cyrilzakka/clinical-trials huggingface dataset:
Inhaled Corticosteroid Use to Prevent Acute Chest Syndrome Recurrence in Children Between 1 and 4 With Sickle Cell Disease: a Feasibility Trial

Acute and chronic pulmonary complications with concomitant inflammatory response are a leading cause of morbidity and mortality in children with sickle cell disease (SCD). Acute chest syndrome (ACS), defined broadly as an increase in respiratory effort, fever and new radiodensity on chest x-ray, is a major cause of death in children and adults with SCD. There is a high rate of ACS in children between 1 and 4 years of age that is associated with an asthma diagnosis, and children with ACS events before 4 years of age have a 50% rate of being hospitalized for either ACS or pain within 1 year of admission. For children with SCD that develop ACS, the investigators propose that the use of budesonide inhalation suspension (BIS) will attenuate pulmonary inflammation after an ACS episode and will decrease future vaso-occlusive pain and ACS episodes. Through a single-arm prospective feasibility trial and in preparation for a limited-institution randomized trial, the investigators plan to test the following primary hypothesis for a phase III definitive trial: In children with SCD admitted to the hospital for an ACS episode between 1 and 4 years of age, low dose BIS for 6 months will result in a 50% reduction in the recurrent incidence rate of ACS or pain requiring hospitalization. Through this trial, the investigators will determine the acceptability of and adherence to BIS in the study population. The investigators will track respiratory symptoms in cases versus controls over 6 months. Finally, the investigators will explore the impact of BIS on biological correlates (sVCAM-1).


Eligibility Criteria:
Inclusion Criteria:

* 1) confirmed diagnosis of sickle cell disease (SCD)
* 2) age between 1 and 4 years (must have reached 1st but not yet 4th birthday)
* 3) a prior diagnosis of ACS, defined as acute respiratory illness with a new radiodensity on CXR, and one of the following: fever (temperature \> 38.50C), decrease in oxygen saturation more than 3% from baseline, or increase in respiratory rate above baseline

Exclusion Criteria:

* 1) patients already taking inhaled corticosteroids
* 2) those receiving blood transfusions for elevated TCD or strokes
* 3) presents over 2 weeks after discharge from hospital following initial ACS episode.

Participants may be on hydroxyurea and participate in this trial.
NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria

Primary objective:

- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria

Secondary objectives:

* To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c)
* To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function
* To assess the safety and tolerability of study drug
* To determine the population pharmacokinetics (PK) of study drug


Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes mellitus according to American Diabetes Association (ADA) definition
2. Age ≥ 18
3. HbA1c between 6.0% and 10.5%, inclusive
4. ACR \> 100 mg/g calculated 3 times in first morning void urine, at least 2 of the measurements \> 100 mg/g
5. Patients on stable (unchanged medication for at least 3 months) treatment to control hypertension, hyperglycemia and (if applicable) dyslipidemia
6. Stable treatment with angiotensin-converting enzyme inhibitors (ACEi) and/or Angiotensin II receptor blockers (ARBs) (renin-angiotensin system \[RAS\] blockade)
7. Willing and able to understand and sign an approved Informed Consent form
8. Men must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment. Women must be of non-childbearing potential.

Exclusion Criteria:

1. Type 1 diabetes mellitus
2. Estimated Glomerular Filtration Rate (eGFR) ≤25 mL/min/1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
3. Recent cardiovascular events (3 months)
4. Uncontrolled hypertension (upper limits 180/110 mmHg)
5. Dialysis and/or acute kidney injury within 3 months before screening
6. Significant edema, infectious diseases, leg ulcers
7. Severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study
8. Treatment with any other investigational agent, or participation in another clinical study within 90 days prior to baseline visit
9. Patient with known infection with human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C
10. In the judgment of the clinical investigator, clinically significant abnormal laboratory values at the screening visit
11. Use of thiazolidinedione class drugs, immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors, two or more diuretic drugs and/or aliskiren
12. In the judgment of the clinical investigator, patients who are likely to be non-compliant or uncooperative during the study.
13. Previous participation in this study.
Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina

The study will determine the feasibility and efficacy of adapting an evidence-based intervention (EBI) to reduce cardiovascular disease (CVD) risk factors in rural African American communities and determine the acceptability of mobile technology in these communities to support behavior change.

Cardiovascular disease (CVD), the leading cause of death in the United States (US), disproportionately burdens rural communities. CVD prevalence rates for residents of rural areas (13.1%) is higher compared to those in urban areas (11.2%) of the US. The proposed settings for this research report similar trends in CVD prevalence, where CVD and stroke are among the top three leading causes of death. In community health assessments conducted in the last three years CVD risk factors such as obesity and hypertension were among the top 10 health priorities in our target counties. Compared to residents of metropolitan areas, rural residents have higher rates of cigarette smoking, obesity, mortality from ischemic heart disease, and are physically inactive. These disparities are likely to widen; at the current rate, its estimated 50% of individuals in the US will have CVD by 2030.

Using a community-based participatory research (CBPR) approach, our specific aims for the study are to:

1. Expand and sustain a coalition of community and academic stakeholders to develop successful CVD risk prevention strategies in rural communities;
2. Conduct a mixed-method community needs and assets assessment based on: a) assemble, review and assess existing sources of CVD data; b) identification of community strengths and resources using a web-based survey of community, faith based, social service and healthcare organizations; c) determine the acceptability of components of CVD risk reduction EBIs and community members' perceptions of possible targets for intervention using focus group interviews; d) determine specific family influences (barriers and facilitators) on acceptability of EBI acceptability;
3. Adapt PREMIER, a multi-component EBI using intervention mapping;
4. Conduct a small-scale randomized control trial to assess a) efficacy; and, b) feasibility and adaption of implementing adapted PREMIER in rural settings.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Aged 21 and older
* Has at least one of the following cardiovascular disease (CVD) risk factors: pre-diabetes, hypertension, obesity, family history of early CVD, prior CVD
* Reside in Nash or Edgecombe counties of North Carolina

Exclusion Criteria:

* Evidence of active or unstable CVD
* Cognitive impairment that limits informed consent
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥22 years of age)
* Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.

  * Sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a Sequential Organ Failure Assessment (SOFA) score ≥2
  * Septic shock: sepsis requiring vasopressors and serum lactate levels \>2 mmol/L (18 mg/dL)
* Admitted or intended to be admitted to the ICU
* At least 3 mL plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock.

Exclusion Criteria:

* Prisoners or imprisonment at time of enrollment
* Prior enrollment into this study
* Informed consent as approved by IRB is unable to be obtained.
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma

This study is being done in order to determine the effectiveness of the combination of fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma. The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet been investigated in patients with mantle cell lymphoma and therefore the combination in investigational.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of Non-Hodgkin's Lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
* Newly diagnosed and patients who have received prior treatment are eligible
* Measurable or evaluable disease
* Karnofsky performance status greater or equal to 50%
* Men and women, age greater or equal to 18 years old
* AGC greater or equal to 1.0; platelets greater or equal to 75,000; Hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
* Creatinine less than 2.0; bilirubin less than 2.0; SGOT less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
* Women of child bearing potential must have negative pregnancy test within 14 days of study entry.
* Signed informed consent

Exclusion Criteria:

* History of congestive heart failure or significant cardiac disease
* Prior exposure to either fludarabine or mitoxantrone. Prior exposure to rituximab allowed
* Active infection
* HIV seropositive
* Pregnant or lactating females
* Second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
* Presence of psychological or emotional disorders which would make valid informed consent impossible
Lipid Lowering in Patients With Statin Intolerance

This study will attempt to further validate a clinical treatment plan to lower LDL values using non-prescription supplements combined with a lifestyle change and education program which could represent an alternative approach to improve compliance in group of people who are unable to take traditional medication to lower cholesterol.

Up to 70 participants will be randomized into 2 groups. Each shall have similar total and LDL cholesterol values obtained prior to the study. Study Group 1 will participate in the Change of Heart Program (an intensive program to make therapeutic lifestyle changes) and take a placebo pill. Study Group 2 will also participate in Change of Heart. Group 2 will be provided an over the counter supplement consisting of red rice yeast 2.4-3.6 gms day)

Blood work consisting of a lipid panel, cardiac CRP, CPK, liver function panel and TSH will be obtained prior to study, and at 12 and 26 wks. Questionnaires will be administered regarding quality of life indexes, and ancillary symptom relief (i.e. degree of arthritis discomfort, generalized weakness) before, 12 and 26 weeks. After the Change of Heart program ends (12 weeks), participants will continue on study medication for a total of 6 months. A final questionnaire and final blood work will be obtained at 6 months, and at that point, medications can be discontinued.

Eligibility Criteria:
Inclusion criteria:

1. Baseline cholesterol - LDL more than 160 with one risk factor or LDL more than 130 with 2 or more risk factors for developing coronary artery disease (Smoker, age \>40, male, Family history, diabetes, obesity) utilizing ATP III guidelines
2. Have had a statin prescribed by a doctor for high cholesterol, and have stopped medication because of side effects
3. Ability to exercise without physical restrictions
4. Ability to attend 12 week consecutive Change of Heart sessions
5. Not taking any cholesterol lowering medication for at least 1 month prior to initiation of trial. Not taking red yeast rice for at least 1 month prior.

Exclusion Criteria:

1. Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year
2. Known intolerance to one of the study drugs
3. Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease
4. Uncontrolled hypertension (defined as SBP\>180 mmHg or DBP \> 100mmHg.
5. Heart attack, bypass surgery, or angioplasty/stent within 1 year of study
6. Triglyceride level more than 400 mg/dl
Switching From Preserved to Preserved-free Treatments for Glaucoma.

A 1-year prospective, randomized, investigator-masked trial comparing the confocal and clinical effects of treatment with unpreserved prostaglandins (tafluprost) versus preserved prostaglandins (latanoprost) in newly-diagnosed glaucoma patients.

The study protocol comprises 5 visits: baseline, month 3, month 6, month 9, month 12.

At baseline a clinical evaluator will perform a complete ophthalmologic evaluation to confirm diagnosis. The following examinations will be done in the following sequence: anterior segment examination, Shirmer test, Break-up time test. Thereafter, a confocal evaluator will perform confocal microscopy of the central and the peripheral cornea. Finally, contact measurements will be done in the following order: IOP (which will be measured at 3 pm), pachimetry (only at baseline visit) and gonioscony (only at baseline visit). A 15 minutes interval will elapse between two consecutive tests.

Eligibility Criteria:
Inclusion Criteria:

* The patient is suffering from ocular hypertension, POAG, PEX, NTG. Glaucoma definition is based on the European Glaucoma Society Guidelines.
* The patient is newly-diagnosed
* No fluorescein staining at baseline and no observable signs of ocular surface disease
* No treatment with topical BAK-containing products for at least 6 months
* Treatment of naïve patients

Exclusion Criteria:

* Unwilling to sign informed consent
* Not at least 18 years old
* Ocular condition that are of safety concern and that can interfere with the study results
* Closed/barely open anterior chamber angles or history of acute angle closure.
* Ocular surgery or argon laser trabeculoplasty within the last year. Ocular inflammation/infection occurring within three months prior to pre-trial visit.
* Presence of the following ocular conditions: KCS, moderate-severe blepharitis, Rosacea, Sjogren syndrome, pterygium, contact lens users.
* Use of concomitant topical ocular medication that can interfere with study medication
* Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
* Any corneal pathology
* Diabetes at any stage
* Other abnormal condition or symptom preventing the patient from entering the trial, according to the Investigator's judgement.
* Refractive surgery patients
* Women who are pregnant, are of childbearing potential and are not using adequate contraception or are nursing.
* Inability to adhere to treatment/visit plan.
* Have participated in any other clinical trial (i.e., requiring informed consent) within one to three month prior to pre-trial visit (depending on ethics committee decisions).
Effect of Intravitreal Bevacizumab on Corneal Endothelium

To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection

Intravitreal Bevacizumab has been used by retinal specialist in treatment many retinal diseases. Although it not approved by FDA for treatment. In many In vitro studies, its showed saftey in the eyes especially for corneal endothelium cells, that important cells to keep cornea clear. This study use Confoscan-Corneal confocal microsope to evaluate corneal endothelium before and after intravitreal Bevacizumab injection in routine retinal disease at 6 month follow up.

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 80 years old
* can come to regular follow up at 6 month
* signed written consent forms
* not have corneal scar, or glaucoma
* history of treatment with laser or anti-VEGF therapy in 3 month prior to recruit
* high risk in cerebrovascular and cardiovascular diseases
* Pregnancy and breastfeeding
* can undergo confocal microspopy

Exclusion Criteria:

* History of intraocular surgery or ocular trauma during study
Ulinastatin Improves Postoperative Oxygenation After Cardiopulmonary Bypass

Retrospective study determine whether ulinastatin enhances postoperative pulmonary oxygenation after cardiopulmonary bypass (CPB).

This retrospective study evaluate patients who underwent aortic valvular surgery under moderate hypothermic CPB. The patients were classified into two groups: patients in whom high-dose ulinastatin (10,000 U/kg and 5,000 U/kg/h) was administered during CPB (Group-U); and patients in whom ulinastatin was not administered (Group-C). We measured PaO2/FiO2 at the following time points: before CPB (Pre-CPB), 2 hours after weaning from CPB (Post-CPB) and within 6 hours after admission to the ICU. The lengths of ventilator care and ICU stay were also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent aortic repair or replacement under moderate hypothermic CPB

Exclusion Criteria:

* Preoperative:

\< 19 years old, \> 85 years old, emergency operation, reoperation, left ventricular ejection fraction \< 50%, arrhythmia, ischaemic myocardial disease, uncontrollable hypertension or hypotension, pericardial disease, pre-existing hepatic dysfunction, pre-existing renal dysfunction or underlying lung disease.

* Intraoperative:

intraoperative application of an intra-aortic balloon pump, administration of steroids or tranexamic acid, and transfusion of fresh frozen plasma or platelet concentrates during CPB.

* Postoperative:

reoperation for surgical correction of intractable postoperative bleeding within 2 hours after the end of surgery and transfusion of any banked blood products.
A Structured Protocol to Evaluate Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette) Efficacy and Safety of a Popular Electronic Nicotine Delivery Device (E-Cigarette)

The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (E-Cigarette) loaded with low dose nicotine to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to investigate changes in withdrawal symptoms and cravings and to examine whether concomitant use of the E-Cigarette and smoking is safe. The study will monitor smoking reduction/abstinence effects, changes in withdrawal symptoms, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette) using initially for 6 weeks "ORIGINAL" 7.4 mg nicotine cartridges followed by a further 6 weeks of "CATEGORIA" 5.2 mg nicotine cartridges. The primary hypothesis is that the E-Cigarette used in a structured protocol is a safe device that allows smoking reduction or abstinence in smokers possibly by suppressing withdrawal symptoms and cravings.

The electronic cigarette (E-Cigarette) is an electronic nicotine delivery systems designed for the purpose of nicotine delivery to the respiratory system where nor tobacco nor combustion are necessary for its operation. For these reasons, it is possible that this product may be safer than cigarettes. Marketing claims also include that they can be useful smoking cessation aids. Although E-Cigarette may produce lung delivery of nicotine similar to that of tobacco cigarettes and reproduces the gesture component associated with tobacco smoking, very little is known about the effect of E-Cigarette on the smoking habits of regular tobacco smokers. Therefore, we designed a prospective observational study consisting of 8 office-based visits (a baseline visit and a 2, 4, 6, 8, 10, and 12-weeks and a final visit at 24-weeks) to monitor possible modifications in the smoking habits of a group of well characterized regular smokers experimenting the e-cigarette focusing on long-term smoking reduction/abstinence, changes in withdrawal symptoms/cravings and adverse events. Specifically, 100 smokers will be given "Categoria" electronic cigarette initially loaded with "ORIGINAL" 7.4 mg nicotine cartridges for 6 weeks followed by "CATEGORIA" 5.2 mg nicotine cartridges for a further 6 weeks. A final follow up visit will be carried out at 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* healthy smokers unwilling to quit
* 18 and 60 years of age
* cigarette intake of ≥ 15 cig/day for at least 5 years
* CO level of ≥ 15 ppm
* FTND ≥ 5

Exclusion Criteria:

* alcohol and illicit drug use
* breastfeeding, or pregnancy
* current attempts to quit smoking
* previous experience with electronic cigarettes