louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05897463: Nipple Neurotization
Official title: Breast and Nipple Neurotization Via Elongation of the Lateral Cutaneous Branches Using Intercostal Branches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 75
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who received breast reconstruction and neurotization from July 2019 to August 2022 from a single breast reconstruction surgeon.

Brief summary: A retrospective chart review will be conducted to identify patients receiving breast reconstruction and simultaneous breast neurotization. Their reconstructed breasts will be included as study group. Patients receiving breast reconstruction without neurotization will be included as negative control group. Their contralateral normal breasts in the study and the negative control group will be included as positive control. Patients' demographic data, their breast cancer treatment parameters, such as the staging, previous radiotherapy history, postmastectomy radiotherapy, neoadjuvant and adjuvant chemotherapy will be included. The reconstruction results will be evaluated as well.

Statistics Data will be analyzed using graphing and statistical analysis software. Independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant.

Potential risks: No

Confidentiality:

All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.


Eligibility criteria: Inclusion Criteria:

* patients who received breast reconstruction and neurotization from July 2019 to August 2022 from a single breast reconstruction surgeon.
* patients who received breast reconstruction without neurotization were included as the non-neurotized group.

Exclusion Criteria:

* patients unable to complete the follow-up were excluded from the study

Primary outcomes:
measure: Changes of monofilament force at 6, 12, 18, 24, and 30 months post-operatively
timeFrame: post-operative 6, 12, 18, 24, and 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: ChangGungMH
Study officials:
References:
Clinical trial NCT01831063: A Simulation-based Intervention for Caregivers of Children With Seizures
Official title: Simulation for Family Centered Care: Improving Caregivers Skills, Self-Efficacy and Quality of Life Using a Practice-Until-Perfect Simulation Intervention for Seizure Management in the Home Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dependency on Medications Prescribed for Patient
Types of Seizures and Epileptic Syndromes
Keywords: Seizure
Caregivers
Family Centered Care
Learning modality
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 61
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Caregivers of children with seizures receiving simulation based seizure management teaching in addition to the traditional seizure teaching will report more confidence with seizure management and demonstrate a higher level of performance with seizure management.


Eligibility criteria: Inclusion Criteria

* Clinical diagnosis of Seizure disorder
* Dependence on a anti-seizure medication

Exclusion Criteria

* No dependence on rescue medication

Primary outcomes:
measure: KidSIM Emergent Seizure Management Checklist
timeFrame: Baseline, 48 hours and 6 months
Secondary outcomes:
measure: The Aspire KidSIM Parent Seizure Self-efficacy Questionnaire
timeFrame: Baseline , 48 hours and 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: Alberta Children's Hospital
name: Elaine Sigalet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital, University of Calgary
name: Vincent Grant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital, University of Calgary
name: Adam Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03465163: A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability
Official title: Safety and Efficacy of a Deep Brain Stimulation System in Epilepsy: A Feasibility Study for Tracking Neural Excitability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Nodular Heterotopia
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
Collaborators: name: University of Melbourne
First posted: 2018-03-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The main purpose of this research project is to evaluate the safety and effectiveness of a surgically implanted device called the Medtronic Activa PC+S System in patients with medically refractory epilepsy (people who have seizures that are not completely controlled by medical therapy). The system sends small electrical pulses into a part of the brain called the thalamus to help control seizures. It sends this signal in regularly, regardless of if a seizure is occurring. A different version of this device is already approved for the treatment of epilepsy in Australia. This study aims to use the brain's responses to single pulse electrical stimulation to measure the level of seizure susceptibility. The investigators would like to show that this measure can be used to provide more effective deep brain stimulation therapies, to stop seizures.


Eligibility criteria: Inclusion Criteria:

Patients with epilepsy with non-resectable pathologies, or clearly defined focal seizures without a defined structural pathology.

Patients will be required to have a seizure diary (of up to 3 months) recording at least five seizures per month that are well separated in time (at least 8 hours apart).

Exclusion Criteria:

Previous diagnosis of psychogenic/non-epileptic seizures

Primary outcomes:
measure: Change in Seizure Rate
timeFrame: Recorded throughout the baseline (2-4 months post implant) and probe calibrated DBS phase( 6-8 months post implant)
Secondary outcomes:
measure: Determine if probing responses provide a seizure susceptibility measure.
timeFrame: Throughout probing phase (4-6 months post implant)
measure: Change in brain excitability following DBS treatment, assessed according to changes in probing response energy before and after stimulation therapy.
timeFrame: Throughout probing phase (4-6 months post implant) and probe calibrated DBS phase (6-8 months post implant).
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victora
Study officials:
References:
Clinical trial NCT05135663: Extension Study of NS-089/NCNP-02 in DMD
Official title: A Phase II, Open-Label, Extension Study of NS-089/NCNP-02 in Patients with Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Duchenne Muscular Dystrophy (DMD)
Lead sponsor: Nippon Shinyaku Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 6
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is the extension study of NS-089/NCNP-02 (Study NCNP/DMT02), which is designed to assess the safety, tolerability and efficacy of NS-089/NCNP-02 in patients with Duchenne muscular dystrophy (DMD).


Eligibility criteria: Inclusion Criteria:

1. Patient completed Study NCNP/DMT02

Exclusion Criteria:

1. Patient had any serious adverse events in Study NCNP/DMT02 that, in the opinion of the Investigator and/or Sponsor, was probably or definitely related to NS-089/NCNP-02 use and precludes safe use of NS-089/NCNP-02 for the patient in this study.
2. Patient had a treatment which was made for the purpose of dystrophin or dystrophin-related protein induction after completion of Study NCNP/DMT02.
3. Patient took any other investigational drugs after completion of Study NCNP/DMT02.
4. Patient was judged by the investigator and/or the Sponsor that it was not appropriate to participate in the extension study for other reasons.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to Week 247
Secondary outcomes:
measure: Expression of dystrophin protein (Western blot)
timeFrame: Week 99
measure: Percentage of exon 44-skipped mRNA of dystrophin
timeFrame: Week 99
measure: North Star Ambulatory Assessment (NSAA)
timeFrame: Up to Week 243
measure: Time to stand test
timeFrame: Up to Week 243
measure: Time to run/walk 10 meters test
timeFrame: Up to Week 243
measure: Six-minute walk test/Two-minute walk test
timeFrame: Up to Week 243
measure: Timed Up & Go test
timeFrame: Up to Week 243
measure: Quantitative muscle strength assessment
timeFrame: Up to Week 243
measure: Performance of Upper Limb test
timeFrame: Up to Week 243
measure: Change in serum creatine kinase concentration from baseline
timeFrame: Up to Week 243
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Tokyo
country: Japan
facility: National Center of Neurology and Psychiatry
Study officials:
References:
Clinical trial NCT04360863: The Impact of COVID-19 Pandemic on the Smoking Behaviour of Young Smokers and the Youth Quitline Service in Hong Kong
Official title: The Impact of Coronavirus Disease (COVID-19) Pandemic on the Smoking Behaviour of Young Smokers and the Youth Quitline Service in Hong Kong: A Survey Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking Cessation
Keywords: Youth smokers
COVID-19
smoking behaviors
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth smokers

Brief summary: The aims of the present study are:

1. To explore the impact of COVID-19 pandemic on the smoking behavior of youth smokers
2. To explore the impact of COVID-19 pandemic on the Youth Quitline service in Hong Kong

Detailed description: The coronavirus disease 2019 (COVID-19) pandemic has spread rapidly across the globe. According to World Health Organization (WHO), due to the harmful effects on the lungs and the possible viral transmission from fingers to mouth during smoking, tobacco use is considered a major risk factor for developing COVID-19. Both tobacco use and COVID-19 can cause damage to the cardiovascular and respiratory systems. Smokers infected with COVID-19 are at higher risk of developing severe COVID-19 symptoms or death than non-smokers.

The Hong Kong SAR (HKSAR) government has announced different regulations to combat the spread of COVID-19 since late January 2020, which significantly affect the working patterns and everyday lives of people. It remains unknown how smoking habits and smoking cessation services are being affected during the pandemic.

Eligibility criteria: Inclusion Criteria:

* Hong Kong resident aged 25 or below
* Able to communicate in Chinese (Cantonese)
* Smoked in the past 30 days

Exclusion Criteria:

* Have difficulty to communicate via telephone

Primary outcomes:
measure: Smoking behaviors
timeFrame: Baseline
measure: Knowledge
timeFrame: Baseline
measure: Readiness to quit
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References:
Clinical trial NCT02535663: Consumption of Dairy Yogurt Enhanced Immune Function
Official title: Consumption of Dairy Yogurt With Rhamnogalacturonan in Korean Citrus Hallabong Peel Polysaccharide Enhanced Immune Function and Attenuated Inflammatory Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy Volunteers
Keywords: rhamnogalacturonan
Natural killer cell activity
interleukin-12
interferon-gamma
immune function
inflammatory
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To investigate the impact of consumption of dairy yogurt with rhamnogalacturonan (RG) in Korean citrus Hallabong peel polysaccharide on Natural Killer (NK) cell activity and circulating cytokine levels.

Detailed description: A randomized, double-blind, placebo-controlled study was conducted on 120 nondiabetic and nonobese subjects. Over an 8 week period, the test group consumed one pack (150ml) of dairy yogurt with 50mg probiotics and 100mg Korean citrus Hallabong peel polysaccharide (60% RG, 20% mono- and di-saccharide, 5% polyphenol) each day, whereas the placebo group consumed the same product without Korean citrus Hallabong peel polysaccharide. NK cell activities (%) were measured based on the ratios of effector cells (E) (peripheral blood mononuclear cell, PBMC) from each participant to Target cell (T) (K562 cells) as 10:1, 5:1, 2.5:1 or 1.25:1.

Eligibility criteria: Inclusion Criteria:

* The levels of white blood cells under 8x10\^3/μL
* males and females
* 30-69 years old
* nondiabetic and nonobese subjects
* able to give informed consent

Exclusion Criteria:

* consumption of any probiotic products within 1 month before screening
* unstable body weight (body-weight change \> 2 kg within 3 months before screening)
* diabetes
* history/presence of significant metabolic disease
* pregnancy or breast-feeding
* acute or chronic infection
* liver disease, kidney disease, gastrointestinal disease, or any other acute or chronic disease requiring treatment
* subjects taking any drugs or supplements

Primary outcomes:
measure: serum cytokine concentrations
timeFrame: change from baseline in RG at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
affiliation: Yonsei University
name: Jong-Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee MH, Kim M, Kim M, Kwak JH, Chang DH, Yu WK, Lee SH, Lee JH. Consumption of dairy yogurt with the polysaccharide rhamnogalacturonan from the peel of the Korean citrus hallabong enhances immune function and attenuates the inflammatory response. Food Funct. 2016 Jun 15;7(6):2833-9. doi: 10.1039/c5fo01103e.
Clinical trial NCT04460963: Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
Official title: Role of Adrenomedullin in Leukemic Endosteal/Vascular Niches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: adrenomedullin
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The present study will be divided into 5 phases:

1. Collection of bone marrow and peripheral blood (PB) samples from AML patients at diagnosis;
2. Measurement of Midregional Proadrenomedullin (MR-proADM) plasma concentrations with an Immunoluminometric Assay of newly diagnosed AML patients not affected by concomitant cardiovascular disease or sepsis.
3. Analysis of exosomes and microvesicles derived from PB and bone marrow samples of AML patients and culture media collected from AML samples stimulated with ADM and/or ADM (22-52)
4. Study of adrenomedullin system in leukemic stem cells (CD44+/CD38-/CD31+/Lin-) in order to define a correlated expression of ADM and ADM receptors (RAMPs, PAM) with adhesion molecules (CD31, CD38, CD44s, CD44v6), cell cycle regulatory proteins (p21, p27) and genes or molecules involved in the hematopoietic differentiation process (Cul5, CD11b, CD11c, CD66, CD14, CD15, PML-RARα)
5. In vitro evaluation of ADM activity in the growth, maturation and trans-endothelial migration of blasts and/or fusion of leukemic cells with endothelial cells. To do this, leukemic cells will be alternatively cultured by using in vitro models of endosteal and vascular niches.


Eligibility criteria: Inclusion Criteria:

1. Patients with new diagnosis of primary or secondary AML.
2. Participant is willing and able to give signed written informed consent according to ICH/EU/GCP and national local laws.
3. Male or Female, aged \>18 years.

Exclusion Criteria:

1. Patients affected by concomitant cardiovascular disease , such as essential hypertension (any grade), chronic renal failure (creatinine\>1.5 mg/dL), heart failure (any NYHA class), and peripheral arterial occlusive diseases, or sepsis.
2. Patients affected by HIV, B or C hepatitis.

Primary outcomes:
measure: Evaluation of therapeutic potential of ADM inhibition on leukaemia stem cells
timeFrame: at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi - Uoc Ematologia
city: Bolzano
country: Italy
facility: As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo
city: Castelfranco Veneto
country: Italy
facility: U.O. Oncoematologia IOV
city: San Giovanni Rotondo
country: Italy
facility: Ente Ecclesiastico Casa Sollievo Della Sofferenza - Ematologia
city: Treviso
country: Italy
facility: Uo Ematologia - Azienda Ulss N.2 Marca Trevigiana
Study officials:
References:
Clinical trial NCT05805163: Tailored COVID-19 Testing Support Plan for Francophone African Born Immigrants
Official title: A Culturally Relevant Communication and Support Plan to Ensure Access to and Use of Covid-19 Testing for Francophone African Born Immigrants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID19 Testing
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to test the effectiveness of a culturally sensitive COVID-19 testing intervention designed for Francophone (French speaking) African Born Immigrants (FABI) . The main question this study aims to answer is whether or not a a culturally sensitive COVID-19 educational pamphlet added to the home-based test will improve testing rates compared to receiving a standard home-based test alone.

Detailed description: Upon consenting, all participants will receive basic COVID-19 testing instructions from trained bilingual/bicultural Francophone African Born Immigrant (FABI) Community Health Workers (CHW's). Next, participants will be randomly assigned to either the control or intervention study arms. In the control condition (n=50) participants will receive a standard COVID-19 home-based test kit. In contrast, those assigned to the intervention condition (n=50) will receive the same COVID-19 home-based test kit plus a FABI culturally sensitive COVID-19 educational pamphlet. Lastly, (n=10) participants from each arm will be randomly selected to participate in qualitative interviews to assess their experiences with CHWs and their test kit.

Eligibility criteria: Inclusion Criteria: FABI living in Dallas Fort Worth (DFW) -

Exclusion Criteria: None

-

Primary outcomes:
measure: Return rate
timeFrame: Tests returned within 3 months
Secondary outcomes:
measure: Qualitative assessment
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05749263: A Study of Sleep Patterns to Determine Predictive Markers Due to Cardiovascular Disease in Elderly Patients
Official title: Sleep Patterns as Predictive Markers of Hospitalization or Death Due to Cardiovascular Disease in Elderly Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiovascular Diseases
Keywords: Elderly Patients
Sleep Patterns
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Sleep Number Corporation
First posted: 2023-03-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants eligible for this study will be people who are living in the Masonic Homes/Acacia Creek Retirement Community in Union City, California and who have Sleep Number® beds that record their nightly sleep and physiologic patterns.

Brief summary: The purpose of this study is to learn if there are predictive markers of hospitalization or death that can be found from data gathered from a Sleep Number® bed. This is a prospective observational cohort study that will follow participating subjects in the Masonic Homes/Acacia Creek Retirement Community in Union City, California.


Eligibility criteria: Inclusion Criteria:

* Subjects living at Masonic Homes/Acacia Creek Retirement Community who use a Sleep Number® bed and are cognitively able to consent on their own accord.

Exclusion Criteria:

* Subjects who do not have a Sleep Number® bed.
* Subjects without an internet connection to transmit nightly SleepIQ® data.

Primary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Number of subject hospitalizations
timeFrame: 5 years
Secondary outcomes:
measure: Change in daytime sleepiness
timeFrame: Baseline, every 6 months for 5 years
measure: Change in alertness
timeFrame: Baseline, every 6 months for 5 years
measure: Change in depression symptom severity
timeFrame: Baseline, every 6 months for 5 years
measure: Change in sleep quality
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Attention-deficit/hyperactivity disorder (ADHD) symptom severity
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Verbal Memory
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Visual Memory
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Motor Skills
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Processing Speed
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Stroop Task
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Executive Function
timeFrame: Baseline, every 6 months for 5 years
measure: Change in Vigilance
timeFrame: Baseline, every 6 months for 5 years
Other outcomes:
Locations:
city: Union City
country: United States
facility: Masonic Homes of California-Acacia Creek
state: California
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: