louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01344109: A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Official title: A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Neoplasms
Lead sponsor: Leo W. Jenkins Cancer Center
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed breast cancer patients prior to neoadjuvant chemotherapy treatment and healthy volunteers

Brief summary: This is a pilot study evaluating the use of tumor derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer. Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in breast cancer, which could prove to be a tool for earlier diagnosis, more effective treatments, and improved markers of response in order to increase survival rates.


Eligibility criteria: Inclusion Criteria:

* Women with biopsy proven invasive carcinoma of the breast
* Women with locally advanced breast cancer and breast tumors measuring \>/= 2cm who are deemed candidates for preoperative chemotherapy
* Age \>/= 18 years old
* Expected survival \>/= 6 months
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at initiation of study
* Initial required laboratory values:

Absolute neutrophil count \>/= 1.5 x 10(9)/L Platelet count \>/= 100,000 x 10(9)/L Creatinine clearance \>/= 50mL/min (calculated by Cockcroft-Gault method) Liver function tests (AST, ALT, total bilirubin) \</= 2.5 x ULN Urine or serum HCG negative (if female of childbearing potential)

* Women may be enrolled on ongoing therapeutic preoperative chemotherapy trials

Exclusion Criteria:

* No prior chemotherapy for breast cancer
* No limitations for prior radiation therapy
* No active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial
* Non-pregnant and non-nursing patients only. Patients of reproductive potential must agree to use an effective means of birth control
* No prior liver transplant or bone marrow transplant

Primary outcomes:
measure: To characterize protein surface markers and RNA profiles in tumor derived exosomes from breast cancer patients undergoing neoadjuvant chemotherapy
timeFrame: up to 2 years from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center
state: North Carolina
Study officials:
affiliation: Brody School of Medicine at ECU
name: Rachel Raab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01311609: A Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients
Official title: Multi-Site Post Marketing Surveillance Study for Systane in Indian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate to Severe Dry Eye
Keywords: Systane, Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-03-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops.

Detailed description: This study is a multi-site, unmasked PMS Study. The purpose of the study is to evaluate the physical effects of Systane Lubricant Eye Drops. The assessed effects include: corneal and conjunctival staining, and ocular signs and symptoms. This is a two week prospective study.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older, of both sexes, and any race.
* Willing and able to make all required visits and follow study instructions.
* A sodium fluorescein corneal staining sum of \>/ 3 in either eye. A best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed during an ETDRS chart

Exclusion Criteria:

* A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
* Lasik patients can be included if Lasik surgery was \> 6 months prior to the initiation of the study.
* A history of intolerance or hypersensitivity to any component of the study medications.

Primary outcomes:
measure: Corneal Staining
timeFrame: Visit 2 (Week 2) - change from baseline
measure: Best-corrected visual acuity
timeFrame: Visit 2 (Week 2) - change from baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00785109: Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
Official title: Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Valve Calcification
Keywords: aortic valve calcification
vitamin K supplementation
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 99
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. This will be done by means of measurements of concentrations from osteocalcine and MPG in blood serum, echocardiography, cardiac computed tomography and cardiac MRI

Detailed description: Patients will be allocated to two groups with either

1. additional intake of 2 mg vitamin k1 daily
2. controll group without additional intake of Vitamin K

Treatment group a will include 100 patients, the controll group should include 100 patients. None of all patients should require renal dialysis.

Eligibility criteria: Inclusion Criteria:

* aortic valve calcification,verified by echocardiography

Exclusion Criteria:

* chronic or acute intestinal diseases
* terminal renal failure
* allergic reaction on soya containing products
* recent additional intake of vitamin K
* oral anticoagulation with vitamin K antagonists (Marcoumar)
* systemic therapy with corticosteroids
* anamnestic venous thrombosis (pelvet or legs)or embolization of lung arteria
* pregnant or breastfeeding women
* persons without mental ability or capacity to understand and follow the instructions of the investigator
* women of childbearing age without safe contraceptional devices
* minority

Primary outcomes:
measure: Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
timeFrame: 18 months
Secondary outcomes:
measure: progression of diastolic and systolic dysfunction in the three treatment groups
timeFrame: 18 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
state: NRW
Study officials:
affiliation: RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
name: Ralf Koos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02449109: Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma
Official title: Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Carcinoma：Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Keywords: Liver Cancer
Nano drug
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 60
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 study is to evaluate the safety and efficacy of nano drug（Gemzar® mix with Compound Glycyrrhizin Injection） interventional therapy using digital subtraction angiography（DSA） for liver cancer.

Detailed description: By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（DSA）for liver cancer.

The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection. The nano drug's size is detected by laser diffraction particle size analyzer.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of liver cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except liver cancer
2. History of coagulation disorders or anemia

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after interventional therapy
timeFrame: 1 year
measure: Progress free disease (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.
Clinical trial NCT02969109: Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
Official title: Clinical Validation of a Urine-based Assay With Genomic and Epigenomic Markers for Predicting Recurrence During Surveillance for Non-muscle Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-muscle Invasive Bladder Cancer
Lead sponsor: Genomic Health®, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-muscle invasive bladder cancer patients

Brief summary: A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with a prior diagnosis of non-muscle invasive, ≤T1, urothelial cell carcinoma of the bladder scheduled to undergo surveillance cystoscopy.

Exclusion Criteria:

* Patients younger than 18 years
* Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell carcinoma of the bladder
* Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2 or greater)
* Patients who are unable or unwilling to give informed consent

Primary outcomes:
measure: The recurrence status based on the pathology results
timeFrame: 1 year
measure: The Genomic Health bladder cancer assay results.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Institute for Prostate and Urologic Cancers - University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT01051609: Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
Official title: Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Post Menopausal
Breast Cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent

Brief summary: The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.


Eligibility criteria: Inclusion Criteria:

* Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent.
* Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.

Exclusion Criteria:

* History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints.
* Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
* Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
* Active or ongoing infection
* Known metastatic disease
* Known history of HIV or hepatitis infections
* Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI)
* Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer)
* Pregnant or lactating
* Unable to speak, read, and write in English

Primary outcomes:
measure: Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.
timeFrame: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Sara Hurvitz, M D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02482909: A Study Comparing Radiofrequency Ablation and Hepatic Resection for Hepatocellular Carcinoma
Official title: A Prospective Randomized Study to Compare the Efficacy of Radiofrequency Ablation and Hepatic Resection as a Primary Treatment for Single Small Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
First posted: 2015-06-26
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective randomized study is to compare the efficacy and safety of radiofrequency ablation and hepatic resection for small hepatocellular carcinomas with very homogeneous underlying conditions.


Eligibility criteria: Inclusion Criteria:

1. Age between 20 and 70 years
2. Child-Pugh class A (score 5-6)
3. Single hepatocellular carcinoma
4. Maximal diameter of the tumor from 2 to 4 cm when measured on MRI or CT (The diameter on MRI was measured prior to that on CT)
5. No previous treatment
6. Platelet count \> 80,000/mm3

Exclusion Criteria:

1. HCC abutting main hepatic veins or the first branches of the main portal vein
2. HCC abutting vessels ≥ 0.5 cm

Primary outcomes:
measure: The patient survival
timeFrame: From the intervention up to 5 years or until the death of the participant whichever came first
Secondary outcomes:
measure: The disease-free survival
timeFrame: From the intervention up to 5 years or until hepatocellular carcinoma recurrence whichever came first
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Suk Suh, ME, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04664309: Understanding Immunity to the COVID-19 Vaccines
Official title: Understanding Immunity to the COVID-19 Vaccines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Immunity
Vaccine
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-12-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years and older) receiving a COVID-19 vaccine

Brief summary: The purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate.


Eligibility criteria: Inclusion Criteria:

* Adults who are receiving a COVID-19 vaccine

Exclusion Criteria:

* Patients with special risks attendant to venipuncture

Primary outcomes:
measure: Percentage of participants with immunity to COVID-19 vaccines over time
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, Hospital, and Clinics
state: California
Study officials:
affiliation: Stanford University
name: Kari Nadeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00653809: Racial Differences: Nitric Oxide(NO) and Endothelin-1(ET-1) in Preeclampsia (PreE)
Official title: Elucidating the Role of Nitric Oxide and Endothelin-1 Activation in Endothelial Cells Co-cultured With Placental Explants From African-american and Caucasian High Risk Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Office of Minority Health
name: Mississippi Institute for Improvement of Geographic Minority Health
First posted: 2008-04-07
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women delivering babies at the University of MS Medical Center

Brief summary: The goal of this study is to examine the activation of markers of endothelial and cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this study will hopefully provide enough information to determine a link between race, the advent of high risk pregnancies and cardiovascular markers. With this information it might be possible to intervene with approved pharmacological treatments.


Eligibility criteria: Inclusion Criteria:

* African-american or Caucasian
* Pregnant
* Between ages of 18 - 40 years of age

Exclusion Criteria:

* Presence of a disease or condition which is not preeclampsia
* Drug or alcohol abuse during pregnancy
* Obesity

Primary outcomes:
measure: Nitric oxide and Endothelin-1 levels
timeFrame: 48 hours after tissue collection
Secondary outcomes:
measure: Nitric oxide isoforms and Endothelin-1 receptor activation based on primary outcome
timeFrame: within 6 months from tissue collection
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of MS Medical Center
state: Mississippi
Study officials:
affiliation: Obstetrics & Gynecology
name: Kedra L Wallace, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00384709: Geriatric Education and Its Effect on Certain Aspects of Hospital Care of Nursing Home Patients
Official title: Geriatric Education and Its Effect on Certain Aspects of Hospital Care of the Nursing Home Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly
Patient Care
Keywords: Elderly
Hospitalization
Geriatrics
Mortality
Readmission
Length of Stay
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2006-10-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - All patients admitted to Maimonides Medical Center (MMC) from affiliated Metropolitan Jewish Geriatric Nursing Home (MJGNH) for a 3 month period.

Brief summary: Nursing home patients admitted to the hospital pose a significant challenge for health care providers. Geriatric teaching pays particular attention to these admissions and related problems. However, it is yet to be proven, whether geriatric training helps to overcome any of these issues in a better way than through non-geriatric education. The study aims to prove that geriatric training provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital.

Detailed description: Context: Nursing home patients admitted to the hospital pose a significant challenge for health care providers. Geriatric age, frailty, multiple readmissions, prolonged length of stay, and high mortality are just a few attributes of nursing home patients in the hospital. Geriatric teaching pays particular attention to these challenging problems. However, it is yet to be proven, whether geriatric training helps to overcome any of these issues in a better way than through non-geriatric education.

Objective: To test the hypothesis that geriatric care provides advantages over non-geriatric training in caring for nursing home patients admitted to the hospital in regards to length of stay, rate of expirations and rate of readmissions. The secondary objective is to compare expirations and readmissions among patients cared for by geriatricians and non-geriatricians.

Design, Setting, and Participants: Retrospective cohort study of patients admitted from Metropolitan Jewish Geriatric Nursing Home (MJGNH) to Maimonides Medical Center (MMC) over a certain period of time and under the care of geriatricians, non-geriatric internists, and surgeons. Comparison of the three study groups by age, sex, expiration rate, length of hospital stay (LOS) and readmission rate. Comparison of expired patients by age, sex and average LOS. Comparison of readmissions, expiration rate, by preservation of continuity of care, and by emergency room visits without admission.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to Maimonides Medical Center (MMC) from affiliated Metropolitan Jewish Geriatric Nursing Home (MJGNH) for a 3 month period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maimonides Medical Center
name: Sergey I Genkin, MD
role: PRINCIPAL_INVESTIGATOR
References: