louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07004348: Animation-based Storytelling Education in Relation to Moral Development in 8-12 Year Olds With Dementia-affected Caregivers
Official title: Animation-based Storytelling Education in Relation to Moral Development in 8-12 Year Olds With Dementia-affected Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Keywords: young people
caregivers
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2025-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young people in the community

Brief summary: This retrospective, single-blind, parallel group study investigates the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.

Detailed description: With the measure of moral reasoning and empathy-related traits to investigate the impact of animation-based storytelling influence moral development in 8-12 year olds with dementia-affected caregivers.

Eligibility criteria: Inclusion Criteria:

* full time students in public education. Live with family members who have dementia. Can keep attention for a 15-min animation

Exclusion Criteria:

* any major neurological illness

Primary outcomes:
measure: The Chinese Prosocial Reasoning Objective Measure (PROM) was used to assess children's moral reasoning. The PROM presents five stories and asks participants to rate the importance of various reasons for helping or not helping in these ethical dilemmas sc
timeFrame: baseline and 1 week after intervention
Secondary outcomes:
measure: The Chinese interpersonal reactivity index(C-IRI)
timeFrame: baseline and 2 weeks after the intervention
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Northumbria University
state: Newcastle upon Tyne
Study officials:
affiliation: The Northumbria University
name: Frank Lai, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02538848: Study of HTD4010 in Healthy Volunteers
Official title: A First in Human, Randomized, Double-Blind Study to Assess Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Effects of HTD4010 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: HighTide Biopharma Pty Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To investigate safety and tolerability of HTD4010 after single ascending doses (SAD) in healthy volunteers

Detailed description: Safety, tolerability and pharmacokinetics(PK) assessments are the outcome measure.

Eligibility criteria: For volunteers in SAD:

Inclusion Criteria:

1. Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
2. Non-diabetic, fasting plasma glucose \< 5.6 mmol/L
3. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months.

   Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from screening and for a period of 60 days after the last dose of Study Drug.
4. Ability to provide written informed consent.

Exclusion Criteria:

1. Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>90 mmHg at screening.
2. Pregnant or lactating women
3. Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
4. Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. Use of ≤2g paracetamol per day is allowed prior to and during the study at Investigator discretion.
5. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
6. History of any major surgery within 6 months prior to Screening
7. History of any serious adverse reaction or hypersensitivity to any of the product components.
8. Use of parenterally administered proteins or antibodies within 12 weeks of screening.

etc.

Primary outcomes:
measure: Incidence, severity and causality of adverse events
timeFrame: One day in SAD
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical Research Limited
Study officials:
affiliation: Linear Clinical Research Limited
name: Janakan Krishnarajah, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03849248: Maternal Scent and Preterm Infant Nutrition
Official title: The Effect of Maternal Scent on Nutrition and Development of Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior, Infant
Development, Infant
Development, Child
Keywords: maternal scent
infant behavior
feeding patterns
stress levels
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 132
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To study the effect of maternal scent on the oral feeding, behavior and stress level of premature infants hospitalized in the Neonatal intensive care unit and to assess its potential effect on their development at 18 to 24 months.

Detailed description: Premature infants develop their sense of smell very early in the womb. After birth infants can recognize and distinguish the odor of their mother from their father and others. Premature infants are capable of smelling and they experience less pain and agitation when they smell their mother's milk; studies have shown that premature infants have better sucking and feeding, and they may go home earlier when they are exposed to the odor of breast milk. It is not known whether the same will happen if preterm infants are exposed to their mother's smell rather than the smell of the maternal milk.

Eligibility criteria: Inclusion Criteria:

* Mother of a baby who was born premature before completing 36 weeks of pregnancy
* Baby between ages of 5-10 days
* Medically stable baby
* Baby already began feeding by mouth or by feeding tube

Exclusion Criteria:

* Medically unstable baby born after 36 weeks of gestation.

Primary outcomes:
measure: Salivary cortisol level
timeFrame: Two years
Secondary outcomes:
measure: Physiological parameters: Heart rate and respiratory rate
timeFrame: Two years
measure: Achievement of oral feeding
timeFrame: Two years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: American University of Beirut Medical Center
name: Lama Charafeddine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03753048: Total Arterial Revascularization (TAR)
Official title: Comparison of Total Arterial Revascularization of Y-Graft Versus In-Situ Configuration Using Bilateral Internal Thoracic Arteries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Bypass Grafting
Keywords: Total Arterial Revascularization
Y-Graft
In-Situ
Coronary Artery Bypass Grafting
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Kemerovo Cardiology Center
First posted: 2018-11-26
Enrollment: 880
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.

Detailed description: The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.

Eligibility criteria: Inclusion Criteria:

* Coronary Artery Disease
* Stable angina
* The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization
* Informed Consent Form

Exclusion Criteria:

* The diameter of the target arteries is less than 1 mm
* Stenosis of the subclavian arteries more than 60%
* STEMI less than 3 month
* Previous cardiac surgery
* BMI \>35
* COPD with FEV1 \<60%
* Concomitant pathology that requires simultaneous surgical treatment
* Cancer with life expectancy less than 5 years

Primary outcomes:
measure: Freedom from MACCE
timeFrame: 5 years
Secondary outcomes:
measure: Graft patency
timeFrame: 5 years
measure: Quality of life (SF-36)
timeFrame: 5 years
measure: Treadmill stress test
timeFrame: 5 years
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin National Medical Research Center
state: Novosibirsk Region
Study officials:
affiliation: Meshalkin National Medical Research Center
name: Dmitry Sirota, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01650948: Genetic Load and Phenotype in Aggressive AMD
Official title: Evaluation of Genetic Variants in Patients Under Treatment for Choroidal Neovascular (CNV) Age-related Macular Degeneration (AMD), Receiving Intravitreal antiVEGF Injections to Evaluate the Association Between Genetic Load and Phenotypes Associated With More Aggressive Forms of Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Keywords: age-related macular degeneration
AMD
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AMD who are or have been treated with anti-VEGF therapy

Brief summary: Patients with AMD will provide cheek cell samples to determine if their is a correlation between genotype (DNA markers) and phenotype (the type of AMD the patient has).

Detailed description: This study seeks to test individuals who have already progressed to various forms of AMD to evaluate correlations between genetic markers and particular features of AMD including geographic atrophy and pigment epithelial detachments. We hypothesize that patients with more aggressive forms of AMD will have a higher genetic burden contributed by markers in ARMS 2, Complement Factor H (CFH), Complement component 3 (C3), Complement component 2 (C2) , Factor B (FB), or other genetic polymorphisms associated with CNV.

Eligibility criteria: Inclusion Criteria:

* Subject is male or female 50 years of age and older
* Subject provides a signed and dated informed consent
* Subject agrees to provide two buccal swabs in accordance with this protocol
* Diagnosis of CNV secondary to AMD in at least one eye

Exclusion Criteria:

* Previous sample donation under this protocol
* Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases which have been present prior to the age of 50.
* Opacities of the ocular media, limitations of pupillary dilation or other problems sufficient to preclude adequate imaging of the posterior segment.

Primary outcomes:
measure: The identification of individual genetic markers or a quantitative measure of total genetic burden found to be significantly associated (p value <0.05) with group classification (CNV only versus CNV with GA and/or RPED).
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Eye Associates
state: California
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
Study officials:
References:
Clinical trial NCT01215448: Wheatgrass Juice / Lifestyle Recommendations / Cancer Patients' Quality of Life / Chemotherapy Treatment
Official title: Impact of Wheatgrass Juice and Lifestyle Recommendations on Cancer Patients' Quality of Life During Chemotherapy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Fatigue
Quality of life
Lifestyle
Complementary medicine
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is aimed to study the impact of wheatgrass juice and lifestyle recommendations (diet, physical activity and breathing exercises) on the well being, fatigue and hematological parameters of chemotherapy-naive patients with no evidence for symptoms of active oncological disease.The researchers hypothesize that both wheatgrass juice and lifestyle recommendations can improve patient's well-being during chemotherapy.

Detailed description: Chemotherapy-naive patients will be offered to participate in a two arms study. Following consent, patients will be randomized to one of two arms. Patients in both arms will be provided by booklet and audio-cassette that specify lifestyle recommendations (diet, physical activity and breathing exercises). Patients in one of the study arms will be provided in addition with frozen wheatgrass juice (recommended daily dosage of 55-110 CC daily). Patients in both arms will be asked to fill in a daily patient's diary monitoring the practice of the lifestyle recommendations.

Baseline assessment will include the following questionnaires: ESAS, MYCAW, FACIT- Fatigue. Evaluation will include weekly ESAS and FACIT-Fatigue questionnaire and subsequent evaluation (including ESAS, MYCAW, FACIT- Fatigue questionnaires) following 3 and 4 chemotherapy cycles of treatment. Follow-up evaluation will be performed at the completion of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cancer with no sign of active disease
* First-time treatment with chemotherapy

Exclusion Criteria:

* Treatment with per os administration of chemotherapy

Primary outcomes:
measure: Assessing impact of wheatgrass juice and lifestyle recommendations on cancer patients' quality of life
timeFrame: 4 months
Secondary outcomes:
measure: Assessing compliance of patients to lifestyle recommendations during chemotherapy
timeFrame: 4 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Lin Medical Center
Study officials:
affiliation: Clalait Health Services
name: Eran Ben-Arye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bar-Sela G, Tsalic M, Fried G, Goldberg H. Wheat grass juice may improve hematological toxicity related to chemotherapy in breast cancer patients: a pilot study. Nutr Cancer. 2007;58(1):43-8. doi: 10.1080/01635580701308083.
Clinical trial NCT02715648: Using Phenazopyridine for In-office Cystoscopy
Official title: Using Phenazopyridine for In-office Cystoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystoscopy
Phenazopyridine
Lead sponsor: Boston Urogynecology Associates
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators propose to conduct a randomized controlled trial to evaluate whether administration of phenazopyridine prior to the procedure decreases office cystoscopy time. Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.

Detailed description: All potentially eligible participants will have had a complete history, physical examination, urinalysis and urine culture for clinical purposes. After eligibility is confirmed and written, informed consent is obtained, participants will be randomized to one of the two study arms. Participants randomized to phenazopyridine arm will receive 200 mg by mouth approximately 60 minutes prior to the scheduled cystoscopy. During the cystoscopy, at various time points, the time will be recorded.The color of the efflux will also be documented.

Eligibility criteria: Inclusion Criteria:

* Female patients undergoing in-office diagnostic cystoscopy at Boston Urogynecology Associates

Exclusion Criteria:

* Women who have taken vitamin B the day of the cystoscopy
* Cystoscopy with concurrent treatments such as botulinum toxin or periurethral bulking injections
* Allergy to phenazopyridine

Primary outcomes:
measure: Total cystoscopy time
timeFrame: at time of cystoscopy
Secondary outcomes:
measure: Time to visualization of ureteral jets
timeFrame: at time of cystoscopy
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Boston Urogynecology Associates, 725 Concord Ave. Suite 1200
state: Massachusetts
Study officials:
affiliation: Practitioner
name: Eman Elkadry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164148: Heart Rate Variability (HRV) in Pituitary Adenoma
Official title: A Study to Observe the Change of the Biological Signal (Heart Rate) During the Combined Pituitary Stimulation Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pituitary Adenoma
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Several studies have been reported that heart rate is known to be associated with prognosis in chronic diseases and acute diseases. For example, a decrease in heart rate following myocardial infarction may lead to a higher mortality rate. It is also known to predict heart failure, diabetic neuropathy, and even depression.

The combined pituitary function test artificially induces hypoglycemia to observe the secretion of pituitary hormone. The degree of change in heart rate during hypoglycemia can predict the adequacy of the test, and heart rate can be changed according to the characteristic of the tumor. Also, the prognosis can be predicted based on this.

In our study, we used a licensed device approved by KFDA (Korea Food and Drug Administration) to measure heart rate variability in patients with pituitary adenoma.


Eligibility criteria: Inclusion Criteria:

* Over 19 year old
* Those with Normal blood pressure range:

  90mmHg \<systolic \<140mmHg, 60mmHg \<diastolic \<100mmHg
* Voluntary participants who visited Seoul St. Mary's Hospital

Exclusion Criteria:

* Those who have been diagnosed with sleep disorders, diabetes, arrhythmia, psychiatric disorder, physical or mental breakdown, drug addicts
* Diabetes, hypertension, cardiovascular disease diagnosed by taking a drug related to the disease
* Pregnant or lactating women
* Those who drank within 12 hours before participating in the trial
* Those who are deemed inappropriate by clinical trial researchers

Primary outcomes:
measure: Changes in Heart rate variability according to the types of pituitary adenoma
timeFrame: 5 month of initial recruit
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: DongJun Lim, M.D, PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT00094848: Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
Official title: A Multi-Center, Open-Label, Dose-Escalation Study to Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human Monoclonal Antibody to the TRAIL-R1) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2004-10-27
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: The purpose of this study is to evaluate the safety, efficacy and exposure to TRM-1 in subjects with relapsed or refractory Non-Hodgkin's Lymphoma (NHL).


Eligibility criteria: Primary Inclusion Criteria:

* Relapsed or refractory histologically confirmed Non-Hodgkin's Lymphoma
* Previously treated with at least 1 therapeutic regimen and relapsed or progressed or failed to achieve a response after the last regimen
* 18 years of age or older

Primary Exclusion Criteria:

* Received a non-FDA approved investigational agent within the last 4 weeks
* Received cancer therapies (chemotherapy, biological therapy \[including hormonotherapy\], radiation therapy or immunosuppressants within the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or nitrosourea
* Eligible for a hematopoietic stem cell transplant (HSCT) or have had an autologous HSCT within the last 16 weeks
* Prior history of an allogeneic HSCT
* HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma, Hepatitis-B or Hepatitis-C
* Infection requiring antibiotics within the last 4 weeks
* Major surgery within the last 4 weeks
* Pregnant or breast-feeding women
* History of other cancers within the past 5 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: