cyrilzakka/clinical-trials huggingface dataset:
The "Step4Life" Randomized Control Trial in Hemodialysis

Persons with end-stage kidney disease (ESKD) have very low physical activity, and among ESKD patients, the level of inactivity is strongly associated with morbidity and mortality. This study aimed to assess the feasibility and effectiveness of a 12-week intervention coupling use of wearable pedometers (FitBit ®) and feedback coaching to increase physical activity in hemodialysis patients.

Physical activity is an important modifiable behavior that is known to impact morbidity and mortality. The patients with advance kidney disease especially those on chronic hemodialysis are deconditioned with decreased muscle mass, and have co-morbidities such as anemia, malnutrition, and depression. These factors may explain why hemodialysis patients are known to have very low physical activity relative to healthy populations. We have recently demonstrated that hemodialysis patients are frequently sedentary, walk less with lower levels of physical activity. Thus, this provides an opportunity to design interventions to improve and sustain physical activity levels in hemodialysis patients.

There is a growing experience of digital technology and intervention delivery modalities to promote physical activity in chronic comorbid conditions, but little is known in hemodialysis patients. We set forward to test a weekly coaching intervention guided by a wearable pedometer to determine whether it would be feasible, promote physical activity, and be sustained for 12 weeks in hemodialysis patients. Equipped with pedometer data, informing subjects quantitatively about their levels of physical activity relative to other hemodialysis patients, might promote physical activity in this high-risk population.

We conduct a 12-week, open label, randomized controlled trial to determine the feasibility and effectiveness of providing structured feedback instruction (e.g., behavioral feedback, goal setting) along with a wearable pedometer (FitBit ®) in sustaining or improving physical activity levels in chronic hemodialysis patients as compared to the wearable pedometer (automated self-managed) alone. I hypothesized that the structured feedback intervention coupled with the wearable pedometer would be feasible, would improve physical activity, and would be sustainable for 12 weeks in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

1) HD for ≥3 months, 2) age ≥18 years, and 3) ability to walk with or without assistive devices,

Exclusion Criteria:

1) wheelchair bound, 2) unstable severe health conditions (e.g., acute infections, heart failure (HF) NYHA class 4 and/or unstable angina), 3) hospitalization within 3 months before enrollment for non-access related reasons, or 4) clinically recognized cognitive impairment including dementia or psychosis.
Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis

The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD.

Coronary CT angiography (CCTA) has become a reliable diagnostic technique to evaluate coronary artery disease (CAD) with high sensitivity and a negative predictive value. However, CCTA provides only anatomic information and tends to overestimate stenosis severity and is limited in its ability to diagnose myocardial ischemia. Undertaking additional CT myocardial perfusion imaging(CT-MPI) and CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD. SPECT myocardial perfusion imaging (SPECT-MPI)and invasively measured fractional flow reserve (FFR) will serve as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Understand the purpose of the trial, voluntarily participate in this study, and have signed an informed consent form.
3. Patients with known or suspected CAD

Exclusion Criteria:

1. Patients with acute coronary syndrome.
2. Severe cardiac dysfunction (LVEF ≤ 0.3).
3. Cardiomyopathy with non-coronary causes such as hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, and myocardial amyloidosis.
4. Severe cardiac valve disease with more than moderate valvular regurgitation and/or valvular stenosis.
5. Severe hepatic and renal dysfunction (ALT ≥ 3 Upper Limit of Normal, Cr\> 134μ/mol/L (2mg/dl) or estimated Glomerular Filtration Rate\<45ml/min/1.73m2).
6. Severe arrhythmias (persistent atrial fibrillation, second-degree or third-degree atrioventricular block, etc.)
7. Malignancy or other pathophysiological conditions with an expected survival of less than 1 year
8. Allergic to the drug components involved in this study and those who are intolerant to loading tests
9. Pregnant or lactating women.
10. Mental disorders.
11. Failure to sign the informed consent form.
12. Other conditions that are incompatible with the clinical study.
Coronary Artery Disease: a Case- Control Study

Atherosclerosis is a chronic inflammatory condition, which is associated by the involvement of several pathological events, and alteration in the serum levels of pro- and anti-inflammatory, and lipid markers.

The investigators evaluated the contribution of serum biomarkers levels to the pathogenesis of coronary artery disease, namely their association with risk factors, clinical presentation, extent and severity of atherosclerotic changes accompanying coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Coronary Artery Disease

Exclusion Criteria:

* Severe respiratory disease
* Liver disease
* kidney disease
* Inflammatory diseases (infections, autoimmune disorders, malignancy).
Selective Omission of Axillary Surgery in Triple-negative and HER2-positive Breast Cancer After NACT

Neoadjuvant chemotherapy (NACT) is standard treatment for many triple-negative (TNBC) and HER2-positive breast cancer. Study showed about half of the biopsy-proven axillary disease will be eradicated by NACT and converted to ypN0 indicating the efficacy of systemic treatment in local disease control.

According to current guidelines, all initial cN0 patients will undergo sentinel lymph node biopsy (SLNB) after NACT and further axillary dissection (ALND) if tumor residual is discovered after SLNB. Data suggest patients who underwent SLNB have a significantly higher rate of disability in the early post-operative period compared to patients who did not and the avoidance of SLNB might translate into a considerable reduction of physical and emotional distress. Recent studies revealed the association between breast pCR and ypN0 status after NACT. Initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT have a very low risk of positive lymph node residual and are very unlikely to benefit from further axillary surgery including SLNB.

The investigators designed a clinical trial to test the hypothesis that selective omission of axillary surgery in distinct responders after NACT will not deteriorate survival. In the planned trial, axillary surgery will be completely eliminated for initially cN0 TNBC and HER2-positive breast cancer patients who achieve pCR in breast after NACT determined by lumpectomy.

The trial is designed as a prospective, single-center, single-arm study with a limited number of patients (N=136). Patients will be recruited in China over a period of 36 months. Our results, together with other ongoing studies in other parts of the world with a similar design, might give practice-changing results and spare the time and the costs of a randomized comparison.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Core biopsy confirmed unicentric primary invasive triple-negative or HER2-positive breast cancer. Multifocal or multicentric tumors allowed only if breast-conserving surgery is deemed feasible.
* At least 18 years of age
* Initial tumor stage cT1c-T3N0M0 prior to NACT. cN0 stage established by clinical examination and ultrasonography
* In cases with suspicious lymph node, a negative core biopsy or fine needle aspiration (FNA) biopsy of the sonographically suspected lymph node is required
* Standard NACT with evident radiologic response
* Planned breast-conserving surgery with postoperative external whole-breast irradiation

Exclusion Criteria:

* History of previous malignancy
* Histologically proven N1 patients, patients with distant metastasis (M1)
* Pregnant or lactating patients
* Inflammatory breast cancer
* Radiologically non-responsive after NACT
* Mastectomy planned after NACT
* planned intraoperative radiotherapy (e.g. Intrabeam) or postoperative partial breast irradiation (e.g. multicatheter technique) alone; both procedures are allowed as boost techniques
* Written informed consent not obtained
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis
* Patients with degenerative spondylolisthesis
* Patients with at least 3 months failed conservative treatment
* Narrowing of the lumbar spinal canal
* Patients with lower back pain or sciatica

Exclusion Criteria:

* Discogenic back pain at TOPS System level
* Back or non-radicular leg pain of unknown etiology at TOPS System level
* Lytic spondylolisthesis at TOPS System level
* More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure
* Known allergy to titanium and/or polyurethane
Bariatric Surgery and Pharmacokinetics of Ibuprofen

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on ibuprofen are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Endothelial Progenitor Cells in Umbilical Cord Blood in Preeclampsia and IUGR

The objective of this study is to determine whether there are alterations in the population of endothelial progenitor cells in umbilical cord blood samples of infants born in the setting of maternal preeclampsia or fetal growth restriction.

Preeclampsia remains a significant cause of neonatal and maternal morbidity and mortality. This disorder is found in 5-7% of pregnancies and its incidence is increased in gravid patients with multiple gestations, chronic hypertension, renal disease, autoimmune disease, and at extremes of maternal age. It is responsible for 15% of preterm births which is accompanied by a resultant increase in neonatal morbidity and mortality. In developing countries, it is responsible for approximately 50,000 maternal deaths each year. No widespread intervention to prevent this disease has been found effective and the only effective treatment remains delivery of the fetus.

To date, the cause of preeclampsia is not known although many agree that preeclampsia is a two-stage disease as described by Roberts et al. with the placenta of central importance. The first stage involves poor placental perfusion usually a result of impaired vascular remodeling in early pregnancy or from maternal disease. This leads to the second stage, which is the maternal syndrome of preeclampsia and involves both endothelial and leukocyte activation.

Preeclampsia is associated with an increased maternal cardiovascular risk later in life. Women with a history of preeclampsia demonstrate altered expression of angiogenesis-related proteins and increased insulin resistance as measured by the homeostasis model of insulin resistance. Additionally, preeclampsia is associated with an increase in future cardiovascular risk in the fetus.

Endothelial dysfunction and abnormal regulation of vascular tone that is present in preeclampsia suggests abnormal development of vascular cells such as endothelial progenitor cells. The increased cardiovascular risk of neonates born in the setting of IUGR and preeclampsia also suggests the possibility of abnormal development of endothelial progenitor cells in the fetal compartment in these disease states. The purpose of this pilot project is to determine the effects of preeclampsia/IUGR on endothelial progenitor cells derived from fresh umbilical cord blood.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18-45
* Gestational age between 30-40 weeks plus:

  * Uncomplicated pregnancy or
  * Fetal estimated weight \<10% for gestational age or abdominal circumference \<5% or
  * Preeclampsia by ACOG criteria:

    1. HTN \> 140/90 on two occasions
    2. Proteinuria \> 300mg on 24 hour urine specimen or 1+ on urine dip

Exclusion Criteria:

* Non-reassuring fetal status
* Congenital abnormalities
* Multiple gestations
* Clinical Chorioamnionitis
* Recent infectious disease (within 2 weeks)
Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.

Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance.

The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years old or older ;
* At least one condition of myocardial oxygenation imbalance :

  * Oxygen saturation below 90% ;
  * Haemoglobin level below 130 grams/Liter (g/L) for men, 120 g/L for women ;
  * Persistent heart rate over 110 beats per minute, for more than 20 minutes ;
  * Persistent systolic blood pressure below 90 millimeters of mercury (mmHg) for more than 20 minutes despite fluid resuscitation ;
  * Persistent systolic blood pressure over 180 mmHg for more than 20 minutes.

Exclusion Criteria:

* Patient admitted with type 1 myocardial infarction ;
* Patient presenting a condition for Non Ischemic Myocardial Infarction (pulmonary embolism, acute stroke, acute kidney failure, etc...)
* Patient who declines to participate;
* Pregnant or breastfeeding women ;
* Patient deprived of liberty (inmate, administrative protection)
Patient Important Gastrointestinal Bleeding in the ICU

This study will engage patients and families to create a definition of what matters most to them about upper gastrointestinal (GI) bleeding. This information will help to define the outcome of "patient-important GI bleeding" which is a secondary endpoint for the ongoing international randomized trial REVISE (NCT03374800), comparing acid suppression versus no acid suppression in the intensive care unit (ICU). Other outcomes in REVISE are clinically important upper GI bleeding, mortality, pneumonia and Clostridioides difficile infection. Guided by patient and family input, a series of open-ended questions will elicit patient and family views about what matters most about this complication in interviews and focus groups. The investigators will develop the definition of "patient-important GI bleeding" by analyzing interview and focus group transcripts of critically ill survivors and family members of critically ill patients who may or may not have had GI bleeding, and who were not enrolled in the REVISE trial. Patient and family perspectives (anticipated to be different from what clinicians consider to be clinically important GI bleeding), will be used to refine a new trial outcome for research on GI bleeding in the intensive care unit (ICU). Also, study results will help clinicians understand how to better support patients and families; to explain testing and treatment options when GI bleeding occurs in practice in the ICU.

This is a parallel mixed-methods multi-center study.

Design: This is a parallel mixed-methods multi-center study in which the qualitative data are dominant and patient and family involvement is paramount. Data collection will be quantitative and qualitative interviews and focus groups. The objective is to elicit views from patients and families regarding the features of a GI bleed that are important to patients. The investigators will recruit 6-10 patients and 6-10 family members for individual interviews, along with 6-10 focus groups consisting of 3-4 patients and family members.

Eligibility Criteria:
Patient Inclusion Criteria:

* Was admitted to an ICU, whether or not a GI bleed developed in the ICU
* \> 18 years of age

Family Member Inclusion Criteria:

* Family members of ICU patients whose loved one was in the ICU for at least 72 hours, whether or not their family member developed a GI bleed
* \> 18 years of age

Patient/Family Member Exclusion Criteria:

* Prohibitive communication challenges (e.g., serious psychological or psychiatric illness in the patient and/or family, inability of patient and/or family to communicate reasonably well in English or other languages for which an interpreter exists - professional staff or otherwise);
* Patient or family declines.
* Family member whose loved one died in ICU
Sepsis Institutional Registry in Hospital Italiano de Buenos Aires

The purpose of this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

The main goal is to describe the occurrence of sepsis and the characteristics of clinical presentation, evolution and predisposing factors within the population of the Hospital Italiano de Buenos Aires.

Eligibility Criteria:
Inclusion Criteria:

1. Over 17 years
2. Two or more sirs criteria
3. Active infection

Exclusion Criteria:

1. Refusal to register or to the informed consent process
2. Ambulatory patients
Sickle Cell Disease, Neurocognitive Disorders, Social Participation

This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders.

Sickle cell anaemia, which is the most frequent genetic disease in France, requires an early and optimal care to reduce its morbidity and mortality. Children with sickle cell anaemia who are significantly anaemic may present neurological complications including stroke with or without clinical signs. A major risk associated to these strokes is the impairment of the general intellectual ability and learning ability, essentially resulting from neuropsychological disorders affecting intellectual functioning, executive and attentional functions. Although the negative impact of sickle cell anemia on the quality of life of the affected children and adolescents is well documented, no study has been focused on the role played by the neurocognitive disorders on their social participation. The objective of this project is the assessment of the influence of neurocognitive disorders in the social participation of children and adolescent with sickle cell anemia (6 to 16 years old), followed in Guadeloupe. This project will promote the development of transdisciplinary analyses. Neuropsychological disorders will be explored with the usual appropriate tests done by psychologists and neuropsychologists regularly involved in the management of sickle cell disease affected children. For the social sciences' component, various methods will be used: Measure of the Life habits (MHAVIE), Measure of Environmental Quality (MQE) and semi-guided interviews will complete the collection of qualitative data. The expected results concern the identification of the barriers or facilitators the sickle cell patients might face in their social participation, whether they are affected or not by neurological disorders

Eligibility Criteria:
Inclusion Criteria:

* Sickle cell anemia
* Age between 6 and 16 years inccuded, attending the centre of reference for sickle cell disease in Guadeloupe
* Informed consent
* Medical insurance

Exclusion Criteria:

* Other sickle cell syndrome other than SS or Sb-thal
* Less than 6 years old or older than 16
* Attending other sickle cell departments
* No medical insurance
Stress Ventricular Function in Evaluating Patients With Pulmonary Hypertension

This study investigated clinical parameters, laboratory data, imaging studies to evaluate patients with suspected pulmonary hypertension.

Left and right ventricular ejection fraction (LV/RV EF) at rest and immediately after exercise treadmill test (ETT) were measured by nuclear medicine study in consecutively symptomatic patients with suspected pulmonary hypertension, along with other clinical variables were correlated with right heart catheterization parameters.

Eligibility Criteria:
Inclusion Criteria:

* patients suspicious for pulmonary hypertension.

Exclusion Criteria:

* pregnant, lactating, CAD history
A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the requirements of the study and provide informed consent
* A Clinical diagnosis of COPD
* A current or prior history of at least 10-pack years of cigarette smoking
* women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study

Exclusion Criteria:

* A Clinical Diagnosis of Asthma
* Other significant disease than COPD
* Subjects who radiation or chemotherapy within the previous 12 months
* Subjects who had any lung resection
* QTcB greater than 0.460 seconds
* History of illegal drug abuse or alcohol abuse within the past 5 years