louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00886444: Comparative Evaluation of Various Combinable Magnetic Resonance (CMR) Pulse-sequences for Macrophage Imaging Using Ferucarbotran
Official title: Comparative Evaluation of Various CMR Pulse-Sequences for Macrophage Imaging Using Ferucarbotran as Molecular Contrast Agent in Human Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Myocardial Infarction
Lead sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to:

* clarify whether macrophage imaging using ferucarbotran is able to delineate the region of myocardial infarction as accurate as gadolinium-based necrosis/fibrosis imaging;
* identify possible differences in infarct imaging using ferucarbotran for macrophage imaging compared to necrosis/fibrosis imaging with gadolinium-based compounds; and
* evaluate which MRI pulse-sequences maximise sensitivity for macrophage imaging with ferucarbotran in the setting of acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

* contraindication to CMR or Magnevist® or Resovist®

Primary outcomes:
measure: Extent of myocardial infarction (as demonstrated with gadolinium-based necrosis/ fibrosis imaging compared to macrophage imaging using ferucarbotran)
timeFrame: within 5 - 15 days after myocardial infarction
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus, Division of Cardiology
Study officials:
affiliation: Robert Bosch Medical Center
name: Udo Sechtem, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03214744: Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants
Official title: Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Infant
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates (\<36 weeks)

Brief summary: Rapid Versus Slow Entral Feeding Advancements on Clinical Outcomes of Preterm Infants

Detailed description: Rapid feeding advancement achieves full enteral volume of feedings earlier than the slower advancement.They received significantly fewer days of parenteral nutrition, exhibited a shorter time to regain birth weight and shorter duration of hospital stay. The incidence of NEC and the number of episodes of feeding intolerance were not significantly different between rapid and slow advancement. while the incidence of culture-proven late onset sepsis was significantly less in infants receiving a rapid feeding advancement

Eligibility criteria: Inclusion Criteria:

- All preterm neonates admitted to NICU with gestational age less than 36 weeks, and haemodynamically stable

Exclusion Criteria:

* gastrointestinal tract anomalies,
* haemodynamically unstable infants,
* gestatinal age equal or more than 36 weeks,
* preterms who develop NEC,
* preterms on mechanical ventilation.

Primary outcomes:
measure: effect of entral feeding on preterm
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: John J Smith
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pike K, Brocklehurst P, Jones D, Kenyon S, Salt A, Taylor D, Marlow N. Outcomes at 7 years for babies who developed neonatal necrotising enterocolitis: the ORACLE Children Study. Arch Dis Child Fetal Neonatal Ed. 2012 Sep;97(5):F318-22. doi: 10.1136/fetalneonatal-2011-300244.
Clinical trial NCT05935644: ORCHID: An Online Intervention for Persons With HIV (Miami)
Official title: ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
HPV Infection
Keywords: depression
mobile applications
cortisol levels
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2023-07-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to test ORCHID (Optimizing Resilience \& Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care.


Eligibility criteria: Inclusion Criteria:

1. Cis-gender women,
2. Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service,
3. Recent history (12-month) of cervical or anal dysplasia or human papilloma virus (HPV) positivity; AND a recent (12-month) history of one or more of the following:

i) drug use (alcohol, tobacco products, marijuana, illicit drugs) or ii) depression or iii) psychiatric condition (anxiety, post-traumatic stress disorder (PTSD)) or iv) unsuppressed HIV viral load d. All life stages - pregnant, non-pregnant, pre/post-menopausal

Exclusion Criteria:

1. Under 18
2. Not able to read/write English at the 6th grade level
3. Cognitively impaired adults (as documented in medical records)
4. Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders)
5. Prisoners

Primary outcomes:
measure: Proportion of Participants who Complete ORCHID
timeFrame: Up to 6 months
Secondary outcomes:
measure: Depression as measured by Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 6 months
measure: Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Lunthita M Duthely, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06103344: The Effect of 4-7-8 Breathing Exercise Training on Sleep Quality
Official title: The Effect of 4-7-8 Breathing Exercise Training Given to Nursing Students on Sleep Quality: A Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Students
Lead sponsor: Kilis 7 Aralik University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Research; it will be carried out Kilis 7 Aralik University Yusuf Serefoglu Health Sciences Faculty, Department of Nursing. The training will take approximately 20 minutes in an empty classroom and will be planned when the students' classes finish. Thus, educational activities in the institution will not be disrupted. Participants will be asked to do the taught exercise in half an hour before going to sleep every evening during the research period (4 weeks). Training will begin when the determined number of samples is reached. The training will be terminated when the 4-week research period determined to see the effect of the application expires.


Eligibility criteria: Inclusion Criteria:

* Volunteer
* Studying in a nursing undergraduate program
* There is no condition that prevents nasal breathing (such as septal deviation)
* No known chronic sleeping disorder

Exclusion Criteria:

* No studying in a nursing undergraduate program
* There is condition that prevents nasal breathing (such as septal deviation)
* Having any chronic sleeping disorder

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: This measurement will be repeated at the beginning of the study and at the end of the 4th week.
Secondary outcomes:
Other outcomes:
Locations:
city: Kilis
country: Turkey
facility: Kilis 7 Aralık University
state: Center
Study officials:
affiliation: Kilis 7 Aralik University
name: Uğur Doğan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01064544: Study on Hemodialysis: Illumination Effects
Official title: Effects of Light Therapy on Sleep, Melatonin Rhythm and Mood in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep Problems
Keywords: Sleep problems
melatonin
mood
Hemodialysis
Lead sponsor: Meander Medical Center
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Previous research has shown that sleep quality in hemodialysis patients is disturbed. One of the possible explanations is an insufficient or disturbed melatonin rhythm. Melatonin rhythm is regulated by exposure to light. In this feasibility study, the investigators examine the effects of light therapy during dialysis on sleep, melatonin rhythm and mood.


Eligibility criteria: Inclusion Criteria:

* informed consent
* men/women aged 18-85 years
* knowledge of the dutch language
* hemodialysis patient
* subjective sleep problems (Epworth sleepiness score \>9)

Exclusion Criteria:

* known major illness, which interferes with patient's participation
* use of melatonin/hypnotics
* use of photosensitizing medication
* jet lag or travel \> 1 time zone

Primary outcomes:
measure: Improvement of sleep parameters
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in subjective sleep parameters
timeFrame: 3 weeks
measure: Change in mood
timeFrame: 3 weeks
measure: change in melatonin concentrations
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
Study officials:
affiliation: Meander Medical Center
name: Carlo Gaillard, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00701844: Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
Official title: Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Acute Leukemia
Acute Lymphocytic Leukemia
Multiple Myeloma
Hematological Cancers
Psychological Distress
Keywords: Aplastic Anemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anemia
Quality of Life
Lymphoproliferative Disorders
Lymphoma
Multiple Myeloma
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2008-06-19
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The Sharing Our Strength study is being conducted to help us understand people's experiences with hematopoietic stem cell transplantation and to test a new program designed to help people recover physically and emotionally after transplant.

Detailed description: This is a study for survivors of hematopoietic stem cell transplantation (also known as bone marrow transplant), which is an intensive medical treatment for cancers such as leukemia, lymphoma, and multiple myeloma as well as other diseases. Because it is a physically and emotionally demanding treatment, many people report having ongoing physical and emotional difficulties after having a transplant. The Sharing Our Strength study is being conducted to help us understand people's transplant experiences and to test a new program designed to help them recover physically and emotionally after transplant. All parts of the study are completed by mail and telephone. Participants will receive compensation for their time.

Eligibility criteria: Inclusion Criteria:

* Be a transplant survivor who is 9 months to 3 years beyond transplant and not currently relapsed. and not currently relapsed
* Be at least 18 years old now (and at least 16 when they had their transplant)
* Speak English
* Have telephone service

Exclusion Criteria:

* None

Primary outcomes:
measure: Psychological Adjustment
timeFrame: At screening, baseline and 3 months following intervention
Secondary outcomes:
measure: Quality of Life
timeFrame: At screening, baseline and 3 months following intervention
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christine Rini, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03473444: Prevalence of Hyperuricemia in Pakistan
Official title: Prevalence of Hyperuricemia in Pakistan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperuricemia
Keywords: uric acid
prevalence
pakistan
Lead sponsor: OBS Pakistan
Sponsor class: INDUSTRY
First posted: 2018-03-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Informed consent was obtained from all patients and their attendant coming to clinics. Those who agreed to be part of this study were asked a questionnaire about co-morbidity and symptoms.

Uric acid levels were assessed by using UASure Blood Uric Acid Monitoring System. Male with uric acid levels greater than 7 mg/dl and female greater than 6 mg/dl were classified as hyperuricemia.

Brief summary: The prevalence of hyperuricemia has rarely been investigated in developing countries Hyperuricemia, or raised serum uric acid (SUA), is the condition closely associated with gout due to the deposition of monosodium urate crystals in peripheral joints and soft tissues. Hyperuricemia is associated with an increased risk for incident hypertension, independent of traditional hypertension risk factors. This risk appears more pronounced in younger individuals and women. Cross-sectional studies show an association of hyperuricemia with the presence of CKD. Insulin resistance plays a potentially key role in the causal relationship between metabolic syndrome, type 2 Diabetes and hyperuricemia. Furthermore, it is likely that hyperuricemia and insulin resistance share a bidirectional causal effect. The rationale of this study is to determine prevalence of hyperuricemia in Pakistan.

Detailed description: Informed consent will be obtained from all patients and their attendant coming to clinics. Those who will agree to be part of this study were asked a questionnaire about co-morbidity and symptoms.

Uric acid levels will be assessed by using UASure Blood Uric Acid Monitoring System. Male with uric acid levels greater than 7 mg/dl and female greater than 6 mg/dl were classified as hyperuricemia.

Eligibility criteria: Inclusion Criteria:

* Informed Consent given

Exclusion Criteria:

* No Informed consent provided

Primary outcomes:
measure: Prevalence of Hyperuricemia
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mirpur
country: Pakistan
facility: Dr. Abid Naeem
state: AJK
Study officials:
References:
Clinical trial NCT05268744: Micronutrient Supplementation in Children With ASD
Official title: Micronutrient Supplementation in Children With Autism Spectrum Disorder (ASD): A Clinical Trial Examining Mechanism of Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.

Detailed description: Children enrolled in Oak Hill School will enroll in this study and take micronutrient supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be taken again at 12 weeks, after 4 weeks of not dosing.

Eligibility criteria: Inclusion Criteria:

1. Male or female, enrolled at Oak Hill School (OHS), age 6-22 and with a diagnosis of ASD.
2. ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
3. Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
2. Taking multivitamins currently and unwilling to stop during the study period

Primary outcomes:
measure: Change in the Autism Behavior Inventory, Short Form (ABI-S)
timeFrame: Baseline to Week 8
measure: Change in the Social Responsiveness Scale (SRS)
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Robert Hendren, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00110344: Research Study for Patients With Metastatic Renal Cell Carcinoma
Official title: A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-05-09
Enrollment: 1
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: This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.


Eligibility criteria: Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon
* At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen
* Patients who have an ECOG performance status of 0 or 1 Exclusion Criteria:
* History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation
* Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field
* Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is \> 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry

Primary outcomes:
measure: Best Overall Response Rate (complete and partial response rate)
timeFrame: During study treatment or within 30 days after termination of active therapy
Secondary outcomes:
measure: Progression-free survival
timeFrame: Last date of tumor assessment
measure: Overall response rate
timeFrame: Last day of tumor assessement
measure: Time to response
timeFrame: throughout study
measure: Safety
timeFrame: all visits
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06689644: Effect of a Plant Based Nootropic on Perceptual Decision Making.
Official title: Effect of a Plant-based Nootropic Supplement on Perceptual Decision-making and Brain Network Interdependencies: a Randomised, Double-blinded and Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Enhancement
Keywords: Perceptual decision-making
Cognitive enhancement
Nootropics
EEG
Brain health
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Nootropics are a group of medicinal substances purported to improve important cognitive functions such as learning, focus and memory. Many of these substances have demonstrated beneficial effects on cognitive performance and overall health. However, a thorough understanding of how these substances and their synergistic effects in the form of a supplement may benefit fundamental brain processes is currently lacking. In the current study, we will investigate the effects of a plant-based, nootropic supplement (https://uk.mindlabpro.com/) on perceptual decision-making (i.e. the ability to make rapid decisions based on sensory stimuli) in healthy adult participants.

Detailed description: Participants will perform a computerised cognitive task assessing their perceptual decision-making pre- and post- 60 days of continuous supplementation with either a plant-based nootropic supplement (Mind Lab pro) or placebo. During testing, electroencephalography (EEG) signals will be captured simultaneously.

Eligibility criteria: Inclusion Criteria:

* Eligibility screening of participants was guided by the following inclusion criteria: (i) be between 20-59 years old, (ii) be right-handed and (iii) be able to cease taking other dietary supplements for two months.

Exclusion Criteria:

* Exclusion criteria included: (i) currently consuming a nootropic supplement, (ii) any known musculoskeletal, or neurological medical conditions or cognitive impairments (iii) have a known diagnosis of epilepsy/history of seizures and (iv) have a known hearing or visual condition that affects daily life function.

Primary outcomes:
measure: Perceptual decision-making performance
timeFrame: Pre- and post- 60 days of supplementation
Secondary outcomes:
measure: Brain network interdependencies
timeFrame: Pre- and post- 60 days of supplementation
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Faculty of Biological sciences
Study officials:
affiliation: University of Leeds
name: Ioannis Delis
role: PRINCIPAL_INVESTIGATOR
References: