cyrilzakka/clinical-trials huggingface dataset:
Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS

This study investigates the mechanism by which kidney dysfunction perpetuates inflammation, immunosuppression, and catabolism (PICS) in chronic critical illness. The investigators will test the hypothesis that persistent kidney dysfunction in sepsis associated by chronic critical illness contributes to decreased survival through the development of PICS. In chronic critical illness, the persistence of the inflammatory state may lead to capillary rarefication in the kidney causing accelerated chronic kidney disease. Progression of chronic kidney disease during chronic critical illness can drive PICS. Indeed, many of the features of chronic critical illness are consistent with the protein-energy malnutrition and muscle wasting associated with chronic kidney disease. Thus, the kidney can play a contributory role in chronic critical illness and PICS.

The main goal of this project is to measure kidney filtration function at day 14 or the day of discharge from hospital (whichever occurs first), in order to determine the presence and magnitude of persistent kidney dysfunction after sepsis episode and to longitudinally assess further decline of kidney function at one year follow-up. The measure of the glomerular filtration rate (GRF) in patients with chronic critical illness and controls (sepsis patients discharged from ICU before day 14) will be used to determine to what degree of kidney dysfunction contributes to decreased survival and increase in chronic kidney disease at year one after sepsis onset.

GFR assessment will be determined at approximately day 14 or approximately at the day of discharge from the ICU and at the one-year follow-up:

1. Determine GFR by Iohexol clearance and/or
2. Estimated GFR by urea concentration and creatinine clearance
3. Estimated GFR using calculations with serum creatinine

Eligibility Criteria:
Inclusion Criteria:

* Presence in the surgery or trauma ICU
* Age of ≥18 years
* Entrance into our sepsis protocol
* Ability to obtain informed consent.

Exclusion Criteria:

* Expected lifespan of the patient is less than 3 months due to severe pre-existing comorbidities (ex. recurrent, advanced or metastatic cancer)
* Severe traumatic brain injury (evidence of neurologic injury on CT scan and a GCS \<8)
* Refractory shock (i.e., patients who die within 12 hours)
* Uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
* Patient or patient's family are not committed to aggressive management of the patient's condition and/or the patient has a DNR/DNI on file.
* Severe CHF (NY Heart Association Class IV)
* Child-Pugh C liver disease or pre-liver transplant.
* Known HIV infection with CD4 count \<200 cells/mm3
* Organ transplant recipient on immunosuppressive agents
* Known pregnancy and mother's that are breastfeeding
* Prisoners
* Institutionalized patients
* Inability to obtain informed consent.
* Chemotherapy or radiotherapy within 30 days prior to sepsis.
* End stage renal disease on admission.
Biomime Stent in All-comers PCI Patients Registry

Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.


Eligibility Criteria:
Inclusion Criteria:

* any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent

Exclusion Criteria:

* patients \<18 years old
Immunological Profiling of Patients With COVID-19 in Respiratory Distress

The study investigators hypothesize that the pneumonia arising in patients with COVID-19 is largely of immunopathological origin. The investigators will therefore seek to define the immune activation phenotype of patients in respiratory distress and to see if this immune signature is predictive of mortality. Finally, the investigators will look for overproduced inflammatory mediators to identify potential therapeutic targets.

SARS-CoV inhibits the viral detection systems and the signaling pathways of type I interferons (IFN-I). The weakness of the initial interferon response is predictive of the severity of future lung disease. The effectiveness of this escape strategy seems to allow these coronaviruses to replicate in the human body without triggering an effective innate immune response. This could explain the contagiousness of asymptomatic infected people.

However, this initial replication causes a cytokine storm involving inflammatory cytokines. The intensity of this cytokine storm is correlated with the severity of COVID-19 cases.

Pulmonary involvement, which is the main cause of death in SARS-CoV infections, has been attributed to local inflammation, with infiltration of CD8 + T cells, polymorphonuclear cells, monocytes and macrophages, infiltration proportional to the severity of respiratory failure as well as increased vascular permeability.

SARS-CoV also induces T cell apoptosis. This pro-apoptotic effect could contribute to the lymphopenia observed in 37 to 63% of COVID-19 cases, which is predictive of severe forms.

Thus the pulmonary involvement could be partly caused by immunopathological mechanisms.

Immunological disturbances associated with respiratory failure need to be better defined. Recently, we measured a panel of soluble and membrane markers allowing to characterize T CD4 +, T CD8 +, B, monocytic, NK, endothelial activation as well as inflammation in a sample made up of 150 volunteers from a general population providing a control population.

The study investigators aim to use this panel to define the immune activation state of patients infected with SARS-CoV-2 hospitalized for respiratory distress. In addition, the investigators will identify the soluble factors linked to the immune activation overproduced by the peripheral blood mononuclear cells (PBMC) of these patients. Finally, the investigators want to characterize the transcriptome of the main circulating immune sub-populations. These parameters will be compared with those of patients infected with SARS-CoV-2 hospitalized before experiencing respiratory distress.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be a member or beneficiary of a health insurance plan
* Patient hospitalized in respiratory resuscitation or in the service of Infectious and Tropical Diseases of the CHU de Nîmes with infection by SARS-CoV-2, confirmed by RT-PCR or by an antigen test.

Exclusion Criteria:

* The subject is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice
* Patient already under ventilation transferred from another center
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease

The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.


Eligibility Criteria:
Inclusion Criteria:

* Newborn babies born \<28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life.

Exclusion Criteria:

* Congenital heart defects
* Suspected inborn error of metabolism
* Inhaled Nitric Oxide treatment during assessment
Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP

The overarching hypothesis of this proposal is that IL-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of IL-5 affects several relevant effector pathways that lead to clinical benefit.

Further characterization of the role of IL-5Rα expression and function on human plasma cells will determine whether inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to plasma cell proliferation. Further characterization of human upper airway epithelial cell IL-5Rα expression and function will determine whether or not inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to epithelial dysfunction. IL-5Rα expression has been identified on several relevant sinus tissue effector cells, including on nasal polyp plasma cells and epithelial cells, and the aim of this study is to further the field by determining the consequences of IL-5 signaling on those cells.

Eligibility Criteria:
Inclusion Criteria:

* AERD, CRSwNP, healthy controls

Exclusion Criteria:

* Not on any systemic steroids or respiratory biologics at time of surgery
Traditional Tibetan Medicine for Patients With Coronary Artery Disease

Coronary artery disease has a high death toll in the Western world. Changes in lifestyle, particularly in nutrition and physical activity may significantly reduce a severe coronary atherosclerosis within one year without the use of medication. Several dietary studies have shown that not only the progress of coronary artery disease can be slowed down, but it may also increase significantly the survival of these patients.

Up until now there is little known about therapeutic effects by complementary medicine. In particular, Traditional Tibetan medicine dietary programs have shown in few case reports that weight could be reduced in patients with obesity.

Therefore, the investigators developed a specific dietary program for patients with coronary artery disease, who have an increased cardiovascular risk profile according to the criteria by the International Diabetes Federation (IDF).


Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old
* male and female
* coronary artery disease
* criteria of International Diabetes Federation (IDF)

Exclusion Criteria:

* \<18 years old
* incapability for informed consent
* history of malignity, psychiatric disorder, tissue, thyroid gland and renal diseases, anorexia or bulimia
* administration of steroids or hormones
* pregnancy
* body mass index \< 25
Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)

The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is (1) on repetitive administration of cell therapy that would allow for long-lasting improvements in heart function and outcome in this patient population. In parallel, the investigators aim to (2) develop a standardized patient-specific stem cell product that could be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for therapeutic application when clinically indicated. By using a unique multimodality imaging platform, the goal of this project is also to (3) define standardized clinical criteria that would serve as a guideline for evaluation of the effects of stem cell therapy in future clinical trials and everyday clinical settings. Finally, to improve the clinical implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery technique that could be used to treat both left and right and ventricular failure and could be implemented in a standardized fashion designed for a widespread clinical use.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years old
* Diagnosis of DCM according to European Society of Cardiology position statement
* Left ventricular ejection fraction (LVEF) by echocardiography 20-40%,
* New York Heart Association (NYHA) functional class heart failure II or III for at least 3 months before referral.

Exclusion Criteria:

* Acute multi-organ failure
* History of any malignant disease within 5 years
* Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity)
* Pregnancy
DYG Versus Cetrorelix in Oocyte Donation

Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter \>18mm.


Eligibility Criteria:
Inclusion Criteria:

* Oocyte donors between 21 and 30 years old, with regular menstrual cycles (24-35 d) and a body mass index (BMI) between 18 and 28 kg/m2 without any relevant personal or family history

Exclusion Criteria:

* AMH less than 3 ng/dL
* A positive screening for sexually transmitted diseases
Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?

The purpose of this study is to determine whether a modified behavioral treatment for weight loss that includes one-on-one treatment for individuals struggling to lose weight is associated with more weight loss than a standard behavioral treatment.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 27 and 45 kg/m2

Exclusion Criteria:

* participating in a weight loss program or taking a weight loss medication
* currently pregnant, lactating, or less than 6-months post-partum or plan to become pregnant during the time of the intervention.
* report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
* report conditions that would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, sever psychiatric condition, dementia).
Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography

According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every 1-2 years for moderate disease and every 3-5 years for mild disease. This results in a multitude of screening studies in the investigators patient population. 3M has developed a new stethoscope and phonocardiography software capable of identifying the peak intensity of the AS murmur and tracking it as it moves towards the second heart sound potentially indicating increasing severity of disease. Currently there exists no data to demonstrate that the aortic stenosis acceleration index (ASAI) correlates to disease severity or progression of disease. The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. In this study the investigators propose to correlate the ASAI to standard TTE measurements of aortic stenosis severity.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 18 years of age and older.
2. Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
3. Subjects must be able to sit for auscultation examination.
4. Subject must be able to complete a TTE .
5. Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.

Exclusion Criteria:

1. Subjects with significant additional valvular heart disease.
2. Subjects with unrecordable heart sounds.
3. Subjects with known or who may have been previously diagnosed with congenital heart disease.
4. Subjects with atrial fibrillation.
5. Subjects with history of cardiac surgery.
6. Subjects who have conditions which the researcher feels may limit the recordability of the heart sounds or the accuracy of the echocardiogram.
Bioequivalence And Food Effect Study Of Bosutinib In Healthy Subjects

The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive.
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests.

Exclusion Criteria:

* Pregnant or nursing women or women of childbearing potential.
Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis

Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Onset of severe sepsis within the previous 24 hours
* Must be receiving antibiotic therapy
* Informed consent form signed by patient, legal next-of-kin or legal guardian
* Able to take medication by mouth or feeding tube

Exclusion Criteria:

* Receipt of investigational medication within 4 weeks prior to participation in the study
* Pregnant or breast-feeding
* Severe congestive heart failure
* Known severe HIV infection
* Presence of severe burns
* Patients on high dose immunosuppressants
* Patients whose death is considered imminent
* Patients whose life expectancy for concurrent illness is less than 6 months
* Severe hypoxic encephalopathy or persistent vegetative state
* Severe liver disease
* Patient, legal representative or patient's primary physician not committed to providing full, aggressive life support
CRRTNet Registry- A Prospective Observational Registry

An observational registry to monitor the outcome of CRRT in adults with acute kidney injury.

Continuous Renal Replacement Therapy (CRRT) is a form of dialysis provided to critically ill patients with acute renal failure, now known as acute kidney injury (AKI). While we have extensive experience with this therapy in critically ill patients, there is no consensus on when to start CRRT or a clinical standard as to the best possible way to deliver the therapy. Previous studies have examined one aspect of CRRT in detail (for instance the dose of delivered therapy, or anticoagulation strategies) or have been small single center studies, or large multinational studies examining very basic practice patterns. This is a prospective observational cohort study. All patients who receive CRRT as part of their standard of local care will be eligible for the study.

Eligibility Criteria:
Inclusion Criteria: Patients initiating CRRT c. Age \> 18 years of age and \<89 year of age -

Exclusion Criteria: ˂ 18 years of age and \> 89 year of age

-
Wheel Assisted Running Training (WART) in Children With Cerebral Palsy

The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to a conventional mixed physical activity training (CT) program on walking and gross motor function in trained children with cerebral palsy (CP).

Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age 11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM), self-selected and fast walking velocity (SSV and FV, respectively), and cadence are administered by a trained physical therapist. The intervention period is six months, with two sessions per week.


Eligibility Criteria:
Inclusion Criteria:

* (a) medical diagnosis of cerebral palsy;
* (b) ability to comprehend instructions in a group setting;
* (c) no medical procedures involving the lower limbs (including casting and Botox injections) during the last six months prior to pre-testing;
* (d) able to walk three minutes at a self paced speed;
* (e) no seizures during the last year, and (f) functional performance levels between II-IV of the gross motor functional classification system (GMFCS)

Exclusion Criteria:

* (a) GMFCS I or V;
* (b) Not being able to comprehend or comply with instructions.
Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD)

Diabetic kidney disease (DKD) is associated with high rates of cardiovascular events and death. In addition, DKD is the major cause of end-stage renal disease (ESRD) in the United States. The purpose of this study is to prevent progression of kidney disease among patients with DKD and uncontrolled hypertension (HTN) using a tailored, telehealth intervention that simultaneously address medication management and modifies multiple risk factors through a combination of patient self-monitoring, behavioral therapies and education to optimize adherence and self-efficacy. Additional goals are to improve control of cardiovascular disease risk factors and reduce cardiovascular events and death.

We hypothesize that patients with DKD and uncontrolled HTN who receive this intervention will have less progression, or a smaller decrease in kidney function, after 3 years when compared to the education control group.

A randomized, controlled trial to slow DKD progression:

1. Using an innovative telehealth approach that is potentially scalable with demonstrable efficacy in reducing antecedents of kidney disease, including poor blood pressure, glucose, and lipid control
2. Enrolling demographically diverse patients from local primary care clinics to allow applicability of our results to the general US population within existing delivery systems; and
3. Targeting patients with moderate DKD (estimated glomerular filtration rate between 45-90 ml/min/1.73m2 with evidence of diabetic nephropathy) and uncontrolled HTN (blood pressure ≥140/90 mm Hg), accounting for about 20% of all patients with diabetes who disproportionately suffer from end-stage renal disease (ESRD), cardiovascular events, and death.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 and less than75 years
* regular use of the Duke University Health System (≥2 primary care visits in 3 prior yrs)
* diagnosis of type 2 diabetes
* have at least 2 serum creatinine values available in the 3 prior years, separated by at least 3 months;
* preserved kidney function (eGFR between 45-90 ml/min/1.73m2 on most recent creatinine)
* evidence of diabetic nephropathy
* uncontrolled HTN (1y mean clinic SBP≥140 and/or DBP≥90).

Exclusion Criteria:

* no access to telephone
* not proficient in English
* nursing home/long-term care facility resident or receiving home health care
* impaired hearing/ speech/ vision
* participating in another trial (pharmaceutical or behavioral)
* planning to leave the area in the next 3 years
* pancreatic insufficiency or diabetes secondary to pancreatitis
* alcohol abuse (\>14 alcoholic beverages/ wk)
* diagnosis of non-diabetic kidney disease
* active malignancy (other than non-melanomatous skin cancer)
* life-threatening disease with death probable within 4 years
* Secondary hypertension (renovascular disease, Cushing's syndrome, primary aldosteronism, pheochromocytoma, hypo-/hyperthyroidism, hyperparathyroidism, coarctation of the aorta)
* Pregnancy, Breastfeeding
* Long-term or chronic dialysis
* Dementia
* Renal Transplant