louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00804869: A-mode vs PalmScan Ultrasonography: Biometric Measurements.
Official title: Standard A-mode Ultrasonography vs PalmScan Ultrasonography: Biometric Measurements.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Axial Length (AL)
Anterior Chamber Deep (ACD)
Lens Thickness (LT)
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who need axial length calculation.

Brief summary: Ultrasonography has become a critical ancillary test in the clinical practice of ophthalmology. It is commonly used as a standardized method for assessing intraocular biometry. The PalmScan ultrasonography (PsU) is a portable A-scan device that uses the same principles as the standard A-scan. The aim of the study is to compare the reliability of their measurements, in order to use them indistinctively.


Eligibility criteria: Inclusion Criteria:

* Patients with indication for a standard A-mode ultrasound

Exclusion Criteria:

* No superficial anormalities.
* Patients with external injuries.
* Intraocular silicon oil.
* Retinal detachment
* Significant ocular pathologies.

Primary outcomes:
measure: axial length (AL).
timeFrame: during examination
measure: Anterior Chamber Deep (ACD)
timeFrame: during examination
measure: Lens Thickness (LT)
timeFrame: during examination
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociación para Evitar la Ceguera en México
state: DF
Study officials:
References:
Clinical trial NCT05246969: Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage
Official title: Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal
Sepsis Syndrome
Sepsis
Sepsis, Severe
Sepsis Bacterial
Keywords: sequential organ failure assessment score
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe subarachnoid hemorrhage requiring intensive care.

Brief summary: The study aims to evaluate the suitability of the SOFA score implemented by the Sepsis 3 guideline to detect sepsis in patients suffering from subrarachnoid hemorrhage.


Eligibility criteria: Inclusion Criteria:

Critically ill patients suffering from moderate to severe subarachnoid hemorrhage (WFNS \>2).

Exclusion Criteria:

children under the age of 18 years Patients with minor subarachnoid hemorrhage \< WFNS stage 2.

Primary outcomes:
measure: Sepsis SOFA positive
timeFrame: up to 2 months
measure: Sepsis SOFA negative
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt Niederrad
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
References:
Clinical trial NCT01274169: Measurment of GFR by Nasal Sensors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measure GFR by Nasal Sensor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-01-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: volunteers subjects with different stages of CKD

Brief summary: to measure kidney function by measuring blood creatinine and to compare it to the measurment of GFR by Nanotechnology


Eligibility criteria: Inclusion Criteria:

adults between 18-70 yrs

Exclusion Criteria:

subject under 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02827669: One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
Official title: One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: One Drop
First posted: 2016-07-11
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a 12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2 diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch in combination with the One Drop app and Experts program, and assess whether this group is more engaged or experiences a different impact as compared to participants who utilized the One Drop app and Experts program only.


Eligibility criteria: Inclusion Criteria:

* Self-reported Type 2 diabetes diagnosis
* Has not changed treatment regimen in the last 3 months
* HbA1c levels ≥ 7.5% by self-report and verified by lab test
* Motivated to use a daily diabetes self-management coaching program to improve diabetes control
* Owns and uses an iPhone with a compatible iOS operating system and has successfully downloaded and used a smartphone application previously

Exclusion Criteria:

* Current use of a smartphone application to manage their diabetes
* Currently participating in a diabetes self-management education or coaching program
* Currently pregnant
* Does not understand English
* History of serious mental illness or dementia
* Has severe diabetic complications such as severe diabetic retinopathy, chronic kidney disease (stages 4-5), severe diabetic neuropathy, diabetic foot ulcer or infection

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Evidation Health
state: California
Study officials:
References:
Clinical trial NCT03902769: Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients.
Official title: Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: One arm open study
Primary purpose: TREATMENT

Brief summary: We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).

Detailed description: Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.

Eligibility criteria: Inclusion Criteria:

* AML diagnosis,
* treated with 3+7 Induction chemotherapy
* Intermediate/standard risk AML

Exclusion Criteria:

* Diagnosed of APL
* high risk molecular/cytogenetic score

Primary outcomes:
measure: Event free survival
timeFrame: Two years
Secondary outcomes:
measure: Overall survivial
timeFrame: two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01350869: Evaluation of Everolimus-Eluting Stents (The K-XIENCE Registry)
Official title: Evaluation of Effectiveness and Safety of Everolimus-Eluting Stents in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
name: Abbott
First posted: 2011-05-10
Enrollment: 3000
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: The registry will be conducted at 33 centers in Korea. Data will be collected on approximately 3,000 subjects treated with XIENCE stents.

Brief summary: The objective of this study is to evaluate effectiveness and safety of everolimus-eluting stents (XIENCE, Abbott) in the "real world" daily practice as compared with first-generation drug-eluting stents (sirolimus-eluting stents).

Detailed description: This study is a non-randomized, open-label registry to compare the efficacy and safety of everolimus-eluting stents versus sirolimus-eluting stents in patients with coronary artery disease.

Eligibility criteria: Inclusion Criteria:

* Patients received XIENCE stents
* The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

* Patients with a mixture of other DESs
* Terminal illness with life expectancy \<1 year.
* Patients with cardiogenic shock

Primary outcomes:
measure: Composite of death, nonfatal myocardial infarction (MI), and Target Vessel Revascularization (TVR)
timeFrame: at 12 months after PCI
Secondary outcomes:
measure: All Death
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: Cardiac death
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: MI
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: Composite of death or MI
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: Composite of cardiac death or MI
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: TVR
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: Target-lesion revascularization (TLR)
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: Stent thrombosis (ARC criteria)
timeFrame: 1month ,6 month and 12 months,2year,3year,4 year and 5year
measure: Procedural success
timeFrame: at discharge
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03211169: Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures
Official title: Comparative Efficacy of Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies for Obtaining Diagnostic Tissue From Indeterminate Biliary Strictures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cholangiocarcinoma
Stricture; Bile Duct
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Rochester
name: The University of Texas Health Science Center, Houston
First posted: 2017-07-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective study
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, randomized, multi-center study. Investigators will compare diagnostic yield of bile duct brushings, pediatric biopsy forceps biopsies and cholangioscopy-directed biopsies for obtaining diagnostic tissue from biliary strictures.


Eligibility criteria: Inclusion Criteria:

1. All patients with obstructive jaundice, and imaging (CT or MRI) suggestive of biliary stricture, without obvious pancreatic mass
2. All patients with obstructive jaundice, and index ERCP suggestive of biliary stricture, without obvious pancreatic mass
3. All patients with obstructive jaundice, and prior ERCP suggestive of biliary stricture
4. Expected patient survival of at least 90 days
5. High likelihood of patient follow-up
6. Patient is able to give a written informed consent
7. Patient is willing and able to comply with the study procedures

Exclusion Criteria:

1. Patients with imaging suggestive of pancreatic tumor
2. Children \< 18 years of age
3. Pregnant women
4. Patients with impaired decision-making
5. Healthy volunteers
6. Primary Sclerosing Cholangitis (PSC)
7. Patients with untreated coagulopathy at the time of procedure or ongoing need for anti-coagulation
8. Patients with any contraindication to endoscopic procedure
9. Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
10. Patients unable to provide informed consent

Primary outcomes:
measure: Diagnostic tissue obtained as assessed by histologic evaluation of biopsy specimen
timeFrame: 1 week
Secondary outcomes:
measure: Cost
timeFrame: 2 years
measure: Radiation Exposure
timeFrame: 2 years
measure: Procedure Duration
timeFrame: 2 years
measure: Latency to diagnosis
timeFrame: 2 years
measure: Adverse Events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References:
Clinical trial NCT01120769: Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Official title: Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Myocardial Infarction
Percutaneous Coronary Intervention
Acetaminophen
Lipid Peroxidation
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that acetaminophen will reduce lipid peroxidation and isoprostane formation during reperfusion after percutaneous revascularization for acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

- Patients presenting with STEMI

Exclusion Criteria:

* Duration of symptoms \> 12 hours
* Suspected LM or proximal LAD occlusion (based on EKG interpretation)
* Hemodynamic instability
* Acetaminophen use in prior 24 hours
* Use of dipyridamole, or Aggrenox, a formulation of aspirin and extended-release dipyridamole, within 48 hours
* Current use of the following medications: phenytoin, valproic acid, phenobarbital, topiramate, rifampin, carbamazepine, cyclophosphamide, ritonavir, efavirenz, St. John's Wort
* Chronic heavy alcohol use
* Chronic liver disease (other than non-alcoholic fatty liver infiltration)
* Severe valvular heart disease
* Stroke in the past 60 days
* Active major bleeding
* Major surgery in the past 30 days
* Ongoing treatment for active malignancy
* Life expectancy less than 12 months as determined by the patient's attending physician
* Pregnancy
* asthma or severe COPD
* active wheezing on presentation
* allergy or prior adverse reaction to adenosine

Primary outcomes:
measure: Plasma isoprostane level
timeFrame: 60 minutes
Secondary outcomes:
measure: Index of microcirculatory resistance
timeFrame: Average 20 minutes
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT00002369: A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official title: An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
Stavudine
HIV Protease Inhibitors
CD4 Lymphocyte Count
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

Detailed description: 100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 cell count of 200 - 700 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

AIDS defining condition within 1 month of study entry.

Prior Medication:

Excluded:

Patients with any history of antiretroviral therapy treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Fort Lauderdale
country: United States
facility: HIV Clinical Research Ctr
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Atlanta
country: United States
facility: Advance Clinical Research
state: Georgia
city: New Orleans
country: United States
facility: Louisiana State Univ Med Ctr / HIV Outpatient Clinic
state: Louisiana
city: Boston
country: United States
facility: Boston Univ Med Ctr Hosp / Evans - 556
state: Massachusetts
city: Brookline
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: St Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: Austin
country: United States
facility: Blackstock Family Health Ctr
state: Texas
city: Ponce
country: Puerto Rico
facility: Hosp Regional de Ponce - Area Vieja
city: Santurce
country: Puerto Rico
facility: San Juan AIDS Program
Study officials:
References:
Clinical trial NCT01292369: Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study
Official title: Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Colon Cancer
Keywords: breath test
colon cancer
breast cancer
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2011-02-09
Enrollment: 560
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women coming for medical tests:

1. Women coming for a breast biopsy following a suspicious breast imaging result.
2. Men and women coming for a colonoscopy, reffered by their family physician, due to complaints indicating the possibility of colon cancer.

Brief summary: The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.

Detailed description: Cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome P- 450 mixed oxidase enzymes (CYP). Both processes affect the abundance of volatile organic compounds (VOCs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by CYP.

In the Technion labs, a new system for breath samples diagnosis, is being developed. The system is based on Nanoparticles technology.

The current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals.

Men and women coming for colonoscopy or breast biopsy will be recruited for the study. Breath samples will be taken from all volunteers before the medical test. Subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control.

The research goal is to test the NaNose system ability to discriminate between healthy and sick.

Eligibility criteria: Inclusion Criteria:

* Men and women attending Rambam medical center for either breast biopsy or colonoscopy.
* Suspicious finding on breast imaging requiring a biopsy.
* Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer.

Exclusion Criteria:

* Other known active malignancy.
* History of malignant disease and treatments.

Primary outcomes:
measure: System performance
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM medical center
city: Haifa
country: Israel
facility: Carmel medical center
Study officials:
References: