cyrilzakka/clinical-trials huggingface dataset:
Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Man, or non-pregnant woman
* Admitted to the hospital with a diagnosis of acute decompensated heart failure
* On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission
* Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)
* Provide written informed consent

Exclusion Criteria:

* New diagnosis of heart failure
* Acute coronary syndromes
* Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment
* Contraindications to systemic anticoagulation
* Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days
* Sepsis or ongoing systemic infection
* Active myocarditis
* Constrictive pericarditis or restrictive cardiomyopathy
* Severe aortic stenosis
* Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival
Educating Providers About Lung Screening

We are conducting a randomized trial to compare the Health Disparities module to an existing provider module on lung cancer screening to evaluate the impact on primary care providers' knowledge, attitudes, and lung cancer screening referrals of African American and White patients.

We are conducting a randomized trial of two online, provider-facing education modules regarding lung cancer screening and smoking cessation. We will accrue 70 MedStar primary care providers (PCP). The baseline survey will incorporate items regarding lung cancer screening knowledge, providers' attitudes towards lung cancer screening, lung cancer screening ordering practices and provider characteristics. At the end of the baseline survey, PCPs will be randomly assigned to the LuCa + Health Disparities or LuCa only. PCPs will be asked to complete the intervention and the post-test within 1 week of randomization. The post test will cover knowledge of lung cancer screening, attitudes and opinions toward LCS. To assess PCP lung cancer screening ordering practices, we will review the MedConnect Electronic Health Record (EHR) to compare the two study groups post-randomization on the number of orders made for LCS.

Eligibility Criteria:
Inclusion Criteria:

* MedStar provider (attending or resident physician, physician's assistant, or nurse practitioner)
* English speaking
* ability to provide meaningful consent
* ability to provide last two digits of NPI.

Exclusion Criteria:

* N/A
Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients

The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and tolerability of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride to those of Levocetirizine and Montelukast monotherapies in Perennial Allergic Rhinitis (PAR) patients.

randomized, double-blind, active-controlled, multicenter, phase 3 trial

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 2 years history of PAR prior to the study
* Positive results of skin prick test
* Patients who provided a signed written informed consent form
* Patients who are able and willing to complete subject diaries
* Patients who agree to maintain consistency in their surroundings throughout the study period
* At Visit, 2 patients whose symptom scores recorded in the subject diary meet all of the followings during the last one week of baseline period A.Daily mean of 6 points or above for Daytime Nasal Symptom Score (maximum 12 points) B.Daily mean of 1.8 points or above for Daytime Nasal Obstruction Symptom Score (maximum 3 points)

Exclusion Criteria:

* Patients also with non-allergic rhinitis with different causes.
* Patients with severe asthma who meet the followings.
* Presence of nasal polyps or any clinically important nasal anomaly.
* History of acute • chronic sinusitis within 30 days of Visit 1
* History of intranasal / eye surgeries within 3 months of Visit 1
* Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
* Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
* Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug
* At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period
Sustained Viral Response in Chronic Hepatitis B Patients Who Achieved HBeAg Seroncongversion After Interferon Therapy

Chronic hepatitis B (CHB) is a serious liver disease worldwide, and the leading cause of cirrhosis and hepatocellular carcinoma (HCC). HBeAg seroconversion is considered to be the satisfied endpoint of antiviral therapy in HBeAg-positive chronic hepatitis B patients. However, HBV reaction, even reverse back to HBeAg positive and clinical relapse could occur in some patients who achieved HBeAg seronconversion by interferon treatment. In this study, the long-term efficacy of interferon therapy in HBeAg positive patients achieved HBeAg seronconversion after interferon treatment and the factors associated with viral and clinical relapse will be observed.

HBeAg positive chronic hepatitis B patients achieved HBeAg seronconversion by interferon treatment will be enrolled and observed for 156 weeks. Serum HBV DNA, HBsAg, anti-HBs, HBeAg, and anti-HBe will be measured every 3 months during the observation period, liver function tests were performed every 3 months also. The liver ultrasonic examination would be taken every 3-6 months. The primary endpoint is sustained viral response, and secondary endpoints is HBV DNA reaction and clinical relapse defined as virla relapse with abnormal ALT during observation period.

Eligibility Criteria:
Inclusion Criteria:

* patients who achieved HBeAg seroconversion by interferon treatment.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
The Application of 3T MRI in Esophageal Cancer

It is very significant that assessing TN staging in esophageal cancer patients before surgery, furthermore, determining the optimize surgical strategy, predict the the efficacy of radiotherapy for patients who were not chosen to be surgeried, and define the range of lymph node for radiotherapy. It has been reported that the application of MRI in metastasis of lymph node of other cancer, but not in metastasis lymph node with esophageal cancer. Only a few studies focused on T staging using conventional MRI in esophageal cancer, however, relatively new sequences in the chest deserve widely used. To develop a pre-treatment evaluation methods for TN staging in patient with esophageal cancer by utilization of the new imaging methods (T2-TSE-BLADE, T2 maps, StarVIBE). By analysising the relationship between TN staging and imaging features to find the imaging characteristics for TN staging, and to find the indicators of magnetic resonance imaging new technology and reference values for facilitate pre-treatment diagnosis of lymphnode metastasis, optimize surgical strategy, predict the the efficacy of adjunctive therapy, and OS and define the range of lymph node for radiotherapy, as making personal treatment planning for esophageal cancer.

To explore the value of 3 T MRI using multiple sequences, including T2-TSE-BLADE, T2 maps and StarVIBE, in evaluating the preoperative TN staging and prediction of response to neoadjuvant therapy and OS in patients with esophageal cancer.

Patients with endoscopically biopsy-proven EC were prospectively enrolled for imaging on a 3 T scanner. The MRI protocol included T2-TSE-BLADE, T2 maps and StarVIBE sequences, and so on. Patients received treatment according to NCCN guideline. Readers assigned a TN stage on MRI, and post-operative pathologic confirmation was considered the gold standard. Inter-reader agreement, the diagnostic accuracy of TN staging on MRI were analyzed and compared to post-operative pathologic TN staging. MRI features were analyzed to find the correlation between pretreatment MRI features and response or OS. The study will includ 400 patients. Inter-reader agreements of TN staging were analyzed excellent for MRI. Diagnostic accuracy of MRI will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with preoperative pathologically con-firmed EC by endoscopy and preoperative imaging data (esophagography\\CT\\EUS\\MRI) were included.
2. No contraindications for MRI examination.
3. The patients participate in this study with informed consent.

Exclusion Criteria:

1. The patients couldn't performed MR scanning or artefacts affect the evaluation.
2. ThePatients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
3. PatientsThe patients refuse to participate in the project.
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a traumatic spinal cord injury.
2. Subject is male and is 18 years or older.

Exclusion Criteria:

1. Subject has been injured less than 1 year.
2. The subject is known to be azoospermic.
3. The subject has an indwelling urethral Foley catheter.
4. Subject is under the age of 18 years.
5. Subject has an unstable medical condition including, but not limited to, Crohn's disease, ulcerative colitis, colon cancer or has other conditions deemed to be exclusionary per the Investigator.
6. Subject is unable to consent or comprehend the procedures and their implications.
7. Subject has a permanent implanted electrical device, i.e., cardiac pacemaker, phrenic nerve stimulator, spinal cord stimulator, etc.
8. Any subject for whom the procedure or medication is otherwise contraindicated.
9. Subject has hypersensitivity to probenecid.
10. Subject has a history of uric acid kidney stones and/or peptic ulcer.
11. The subject has had a febrile Urinary Tract Infection (UTI) within the 2 months prior to enrollment.
12. The subject is taking methotrexate, aspirin, other salicylates, or anti-inflammatory medicines.
13. The subject has a history of Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.


Eligibility Criteria:
Inclusion Criteria:

* Give their signed written informed consent to participate.
* Are at least 40 years of age and no older than 80 at Visit 1.
* A female of non-child bearing potential or child bearing potential, has a negative serum pregnancy test, and agrees to approved contraceptive methods.
* COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society(ATS)/European Respiratory Society (ERS).
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
* FEV1/FVC ratio of \<0.70.
* Post-bronchodilator FEV1 must be ≥ 30% and \<80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations, and must also be greater than or equal to 750 mL.
* Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.

Exclusion Criteria:

* Pregnancy, nursing females or subjects trying to conceive.
* Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study.
* Current primary diagnosis of asthma.
* History of ECG abnormalities.
* Poorly controlled or worsening COPD prior to Screening or during the Screening Period.
* Clinically significant bladder neck obstruction or urinary retention.
* Male subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening.
* Cancer that has not been in complete remission for at least five years.
* Inadequately treated glaucoma.
* History of allergic reaction or hypersensitivity to any component of the formulations used in this study.
Radiotherapy vs Observation for CRPC

The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
2. Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal.
3. Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies.
4. Normal cardiac function was required.

Exclusion Criteria:

1. patients had a Karnofsky performance-status score of at most 60 percent
2. prior treatment with cytotoxic agents or radioisotopes
3. with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.
Management of Tubo-ovarian Abscess: a Single Center Experience

Electronic database of our tertiary obstetrics and gynecology clinic was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities.

This retrospective study is conducted at Health Sciences University Turkey, Sisli Hamidiye Etfal Training and Research Hospital Department of Obstetrics and Gynecology. Electronic database was searched for patients who were treated for tub-ovarian abscess during the last 10 years (January 2010- November 2020). Patients' biometric data, admission date and duration, medical and surgical treatment modalities were recorded using an Excel sheet. Patients will be evaluated on the basis of the treatment they receive, length of treatment, if surgically treatment the type of surgery performed. Hospitalization length, readmission, recurrence will be compared between treatment modalities. A change in management strategy over the years if any will be reported.

Eligibility Criteria:
Inclusion Criteria:

* presence of a pelvic mass \> 3 cm with transvaginal ultrasound or magnetic resonance imaging indication abscess
* cervical and uterine tenderness
* abdominal rebound-defense under physical examination indication peritoneal irritation
* presence of symptoms such as fever, pelvic pain and increase in laboratory infection parameters

Exclusion Criteria:

* Patients with known malignities
* Patients with incomplete data in the clinic's electronic database
* Patients who continued their treatment at other centers
Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents

In this multicenter cluster randomized controlled trial stratified by school baseline prevalence of smoking will be randomly allocated to the control or intervention group. Control schools will receive normal smoking education and intrvention schools will receive a four year class-based curriculum intervention (22 Classroom lessons), reinforcement of smoke-free school policy, smoking cessation in parents, pupils, and teachers and information and annual meeting with parents.

Study participants will be children aged 12 to 15 years old ; they will be followed to 2 years after high school. External evaluator and analyst will be blinded to school allocation.

The aim of this study is to analyze the effectiveness of a complex intervention to reduce the prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old) .


Eligibility Criteria:
Inclusion Criteria:

* Children at first of Secondary education.
* Adolescents and parents accept and sign informed consent

Exclusion Criteria:

* None
High Density Lipoprotein Subspecies and Coronary Disease

To investigate the relative contributions of high density lipoprotein-C (HDL-C) subspecies to risk for coronary heart disease (CHD) in two distinct existing populations (samples from the VA-HIT study and the Framingham Offspring Study \[FOS\]) as well as the response of these subfractions to gemfibrozil treatment.

BACKGROUND:

Coronary heart disease (CHD) continues to be a leading cause of death and disability in the United States. Information about the contribution of different subspecies of HDL-C to increased or decreased risk for premature CHD and the extent to which common lipoprotein lipase (LPL) mutations affect HDL-C composition and subspecies could contribute to an increased understanding of the role of HDL-C in determining CHD risk.

DESIGN NARRATIVE:

The following parameters will be measured in blood samples collected from the VA-HIT study and the Framingham Offspring Study: apo A-I-containing HDL subspecies (prebeta, alpha, and prealpha) in plasma using two-dimensional gel electrophoresis immunoblot and image analysis, LpA-I and LpA-I/A-II in plasma using differential electroimmunoassay, and apo C-III in HDL using immunoturbidometric assay. The study hypotheses are as follow. a) Subjects from the placebo arm of VA-HIT will have significantly lower alpha l HDL subspecies, LpA-I, and apo C-III in HDL, and higher HDL/alpha l and apo A-I/alpha l ratios than subjects free of coronary heart disease from the Framingham Offspring Study. b) These parameters will also predict prospectively risk of coronary heart disease in both groups. c) In the VA-HIT study, treatment with gemfibrozil, which has been shown to be associated with a 22 percent reduction in myocardial infarction and coronary heart disease death, will be associated with increases in alpha l HDL subspecies, LpA-I, and apo C-III in HDL, as well as decreases in HDL/alpha l and apo A-I/alpha l ratios, compared to placebo. d) The hypothesis that subjects with specific mutations in the lipoprotein lipase gene have less beneficial changes in HDL subspecies with gemfibrozil than subjects with no mutations will also be tested.

Eligibility Criteria:
VA-HIT: men, established CHD, HDL-C\<40 mg/dl, LDL-C \< 140 mg/dl, TG \< 300 mg/dl FOS: men having no evidence of CHD
A Study to Select the Dose and Evaluate the Effectiveness and Safety of the Drug Refralon®, Tablets, 1 mg for Long-term Use to Prevent Recurrence of Atrial Fibrillation/Flutter After Terminating Its Persistent Form

Refralon® tablets in two different doses (1 or 2 tablets per day) will be evaluated vs. placebo in patients with persistent atrial fibrillation/flutter after synus rhythm restoration in order to prevent recurrence of arrhythmia. Efficacy and safety of Refralon® tablets will be studied, its optimal dose will be selected and its pharmacokinetics will be evaluated in 14 days, 1, 3 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Persistent form of AF/AFL lasting 7 days - 1 year (including patients who have previously undergone ineffective catheter or surgical ablation of AF or AFL and patients with a pacemaker or implanted cardioverter-defibrillator (ICD));
* Basic rhythm - AF and/or AFL according to the results of 12-lead ECG at randomization (Visit 2);
* Left ventricular ejection fraction (LVEF) \>40% according to the Simpson method;

Exclusion Criteria:

* Intake of class IA, IC and class III antiarrhythmic drugs less than 7 days (for amiodarone less than 60 days) before the study drug intake;
* History of myocardial infarction or other structural heart disease;
* QT prolongation over 500 ms.
Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects


Eligibility Criteria:
Inclusion Criteria:

* Women not of childbearing potential (WNOCBP) and males. Women must have documented proof they are not of childbearing potential
* BMI of 20.0 to 38.0 kg/m2, inclusive
* Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen
* Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values

Exclusion Criteria:

* Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation
* Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing
* Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months
* Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug

Other protocol defined inclusion and exclusion criteria may apply