cyrilzakka/clinical-trials huggingface dataset:
Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results

First Sense Medical®, LLC is a medical device company developing a novel breast cancer screening tester called the First Sense Breast Exam® Tester. This radiation free tester is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. When the tester is in production, a test will take approximately 7 minutes and will be performed in a doctor's office.

This study is designed to evaluate the First Sense Breast Exam® test and the analysis by Therma-Scan. The First Sense Breast Exam® test is an adjunct to a mammogram. Currently, mammography is the standard of care in screening for breast cancer, and manual thermology is an adjunctive screening method. All of the study costs will be incurred by the sponsor and the subject will incur no costs to participate in the study. The First Sense Tester is a non-significant risk device where the tester's imaging camera makes no contact with the subjects during the entire procedure.

Eligibility Criteria:
Inclusion Criteria:

* Female, over the age of 18 years of age.
* Asymptomatic women and women who are being screened for breast abnormality.
* Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
* Not pregnant or breast feeding.
* Signed Informed consent.

Exclusion Criteria:

* Subject does not meet inclusion criteria, noted above.
* Use of niacin or niacin patch.
* Use of nitroglycerin.
* Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
* Patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.).
* History of breast cancer
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus

The purpose of this study is to determine the ability of XmAb5871 to maintain Systemic Lupus Erythematosus (SLE) disease activity improvement achieved by a brief course of disease-suppressing steroid therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of SLE as defined by the ACR criteria
* Patients have a history of a (+) ANA, (+) ENA or a (+) anti-dsDNA serology documented within one year prior to randomization
* Investigator has assessed the patient and in their judgment, the SLE disease activity is not organ threatening
* Both investigator and patient agree that it is acceptable to discontinue their current immunosuppressant SLE medications and receive a brief course of IM steroid therapy
* If patients are on oral steroids, they must be on the equivalent of ≤15 mg/day of prednisone to enter screening, and must be able to taper to ≤10 mg/day by randomization

Exclusion Criteria:

* History or evidence of a clinically unstable/uncontrolled disorder, condition or disease, other than SLE that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures or completion
* Patients who have organ threatening manifestations of SLE including active Class 3 or 4 lupus nephritis requiring induction or maintenance therapy or any other disorder for which stopping SLE therapy is contraindicated
* Active CNS lupus such as seizures or psychosis that in the opinion of the investigator would preclude participation
* Unstable hemolytic anemia or thrombocytopenia
* Patient is pregnant or breast feeding, or planning to become pregnant while participating in the study
* Use of any biologic therapy (including belimumab) within 6 months of randomization, or prior exposure to a monoclonal antibody directed to CD20 (such as rituximab) within 12 months of randomization
Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound：a Randomized Controlled Trial

The goal of this randomized control trial is to compare the efficacy and safety of Platelet Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question it aims to answer are:

* Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma in treatment of diabetes foot ulcer？
* Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in treatment of diabetes foot ulcer？ Participants will be assigned with a 1:1 ratio into intervention group and control group.

Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is aged 18-80 years old;
2. Diagnosed as type 1 or type 2 diabetes according to the World Health Organization standard, blood sugar has been controlled before enrollment, and the level of Glycated hemoglobin HbA1c is less than 10%;
3. diabetes wounds with poor healing or prolonged healing need standard wound treatment;
4. There is no disseminated infection or the disseminated infection has been controlled;
5. After preparing the wound bed, the condition for using platelet plasma to close the wound is met;
6. Voluntarily sign an informed consent form;

Exclusion Criteria:

1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
2. Severe ischemia of the wound surface, unable to seek medical attention or not yet corrected;
3. Uncontrolled systemic or disseminated infections;
4. Blood glucose is out of control or not yet effectively controlled;
5. Blood system diseases with uncorrected coagulation dysfunction or platelet dysfunction;
6. There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
7. Platelets ≤ 80 × 10\^9, hemoglobin\<90g/L;
8. Patients with advanced malignant tumors;
9. Active period of autoimmune diseases;
10. The patient is unable to cooperate or has mental disorders;
11. According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
Randomized Clinical Trial of 8 Weeks Pulmonary Rehabilitation in Advanced Stage Lung Cancer Patients With COPD During Cytotoxic Chemotherapy

Pulmonary rehabilitation might be benificial in advanced lung cancer patients with COPD who undergo cytotoxic chemotherapy.

We will compare two groups, 8 week pulmonary rehabilitation group and usual care group.


Eligibility Criteria:
Inclusion Criteria:

* pathologically proven lung cancer
* chronic obstructive pulmonary disease
* age \> 20
* ECOG 0-1
* cytotoxic chemotherapy

Exclusion Criteria:

* other history of cancer within 5 years
* other major disease associated with heart, lung, neurology, mental and metabolic disorders
* osteolytic bone metastatis to weight bearing site
* uncontrolled infection
Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.

Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* non-ST segment elevation acute myocardial infarction
* within 48 hours presence of chest pain
* Troponin-T or I positive before CAG
* First myocardial infarction
* will be performed coronary angioplasty

Exclusion Criteria:

* under 18 years of age,80 years or older
* Bleeding tendency
* History of major surgery within 4 weeks
* Major stroke within 2 years
* Thrombocytopenia (\<120,000 / uL)
* Cardiogenic shock
* Known allergy to aspirin, heparin, or abciximab
* Contraindication of MRI at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc)
* Chronic atrial fibrillation
* Pregnancy
Livalo Acute Myocardial Infarction Study

Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs concomitantly; there are some risks due to the drug interaction. Especially, statins are reported to have many drug interactions, these might influence to therapeutic prognosis and safety in AMI patients.

This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI patients over 1 year, and the results will be compared with the other results from the KAMIR study which is expected to the large scale of AMI patients using statins be enrolled. Finally, from that comparison, we will investigate the influence of the statins metabolism by CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major ADR of statins like CK increase, myalgia.


Eligibility Criteria:
Inclusion Criteria:

* The patients who have taken pitavastatin since AMI

Exclusion Criteria:

* none
Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of RAY1216 tablets in the treatment of mild to moderate SARS-CoV-2 infection. The total study duration is up to 28 days.


Eligibility Criteria:
Inclusion Criteria:

1. Participants who provide written informed consent before the trial, and fully understand the trial content, process and possible adverse reactions.
2. Participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures.
3. Male or female participants aged 18-75 (including 18 and 75 years old).
4. Confirmed SARS-CoV-2 infection 120 hours prior to randomization.
5. Initial onset of COVID-19 symptoms/signs within 48 hours before randomization.
6. Fertile participants must agree to take effective contraceptive measures.

Exclusion Criteria:

1. Patients with severe or critical COVID-19 who currently require hospitalization, or patients who are expected to develop into severe or critical disease and require hospitalization within 48h after randomization.
2. Difficulty swallowing or a history of gastrointestinal diseases that seriously affect drug absorption.
3. Active liver disease, or obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥ 2ULN).
4. WBC \>1ULN, or NEU \<0.5ⅹ109/L.
5. Receiving dialysis or have known moderate to severe renal impairment (eGFR\<60mL/min/1.73m2).
6. Other suspected or confirmed systemic infections.
7. Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 or CYP2C19 for clearance.
8. Prior or anticipated receipt of any vaccine within 28 days prior to enrollment and during study period.
9. Use of antivirals against SARS-CoV-2 within 7 days prior to enrollment.
10. Weight≤40kg.
11. Pregnant, lactating women or those with a positive pregnancy test (sterilized or postmenopausal women may not have a pregnancy test).
12. Previous administration with any investigational drug within 3 months before the study drug administration.
13. Participants who are judged by the investigator to be unsuitable to participate in this study.
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia

The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized, crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a) 2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects will collect stool samples and provide blood and urine samples.


Eligibility Criteria:
Inclusion Criteria:

* Subjects on stable hemodialysis for more than 90 days.
* Age 18-85 years.
* Persistent hyperkalemia, defined as elevated serum potassium \> 5.0 mEq/L in more than 2 occasions during the previous 3 months.

Exclusion Criteria:

* Use of pre- or probiotics during the past 2 months
* Use of antibiotics within the past 2 months, if the patient received a single course of antibiotic.
* Presence of chronic wound infection and osteomyelitis
* Inflammatory bowel disease, chronic diarrhea, current C. difficile infection
* Liver cirrhosis or chronic active hepatitis
* Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone \> 10 mg in the last 3 months
* Anticipated kidney transplant within 9 months
* Expected survival \< 9 months
* Pregnancy, anticipated pregnancy, or breastfeeding
* Incarceration
* Participation in another intervention study
* severe anemia defined as hemoglobin \< 8.0 g/dl any time during the last 2 months
Influence of the Method of Alleviation of Aorto-Caval Compression on the Trans-Hepatic Ultrasound-Assessed Inferior Vena Cava Diameter In Pregnant Patients

Cardiac arrest during pregnancy is rare but may result in poor maternal and fetal outcome. Because of its rare occurrence and ethical issues this topic is not very well studied and many questions pertaining to maternal resuscitation remain unanswered. One of the challenging aspects of cardiopulmonary resuscitation in a term pregnant patient is the ideal positioning during chest compressions. International societies have made recommendations regarding management of pregnant patients during cardiac arrest. They advocate the use of left lateral position with 30 degrees tilt or manual uterine displacement. However these recommendations are not based on high level of evidence. Ultrasound has been used to visualize the change in diameter of great vessels to determine the volume status or adequacy of blood circulation of these patients. This approach can be used to study the adequacy of blood circulation of pregnant patients in different positions. The objective of this study is to compare the change in Inferior vena cava diameter obtained with pregnant women in either the left lateral tilt or in the supine position with a manual uterine displacement, compared to the left lateral position and the supine position.

