louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05004740: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c
Official title: Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1c
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccine
Breastmilk
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Sinai Health System
First posted: 2021-08-13
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: This will be a prospective observational study of lactating mothers who are planning to, have scheduled or have received vaccination against SARS-COV-2 (COVID-19 vaccine). Mothers may have delivered at Mount Sinai Hospital or may be from the general public recruited by social media or word of mouth. As the study participants will be lactating mothers, they will not be under the care of the investigators. Due to lack of information, we are unsure of an appropriate sample size but envision we will recruit at least 10 women each immunized with the approved mRNA vaccines (e.g. Pfizer-BioNTech and Moderna COVID-19 vaccines) and in the future at least two other vaccines (e.g. Oxford-AstraZeneca) as they are approved and become available. Milk samples will be analyzed for the presence of antibody to SARS-CoV-2 using the Anti-SARS-CoV-2 ELISA (IgG and IgA). These analyses will be conducted in the Department of Microbiology at Sinai Health following validation of the procedures in human milk.


Eligibility criteria: Inclusion Criteria:

* lactating birthing persons from the general public or Sinai Health System

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of participants with and timing of SARS-CoV-2 specific antibodies in breastmilk post-vaccination
timeFrame: Week prior to first dose of vaccination and until 4 weeks following the second dose of vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sinai Health System
state: Ontario
Study officials:
References:
citation: Ismail S, Unger S, Budylowski P, Poutanen S, Yau Y, Jenkins C, Anwer S, Christie-Holmes N, Kiss A, Mazzulli T, Johnstone J, McGeer A, Whittle W, Parvez B, Gray-Owen SD, Stone D, O'Connor DL. SARS-CoV-2 antibodies and their neutralizing capacity against live virus in human milk after COVID-19 infection and vaccination: prospective cohort studies. Am J Clin Nutr. 2024 Feb;119(2):485-495. doi: 10.1016/j.ajcnut.2023.10.008. Epub 2023 Dec 14.
Clinical trial NCT00237640: Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
Official title: Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Adult Onset
Keywords: Cinnamon
Diabetes mellitus
Hyperlipidemia
Insulin Resistance
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2005-10-12
Enrollment: 85
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 determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.

Detailed description: Forty people with non-insulin dependent type 2 diabetes mellitus will be randomized to receive either cinnamon or placebo for three months. The dose of cinnamon will be one gram daily. Fasting serum glucose, triglyceride, total cholesterol, LDL, HDL, and insulin levels will be measured at baseline and at 1, 2, and 3 months. HbA1c levels will be measured at baseline and at 3 months. Patients will be monitored for compliance, adverse effects, and dietary changes.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* HbA1C \> 6.0%
* Age 18 and above
* Able to obtain consent

Exclusion Criteria:

* Currently taking insulin
* Pregnancy
* End-stage renal disease
* Hemolytic anemia
* Cinnamon intolerance
* Inability or unwillingness to adhere to study protocol

Primary outcomes:
measure: - Primary outcomes include HbA1c, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides levels.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: General Clinical Research Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Steve M Blevins, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blevins SM, Leyva MJ, Brown J, Wright J, Scofield RH, Aston CE. Effect of cinnamon on glucose and lipid levels in non insulin-dependent type 2 diabetes. Diabetes Care. 2007 Sep;30(9):2236-7. doi: 10.2337/dc07-0098. Epub 2007 Jun 11. No abstract available.
Clinical trial NCT06729840: Intralesional Treatment of Keloids
Official title: Vitamin D in Keloids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Scar, Hypertrophic
Keywords: keloids , vitamin D
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups
Primary purpose: TREATMENT

Brief summary: Intralesional injection in treatment of keloid

Detailed description: Our study will include 45 patient diveded into three groups , follow up will done before each session , 3month after the last session using photographing assessment , scoring , dermoscope

Eligibility criteria: Inclusion Criteria:

Both sex aged 18-60 having keloid

-

Exclusion Criteria:

* pregnancy , lactation Skin disease

Primary outcomes:
measure: Posas score
timeFrame: One session every two weeks total duration 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
References:
Clinical trial NCT01801540: The Effects of L-arabinose in a Meal in Healthy Men
Official title: The Effects of L-arabinose in a Meal on Glucose Metabolism in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of a meal containing different doses of L-arabinose, on the intestinal sucrase activity after intake We measure this by measuring the glucose, insulin and c-peptide after meals. Other measurements are made (glucagon and GLP-1) to explain the correlations.


Eligibility criteria: Inclusion Criteria:

* Healthy male
* normal weight (BMI 18,5-25 kg/m2)
* 18-30 years of age

Exclusion Criteria:

* Not healthy,including those with diabetes Mellitus, high bloodpressure, dyslipidemia or a infectious diseases (hepatitis or HIV), gastrointestinal disorders
* Central adipositas (defined as waist circumference \> 94 cm for european men)
* Daily intake of vitamins and minerals, 3 months before the trail starts and during the trail.
* elevated alcoholcunsumption(\> 21 units af alcohol pr. week)
* take medicine
* Elite athlete with intensive training
* given bloddonation within the last 3 months
* smoking

Primary outcomes:
measure: Glucose
timeFrame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
measure: Insulin
timeFrame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
measure: C-peptide
timeFrame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Secondary outcomes:
measure: Glucagon
timeFrame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
measure: GLP-1
timeFrame: -15, 0, 15, 30, 45, 60, 90, 120, 180 min
Other outcomes:
Locations:
Study officials:
affiliation: Unit of Nutrition 5711, Rigshospitalet, Blegdamsvej 9, 2100 København Ø
name: Jens Rikardt Andersen, MD, lector
role: STUDY_DIRECTOR
References:
Clinical trial NCT03726840: Sensory Stimulation During Simulated Driving
Official title: Sensory-based Stimulation to Increase Alertness and Behavioral Performance During Simulated Driving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 75
Sex: ALL
Minimum age (years): 24
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the effect of three specific odors on simulated driving performance. It is hypothesized that the presence of peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions

Detailed description: This study will examine the effect of scented odors on the attention and behavioral performance of healthy young adult and older adult drivers. Past research indicates that specific scented odors (i.e., peppermint and cinnamon) enhance motivation, performance and alertness, decrease fatigue and stimulate the central nervous system in a variety of contexts. The current study will examine the effect of three different odors on simulated driving as participants perform navigation and braking scenarios. This study will be the first of its kind to elucidate the association between specific scents and performance gains in simulated driving. The data will serve as proof-of-concept for eventual patient focused interventions relative to sensory stimulation and driving.

Eligibility criteria: Inclusion Criteria:

* valid drivers license
* normal or corrected to normal vision

Exclusion Criteria:

* no drivers license
* hyperopic vision without contact lenses
* history of congenital or acquired cognitive, ophthalmologic, or neurological disorders including developmental delay, brain tumor, stroke, or known peripheral or central vestibular disorders
* participants who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) will be excluded
* Participants will also be excluded if they have: (a) a history of skin irritation or sensitivity to scented products or cosmetics, (b) known skin allergies, sensitive skin or allergies to fragrance, (c) suffers from a cold, allergy, sinus condition or any other condition that might interfere with their sense of smell and (d) is pregnant or nursing.
* Participants will also be excluded if they smoke or use tobacco related products
* participants will be excluded if they commonly experience motion sickness

Primary outcomes:
measure: Navigation Assessment
timeFrame: 30 minutes
Secondary outcomes:
measure: Braking Assessment
timeFrame: 15 minutes
measure: Workload and mood assessment
timeFrame: 5 minutes
measure: Scent assessment
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinanti Childrens Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT03514940: Perinatal Diagnosis of GIT Anomalies
Official title: Perinatal Diagnosis of Fetal GIT Anomalies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Anomalies
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
First posted: 2018-05-03
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant ladies either primi or multigravida

Brief summary: fetal gastro intestinal abnormalities can be accurately diagnosed in second trimester

Detailed description: prenatal diagnosis of these anomalies allows for early postnatal interventions and implementation of treatment options

Eligibility criteria: Inclusion Criteria:

* pregnant women either primi or multigravida
* pregnant in 18- 24 weeks

Exclusion Criteria:

* first trimester pregnant ladies

Primary outcomes:
measure: The number of participants who will be diagnosed to have GIT anomalies
timeFrame: within 5 moths
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, M.s.c
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00444340: An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
Official title: An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additional years.


Eligibility criteria: Inclusion Criteria:

* Completed study 0881A3-312-EU
* Agreeable to utilize medically acceptable form of contraception
* Able to reconstitute and self-inject or have a designee

Exclusion Criteria:

* Withdrawn from study 0881A3-312-EU
* Abnormal hematology or chemistry profiles
* Clinically relevant medical conditions including: congestive heart failure, multiple sclerosis or other central demyelinating diseases, blood dyscrasias, cancer or serious infection

Primary outcomes:
measure: To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Secondary outcomes:
measure: To assess the long-term clinical efficacy of etanercept in these study subjects.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05843240: Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 128
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 was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

Detailed description: Current studies have shown that repetitive transcranial magnetic stimulation can change the excitability of nerve cells, improve intracerebral artery blood supply, and even reduce the degree of neurological impairment in patients with ischemic stroke. The purpose of this study was to investigate the effect of repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years, both sexes;
2. Clinically definite diagnosis of acute ischemic stroke;
3. Baseline National Institute of Health Stroke Scale (NIHSS) score ≤25;
4. Pre-onset modified Rankin Scale (mRS) score ≤1;
5. Randomized and initiated transcranial magnetic stimulation within 1 week of onset;
6. Subject or legal representative agreed to the treatment and signed the informed consent.

Exclusion Criteria:

1. Presence of a medical condition such as severe cognitive impairment or mental impairment;
2. Patients with serious physical diseases or who have had craniocerebral surgery;
3. Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors;
4. Pregnancy or breastfeeding;
5. The presence of metal foreign bodies near the stimulation site, such as intracranial metal implants, cochlear implants, built-in pulse generators (brain pacemakers, cardiac pacemakers), etc.;
6. Patients who are unable to complete cerebral autoregulation, or bilateral temporal window penetration poorly;
7. life expectancy of ≤3 months or inability to complete the study for other reasons;
8. unwillingness to be followed up or poor treatment compliance;
9. Those who are participating in other clinical investigators, or who have participated in other clinical studies within 3 months prior to enrollment, or who have participated in this study;
10. Other conditions that the investigators deemed unsuitable for enrollment.

Primary outcomes:
measure: phase difference(PD) in degree
timeFrame: 0-5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT05212740: Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
Official title: Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Keywords: frozen shoulder
adhesive capsulitis
corticosteroid
exercise
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.

Detailed description: After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double blind manner in a 1:1 (participant and investigator) to oral corticosteroids or exercise.

Eligibility criteria: Inclusion Criteria:

1. between ages 18-60 years
2. loss of passive motion of the glenohumeral joint greater than 25% or 30 in at least 2 directions (flexion, external rotation, and internal rotation) compared with the contralateral side
3. The pain VAS more than 7 (10 in total)

Exclusion Criteria:

1. bilateral frozen shoulder
2. rotator cuff tear
3. previous corticosteroid injection at the affected shoulder within 3 months

Primary outcomes:
measure: Change from baseline in function on DASH at 6th and 12th week
timeFrame: Baseline,6th week and 12th week
Secondary outcomes:
measure: Change from baseline in function on ASES at 6th and 12th week
timeFrame: Baseline,6th week and 12th week
measure: Change from baseline in range of motion (ROM) at 6th and 12th week
timeFrame: Baseline,6th week and 12th week
measure: Change from baseline in depression and anxiety on HADS at 6th and 12th week
timeFrame: Baseline,6th week and 12th week
measure: Change from baseline in pain on VAS at 6th and 12th week
timeFrame: Baseline,6th week and 12th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty Medicine
state: Fatih
city: Istanbul
country: Turkey
facility: İÜC Sağlık Bilimleri Fakültesi
Study officials:
affiliation: Istanbul University
name: Derya Çelik
role: STUDY_DIRECTOR
References:
Clinical trial NCT01368640: Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Official title: Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bioelectrical Impedance Measurement of Healthy Adults
Lead sponsor: Seca GmbH & Co. Kg.
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Data of 130 healthy adults are planned to be collected.

Brief summary: Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice.


Eligibility criteria: Inclusion Criteria:

The study will cover 130 healthy adults. 65 men and 65 women in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.

Exclusion Criteria:

* acute and chronic diseases
* regular intake of medications (except for contraceptives)
* amputation of limbs
* electrical implant as cardiac pacemaker
* insulin pumps
* artificial joints
* metallic implants (except tooth implants)
* claustrophobia
* pregnancy or breastfeeding period
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the inv. site
* current alcohol abuse
* frequent hypersensitivity reactions/allergies determ. anamnestically
* body weight of more than 150 kg
* extensive tattoos at arms or legs

Primary outcomes:
measure: Bioelectrical Impedance of 5 and 50 kHz for one body side
timeFrame: 15 minutes
measure: Bioelectrical Impedance of 50 kHz for all 4 extremities
timeFrame: 15 minutes
Secondary outcomes:
measure: Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
timeFrame: 15 minutes
measure: Generation of prediction equations for Sceletal Muscle Mass based on MRI
timeFrame: 1 hour
measure: Bioelectrical Impedance in sitting, lying and standing
timeFrame: 15 minutes
measure: Precision Study
timeFrame: 15 min
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Institute of Human Nutrition and Food Science
Study officials:
affiliation: Christian-Albrechts-University of Kiel
name: Manfred J. Mueller, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen B, Braun W, Both M, Gallagher D, Clark P, Gonzalez DL, Kluckmann K, Bosy-Westphal A. Configuration of bioelectrical impedance measurements affects results for phase angle. Med Eng Phys. 2020 Oct;84:10-15. doi: 10.1016/j.medengphy.2020.07.021. Epub 2020 Jul 30.