cyrilzakka/clinical-trials huggingface dataset:
Role of Estrogen in the Flarring up of Lupus Nepheritis

Role of estrogen in the flarring up of lupus nepheritis

Systemic lupus erythematosus SLE is an autoimmune disease that affects ∼5.5 per 100,000 individuals worldwide . SLE is characterized by loss of tolerance against nuclear autoantigens, lymphoproliferation, polyclonal autoantibody production, immune complex disease, and multiorgan tissue inﬂammation. Up to 50% of SLE patients develop some degree of renal involvement, with up to 20% progressing to end-stage renal disease, depending on racial background . Lupus nephritis LN is characterized by anti-nuclear Ab production, immune complex deposition, and immune-mediated kidney damage. Development of LN remains a sign of poor prognosis and is a signiﬁcant cause of morbidity and mortality . Because 9 of 10 SLE patients are women, the role of the sex hormones estrogens in this disease is of key interest. Estrogens signal through two receptors: estrogen receptor a ERa and estrogen receptor b ERb. In contrast to estrogen receptor b, ERa is found in female reproductive organs, yet is robustly expressed in kidney, liver, heart, and lungs in males and females,as well as on most immune cells however the kidney is considered the most estrogenic nonreproductive organ. The overwhelming female predominance for SLE begins at puberty and extends to menopause , supporting the concept that estrogens or other reproductive factors stimulate lupus development. This concept is further evidenced by reports of menstrual cycle flares of SLE , disease exacerbations by oral contraceptives or estrogen administration , and induction of lupus by ovulation regimens . Ultraviolet rays has arole in the flarring up SLE. There is evidence that fibroblasts and blood lymphocytes from SLE patients are hypersensitive to the cytotoxic effects of UV light radiation

. RNA and protein synthesis is also affected by UV light 18. A study from 1986 found that people were more likely to menstruate during a new moon, which occurs during the opposite half of the lunar cycle than the full moon . There are different evolutionary theories speculating why the human menstrual cycle length evolved to be so close to the lunar cycle in length. Stories and beliefs connecting the two are also found in various cultures and mythologies . The terms menstruation and menses even come from Latin and Greek words meaning month mensis and moon mene

Eligibility Criteria:
Inclusion Criteria:

1. Patients with SLE complicated with LN.
2. Patients with age more than 18 years old.

Exclusion Criteria:

* 1- Pragnancy, lactation. 2- Menpause. 3- Primary amenorrhea. 4- Patients with current use of oral contraceptive agents. 5- Patients who receive pulse therapy during the study
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure

The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, regardless of color or social class
* Age over 18 years with a good clinical medical criteria
* Patients who agreed to participate and signed the Informed Consent
* Insufficient patients in chronic renal dialysis schedule (3 times per week)
* Patients with creatinine clearance \<30ml/min
* Patients with indication for anticoagulation during hemodialysis

Exclusion Criteria:

* Patients with sensitivity to heparin sodium;
* Patients with hypersensitivity to benzyl alcohol
* Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer
* Patients with a history of peptic ulcer
* Patients with body mass index greater than 30
* Cancer patients because of the possibility of compromising the function of the variable coagulation
* Patients in period of pregnancy or after delivery
* Patients with genetic abnormality of the clotting system
* Polytraumatized patients
* Patients using glucocorticoids for at least 1 month
* Patients using other anticoagulants
* Patients with high rate of bleeding
* Patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery
* Hypertension above 140/90 mmHg
* Patients using medications that could affect hemostasis
* Patients using the following medicines: hormonal anti not including Ketorolac; Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.
Fluid ORiented Therapy for yoUNg Asa 1patients

In this retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic was managed by using the FloTrac system; in the control group a standard hemodynamic monitoring was used.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1

Exclusion Criteria:

* cardiac diseases
* pulmonary diseases
* renal diseases
* metabolic disorders
Multiple Biomarkers in ICU Sepsis Patients

Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients.

Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Research on AKI has focused on new damage biomarkers for early detection of AKI and worsening of renal function. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining functional and damage markers as well as oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients. Therefore, this prospective, observational study will be conducted in Mainland China

Eligibility Criteria:
Inclusion Criteria:

* sepsis patients in appropriate age

Exclusion Criteria:

* ever blood transfusion ever CPR（cardiopulmonary resuscitation)
Radiation Eliminates Storming Cytokines and Unchecked Edema as a 1-Day Treatment for COVID-19

This phase I/II trial studies low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS associated with COVID-19 infection.

PRIMARY OBJECTIVE:

I. To compare treatment of COVID-19 between best supportive care plus provider's treatment choice versus best supportive care plus low-dose, whole-lung radiation therapy

OUTLINE:

Patients undergo 1 fraction of low-dose radiation therapy.

After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Have had a positive test confirming the diagnosis of COVID-19
* Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment)
* Have visible consolidations/ground glass opacities on chest x-ray or computed tomography
* Have received pre-intubation respiratory support or undergone endotracheal intubation and have been on ventilator support for no longer than 5 (five) calendar days prior to the schedule date of delivery of low-dose radiation therapy.
* Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions
* Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation

Exclusion Criteria:

* No use of disallowed medications 1 day prior to delivery of LDRT: Azithromycin, chloroquine, hydrochloroquine, COVID-targeted antiviral medications
* Pregnant and/or planned to be pregnant within in next 6 months
A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients

Subjects with hematologic malignancies or recipients of a first allogenic or autologus hematopoietic stem cell transplant, without any evidence or respiratory infection, will receive 4 doses of PUL-042 Inhalation Solution over a 2 week period. Subjects will be evaluated for tolerability of the drug. If tolerated, dose escalation may occur with up to 4 dose levels tested

This is an open-label multiple ascending dose study with a 3+3 study design to examine the safety and tolerability of PUL-042 Inhalation Solution in subjects with hematologic malignancies or recipients of a first allogenic or autologus hematopoietic stem cell transplant. Subjects will receive 4 doses over 2 weeks.

Cohort size will be 3 subjects, once 3 subjects have completed treatment and follow-up at a dose level, subject data will be evaluated by an independent data safety monitoring committee prior to dosing additional subjects. The Committee may recommend increasing the dose, maintaining the same dose, or decreasing the dose.

Once the maximum dose is determined, there may be up to 6 additional subjects dosed at that level.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with hematologic malignancies or recipients of a first allogeneic or autologous hematopoietic stem cell transplantation and presently clinically stable
2. Pulse oximetry of hemoglobin saturation ≥92% on room air
3. Adult (≥18 years)
4. Spirometry (FEV1 and forced vital capacity \[FVC\]) ≥80% of predicted value
5. If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control
6. If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study
7. If male, must be surgically sterile or willing to practice two effective methods of birth control
8. Ability to understand and give informed consent

Exclusion Criteria:

1. Subjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI)
2. Known history of chronic pulmonary disease
3. Subjects who are being treated for fungal, viral, or bacterial pneumonia
4. Exposure to any investigational agent (defined as any agent not approved by the Food and Drug Administration \[FDA\]) within 30 days prior to the Screening Visit
5. Patients with a relapsed and/or refractory underlying hematologic malignancy
6. HSCT recipients who underwent ex vivo T-cell depletion of the graft, or a mismatched, or cord or haplo identical blood transplantation
7. HSCT recipients with active and/or chronic graft versus host disease
8. Patients on systemic corticosteroids (oral or intravenous)
9. Absolute neutrophil count (ANC) \< 1,000 cells/mL
10. Clinically significant bacteremia or fungemia
11. Current smokers or subjects with any history of smoking
A Critical Pathway for Implantable Cardioverter-Defibrillators in Patients With Ischemic Cardiomyopathy

The purpose of this study is to develop and implement a critical pathway to identify patients with ischemic cardiomyopathy who are candidates for an implantable cardioverter-defibrillator (ICD). This study will also determine whether the use of the critical pathway for ICDs is associated with a change in the ICD referral and implantation rate.

Despite improvements in both medical management and revascularization strategies, sudden death is still a significant complication in patients with ischemic cardiomyopathy. There is strong evidence to support the role of ICDs for the primary prevention of sudden death in this population. However, in Canada and the United States, ICDs are underutilized.

Critical pathways are algorithms that improve health care delivery and clinical outcomes while reducing practice variability. The use of a critical pathway to assess a patient's eligibility for an ICD may increase the appropriate use of this evidence-based technology.

Eligibility Criteria:
Inclusion Criteria:

* acute ST segment elevation myocardial infarction (STEMI)
* candidate for percutaneous revascularization
* permanent residents of British Columbia, Canada

Exclusion Criteria:

* patients with heart disease or a comorbid illness who have a documented life expectancy of less than 1 year
SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.

The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.

The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 anni -85 years
* PS according to ECOG 0-2
* Histopathologically confirmation of soft tissue sarcoma
* Metastatic lung lesion less than 4
* Controlled primary tumor and other metastatic lesions
* Metastatic lesion less than 5 such as the definition of oligometastatic patients
* Written informed consent
* Contraindication to surgical resection
* Estimated survival ≥ 3 months
* Absence of progressive disease longer than 6 months
* No chemotherapy was given for at least 3 months after SBRT
* Maximum diameter ≤ 5 cm

Exclusion Criteria:

* Prior thorax radiation therapy
* Age \> 85 years
* PS according to ECOG \>2
* Pregnant women
* Maximum diameter ≥ 5.1 cm
* Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima
Effect of Liraglutide on Heart Frequency in Healthy Volunteers

