louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03899844: Study to Evaluate Amyloid in Blood and Imaging Related to Dementia
Official title: Blood Amyloid-Beta Relationship With Amyloid Plaques and CSF Amyloid-Beta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Alzheimer Dementia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 1122
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from clinics and communities throughout the greater St. Louis metropolitan area.

Brief summary: The purpose of this study is to determine how well a blood test can detect amyloid beta, a protein involved in Alzheimer's disease. Participants will be asked to complete an initial blood collection and cognitive testing, and a subset of participants will be asked to complete a larger blood collection, amyloid PET imaging, and an MRI.

Detailed description: Alzheimer's disease is the most common cause of dementia and currently has no disease-modifying treatments or simple, accurate diagnostic tests. Amyloid beta builds up in the brain and forms plaques in people with Alzheimer's disease, and the buildup of this protein is found decades before symptoms of dementia begin. A blood test may be able to quickly and inexpensively screen people for Alzheimer's disease clinical trials and eventually diagnose Alzheimer's disease in the clinic.

Eligibility criteria: Inclusion Criteria:

1. At least 60 years of age

Exclusion Criteria:

1. Unable to perform one or more activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment or dependent on others due to cognitive impairment.
2. Body weight of \<100 pounds
3. Active infectious disease (e.g., HIV, hepatitis B, hepatitis C)
4. Bleeding disorder
5. Taking an experimental drug for AD
6. Blood donation in the last two months
7. Blood transfusion in the last three months
8. On hospice

Primary outcomes:
measure: Plasma amyloid-beta 42/40 ratio
timeFrame: Baseline
measure: Plasma amyloid-beta 42/40 ratio
timeFrame: 6 months
measure: Area under the curve (AUC) of the blood test (plasma amyloid-beta 42/40 ratio) in predicting amyloid PET status
timeFrame: 6 months
Secondary outcomes:
measure: Coefficient of variation for the initial and confirmatory blood amyloid-beta test results
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Randall Bateman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02044744: Physical Activity Referrals to the Community
Official title: Primary Care Physical Activity Referrals to the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Obesity
Pediatric Obesity
Physical Activity
Physical Fitness
Primary Health Care
Referral and Consultation
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of primary care referrals to community physical activity programs for overweight and obese youth aged 6-18 years on objectively measured physical activity and cardiorespiratory fitness, as well as other cardiovascular health indicators. We hypothesize that physical activity referrals will result in higher levels of physical activity and fitness.


Eligibility criteria: Inclusion Criteria:

* Aged 6-18 years
* Body mass index greater than or equal to the 85th percentile for age and sex or greater than or equal to 25 for youth aged 18
* Fluent in English
* Parent of participant must be fluent in either English or Spanish

Exclusion Criteria:

* Medical conditions that preclude participation in physical activity

Primary outcomes:
measure: Change in minutes per day of moderate-to-vigorous physical activity
timeFrame: Baseline and at 8-11 weeks
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and at 10-12 weeks
Secondary outcomes:
measure: Change in body mass index
timeFrame: Baseline and at 10-12 weeks
measure: Change in body composition
timeFrame: Baseline and at 10-12 weeks
measure: Change in blood pressure
timeFrame: Baseline and at 10-12 weeks
Other outcomes:
measure: Enrollment and participation in a physical activity program
timeFrame: Baseline and at 10-12 weeks
measure: Change in waist circumference
timeFrame: Baseline and at 10-12 weeks
measure: Change in perceptions about physical activity
timeFrame: Baseline and at 10-12 weeks
Locations:
city: San Francisco
country: United States
facility: Healthy Lifestyles, San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: Mission Neighborhood Health Center
state: California
city: San Francisco
country: United States
facility: Southeast Health Center
state: California
city: San Francisco
country: United States
facility: Silver Avenue Health Center
state: California
Study officials:
affiliation: University of California, Berkeley
name: Kristine A Madsen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00558792: Coronary MDCTA With Iopamidol Injection 370
Official title: A Phase II Multicenter Randomized Double Blind Dose Finding Study of Iopamidol Injection 370 in Multidetector Computed Tomographic Angiography (MDCTA) in Patients With Suspected Coronary Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 210
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.


Eligibility criteria: Inclusion Criteria:

* Provide informed consent
* At least 30 years of age
* Weight less than 250 lbs
* Known or suspected coronary artery disease and suspected to have significant coronary artery stenosis
* Undergo MDCTA scan
* Undergo coronary angiography within 2 weeks of MDCTA scan

Exclusion Criteria:

* Hx of hypersensitivity to iodinated contrast agents
* Known or suspected hyperthyroidism or pheochromocytoma
* Renal impairment
* History of coronary artery stent placement or bypass grafts
* Unstable
* Pregnant or lactating

Primary outcomes:
measure: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 1
timeFrame: Immediately post dose
measure: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 2
timeFrame: Immediately post dose
measure: Diagnostic Quality of Visualization of Coronary Arteries, Off-Site Reader 3
timeFrame: Immediately post dose
measure: Contrast Density (CD) Measurements, Off-Site Reader 1
timeFrame: Immediately post dose
measure: Contrast Density (CD) Measurements, Off-Site Reader 2
timeFrame: Immediately post dose
measure: Contrast Density (CD) Measurements, Off-Site Reader 3
timeFrame: Immediately post dose
measure: Validity (Sensitivity and Specificity), Off-Site Reader 1 - Sensitivity
timeFrame: Immediately post dose
measure: Validity (Sensitivity and Specificity), Off-Site Reader 1 - Specificity
timeFrame: Immediately post dose
measure: Validity (Sensitivity and Specificity), Off-Site Reader 2 - Sensitivity
timeFrame: Immediately post dose
measure: Validity (Sensitivity and Specificity), Off-Site Reader 2 - Specificity
timeFrame: Immediately post dose
measure: Validity (Sensitivity and Specificity), Off-Site Reader 3 - Sensitivity
timeFrame: Immediately post dose
measure: Validity (Sensitivity and Specificity), Off-Site Reader 3 - Specificity
timeFrame: Immediately post dose
Secondary outcomes:
measure: Number of Participants Who Experienced Adverse Events With Incidence of 5% or Greater
timeFrame: up to 72 hours post dose
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Jiefen Yao, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04933292: A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
Official title: A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Autoimmune Hepatitis
Primary Biliary Cirrhosis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-70 years;
2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
3. Agreed to participate in the trial, and assigned informed consent;
4. The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of serious decompensated cirrhosis;
3. Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease.
5. Pregnant and breeding women;
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Parenteral administration of blood or blood products within 6 months before screening;
8. Recent treatment with drugs having known liver toxicity;
9. Taken part in other clinic trials within 6 months before enrollment.

Primary outcomes:
measure: Biochemical remission
timeFrame: 6 months
Secondary outcomes:
measure: The level of IgG value in both groups
timeFrame: at 1 month
measure: The level of IgG value in both groups
timeFrame: at 3-month
measure: The level of IgG value in both groups
timeFrame: at 6-month
measure: Adverse drug reactions
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan Univerisity
state: Sichuan
Study officials:
References:
Clinical trial NCT01225692: Brain Trauma Outcomes in Nova Scotia Study
Official title: Brain Trauma Outcomes in Nova Scotia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries,Traumatic
Outcome Assessment (Health Care)
Craniocerebral Trauma
Emergency Medical Services
Organizational Innovation
Keywords: Brain Injury
Head Trauma
Trauma Systems
Head Injury Guideline
Time to Tertiary Care
Lead sponsor: Queen Elizabeth II Health Sciences Centre
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Nova Scotia's centralized Neurosurgical services and integrated provincial Emergency Health Services provide a rich opportunity to construct a cohesive, integrated data management system. This system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma.

Retrospective data collection The retrospective arm of the BTO study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. Investigators continue to analyze this large amount of data and prepare it for publication.

Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been considered for enrollment in the BTO study.The prospective arm of the BTO study has 52 patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.


Eligibility criteria: Retrospective Arm Cohort 1: AIS ≥ 3, head +/- other injuries Cohort 2: AIS ≥ 3, isolated head injury (cohort 2 is a subset of cohort 1)

Inclusion Criteria:

1.patient treated in at least one facility prior to arrival at QEII.

Exclusion Criteria

1. injured out of province
2. time from injury to 1st facility presentation known to be \> 24 hours
3. time arrival at 1st referring facility to time arrive at QEII known to be \> 24 hours
4. direct ground or air scene transport

Prospective Arm:

Inclusion Criteria:

1. have a head injury requiring hospital admission
2. able to provide informed consent or have next- of -kin able to provide consent on patients' behalf

Exclusion Criteria:

1. unwilling or unable to provide consent

Primary outcomes:
measure: Time Measurement; Hours:minutes
Secondary outcomes:
measure: Clinical Follow-up; Numerical Score 1-5;Glasgow Outcome Scores (GOS)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01792492: The Role of an Optical Probe in Thyroid Cancer Diagnosis: Pilot Study
Official title: The Role of an Optical Probe in the Detection of Thyroid Cancer and Normal Thyroid Tissue in a Thyroidectomy Specimen: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Thyroid Neoplasms
Thyroid Cancer
Keywords: Thyroid Neoplasms
Optical Devices
Spectrum Analysis
Thyroid diseases
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary hospital setting Urban hospital

Brief summary: This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen.

Detailed description: The optical real-time readings will be compared to the histological analysis from the same area. Subjects undergoing thyroid surgery for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. After the removal of the thyroid gland, optical readings will be taken from the ex vivo thyroid gland and these same areas will then be analyzed in the usual standard fashion. The reading will then be correlated with the histological results. In addition, if lymph nodes are removed as part of the surgery they will also be tested prior to histological standard processing. All specimens and data will be de-identified.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing thyroid surgery for thyroid nodules, thyroid cancer, and thyroid goiter with nodules.

Exclusion Criteria:

* Subjects whose thyroid specimens have been put in formalin

Primary outcomes:
measure: Assess optical probe for the differentiation of thyroid cancer from normal thyroid tissue and benign thyroid nodules
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jennifer E Rosen, M.D. FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04092192: Forceps vs. Snare IVC Filter Removal
Official title: Prospective Comparison of Rigid Forceps Versus Endovascular Snare for Routine IVC Filter Retrieval
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: DVT
Keywords: IVC filter, filter removal, filter retrieval
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: IVC filters are mechanical filters placed in a patient's body to trap blood clots in the legs migrating to the lungs. When no longer indicated, interventional radiologists are consulted for IVC filter removal. Currently, many methods for extracting IVC filters exist. Two of the most common methods involve using an endovascular snare device or rigid forceps. We intend to prospectively compare these two methods in an attempt to see if one offers an advantage to the other. This will be compared by evaluating success rates and procedure time.

Detailed description: Currently the optimal method for IVC filter retrieval with respect to success rate and fluoroscopic time (i.e. radiation exposure) is poorly understood. Both snare and forcep techniques have independently evaluated in literature but have never been compared directly. The proposed study would prospectively assess whether one of these established technique offers an advantage with respect to either of these variables.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant females
* Adult patients (age 18 years and older)
* Referred to Interventional Radiology for IVC filter removal
* IVC filter implanted less than 6 months with the procedure being performed at UCMC by current IR staff.
* Cook Celect filter or Argon Medical Option Elite

Exclusion Criteria:

* Patients with outside hospital filter placement
* Filters other than Cook Celect or Argon Medical Option Elite
* Implantation period \>6 months
* Evidence of coagulopathy (INR \<1.8, platelet count \>50k)
* Clotting disorder
* Central venous occlusion
* Prior filter placement/removal.

Primary outcomes:
measure: Removal success rate
timeFrame: Procedure date
measure: Flouroscopy time
timeFrame: Procedure start to finish
measure: Costs
timeFrame: Date of procedure up through 6 months following IVC filter removal
measure: Procedure related complications
timeFrame: Date of procedure through 6 months following IVC filter removal
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: UChicago Medicine
state: Illinois
Study officials:
affiliation: UChicago Medicine
name: Osmanuddin Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02663492: Transcutaneous Electrical Acupoint Stimulation for Non-small Cell Lung Cancer Patients
Official title: Transcutaneous Electrical Acupoint Stimulation Ameliorates Chemotherapy-Induced Bone Marrow Suppression in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Lung Cancer
Keywords: Acupuncture
electrical stimulation of acupoints
chemotherapy
Diyu Shengbai Pian
nursing care
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.

Detailed description: Lung cancer is the malignant neoplasm with the highest incidence and mortality in China as well as worldwide. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancer cases. Chemotherapy is the preferred treatment method for NSCLC, but many patients cannot tolerate the adverse reactions of chemotherapy. Among the most common and most severe adverse reactions is bone marrow suppression. The more serious the bone marrow suppression, the higher the direct medical cost of chemotherapy. Literatures showed Acupuncture was used to treat patients with chemotherapy-induced bone marrow suppression. In this study, the effect of percutaneous electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4) will be investigated, compared with the medication group treated by oral administration of prophylactic agents, and the control group received routine nursing care on chemotherapy-induced bone marrow suppression in patients with lung cancer.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Non-small cell lung cancer(NSCLC)
* age between 20 and 75 years
* chemotherapy naive after diagnosis
* GP regimen as treatment
* an expected survival of more than 12 weeks based on a score equal to or greater than 60 points on Karnofsky performance status (KPS) scale
* the ability to understand and speak Mandarin

Exclusion Criteria:

* diagnosis of a hematological system tumor
* mental illness
* bone marrow suppression prior to chemotherapy
* pregnancy

Primary outcomes:
measure: Change of Blood routine indexes in 1 month
timeFrame: Day 0, Day 5, Day 8, Day 11, Day 14, Day 21 and Day 28
Secondary outcomes:
measure: Change of Comfort Degree
timeFrame: Day 0, Day 8, and Day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital Medical Oncology Department
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital of Tongji University, Shanghai, China
name: Caicun Zhou, Doctor
role: PRINCIPAL_INVESTIGATOR
References: