louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04969367: Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome
Official title: Measuring Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome (MDS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myelodysplastic Syndromes
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 0
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: Patients with myelodysplastic syndrome (MDS) recruited from the Department of Medical Oncology- Jefferson Health

Brief summary: This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.

Detailed description: This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.

Eligibility criteria: Inclusion Criteria:

* Confirmed pathologic diagnosis of MDS
* Requiring \>= 2 blood transfusions in the past month if previously diagnosed or hemoglobin =\< 8 g/dL if newly diagnosed
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Ambulatory (use of a walking aid, such as a cane or rollator, is acceptable)
* Able to give informed consent
* Willing to comply with all study procedures and available for the duration of the study
* Able to read and/or understand English
* Have access to an iPhone 4S or later, iPad 3 generation or later, Android 5.0 or later, or Windows 10 device
* Have access to Bluetooth low energy (LE) and internet connection for syncing

Exclusion Criteria:

• Uncontrolled illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Primary outcomes:
measure: Accrual rate
timeFrame: Up to 90 days
measure: Acceptability
timeFrame: Up to 90 days
measure: compliance with device
timeFrame: Up to 90 days
measure: retention rate
timeFrame: Up to 90 days
measure: Acceptability
timeFrame: Up to 90 days
Secondary outcomes:
measure: Daily step count
timeFrame: Up to 90 days
measure: Average daily resting heart rate
timeFrame: Up to 90 days
measure: Fact-An score (assessed twice a week),
timeFrame: Up to 90 days
measure: Hemoglobin level measured by CBC twice a week
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01442467: Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification
Official title: Correlation Between Echocardiographic Indices of Diastolic Function (E/E') and Left Ventricular End Diastolic Pressure (LVEDP) in Patients With Mitral Annular Calcification
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mitral Annulus Calcification
Keywords: mitral annular calcification
MAC
left atrial pressure
LAP
left ventricular end diastolic pressure
LVEDP
Echocardiogram
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elective/planned cardiac catheterization

Brief summary: This study aims to evaluate the accuracy of the echocardiographic data obtained from patients with calcifications in the mitral valve who are undergoing a cardiac (heart) catheterization.

Echocardiography is a non-invasive (does not break the skin) procedure used to see an image of the heart. It uses harmless sound waves to create an image of the heart on a computer screen. These images will show the valves of the heart, how well the heart is pumping blood, the blood flow across these valves and how large the heart is. A silver paddle-shaped device is moved easily over the skin to capture these images.

Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding the valves) is a common finding and it increases with age. The presence of calcification changes the blood flow through the heart valves. This makes any echocardiographic data (information) obtained from patients with calcifications difficult to interpret.

Detailed description: Patients with significant mitral annular calcification (MAC) have largely been excluded from studies validating non invasive (echocardiographic) measurements of left ventricular filling and diastolic function. The investigators hypothesize that echocardiographic estimates of diastolic function, left atrial pressure (LAP) and left ventricular end diastolic pressure (LVEDP) are likely to be fallacious in patients with moderate to severe mitral annular calcification due to the structural alterations and technical difficulties involved.

Eligibility criteria: Inclusion Criteria:

* \>= 19 years of age
* undergoing planned cardiac catheterization

Exclusion Criteria:

* \< 19 years of age
* acute coronary syndrome
* decompensated heart failure
* not in sinus rhythm
* \> mild MR
* hypertensive urgency/emergency
* severe aortic stenosis
* poor echo windows for Doppler imaging

Primary outcomes:
measure: Agreement between invasive and non-invasive measures of LVEDP
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton Unviversity Medical Center
state: Nebraska
Study officials:
References:
Clinical trial NCT06065267: Levofloxacin Concomitant Versus Levofloxacin Sequential
Official title: Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori
levofloxacine
concomitant
sequential
Lead sponsor: Damascus Hospital
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 150
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 goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population


Eligibility criteria: Inclusion Criteria:

* Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
* Positive rapid urease test (CLOtest).
* Histologic evidence of H. pylori by modified Giemsa staining.
* Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

* Children and teenagers aged less than 18 years.
* Previous eradication treatment for H. pylori.
* Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
* History of gastrectomy.
* Gastric malignancy, including adenocarcinoma and lymphoma,
* Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
* Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
* Contraindication to treatment drugs.
* Pregnant or lactating women.
* Severe concurrent disease.
* Liver cirrhosis.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori infection
timeFrame: 8 week from begning of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: General Assembly of Damascus Hospital
Study officials:
affiliation: general assambly of damascus hospital
name: Marouf M Alhalabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00471367: Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877
Official title: A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients With Advanced Solid Malignancies Including Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma
NHL
Non-Hodgkin Lymphoma
Keywords: Phase I
AZD4877
Lymphoma
B-cell non-Hodgkin lymphoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth


Eligibility criteria: Inclusion Criteria:

* Part A: Advanced solid tumors (including lymphoma without bone marrow involvement) for which standard treatment doesn't exist or is no longer effective.
* Part B: B-cell non-Hodgkin lymphoma that is not eligible for curative therapy or has relapsed.
* Relatively good overall health other than your cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function

Primary outcomes:
measure: To identify a maximum tolerated dose of AZD4877 by assessment of the incidence of dose limiting toxicities
timeFrame: on a twice a week schedule for two weeks out of every three weeks
Secondary outcomes:
measure: To evaluate the safety and tolerability of AZD4877 by assessment of Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) grade and type of AE, changes in laboratory values, vital signs, and incidence of protocol defined dose modification
timeFrame: assessed after each course of treatment
measure: Dose Expansion (Part B):Estimate efficacy of AZD4877 through evaluation of objective response rate, progression-free survival and disease control rate in patients with B-cell non-Hodgkin lymphoma using the revised response criteria for malignant lymphoma
timeFrame: Assessed during treatment and post treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Site
state: New York
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Research Site
state: South Carolina
Study officials:
affiliation: AstraZeneca
name: Jeffrey Skolnik, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Lea Burke
role: STUDY_CHAIR
References:
Clinical trial NCT03149367: Surgical Management of Blepharoptosis
Official title: Fixed Versus Adjustable Sutures in Management of Blepheroptosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blepharoptosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the results of levator resection operation with the use of fixed sutures technique in which the levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle versus the results with the use of adjustable sutures in which the suture passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.


Eligibility criteria: Inclusion criteria:

* Cases of blepharoptosis admitted at Assiut University Hospital.
* Cases that are fit for surgery.

Exclusion criteria:

* Cases not fit for surgery.
* Cases of pseudoptosis may result from many conditions that simulate an asymmetry of the upper eyelid level. Dysthyroid ophthalmopathy, enophthalmos, or exophthalmos can accentuate a minimal blepharoptosis or produce the appearance of blepharoptosis on the contralateral normal side,
* Cases with diseases, such as myasthenia gravis; negativity for Bell palsy symptoms; and Marcus Gunn jaw-winking syndrome.

Primary outcomes:
measure: The cosmetic appearance
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit university hospital
Study officials:
References:
Clinical trial NCT05525767: Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
Official title: Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Solid Tumor
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 75
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 is an prospective, multicenter, single-arm clinical study.

Detailed description: Prospective, multicenter, single-arm clinical study of chemotherapy combined with bevacizumab neoadjuvant therapy for early or locally advanced HER2-negative breast cancer

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. Signed the informed consent and volunteered to join the study with good compliance;

3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER/PR positive and HER2 negative) :

* HER2 negative was defined as 0/1+ on standard IHC test; HER2/CEP17 ratio was less than 2.0 or HER2 gene copy number was less than 4.
* ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%;

  4. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0);

  5. The main organs function well and meet the following standards:

A) Hemoglobin (HGB)≥90g/L;

B) Neutrophil absolute value (NEUT)≥1.5×109/L;

C) Platelet count (PLT)≥ 100×109/L;

D) leukocyte ≥3.0×109/L;

E) Total bilirubin \<1.5 ULN (upper limit of normal)

F) Creatinine \< 1.5×ULN

G) AST/ALT \< 1.5×ULN;

6. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);

7. The investigators determined that the patients were suitable for treatment with bevacizumab.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer;
2. Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.;
3. Patients who are participating in other intervention studies;
4. Women with confirmed pregnancy or lactation;
5. According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.

Primary outcomes:
measure: PCR
timeFrame: 24 months
Secondary outcomes:
measure: ORR
timeFrame: 24 months
measure: AE Advese Event Advese Event breast conservation rates
timeFrame: 24 months
measure: BCR breast conservation rates
timeFrame: 24 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
References:
Clinical trial NCT02984267: Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Official title: Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: West Penn Allegheny Health System
First posted: 2016-12-06
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.


Eligibility criteria: Inclusion Criteria:

* Current (pregnant) BMI ≥ 40
* Age ≥ 18
* ASA score of 3 or less
* Full term pregnancy (37 weeks gestational age or greater)

Exclusion Criteria:

* Known scoliosis
* Known contraindications to neuraxial blockade
* Intrauterine fetal demise or non-viable fetus.

Primary outcomes:
measure: Total Time Required for Epidural Catheter Placement
timeFrame: Assessed immediately during epidural catheter placement
Secondary outcomes:
measure: Epidural Procedure Time
timeFrame: Assessed immediately during epidural catheter placement
measure: Number of Attempts at Epidural Catheter Placement
timeFrame: Assessed immediately during epidural catheter placement
measure: Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
timeFrame: Assessed immediately during epidural catheter placement
measure: Complications
timeFrame: Assessed immediately during epidural catheter placement and within 24 hours after delivery
measure: Epidural Failure Rate
timeFrame: Assessed within 24 hours after delivery
measure: Epidural Catheter Placement Satisfaction Level
timeFrame: Assessed immediately following epidural catheter placement
measure: Patient Anxiety Level
timeFrame: Assessed immediately following epidural catheter placement
measure: Palpation or Ultrasound Time
timeFrame: Assessed immediately prior to epidural catheter placement
measure: Overall Anesthesia Experience Satisfaction
timeFrame: Measured within 24 hours of delivery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02456467: HemoSonics-UVA HemoSonics-UVA Cardiac Surgery Clinical Study Protocol
Official title: HemoSonics-UVA Cardiac Surgery Clinical Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: HemoSonics LLC
First posted: 2015-05-28
Enrollment: 50
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: Participants for this study will be recruited at UVA. The subject population will be representative of the local racial and ethnic population.

Brief summary: This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

Detailed description: HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the University of Virginia Health System and will involve patients undergoing cardiac surgery requiring bypass.

Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for cardiac surgery involving bypass circuit
* Subject is older than 18 years
* Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
* Patients with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
* Patients with history of active liver disease
* Patients on emergency cases
* Patients on heparin anticoagulation before the beginning of the study

Primary outcomes:
measure: Clot time
timeFrame: 1 day
measure: Clot Amplitude
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: UVA Anesthesiology Faculty
name: Danja Groves, MD
role: PRINCIPAL_INVESTIGATOR
References: