louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00512694: Duke Lupus Registry
Official title: Duke Lupus Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Cutaneous Lupus
Keywords: Lupus
Systemic Lupus Erythematosus
Cutaneous Lupus
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-08-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients with lupus.

Brief summary: Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women.

The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.

Detailed description: The Duke Lupus Registry is a prospective cohort comprised of patients with lupus seen in the Duke Rheumatology clinic.

The Duke Lupus Registry has two main purposes:

1. Improved patient care. By following disease activity scores and medication usage, we expect to improve our care of the patients seen in clinic.
2. Future research on lupus outcomes. This may encompass a broad array of areas, including but not limited to cardiovascular health, pregnancy and fertility, infections, medication use, quality of life, and depression.

At each office visit, patients will complete a questionnaire, physicians will measure lupus activity, and patients may be asked to provide a small blood sample. Patients will not be required to make extra visits to Duke in order to participate -- all paperwork and blood draws will occur during a regularly scheduled office visit with the physician.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus
* Patient of a rheumatologist at Duke University Medical Center

Exclusion Criteria:

* Inability to travel to Duke for follow-up visits
* Inability to speak English
* Not able to provide informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Megan E. B. Clowse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03806894: Clopidogrel Resistance in Stroke Patients From Different Ethnicities
Official title: Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clopidogrel, Poor Metabolism of
Ischemic Stroke
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2019-01-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective study will be conducted in two sites (Ziv Medical Center, Safed, department of neurology, and Galilee Medical Center, Nahariya, department of neurology) on 300 patients from different ethnic backgrounds with an ischemic cerebrovascular event (ischemic stroke and TIA), treated with clopidrogel for secondary stroke prevention. The groups will consist of Jewish communities (Ashkenazi, Sephardi and Ethiopian) and Arab populations (Muslim, Christian and Druze).

To be considered eligible to participate in this study, patients have to be able to provide signed and dated written informed consent or written assent from their relatives. Both genders aged 18 and above are eligible for this trial. Pregnant patients will be excluded.

Brief summary: Clopidogrel is an anti-platelet agent used to inhibit blood clots. Variation in response to clopidogrel has been reported among different population and may lead to reoccurring ischemic events. The aim of the present study is to evaluate the incidence of clopidogrel resistance in ischemic stroke patients from different ethnicities in Northern Israel and to find different strategies to overcome high platelet reactivity including clopidogrel dose adjustment or the choice of alternative agents. Quantification of platelet aggregation will be determined by vasodilator stimulated phosphoprotein (VASP) assay.


Eligibility criteria: Inclusion Criteria:

1. Ability to provide written informed consent and to be compliant with protocol assessments.
2. Ages 18 and above inclusive
3. Both genders eligible for the study
4. Diagnosis of ischemic cerebrovascular event

Exclusion Criteria:

1. Pregnant patients will be excluded
2. Ages below 18
3. Patients not able to provide informed consent

Primary outcomes:
measure: Rates of clopidogrel resistance assessed among the different ethnicities
timeFrame: 6 months
measure: Identifying of high-risk subgroups of adverse clinical outcomes
timeFrame: 6 to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06744894: SIL as Maintenance Therapy in Multiple Myeloma
Official title: Selinexor Combined With Ixazomib and Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.

Detailed description: The investigators will evaluate safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma post complete remission. Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed Multiple Myeloma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Documented response to ASCT (PR, VGPR, CR/stringent complete response \[sCR\]) according to IMWG criteria.

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women

Primary outcomes:
measure: PFS
timeFrame: 2 years
Secondary outcomes:
measure: EFS
timeFrame: 2 years
measure: OS
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02738294: Necessity Assessment of ME-NBI Targeted Biopsy Compared With EFB
Official title: Necessity Assessment of Magnifying Endoscopy With Narrow Band Imaging Targeted Biopsy Compared With Endoscopic Forceps Biopsy From White Light Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 211
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present study was to assess whether it was necessary to conduct magnifying endoscopy with narrow band imaging (ME-NBI) targeted biopsy compared with endoscopic forceps biopsy (EFB) from white light endoscopy in diagnosing early gastric cancer (EGC). Meanwhile, the investigators proposed the most cost-effective way to diagnose EGC.

Detailed description: ME-NBI has been widely used for the diagnosis of stomach diseases, especially in the early diagnosis of gastric cancer. The aim of the present study was to evaluate diagnostic efficacy of ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy compared with EFB from white light endoscopy and ME-NBI combined with EFB.

A prospective study was conducted encompassing suspected EGC. All patients were performed white light endoscopic examination with EFB and then ME-NBI with ME-NBI targeted biopsy. Outcome measures were assessed and compared, including diagnostic efficacy of EFB from white light endoscopy,ME-NBI combined with EFB, ME-NBI targeted biopsy and ME-NBI combined with targeted biopsy.

Eligibility criteria: Inclusion Criteria:

* consecutive patients with gastric lesions detected by white light endoscopy and suspected of EGC

Exclusion Criteria:

* they had advanced gastric cancer
* lesions were histopathologically confirmed to be submucosal tumors
* they had a history of gastrectomy
* tissue biopsy wasn't obtained during last white light endoscopy
* they couldn't tolerate another endoscopic examination

Primary outcomes:
measure: Accuracy in distinguishing high-grade neoplasia (HGN) from non-HGN
timeFrame: 30 months
measure: Sensitivity in distinguishing HGN from non-HGN
timeFrame: 30 months
measure: Specificity in distinguishing HGN from non-HGN
timeFrame: 30 months
Secondary outcomes:
measure: Positive predictive value (PPV) in distinguishing HGN from non-HGN
timeFrame: 30 months
measure: Negative predictive value (NPV) in distinguishing HGN from non-HGN
timeFrame: 30 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
References:
Clinical trial NCT00242294: Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)
Official title: A Confirmatory Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease (A Placebo-controlled Double-blind Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Phosphodiesterase 4 inhibitor
Roflumilast
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2005-10-20
Enrollment: 570
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily. The study duration consists of a baseline period (4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility criteria: Main inclusion criteria:

* Patients with chronic obstructive pulmonary disease
* Current smoker or ex-smoker
* 30 to 80% of predicted FEV1 after inhalation of short acting beta stimulant

Main exclusion criteria:

* Patients with poorly controlled COPD
* Patients who need for long-term oxygen therapy
* Patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myoma, which are considered to affect the evaluation

Primary outcomes:
measure: change in lung function parameters (post-bronchodilator).
Secondary outcomes:
measure: pulmonary function test, COPD symptoms, rescue medication, evaluation of QOL, COPD exacerbation, adverse events, pharmacokinetics.
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Nycomed Japan and Mitsubishi Tanabe Oharma Corporation
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT02859194: The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Pulmonary Fibrosis ARDS
COPD (Chronic Obstructive Pulmonary Disease)
Bronchiectasis
Lymphangioleiomyomatosis
Primary Pulmonary Hypertension
ARDS (Acute Respiratory Distress Syndrome)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ECMO(Extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure patients. There are two types of ECMO, which is veno-veno (V-V) that can be used in respiratory failure patients and veno-arterial (V-A) that can be used in cardiac failure patients. V-A ECMO can also be used during lung transplantation, substitution of cardiopulmonary bypass, which can show sufficient performance during operation and better postoperative outcome. However, regarding V-A ECMO circulating from femoral vein to femoral artery, there is a pro blem of differential hypoxia which might influence coronary artery and head vessels. In this prospective study, the investigators are planning to put another ECMO catheter into internal jugular vein which takes a role of left to right shunt, to mitigate the hypoxia of coronary artery.


Eligibility criteria: Inclusion Criteria:

1. scheduled for double lung transplantation

Exclusion Criteria:

1. patients who have history of coronary artery occlusive disease
2. patients with arrhythmia

Primary outcomes:
measure: arterial blood oxygen partial pressure (PaO2)
timeFrame: 5 min after jugular catheter flow 0ml/min
measure: arterial blood oxygen partial pressure (PaO2)
timeFrame: 5 min after jugular catheter flow 500 ml/min
measure: arterial blood oxygen partial pressure (PaO2)
timeFrame: 5 min after jugular catheter flow 1,000ml/min
measure: arterial blood oxygen partial pressure (PaO2)
timeFrame: 5 min after jugular catheter flow 1,500ml/min
Secondary outcomes:
measure: venous blood oxygen partial pressure (PvO2)
timeFrame: 5 min after jugular catheter flow 0ml/min
measure: venous blood oxygen partial pressure (PvO2)
timeFrame: 5 min after jugular catheter flow 500 ml/min
measure: venous blood oxygen partial pressure (PvO2)
timeFrame: 5 min after jugular catheter flow 1,000ml/min
measure: venous blood oxygen partial pressure (PvO2)
timeFrame: 5 min after jugular catheter flow 1,500ml/min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT01401894: Perception Prognosis, Goals of Treatment, and Communication
Official title: Pilot Study to Investigate Advanced Cancer Patient's Perspective of Their Prognosis, Goals of Treatment, and Quality of Communication With Their Oncologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Esophageal Cancer
Pancreatic Cancer
Liver Cancer
Biliary Cancer
Keywords: advanced cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a recent diagnosis of advanced gastric, esophageal, pancreatic and hepatobiliary cancer, not being treated with curative intent and receiving their cancer care at Massachusetts General Hospital.

Brief summary: The purpose of this research study is to assess what the participant understands about their illness, prognosis, the goals of the cancer treatment and their communication with their oncology providers. This study will help us to figure out how the investigators can improve how other patients understand their illness and goals of treatment and help us improve communication with their doctors. This research is being done because there is not a lot of information on how much patients understand about their illness and prognosis.

Detailed description: * Participants will be asked to answer a few basic questions regarding race, ethnicity, religion, relationship status, education, income, and living situation.
* They will then be asked to complete a questionnaire which contains questions about their mood, spirituality, quality of life and their understanding of their treatment and prognosis and their communication with their oncologist. They will complete these questionnaires in the clinic or infusion room on one of their regularly scheduled visit.

Eligibility criteria: Inclusion Criteria:

* Confirmed new diagnosis of advanced gastric, esophageal, pancreatic, and hepatobiliary cancer, not being treated with curative intent.
* Planning to receive chemotherapy at Massachusetts General Hospital
* Ability to read and respond to questions in English.

Exclusion Criteria:

* Prior chemotherapy for current stage of disease.

Primary outcomes:
measure: Completion of surveys
timeFrame: 1 year
Secondary outcomes:
measure: Patients perceptions of prognosis, goals of care, and communication with providers
timeFrame: 1 year
measure: Quality of end of life care
timeFrame: 1 year
measure: Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer Temel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310594: Anti-tumor Immune Response in Patients With Cancer Undergoing Radiation Therapy
Official title: The Effect of Radiation Therapy on Tumor Immunity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Malignant Neoplasm
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cancer patients undergoing physician directed radiation treatment.

Brief summary: This research trial studies the effect of radiation therapy on tumor immunity. Standard radiation therapy destroys tumor cells. In response to tumor cell death caused by radiation therapy, the body has an ability to stimulate an anti-tumor response (immunity), but this response is often ineffective in shrinking tumor tissue. Collecting samples of blood from patients before, during, and after radiation therapy to study in the laboratory may help doctors learn more about the effects of radiation therapy on anti-tumor response.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the effect of radiation therapy on tumor immunity.

OUTLINE:

Samples of blood are collected before, during, and within two weeks after radiation therapy and then stored for analysis of anti-tumor immunity.

Eligibility criteria: Inclusion Criteria:

* Signed and dated Institutional Review Board (IRB)-approved Informed Consent form for the study
* Received an explanation of the study, including satisfactory answers to all questions related to the proposed research
* Is undergoing physician directed radiation treatment

Exclusion Criteria:

* The potential Subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent form

Primary outcomes:
measure: Outcome measures include changes in tumor-specific immune responses and general immune signature in patients undergoing Radiation Treatment. Reportable endpoints are absolute values of and changes in innate & adaptive immune cells and serum markers.
timeFrame: The time line of interest covers a baseline, pre-treatment sample as well as mid-treatment and a post-treatment, follow-up sample at 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Michael Steinberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00418860: The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent
Official title: The Optimal Duration of Dual Antiplatelet Therapy After Implantation of Endeavor Stent in the Patients With Coronary Artery Disease (DATE Registry)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
Stent thrombosis
Zotarolimus-eluting stent
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2007-01-05
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study to determine whether the dual antiplatelet therapy (aspirin and clopidogrel) for 3 months after coronary implantation of zotarolimus-eluting stent is safe in terms of death, myocardial infarction, or stent thrombosis.


Eligibility criteria: Inclusion Criteria:

* Patients with clinically significant de novo coronary artery disease
* Stenting only with Endeavor® stents
* The sum of stent length is less than 60 mm for one lesion. The sum of stent length in multiple lesions does not matter.

Exclusion Criteria:

* Cardiogenic shock
* ST-elevation myocardial infarction within 48 hours of symptom onset
* Prior implantation of drug-eluting stents
* Left ventricular dysfunction (echocardiographic left ventricular ejection fraction \< 25%)
* Stenting both branch of bifurcation lesion
* Left main trunk lesion
* Graft vessels
* Patients who have to receive clopidogrel due to other conditions
* Patients who have to receive warfarin, cilostazol or other antiplatelet therapy
* Patient with chronic renal failure (S-Cr \> 2.0 mg/dl)
* Hypersensitivity to clopidogrel or aspirin
* Expectant survival less than 1 year
* Women who plan to become pregnant
* Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Primary outcomes:
measure: Incidence of definite stent thrombosis by Academic Research Consortium Proposed Standard
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: