louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03266848: Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
Official title: Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Disorders
Keywords: Magnetic Resonance Imaging
Ferumoxytol
Lead sponsor: Theranano LLC
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Northeastern University
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with iron deficiency anemia already scheduled to receive ferumoxytol infusion for iron replacement therapy.

Brief summary: This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.

Detailed description: This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 to 80;
* Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.

Exclusion Criteria:

* Known allergy to ferumoxytol or any intravenous iron preparation;
* Iron saturation above the upper limit of normal;
* Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator);
* Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease;
* Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.

Primary outcomes:
measure: Cerebrovascular Angiography
timeFrame: 0-4 hours after ferumoxytol infusion
Secondary outcomes:
measure: Quantitative cerebral blood volume atlas
timeFrame: 0-4 hours after ferumoxytol infusion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Theranano LLC
name: Srinivas Sridhar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412148: Modified SALT Score for Alopecia Areata
Official title: Modified SALT Score for Assessment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alopecia Areata
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy.


Eligibility criteria: Inclusion Criteria:

* localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent.

Exclusion Criteria:

* • pregnant, and lactating females

  * Alopecia totalis or universalis or ophiasis or cicatritial alopecia
  * Usage of systemic treatment of alopecia areata 2 months prior to the study.
  * Any scalp lesion within the treated area
  * Bleeding diathesis, severe anemia or platelet disorders
  * Medical conditions such as autoimmune diseases.

Primary outcomes:
measure: Percentage involvement
timeFrame: 6months to 1 year
measure: Modified Severity of Alopecia Tool (mSALT) score
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy university hospital, Faulty of medicine,Cairo university
Study officials:
References:
Clinical trial NCT01649648: Autologous Cord Blood Cells for Brain Injury in Term Newborns
Official title: Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypoxic Ischemic Encephalopathy
Keywords: Hypoxic ischemic encephalopathy
Autologous cord blood
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2012-07-25
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).

Detailed description: The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.

Eligibility criteria: Inclusion Criteria:

1. Autologous umbilical cord blood available
2. \>36 weeks gestation
3. Brain injury that satisfies criteria for therapeutic hypothermia
4. Parental informed consent

Exclusion Criteria:

1. Inability to enroll by 3 postnatal days of age.
2. Presence of known chromosomal anomaly.
3. Presence of major congenital anomalies.
4. Severe intrauterine growth restriction
5. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
6. Parents refuse consent.
7. Attending neonatologist refuses consent.
8. Failure to collect the infant's cord blood and/or laboratory unable to process cord blood

Primary outcomes:
measure: Safety
timeFrame: 1-3 days of age
Secondary outcomes:
measure: Neurodevelopment
timeFrame: 1 month-2 years old
measure: Brain imaging
timeFrame: 1 week-6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Jiun Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: KK Women's and Children's Hospital
name: Samuel Rajadurai, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore General Hospital
name: Cheo Lian Yeo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591148: A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Official title: A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Morbid Obesity
Keywords: Pharmacokinetics
Pharmacodynamics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will determine how morbid obesity affects the distribution and metabolism of the drug propofol. The investigators hypothesize that propofol will be distributed and metabolized differently in morbidly obese subjects as compared to normal weight subjects.


Eligibility criteria: Inclusion Criteria:

* adult age (ages 18-70)
* body mass index greater than 40 or between 20-25
* American Society of Anesthesiologists Class I, II, or III
* undergoing elective surgical procedure requiring general anesthesia

Exclusion Criteria:

* evidence of cardiovascular or pulmonary disease
* kidney or liver dysfunction
* drug allergy to propofol
* history of difficult airway
* on prescribed or over the counter anxiolytics, antipsychotics, or sleeping aids
* unable to speak or understand English

Primary outcomes:
measure: plasma drug concentration of propofol
timeFrame: measured during the perioperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Jerry Ingrande, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingrande J, Gabriel RA, McAuley J, Krasinska K, Chien A, Lemmens HJM. The Performance of an Artificial Neural Network Model in Predicting the Early Distribution Kinetics of Propofol in Morbidly Obese and Lean Subjects. Anesth Analg. 2020 Nov;131(5):1500-1509. doi: 10.1213/ANE.0000000000004897.
Clinical trial NCT04677348: Comparison of PENG Block and FICB in Hip Fracture Patients
Official title: Comparison of Analgesic Effect of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Dynamic Pain in Patients Undergoing Hip Fracture Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Regional Anesthesia
Keywords: pericapsular nerve group block
fascia iliaca compartment block
hip fracture
regional anesthesia
dynamic pain
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fascia iliaca compartment block (FICB) has been considered the block of choice for patients with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. Since PENG block could block the accessory obturator nerve, PENG block might have greater analgesic effects compared to FICB theoretically. However, the comparison of these two blocks in patients with hip fracture has not performed in clinical setting. Thus, we aimed to compare the analgesic effect of PENG block and FICB.


Eligibility criteria: Inclusion Criteria:

* ASA PS 1-4
* age: ≥19
* baseline pain score (associated with hip fracture): ≥4

Exclusion Criteria:

* patients who do not agree to participate in this study
* patients with uncontrolled hypertension, hyperthyroidism, severe dementia
* allergic to ropivacaine
* contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region
* patients who are considered ineligible with any other reason by investigators

Primary outcomes:
measure: Efficacy of each block (Pain score)
timeFrame: before surgery
Secondary outcomes:
measure: change of blood pressure (systolic, diastolic, mean blood pressure)
timeFrame: before surgery
measure: postoperative pain score
timeFrame: postoperative 6, 24, 48hours
measure: postoperative opioid consumption
timeFrame: postoperative 24, 48hours
measure: postoperative motor function
timeFrame: postoperative 6, 24, 48hours
measure: change of heart rate
timeFrame: before surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Won Uk Koh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06239948: The Brain Symphony For Post-Stroke Rehabilitation
Official title: The Brain Symphony For Post-Stroke Rehabilitation - A Pilot Randomized Controlled Study With P.Ramlee Songs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Music Listening
Stroke
Rehabilitation
Transcranial Magnetic Stimulation (TMS)
Neuroplasticity
P. Ramlee Music
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were categorized into two groups: stroke survivors and healthy individuals and randomized into control group (without music) and experimental group (with music).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Music listening intervention has made great strides in improving the condition of stroke survivors. Thus, this research explores the effects of music listening intervention on post-stroke survivors during rehabilitation by using P. Ramlee songs.

Detailed description: Objective: Music listening intervention has made great strides in improving the condition of stroke survivors. Thus, this research explores the effects of music listening intervention on post-stroke survivors during rehabilitation by using P. Ramlee songs.

Materials \& Methods: In the first phase, surveys were conducted to determine the selection of songs to be used in the second phase. The second phase is applying music listening intervention on a small sample of 20 subjects, aged 55 years old and above. The participants were categorized into two groups: stroke survivors and healthy individuals and randomized into control group (without music) and experimental group (with music). The second phase consists of three stages. Stage one is to pre-screen and select potential subjects before the experiment. The second stage aims to determine the effect of P. Ramlee music on stroke survivors during their rehabilitation through augmenting their brain neuroplasticity with measurement of the MEP using TMS. The final stage compares the effects of MEP between lesion and non-lesion areas.

Eligibility criteria: Inclusion Criteria:

* Healthy
* No history of seizures or epilepsy
* Able to hear well
* Able to attend experiment sessions without scheduling conflicts
* No contraindications to undergoing TMS

Exclusion Criteria:

• None

Primary outcomes:
measure: Transcranial Magnetic Stimulation (TMS)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre
Study officials:
References:
Clinical trial NCT05693948: The Efficacy of Topical Serum X for Skin Brightening
Official title: The Efficacy of Topical Serum X Containing Arbutin and Glutathione for Skin Brightening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Aesthetic
Cosmetic
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is conducted to evaluate the effectiveness of topical serum X containing arbutin and glutathione for skin brightening. The study duration is 12 weeks and the skin assessment will be carried out at baseline, week 4, 8 and week 12.The main questions this study aims to answer are:

1. The skin brightening effect of the product on facial skin.
2. To observe any adverse effect occurrence with the usage of the product.


Eligibility criteria: Inclusion Criteria:

* Malaysia citizen
* Male and female (age 18-30 years old)

Exclusion Criteria:

* Participant with severe acne skin condition
* Participant who is taking isotretinoin, immunocompromised patients and received laser and light treatment within the last three months
* Participant who undergo whitening or cosmetic treatments such as botox and dermal fillers within the previous six month
* Participant with a history of facial surgery such as facelift or nose reshaping
* Participant with history of allergies to any ingredient in the study product
* Participant who is pregnant or plan to get pregnant

Primary outcomes:
measure: Changes in skin tone from baseline and at week 4, week 8, and week 12 after usage of serum X.
timeFrame: Baseline and at week 4, week 8, and week 12
measure: Adverse effect after using serum X
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT00202748: Change of Lifestyle by Persons in Risk of Type 2 Diabetes
Official title: Phase 3 Study of Changing of Lifestyle by Persons in Risk of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: metabolic syndrome
lifestyle
obesity
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2005-09-20
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We know that changing lifestyle can prevent type 2 diabetes. The challenge is how to help people changing their lifestyle. We have people in 2 groups: half of them is meeting in grops of 10 persons (interventiongroup), the other ones are just visiting their doctor (controlgroup).

Detailed description: The intervention group are meeting different healt proffesionals (nurse, doctor, eksperts on nutrition,experts on activity and experts on how to change. They have 7 meetings in groups of 10 persons over 3 months. The controlgroup are just meeting their own doctor or the doctor in the hospital 2 times a year.

We tell all that small changes are making big differenses (in weight and the chanse of getting ill). Everyone is told that lack of aktivity is the main reason to obesity. Lack of activity also influense in whar you eat. herefore is activity in the "center".

Eligibility criteria: Inclusion Criteria: Diabetes risk score above 9 points.

Exclusion Criteria: Persons with diabetes, serious heart disease, cancer or psychiatric disorder. They have to speak and understand Norwegian language.

Primary outcomes:
measure: Weigtreduction
measure: Increase in maximum oxygen uptake
measure: Change in foodintake
measure: Change in self-reported activity
Secondary outcomes:
measure: Quality of life
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
state: Serviceboks 416
Study officials:
name: Frode Gallefoss, Dr.
role: STUDY_CHAIR
References:
citation: Nilsen V, Bakke PS, Rohde G, Gallefoss F. Is sense of coherence a predictor of lifestyle changes in subjects at risk for type 2 diabetes? Public Health. 2015 Feb;129(2):155-61. doi: 10.1016/j.puhe.2014.12.014. Epub 2015 Feb 13.
citation: Nilsen V, Bakke PS, Rohde G, Gallefoss F. Predictors of health-related quality of life changes after lifestyle intervention in persons at risk of type 2 diabetes mellitus. Qual Life Res. 2014 Nov;23(9):2585-93. doi: 10.1007/s11136-014-0702-z. Epub 2014 May 1.
citation: Nilsen V, Bakke PS, Gallefoss F. Effects of lifestyle intervention in persons at risk for type 2 diabetes mellitus - results from a randomised, controlled trial. BMC Public Health. 2011 Nov 25;11:893. doi: 10.1186/1471-2458-11-893.
Clinical trial NCT02076048: LCPUFA Supplementation: A Multi-Modality Imaging Study
Official title: LCPUFA Supplementation: A Multi-Modality Imaging Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Keywords: LCPUFA supplementation
Brain Imaging
MRI
MEG
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2014-03-03
Enrollment: 42
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who were originally enrolled as infants will be invited to participate in the longitudinal follow up study.

Brief summary: The purpose of this study is to take images of the brain in order to see if long-chain polyunsaturated fatty acid (LCPUFA) exposure during infancy influences brain structure and function in middle childhood.

Detailed description: LCPUFAs are essential fatty acids that are found in all cells of the body, particularly in the brain, retina and other nervous tissue. LCPUFAs are found naturally in seeds, nuts, fish and human breast milk. The body can also make LCPUFAs from shorter-chain fatty acid precursors.

The researchers in the study have previously found that LCPUFA supplementation during infancy has a beneficial effect on vision and development in the early years of life. However, researchers feel there is a growing need to better understand if there are structural and/or functional changes in the brain that explain these benefits. It is also important to understand if changes in development are still present later in childhood.

Eligibility criteria: Inclusion Criteria:

* Parents consent for children and children have the ability to assent
* Participation as an infant in the original study

Exclusion Criteria:

* Those with orthodontic braces or extensive dental work that would make them unable to have an MRI

Primary outcomes:
measure: Event-Related Field (ERF) Amplitude and Latency
timeFrame: Within 1 year post enrollment
measure: Regional gray and white matter brain volume
timeFrame: Within 1 year post enrollment
Secondary outcomes:
measure: Identify structural and metabolic mediators
timeFrame: Within 1 year post enrollment
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kathleen M Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lepping RJ, Honea RA, Martin LE, Liao K, Choi IY, Lee P, Papa VB, Brooks WM, Shaddy DJ, Carlson SE, Colombo J, Gustafson KM. Long-chain polyunsaturated fatty acid supplementation in the first year of life affects brain function, structure, and metabolism at age nine years. Dev Psychobiol. 2019 Jan;61(1):5-16. doi: 10.1002/dev.21780. Epub 2018 Oct 11.