louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03517813: CESM ABMR Breast Cancer Screening Trial
Official title: Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Screening
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2018-05-07
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred for a clinical breast MRI.

Brief summary: This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy.

Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).

Secondary Aims:

1. Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities.
2. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).


Eligibility criteria: Inclusion Criteria:

* Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
* Women aged ≥18 years at the time of enrollment
* Referred clinically for breast MRI for any indication

Exclusion Criteria:

* Known allergy or contraindication to iodinated contrast
* Are currently pregnant based on urine pregnancy test
* Have breast implants
* Are lactating

Primary outcomes:
measure: Abnormal interpretation rate
timeFrame: 2 years
Secondary outcomes:
measure: Biopsy rate
timeFrame: 2 years
measure: Positive predictive value for biopsy recommendation (PPV2)
timeFrame: 3 years
measure: Negative predictive value
timeFrame: 3 years
measure: Cancer detection rate
timeFrame: 3 years
measure: Sensitivity
timeFrame: 2 years
measure: Specificity
timeFrame: 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Janie M Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03372213: Healthfulness of Food From Grocery Stores Versus Eating Out Among People Receiving Food Benefits (SNAP)
Official title: Dietary Quality by At-home and Away-from-home Food Sources in the Supplemental Nutrition Assistance Program (SNAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Habit
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-12-13
Enrollment: 4237
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 4,237 low-income adults in the National Health and Nutrition Examination Survey (NHANES) (2003-2006 and 2011-2014)

Brief summary: The objective of this cross-sectional study was to characterize the dietary intake of SNAP participants and nonparticipants by food source, including grocery stores, sit-down restaurants, and fast food.

Detailed description: The study used 4,237 low-income adults from the National Health and Nutrition Examination Survey (NHANES) (2003-2006 and 2011-2014). De-identified data was collected from demographic questionnaires and 24 hour dietary recalls. We assessed intake of calories, solid fats, added sugars, and servings of non-starchy vegetables, whole fruits, and whole grains, by food source in SNAP participants and income-eligible nonparticipants. Associations between SNAP participation and dietary intake were analyzed using multivariate linear regression controlling for relevant sociodemographic characteristics.

Eligibility criteria: Inclusion Criteria:

* Adults ages 20 - 64
* At or below 200% of the federal poverty level
* Completed at least one 24-hour dietary recall

Exclusion Criteria:

* Younger than 20 years old or 65 years and older
* Income above 200% the federal poverty level
* No participation in dietary recall

Primary outcomes:
measure: Caloric intake
timeFrame: 2003-2014
measure: Solid fat
timeFrame: 2003-2014
measure: Added sugar
timeFrame: 2003-2014
measure: Non-starchy vegetables
timeFrame: 2003-2014
measure: Whole fruit
timeFrame: 2003-2014
measure: Whole grains
timeFrame: 2003-2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Barry Popkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608113: Long-term Follow-up of Subfoveal Neovascular AMD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exudative Age-related Macular Degeneration
Keywords: neovascular AMD
Optical coherence tomography
reading acuity
contrast sensitivity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering on treatment naive subfoveal neovascular age-related macular degeneration

Brief summary: Treatment naive patients with subfoveal nAMD initially treated monthly with intravitreal anti-VEGF and subsequently PRN, will be included in this study. Patients will be investigated for the first 2 years monthly and subsequently according to disease activity but at least every two months. Patients will be examined with 4m BCVA ETDRS distance visual acuity, reading acuity measured by Radner-Reading-Charts, contrast sensitivity by Pelli-Robson score, microperimetry and HD-OCT.


Eligibility criteria: Inclusion Criteria:

* treatment naive subfoveal AMD, written informed consent, able to read

Exclusion Criteria:

* choroidal neovascularisation due to other ocular diseases, mature cataract

Primary outcomes:
measure: Long-term visual function performance
timeFrame: four years
Secondary outcomes:
measure: change of morphological alterations assessed by SD-OCT
timeFrame: four years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology Medical University of Vienna
Study officials:
affiliation: Medical University Vienna
name: Christopher G Kiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671913: Scheduled Intranasal Ketamine
Official title: Effects of Opioid Requirements With Scheduled Intranasal Ketamine During Admission for Traumatic Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Pain
Trauma
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine if scheduled intranasal ketamine effects opioid requirements in adult trauma patients with moderate to severe pain in the inpatient setting.


Eligibility criteria: Inclusion Criteria:

* Patient between aged 18-80 years, present following a traumatic incident, rate pain \> 5 on the numeric rating scale (NSR), and require admission to the hospital.

Exclusion Criteria:

* - Patients that arrive at facility intubated
* Patients that received Ketamine in the field
* Patients less than 18 years old or greater than 80 years
* Pregnant or breast-feeding females
* Hemodynamic instability defined as need for vasoactive drugs or Systolic blood pressure \>180
* Weight less than 80 pounds or greater than 300 pounds
* Glasgow Coma Scale less than 15
* Current acute head injury resulting in unconsciousness
* Current or history of eye injury
* Current or history of seizures
* Facial or nasal fractures that require nasal precautions
* Current or history of intracranial hypertension
* History of Schizophrenia
* BAC (Blood Alcohol Content) greater than 0.08
* Current alcohol abuse
* Current drug abuse or positive drug screen
* Chronic pain or patients on pain contracts
* Inability to assess pain intensity
* Contraindications or allergies to the treatment
* Patients with hepatic insufficiency
* Prisoners
* Nursing home residents
* Urine drug screen positive for illicit drugs or medications not on their home medication list.
* BAC \> 0.08
* Positive pregnancy test

Primary outcomes:
measure: Total Morphine Equivalents (TME) throughout hospitalization
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03682913: Personalized Inhibitory Control Training for Compulsive Behavior Change
Official title: Personalized Inhibitory Control Training for Compulsive Behavior Change
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: OCD
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obsessive-compulsive disorder (OCD) is a severe mental illness characterized by repetitive behaviors that a person feels compelled to perform. It has been demonstrated that stimuli in the environment can trigger the compulsive urge, perpetuating the OCD cycle. The main goal of the current proposal, which is based on exciting pilot data, is to test a novel computerized training program to create an association between OCD-related stimuli, which typically trigger the compulsive urge, and the brain system responsible for stopping. The idea is that once this system is triggered, it will be easier for patients to stop the compulsive urge.


Eligibility criteria: Inclusion Criteria:

* OCD patients

Exclusion Criteria:

* Metal/ electronic device
* Under the age of 18
* Pregnant women
* Tattoos that cover over 10% of body mass
* Chronically ill patients
* Psychosis/ Bi-polar
* Substance abuse
* Sever depression
* Active suicide thoughts
* Hearing loss

Primary outcomes:
measure: fMRI- changed inhibition levels in the pre-SMA area in experimental group in comparison to control group
timeFrame: One week after P-CIT training starts
measure: fMRI- changed inhibition levels in the rIFG area in experimental group in comparison to control group
timeFrame: One week after P-CIT training starts
Secondary outcomes:
measure: Behavioural- Y-bocs (Yale-Brown Obsessive-Compulsive Scale) score- change in OCD symptoms in experimental group in comparison to placebo group
timeFrame: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
measure: Behavioural- M.I.N.I (Mini-International Neuropsychiatric Interview) score- change in OCD symptoms in experimental group in comparison to placebo group
timeFrame: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
measure: Behavioural- OCI-R (Obsessive-Compulsive Inventory) score- change in OCD symptoms in experimental group in comparison to placebo group
timeFrame: One week after P-CIT (Personalized Inhibitory Control Training for Compulsive Behavior Change) training
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: The Hebrew University of Jerusalem
Study officials:
References:
Clinical trial NCT00123513: Workplace-Sponsored Program to Reduce Obesity
Official title: Images of a Healthy Worksite-Preventing Weight Gain in the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-07-25
Enrollment: 3938
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to design a comprehensive nutrition and physical activity strategy to gain a broad understanding of the social and cultural role of food and physical activity among workers. Perspectives on innovative interventions that are socially feasible and culturally acceptable will also be obtained. Health lifestyle promotion interventions addressing portion control, healthy nutrition, and increasing physical activity will be tested.

Detailed description: BACKGROUND:

Broad, population-based approaches are needed to stop or reverse the rise in obesity prevalence. According to the World Health Organization, obesity prevention can be achieved by promoting a healthy diet and a physically active lifestyle. A partnership with the Eastman Kodak Company has been developed to test a worksite intervention for obesity prevention in Rochester, New York.

DESIGN NARRATIVE:

The overall goal of this study is to design a comprehensive nutrition and physical activity strategy based on participatory research to promote a healthy lifestyle and to stop the shift of the population body mass index (BMI) curve to the right. Six pairs of worksites will be randomized to either an intervention or control group. Two cross-sectional samples of employees within each worksite will be measured at baseline and at the end of the intervention.

Eligibility criteria: Inclusion Criteria:

* Full-time employees in good health

Primary outcomes:
measure: BMI
timeFrame: Measured at baseline and Year 2
Secondary outcomes:
measure: Number of serving of fruits and vegetables
timeFrame: Measured at baseline and Year 2
measure: Number of steps a day
timeFrame: Measured at baseline and Year 2
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Eastman Kodak Company
state: New York
Study officials:
affiliation: University of Rochester
name: Isabel D. Fernandez, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00257413: Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Arterial Hypertension
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2005-11-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Experimental data suggest that transplantation of endothelial progenitor cells (EPCs) attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition, clinical studies suggest that autogolous progenitor cells transplantation is feasible and safe in patients with ischemic disease. This study will investigate the feasibility, safety, and initial clinical outcome of intravenous infusion of autologous EPCs in patients with idiopathic pulmonary arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic pulmonary arterial hypertension
* in New York Heart Association (NYHA) functional class II to III
* a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization
* the ability to walk ≥50 m during a standardized 6-minute walk test.

Exclusion Criteria:

* Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, NYHA functional class IV, major bleeding requiring blood transfusion, diabetes, renal dysfunction, and evidence for malignant diseases were excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: junzhu chen, MD
role: STUDY_CHAIR
References:
citation: Takahashi M, Nakamura T, Toba T, Kajiwara N, Kato H, Shimizu Y. Transplantation of endothelial progenitor cells into the lung to alleviate pulmonary hypertension in dogs. Tissue Eng. 2004 May-Jun;10(5-6):771-9. doi: 10.1089/1076327041348563.
citation: Wang XX, Zhang FR, Shang YP, Zhu JH, Xie XD, Tao QM, Zhu JH, Chen JZ. Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial. J Am Coll Cardiol. 2007 Apr 10;49(14):1566-71. doi: 10.1016/j.jacc.2006.12.037. Epub 2007 Mar 27.
Clinical trial NCT00984113: Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
Official title: An Open-label, Parallel-group Study to Determine the Single and Multiple Dose Pharmacokinetics of Elinogrel and Its Metabolite in Patients With Mild, Moderate, and Severe Renal Impairment Compared to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Elinogrel
Renal impairment
Healthy
Kidney dysfunction
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2009-09-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the pharmacokinetics and safety of elinogrel and its metabolite in patients with mild, moderate, and severe renal impairment compared to healthy volunteers.

Detailed description: Multiple-dose, open-label parallel-group design in patients with mild, moderate or severe renal impairment and age (±7 years), sex and weight (±15% BMI) matched healthy subjects.

* mild renal impairment: CrCl from 50 to ≤80 ml/min
* moderate renal impairment: CrCl from 30 to \<50 ml/min
* severe renal impairment: CrCl of \<30 ml/min

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign the written informed consent
* Subjects should have either normal renal function or have stable renal disease

Exclusion Criteria:

* History of heart disease
* Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Primary outcomes:
measure: Pharmacokinetics of elinogrel and its metabolite
timeFrame: 7 days
Secondary outcomes:
measure: Safety assessments will include vital signs, electrocardiograms and adverse events
timeFrame: 9 days
measure: Measures of platelet function
timeFrame: 7 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Knoxville
country: United States
facility: NOCR-Knoxville
state: Tennessee
Study officials:
affiliation: Portola Pharmaceuticals Inc.
name: Matthew W McClure, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04845113: Idiopathic Purpura Fulminans Associated With Anti-PS Antibodies in Children
Official title: Idiopathic Purpura Fulminans Associated With Anti-PS Antibodies in Children: a French Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Purpura
Keywords: Protein S acquired deficiency
Idiopathic purpura fulminans
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with diagnostic of idiopathic purpura fulminans and acquired protein S deficiency

Brief summary: Idiopathic purpura fulminans by anti-protein S antibody is a very rare but potentially extremely serious entity. The data in the literature are poor with only isolated report boxes and a single series of less than 10 boxes. The creation of a larger series of cases would make it possible to better understand this pathology and to offer assistance in diagnosis and management.


Eligibility criteria: Inclusion criteria:

* diagnostic of idiopathic purpura fulminans
* Acquired protein S deficiency

Exclusion criteria:

- Other infecious purpura diagnosis

Primary outcomes:
measure: Rate of anti-protein S antibody
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Alexandre THERON
role: STUDY_DIRECTOR
References:
Clinical trial NCT03320213: Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage
Official title: Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Threatened Miscarriage in First Trimester
Keywords: CA125
Yolk sac morphology
Threatened miscarriage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 192
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women at age of 20- 40 years Pregnancy at 6-10 weeks women with single intrauterine spontaneous pregnancy

Brief summary: evaluation of serum CA125 level and yolk sac morphology in women with threatened miscarriage is very important to predict pregnancy outcome


Eligibility criteria: Inclusion Criteria:

* pregnant women between 20-40 years. Pregnancy between 6-10 weeks. single intrauterine spontaneous pregnancy. vaginal bleeding or bloody vaginal discharge with or without pelvic pain for patients with threatened miscarriage.

Exclusion Criteria:

* medical disorders with pregnancy. History of recurrent miscarriage. Any maternal disease that would cause an increase in CA125 level. Local gynecological disorders e.g. fibroid. Presence of any uterine malformation. History of congenital abnormalities in previous pregnancy Presence of multiple pregnancy. Presence of anembryonic sac. Absent fetal heart pulsation.

Primary outcomes:
measure: Evaluation of serum CA125
timeFrame: 6 - 10 weeks
measure: Evaluation of yolk sac morphology
timeFrame: 6 - 10 weeks
Secondary outcomes:
measure: follow up of participants
timeFrame: up to 20 weeks
measure: follow up of participants
timeFrame: up to 20 weeks.
Other outcomes:
Locations:
Study officials:
References: