louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03072498: Collection of Samples From Patients With MDS
Official title: Collection of Bone Marrow, Peripheral Blood (PB), Epithelial Tissue, and Saliva Samples From Patients With Myelodysplastic Syndromes (MDS) to Identify MDS-Specific Antigens (MSA) for Use in Cellular Immunotherapy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndromes(MDS)
Lead sponsor: PersImmune, Inc
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
First posted: 2017-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 24 Subjects (patients and donors) will be recruited over a 3-year period. Both male and female subjects will be included and there will be no restrictions based on race or ethnicity.

Brief summary: The purpose of this study is to collect information and bone marrow, blood, saliva, cheek cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of treating MDS.

Detailed description: Goals of the study:

The purpose of this study is to collect the blood and marrow samples, and non-involved fibroblasts, that are required to identify the unique, personalized array of mutation-driven neoantigens that are expressed by the subject's MDS cells and to assess the feasibility of immunizing and expanding one or more of the patient's T cells ex vivo for investigation of their use as adoptive cellular immunotherapy.

Eligibility criteria: Patients must meet the following initial inclusion criteria:

* Diagnosis or suspected diagnosis of MDS or CCUS
* Age 18 or older

Patient exclusion criteria:

* Currently receiving or within 3 months has received hypomethylating agent(s), lenalidomide, cytotoxic agents, or within the previous 4 weeks corticosteroids \> 5 mg prednisone daily or any other immunosuppressants
* Previous allogenic transplant
* Inability to provide consent
* Prisoners

Primary outcomes:
measure: Genomics of patients with MDS
timeFrame: 2 years
Secondary outcomes:
measure: Identification of patients' MDS-specific variant
timeFrame: 2 years
measure: Immunogenic mutant neoantigen peptide selection
timeFrame: 2 years
measure: Peptide Immunogenicity confirmation and donor T cell stimulation
timeFrame: 2 years
measure: Peptide immunogenicity confirmation and donor T cell stimulation
timeFrame: 2 years
measure: Data analysis and interpretation
timeFrame: 2 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Rafael Bejar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00092898: An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients Homozygous Sitosterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lipid Metabolism, Inborn Errors
Heart Disease
Keywords: Sitosterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 6-month study with patients who have the rare disease, sitosterolemia which may result in heart-related diseases. These patients have unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study investigates whether absorption of these non-cholesterols can be reduced in these patients.

Detailed description: The duration of treatment is 26 weeks.

Eligibility criteria: Inclusion Criteria:

* 18 years or older, with a history of elevated sitosterol levels and have received treatment for at least 6 months prior to study entry.

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Primary outcomes:
measure: Sitosterol concentrations after 26 weeks.
timeFrame: After 26 weeks
Secondary outcomes:
measure: Campesterol concentrations; Achilles tendon thickness; safety and tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Musliner T, Cselovszky D, Sirah W, McCrary Sisk C, Sapre A, Salen G, Lutjohann D, von Bergmann K. Efficacy and safety of ezetimibe 40 mg vs. ezetimibe 10 mg in the treatment of patients with homozygous sitosterolaemia. Int J Clin Pract. 2008 Jul;62(7):995-1000. doi: 10.1111/j.1742-1241.2008.01786.x. Epub 2008 May 14.
Clinical trial NCT05702398: Pilot Trial of Supplemental Vitamin A and Nicotinamide
Official title: Pilot Trial of Supplemental Vitamin A and Nicotinamide and Levels of Blood Vitamin A and Nicotinamide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Skin Cancer
Kidney Transplant Recipients
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to assess the feasibility and safety of oral nicotinamide (NAM; a derivative of vitamin B3 \[niacin\]) and vitamin A in a high-risk population of kidney transplant recipients with a history of skin cancer to generate preliminary data for future cancer prevention clinical trials.


Eligibility criteria: Inclusion Criteria:

* 18 years old or greater;
* Either History of 2 or more histologically confirmed invasive cutaneous SCCs in the past 2 years or
* At least one previously billed Healthcare Common Procedure Coding System code 17004 (destruction of 15 or more benign or premalignant lesions of the integumentary system);
* Understands, reads, and writes English proficiently.

Exclusion Criteria:

* Liver disease;
* Active peptic ulcer disease;
* Recent myocardial infarction;
* Hypotension;
* Internal malignancy within past 5 years;
* Renal impairment with eGFR\<15 mL/min/1.73 m2;
* Being unable for follow up due to social reasons;
* Gorlin's syndrome or other genetic skin cancer syndrome;
* Huge number of current skin cancers;
* Metastatic SCC or invasive melanoma within the past 5 years;
* Pregnancy or lactation;
* Need for ongoing carbamazepine use (which could have a possible interaction with NAM);
* Use of acitretin or other oral retinoids within the past 6 months;
* Use of supplemental NAM, niacin, vitamin A, or beta carotene within the past 6 months;
* Field treatment for actinic keratoses (AKs) within the previous 4 weeks;
* Use of topical steroids.

Primary outcomes:
measure: Change of Blood Vitamin A and Nicotinamide Levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03041298: Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
Official title: Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MR Mammography With Dotarem
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2017-02-02
Enrollment: 1537
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Brief summary: Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013. The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in Magnetic Resonance (MR) mammography.

Detailed description: Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the basis of the frequency and seriousness of adverse drug reactions observed following the injection of Dotarem.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Exclusion Criteria:

-

Primary outcomes:
measure: Image Quality
timeFrame: During MRI procedure
measure: Ability to Make a Diagnosis
timeFrame: During MRI procedure
measure: Diagnostic Results (Percentage of Patients Per Diagnosis)
timeFrame: During MRI procedure
measure: Cytology Test Results (Percentage of Patients Per Cytology Test Result)
timeFrame: During MRI procedure
measure: Frequency of Adverse Drug Reactions
timeFrame: From the beginning of the MR mammography procedure to 30-60 min after
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00610298: Effects of Whole Body Vibration in Elderly Patients Requiring Rehabilitation: A Pilot Study
Official title: Effects of Whole Body Vibration in Elderly Patients Requiring Rehabilitation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neuromuscular Deficits
Musculoskeletal Deficits
Keywords: disability affecting strength, balance and coordination
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Velimir Matkovic
First posted: 2008-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to accumulate data about the influence of whole body vibration on the functional recovery of adult patients with various neuromuscular and musculoskeletal deficits requiring physical medicine and rehabilitation treatments.

Detailed description: We know that whole body vibration can cause remarkable increase in power in athletes, however, to what extent elderly and disabled individuals could benefit from it is currently unknown. Our primary goal is to investigate if treatment with whole body vibration in elderly persons and patients with various neuromuscular and musculoskeletal deficits would result in more rapid return of their function and presumably at a higher level than comparable group of patients undergoing standard physical therapy.

Eligibility criteria: Inclusion Criteria:

* A history of one of the following conditions: CVA, Parkinson's disease, incomplete spinal cord injury, frail elderly, urinary incontinence, COPD, fibromyalgia
* Patients with neuromusculoskeletal problems affecting strength, balance, and coordination
* Must have all appendages (arms and legs) intact, not an amputee

Exclusion Criteria:

* Pregnancy
* Unable o participate in continuing outpatient therapy services at a location where the whole body vibration equipment is available
* Untreated deep venous thrombosis
* Other condition that will lead to poor treatment adherence
* History of join replacement of lower limbs, shoulders, or devices in the spine

Primary outcomes:
measure: Berg Balance Test
timeFrame: begining and end of intervention
Secondary outcomes:
measure: Sit to stand test
timeFrame: begining and end of intervention
measure: timed walking test
timeFrame: begining and end of intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Velimir Matkovic, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06406998: Maternal and Offspring Outcomes in Pregnant Women With Pre-existing ASCVD
Official title: Maternal and Offspring Outcomes in Pregnant Women With Pre-existing Atherosclerotic Cardiovascular Disease: A Nationwide Mother-Child Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Atherosclerosis
Pregnancy Complications
Adverse Cardiac Event
Adverse Birth Outcomes
Keywords: Atherosclerotic cardiovascular disease
Major adverse cardiac and cerebrovascular event
Adverse pregnancy outcome
Adverse birth outcomes
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 5461222
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All womens with live birth from Korea

Brief summary: A growing body of evidence supports associations between cardiovascular health and adverse pregnancy outcome and between adverse pregnancy outcome and atherosclerotic cardiovascular disease and builds on the well-established pathways known to exist between cardiovascular health and atherosclerotic cardiovascular disease across the life course and intergenerationally. Furthermore, previous studies frequently lack comprehensive long-term follow-up, making it difficult to assess the enduring impacts of maternal cardiovascular health on postpartum outcomes and long-term maternal and child health.

Detailed description: the current study aimed to evaluate the associations between maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes, and the combined effect of maternal pre-existent atherosclerotic cardiovascular disease and adverse pregnancy outcomes on the risk of long-term adverse events of offspring.

Eligibility criteria: Inclusion Criteria:

* Women with live birth from Korea (between January 1, 2005 to December 31, 2019)

Exclusion Criteria:

* None

Primary outcomes:
measure: Occurence of post-partum MACCE
timeFrame: up to 5 years
Secondary outcomes:
measure: Occurence of All-cause death
timeFrame: up to 5 years
measure: Occurence of myocardial infarction
timeFrame: up to 5 years
measure: Occurence of revascularization
timeFrame: up to 5 years
measure: Occurence of stroke
timeFrame: up to 5 years
measure: Occurence of adverse pregnancy outcome
timeFrame: At delivery
measure: Occurence of major congenital malformation in offspring
timeFrame: At delivery
measure: Occurence of neonatal adverse events in offspring
timeFrame: within 30 days
measure: Occurence of adverse infant events in offspring
timeFrame: Within 1 year
measure: Occurence of neurodevelopmental disorders
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ki Hong Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00637598: Early Detection of Breast Cancer Using Tomosynthesis Imaging
Official title: Early Detection of Breast Cancer Using Tomosynthesis Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Diagnostic Imaging
Mammography
Breast Tomosynthesis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-03-18
Enrollment: 385
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.

Detailed description: Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.

Eligibility criteria: Inclusion Criteria:

All Subjects accepted for this clinical study must:

* Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
* Provide written informed consent
* Be able to communicate effectively with clinical study personnel.

Exclusion Criteria:

Subjects with any of the following conditions will be excluded from this clinical study:

* Childbearing potential and subject refuses serum pregnancy test or test result is positive.

Primary outcomes:
measure: Radiologist ROC (receiver operating characteristic) area under curve (AUC)
timeFrame: at imaging review by the end of the study, approximately 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: DUMC Mammography, Duke South Hospital, 2nd floor
state: North Carolina
Study officials:
affiliation: Duke Health
name: Joseph Y Lo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01815398: Cognitive Skills Training for Homeless Youth
Official title: Cognitive Skills Training to Improve Vocational Outcome in Homeless Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affective Disorders
Anxiety Disorders
Attention Deficit Disorder
Substance Abuse
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-03-21
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many young people who are homeless have cognitive deficits which impede their ability to secure and maintain employment. This study looks to see if targeting cognitive deficits can improve cognition and vocational outcome.

Detailed description: The aim of this research is to conduct a controlled study of cognitive remediation, to provide feasibility data on adapting an established empirically-based cognitive intervention for homeless youth to help them attain vocational goals. The ultimate purpose is that youth will improve in cognitive functioning and have better functional outcomes including jobs to sustain independent living.

The results of this study will inform a larger trial on the efficacy of cognitive remediation in homeless youth to improve cognition and vocational outcomes. Hypotheses are that, compared to those in an active control group receiving computerized work-skills training, individuals who receive cognitive remediation will show greater cognitive benefits on proximal measures of neurocognition and evidence better vocational outcome as defined by greater number of hours worked. This study will address the service gap in the use of integrated psychosocial interventions for homeless populations as the first investigation of cognitive remediation in homeless youth.

Eligibility criteria: Inclusion Criteria:

* have a current Diagnostic and Statistical Manual (DSM-IV) Axis I diagnosis
* residing at Covenant House New York Rights of Passage Program
* psychiatrically stable for at least 21 days
* English speaking

Exclusion Criteria:

* mental retardation (\<70 Intelligence Quotient; IQ) on premorbid intelligence estimate)
* risk for suicide or violence
* unremitted substance dependence within the past 6 weeks

Primary outcomes:
measure: Global Cognition Score
timeFrame: Baseline, 13, 26 sessions
Secondary outcomes:
measure: Vocational outcome
timeFrame: Baseline, 13, 26 sessions
Other outcomes:
measure: Intrinsic Motivation Inventory
timeFrame: Baseline, 13, 26 sessions
Locations:
city: New York City
country: United States
facility: Covenant House New York
state: New York
Study officials:
affiliation: Columbia University
name: Alice A Medalia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saperstein AM, Lee S, Ronan EJ, Seeman RS, Medalia A. Cognitive deficit and mental health in homeless transition-age youth. Pediatrics. 2014 Jul;134(1):e138-45. doi: 10.1542/peds.2013-4302.
Clinical trial NCT02020798: Glycemic Response Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
Collaborators: name: Glycemic Index Laboratories, Inc
First posted: 2013-12-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.


Eligibility criteria: Inclusion Criteria:

* Subject is 18-75 years of age
* Subject has a body mass index (BMI) ≥ 20.0 and \< 35 kg/m² at screening (visit 1).
* Subject has normal fasting serum glucose (\<7.0mmol/L capillary corresponding to whole blood glucose \<6.3mmol/L).
* Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

-

Primary outcomes:
measure: Incremental area under the blood glucose response curve
timeFrame: 0-2 hours
Secondary outcomes:
measure: Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin
timeFrame: 0-2 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
Study officials:
References:
Clinical trial NCT02080598: Cigarette and Gastric Contents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Variation of the Antral Area After Cigarettes Smoking or Not
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aims of this cross over prospective study are to demonstrate that smoking two cigarettes do not change the gastric contents and volume in fasting volunteers.


Eligibility criteria: Inclusion Criteria:

* ASA 1 or 2 Volunteers habitual smokers = 5 cigarettes / day during at least 1 year

Exclusion Criteria:

* Digestive Diseases, gastroparesis
* Non smokers
* pregnancy
* history of diabetes mellitus
* medication affecting gastric motility
* previous gastrointestinal surgery

Primary outcomes:
measure: Variation of the ultrasonographically measured antral area afer smoking or non smoking cigarette
timeFrame: every 30 minutes during 2h30
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot
Study officials:
References:
citation: Lazaar S, Boselli E, Chassard D, Allaouchiche B, Bouvet L. Effect of acute cigarette smoking on gastric contents in regular smoker volunteers. A prospective randomized cross-over study. Br J Anaesth. 2015 Oct;115(4):590-4. doi: 10.1093/bja/aev264. Epub 2015 Aug 30.