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered as positive control.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Fasting plasma glucose within normal limits (80-100 mg/dl)
* BMI (Body Mass Index): 20.0-29.0 kg/m\^2 (inclusive)
* Heart rate within the range of 50-90 beats per minute (inclusive)
* Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion Criteria:

* Any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease
* Any clinically significant disease history, in the opinion of the investigator, of cardiovascular disease
* Clinically significant abnormalities on any pre-study clinical examination or any abnormal laboratory measurements during screening
* A family history of sudden cardiac death at age less than 50 years old
* T-wave abnormalities
* Individual or familial history of long QT Syndrome
* Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody or HIV (human immunodeficiency virus) antibody
* Positive results on the urine drug and alcohol screen
* Any regular use of prescription or nonprescription drugs or vitamins and herbal/nutritional supplements that cannot be stopped at screening
* Any strenuous exercise (as judged by the investigator) from 4 days prior to randomisation and during the entire trial period
* Blood donation, trauma or surgery with blood loss exceeding 500 ml within the last 2 months prior to dosing
* Subject is a smoker, occasional smoker or has a history of smoking (or use of any tobacco) within the last 3 months
* Excessive use of methylxanthine-containing beverages (more than 8 cups/day of coffee, tea, soda or chocolate)
* Females who are pregnant, breastfeeding, intend to become pregnant within the next 3 months, or who are judged to be using inadequate contraceptive measures
* A history (within the last 2 years) of drug or alcohol abuse
Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households

The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S. over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited. The proposed research will develop, evaluate and disseminate a brief smoke-free homes intervention through the established national infrastructure of 2-1-1 call centers. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services.

The proposed research has four specific aims: 1) Conduct formative research on intervention messages and materials for promoting smoke-free homes in low-income populations, applicable to both smokers and nonsmokers as household change agents; 2) Conduct a randomized controlled trial in the Atlanta 2-1-1 service area to evaluate the efficacy of a brief intervention to create smoke-free homes among 2-1-1 callers; 3) Conduct replication studies in Houston and North Carolina 2-1-1 systems to systematically test the intervention in varied populations and tobacco control climates, and 4) Disseminate the research-tested smoke-free homes intervention through a variety of mechanisms including a national grants program to 2-1-1 systems and through the Tobacco Technical Assistance Consortium's linkages to the state and local tobacco control infrastructure in the U.S.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older.
* Must speak and understand English.
* Must smoke and live with at least one other non-smoking person OR be a non-smoker who lives with a smoker(s).
* Must not have a total smoking ban in their home.

Exclusion Criteria:

* None
Effectiveness of a Home-based Pulmonary Rehabilitation Program in COPD Patients

The study aims to develop and test the effectiveness of a new home-based pulmonary rehabilitation program comprising two distinct phases, the first in which an 8-week respiratory rehabilitation program is carried out the second in which a maintenance pulmonary rehabilitation program is carried out.


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnose with B or E characterization according to GOLD criteria;
* Residence in the area covered by the institution where the study is carried out

Exclusion Criteria:

* Frequency of a PR programme in the previous six months
* COPD exacerbation for less than one week;
* Presence of unstable comorbidities (List of predetermined diagnoses that constitute absolute exclusion criteria);
* Presence of comorbidities that constitute relative exclusion criteria through a medical evaluation.
* Score of the Clinical Frailty Scale 2.0 above six or above five in case of not having a responsible caregiver and living alone
* SpO2 below 85% in the 6-minute walk test
Dry Eye Treatment With Artificial Tears

Dry eye is a chronic irritating eye condition that affects many people, caused by poor tear quality and insufficient quantity. Treatments are traditionally in the form of artificial tears applied to the ocular surface. However, there is little evidence in the scientific literature that demonstrates their efficacy relative compared to each other, nor how to decide which one might be most effective for an individual patient. Therefore the investigators aim to examine the efficacy of different classes of artificial tears (those designed to increase viscosity, reduce evaporation or to mimic the component balance of the natural tears). In addition, the investigators also aim to determine how the treatment preferred by an individual could potentially have been predicted from their baseline condition.

The efficacy of different classes of artificial tears (non-pharmaceutical) will be examined in patients that report dry eyes by prescribing each category of treatment \[0.40% Sodium Hyaluronate (Clinitas Soothe), 0.15% Sodium Hyaluronate (Hyabak), 0.25% Carboxymethylcellulose, electrolyte balanced (Theratears), and Phospholipid liposomal spray (Tears Again)\] for a month in turn following a short wash-out period and to examine their tear film and ocular surface after each one.

Eligibility Criteria:
Inclusion Criteria:

* subjective symptoms indicative of dry eye

Exclusion Criteria:

* Diabetes
* Sjögren's Syndrome
* recent ocular infection
* hay fever
* used any eye drops or ocular medications,
* were currently on medications known to affect the eyes
* wore contact lenses
* were pregnant.