantity of sample for HIV testing. There will be a separate monetary incentive of $30 for this procedure.

Eligibility criteria: Inclusion Criteria:

* Must be either currently enrolled or previously enrolled in the InvolveMENt Study through Emory University
* Over 18 years old
* HIV Negative

Exclusion Criteria:

* Not enrolled or previously enrolled in the InvolveMENt Study through Emory University
* Under 18 years old
* HIV Positive

Primary outcomes:
measure: Viable sample for HIV Testing
timeFrame: Outcome measure will be assessed with in two weeks of all samples being collected
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: AD McNaghten, PHD, MHSA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03999541: Freeze-all Policy in Poor Responders
Official title: Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Al-Yasmeen Fertility and Gynecology Center
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.


Eligibility criteria: Inclusion Criteria:

* All patients that fulfill the Bologna criteria \[at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)\]
* if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
* body mass index 18-32 kg/m2
* Both partners are able to provide written informed consent.
* At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and \<10% fragmentation by volume).
* Endometrial thickness ≥8 mm on trigger day.
* a normal uterine cavity on ultrasound.
* IVF/ICSI with only fresh semen

Exclusion Criteria:

* Pre-implantation genetic testing is being planned.
* if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.

Primary outcomes:
measure: Livebirth rate
timeFrame: 32 weeks
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 2 weeks
measure: Clinical pregnancy rate
timeFrame: 6-8 weeks
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Al-Yasmeen Fertility and Gynecology Center
Study officials:
References:
Clinical trial NCT01311141: Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1
Official title: Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In the present study we will measure and compare the unbound, i.e. microbiologically active concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis technique, which allows for the continuous measurement of unbound drug concentrations in the interstitial space fluid. The findings of the present study will help to assess whether currently employed therapy regimens with doripenem provide effective antimicrobial concentrations in different compartments in man


Eligibility criteria: Inclusion Criteria:

* Healthy
* Male

Exclusion Criteria:

* Female
* Ill

Primary outcomes:
measure: The time versus unbound doripenem concentration profiles in the interstitial space fluid of non inflamed subcutaneous adipose tissue, muscle tissue, saliva and plasma
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT00990041: Release of Cytokines by Stimulated Peripheral Blood Mononuclear Cells (PBMC) From Chronic Periodontitis Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: periodontitis
find cytokines in blood of periodontal patients
Lead sponsor: Escola Bahiana de Medicina e Saude Publica
Sponsor class: OTHER
Collaborators: name: School of Odontology of Piracicaba - Unicamp
First posted: 2009-10-06
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy humans

Brief summary: Background and Objective: It has been reported that peripheral blood mononuclear cells (PBMC) from periodontal patients have a different profile of cytokine release when compared to the ones of healthy patients. Cigarette smoking is a recognized risk factor for periodontitis and is known to affect the systemic and local immune responses. Thus, the aim of the present study was to obtain preliminary data about the interaction of periodontal condition and smoking in the secretion of some cytokines by PBMC.

Material and Methods: PBMC samples were isolated from 19 donors, divided into generalized chronic periodontitis (P; n=10) and periodontal health (H; n=9) groups. In addition, the smokers and non-smokers of each group were separately evaluated: SP- smokers with severe generalized chronic periodontitis (n=5); SH- periodontally healthy smokers (n=5); NSP- non-smokers with severe generalized chronic periodontitis (n=5) and NSH- periodontally healthy non-smokers (n=4). Cells were incubated for 24-48 hours in 500 µL wells containing RPMI 1640 and stimulated with 1.0 ng/mL of E. coli LPS. Supernatants were used to quantify the amounts of TNF-α, IL-6, IL-8 and IL-10 released using ELISA kits.


Eligibility criteria: Inclusion Criteria:

* periodontitis

Exclusion Criteria:

* diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Piracicaba
country: Brazil
facility: Faculdade de Odontologia de Piracicaba
state: SP
Study officials:
References:
Clinical trial NCT05309941: The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect
Official title: The Effects of External Cues Versus Internal Cues Messaging on Heart Rate Variability and Affect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietetics
Diet, Healthy
Nutrition Therapy
Affect
Autonomic Nervous System
Keywords: nutrition messaging
nutrition education
Intuitive Eating
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants attend a single study visit and are randomized to view one of two nutrition education videos.
Primary purpose: BASIC_SCIENCE

Brief summary: This randomized controlled trial will assess the effects of External Cues focused messaging (i.e., government recommendations of MyPlate) compared to Internal Cues focused messaging (i.e., intuitive eating). The investigators will collect data on within-person changes in psychological (e.g. affect) and physiological (e.g. heart rate variability) outcomes in female college students.

Participants will be randomly assigned to one of two study conditions. In condition one, participants will view a five-minute video focusing on traditional nutrition education principles. In condition two, participants will view a five-minute video focusing on intuitive eating principles.


Eligibility criteria: Inclusion Criteria:

* 18-29 years old
* identify as female
* college student

Exclusion Criteria:

* outside of the age range of 18-29 years
* do not self-identify as female
* not able to attend an in-person study visit at the University of Delaware

Primary outcomes:
measure: Change in Heart Rate Variability (HRV)
timeFrame: HRV will be measured during a 3-minute baseline period and while watching a 5-minute intervention video.
measure: Change in Affect
timeFrame: The PANAS is administered before and immediately after viewing the video.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Carly R Pacanowski, PhD RD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: Christine Skubisz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02768441: Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots
Official title: Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Addiction
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.


Eligibility criteria: Inclusion Criteria:

* Have completed at least 80% of the previous study (CATCH)
* Be able and willing to participate in the study and assessments
* Have provided written informed consent.

Exclusion Criteria:

* Any intake of dexamphetamine 7 days or less before the start of the proposed study;
* Contraindications for dexamphetamine
* (desired) pregnancy or continued lactation
* Insufficient command of the Dutch language
* Current participation in another trial

Primary outcomes:
measure: Area under the Curve (AUC) of dexamphetamine
timeFrame: Determined on the 5 day bloodsamples taken
measure: Maximum plasma concentration (Cmax) of dexamphetamine
timeFrame: Determined on the 5 day bloodsamples taken
measure: Half life (T 1/2) of dexamphetamine
timeFrame: Determined on the 5 day bloodsamples taken
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC
Study officials:
affiliation: Academic Psychiatric Center AMC-UvA
name: Wim van den Brink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02004041: Proof of Concept of VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Proof of Concept, Antipruritic Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Subjects With Treatment-Resistant Pruritus Associated With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment-resistant Pruritus Associated With Atopic Dermatitis
Keywords: pruritus
atopic dermatitis
VLY-686
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is randomized, double-blind, placebo-controlled study to test whether VLY-686 can reduce chronic pruritus in subjects with treatment-resistant pruritus associated with atopic dermatitis in comparison with placebo.


Eligibility criteria: Inclusion Criteria:

* Men and women ages 18 - 65 years, inclusive; suffering from atopic dermatitis with a SCORAD index at inclusion ≤80; with atopic lesions on arms, legs, trunk and neck;
* Chronic pruritus with pruritus being actively present for at least 6 weeks prior to screening;
* Males, non-fecund females, or females of child-bearing potential using 2 independent highly effective barrier methods of birth control when used correctly for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline visits.

Exclusion Criteria:

* Chronic pruritus due to conditions other than atopic dermatitis (AD) including the following conditions: Prurigo nodularis, Lichen simplex chronicus, Bullous pemphigoid;
* Acute superinfection of AD.

Primary outcomes:
measure: Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Vanda Investigational Site
city: Hamburg
country: Germany
facility: Vanda Investigational Site
city: Jena
country: Germany
facility: Vanda Investigational Site
city: Kiel
country: Germany
facility: Vanda Investigational Site
city: Munster
country: Germany
facility: Vanda Investigational Site
Study officials:
References:
Clinical trial NCT00173641: The Role of Regulatory T Cell in Patients With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus, and find the pathogenesis of this autoimmune disease.

Detailed description: Type 1 diabetes mellitus (T1D) is an autoimmune disease characterized with T cell mediated destruction of pancreatic βcell. Dysregulated B and T cells were reported in the animal model. The loss of maintenance of immune homeostasis is thought to be major mechanism and result in persistence of autoreactive T cell in the periphery. Therapies which modulate the immune dysfunction may be helpful for the patients of T1D.

Immune homeostasis means a balance between the responses that control infection and tumor growth and reciprocal responses that prevent inflammation and autoimmune disease. CD4+ CD25+ regulatory T cells (Tregs) are critical to maintain such functions. Their actions can be through cell-to-cell contact or bystander effect. The specific markers of Tregs include CD25 molecule (IL-2 receptorαchain), Foxp3 (forkhead-winged helix transcription factor). The Foxp3 is a transcription factor that controls some genes encoding Tregs associated molecules, such as CD25, CTLA-4 and GITR.

The previous studies of modulation of Tregs in T1D show positive results in animal model. But the relative sizes of CD4+CD25+ population in human are still controversial. Our hypothesis is that the imbalance of Tregs and autoreactive T cells is the pathogenesis of T1D. Therefore, we used flow cytometry to determine the number of CD4+CD25+ Tregs population and quantitative real-time PCR to assay the expression of Foxp3, CLTA-4, GITR in patients with different stages and normal control. Besides, autoantibodies to GAD65 is associated with T1D in 60-80% patients. It is a marker of autoimmune diabetes. We anticipated that the realization of Tregs functions in patients of T1D will help our further guide of immunotherapy of patients with T1D and other autoimmune disease.

Eligibility criteria: Inclusion Criteria:

* pediatric type 1 DM

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Ching Tung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Putnam AL, Vendrame F, Dotta F, Gottlieb PA. CD4+CD25high regulatory T cells in human autoimmune diabetes. J Autoimmun. 2005 Feb;24(1):55-62. doi: 10.1016/j.jaut.2004.11.004. Epub 2005 Jan 12.