Our hypothesis is that the inferior vena cava diameter obtained in the supine position with manual left uterine displacement would be larger as compared to that obtained with women positioned with a 30-degree tilt.

Using the non-invasive technology of ultrasound we will be able to determine the degree of aorto-caval compression in pregnant women placed in different positions. The results of this study will help us to determine the optimal patient positioning for each individual. This in future may help us in improving outcomes not only during labor and anesthesia, but also during maternal resuscitation in critical cases.

The results of this study will help us to determine the best technique to minimize aorto-caval compression in the term pregnant patient. The results of this study will be useful to establish firm maternal resuscitation guidelines. We will be able to determine the optimal maternal position during cardiopulmonary resuscitation and this may improve both maternal and fetal resuscitation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* Term pregnancy (36-40 weeks)
* Singleton pregnancy

Exclusion Criteria:

* Patients with known cardiac disease, severe preeclampsia on medication
* Multiple gestation
* Breech presentation
* Patients unable to comply with the 4 positions (left lateral, left tilt, supine and supine with manual displacement)
* Patients unable or unwilling to consent
Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access

This is a multicenter, prospective study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (AVF).

This is a prospective, multi-center, single-arm observational clinical trial investigating a new functional index of success of endovascular treatment of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include 100 consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Exclusion criteria will be (i) patients with arteriovenous synthetic grafts. (ii) Immature AFVs not previously used for hemodialysis (at least once). Patients' demographical data, dialysis access history, and procedural details will be recorded. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation, before sheath removal. Clinical follow-up will be set at 6 months after the index procedure. All DUS measurements will be performed using the same imaging protocol. The study's primary endpoints will be (i) the quantification of angioplasty outcome using DUS volume flow analysis before sheath insertion and at the end of the procedure before sheath removal and (ii) to assess the correlation between volume flow at the end of the procedure and clinically driven re-intervention-free rate at defined as the rate of reintervention due to dysfunction recurrence of the treated AVF. Secondary endpoints will be (i) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month and (ii) identification of independent predictors of re-intervention-free rate.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF
* Signed consent form
* Agree to the study protocol

Exclusion Criteria:

* Patients with arteriovenous synthetic grafts
* Patients with contraindication to antiplatelet therapy
* Immature AFVs, not previously used for at least one dialysis session.
Pharmacogenetic Dosing of Warfarin

Purpose:

Warfarin is now the most commonly used oral anticoagulant. This drug has inter-individual variability due to the genetic polymorphisms in the warfarin metabolizing enzyme, CYP2C9 and warfarin target, VKORC1. The investigators' team developed a pharmacogenetic dosing algorithm which can predict patients required warfarin dose, thus could prevent warfarin induced warfarin adverse events.

Methods:

The investigators recruited patients with indications for warfarin, the genotypes of VKORC1 and CYP2C9 were determined by the hospitals and verified by National Center for Genome Medicine. The investigators then randomized the patients to one of three arms: 1. Warfarin dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic Consortium (IWPC), 2. Algorithm developed by the Taiwan Warfarin Consortium and 3. Standard of care. The investigators aimed to determine whether using genetic dosing algorithm can lead to more stable dose and safer use of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Patients must give their informed consent and complete the case report form.
* Patients must be over the age of 20.
* Patients have clinical indications for warfarin therapy but do not have any prior warfarin treatment.

Exclusion Criteria:

* Patients who did not complete the informed consent form or the CRF
* Patients who are less than the age of 20.
* Patients who had prior or is currently on warfarin treatment.
* Patients who have hemorrhagic tendencies or hemorrhagic diseases defined as copious bleeding caused by viral or bacterial infections; cancer and hepatic dysfunction defined as GOP and GPT values three times higher than normal value
* Patients who has Vitamin K deficiency
* Female patients who is currently pregnant
Yan Nian Jiu Zhuan Fa Improve Chronic Fatigue Syndromes

This study is to disclose the mechanism of characteristic Tao yin exercises regulate Chronic Fatigue Syndromes based on Brain-Gut Axis.Explore the clinical manifestation of Chronic Fatigue Syndromes, changes of neurotransmitter and central brain function. Then provide some new methods of treating Chronic Fatigue Syndromes.

This research will be conducted in Shanghai University of Traditional Chinese Medicine.Then the clinical efficacy of Yan Nian Jiu Zhuan Fa on Chronic Fatigue Syndrome will be observed by examining gastrointestinal function, affecting the content of substances in plasma and analysing the central nerve response mechanism.

Eligibility Criteria:
Inclusion criteria:

The occurrence of four or more of the following symptoms:

* Subjective memory impairment
* Tender lymph nodes
* Muscle pain
* Joint pain
* Headache
* Unrefreshing sleep
* Post-exertion malaise lasting for more than 24 hours

Exclusion criteria:

* Active, unresolved, or suspected medical disease
* Psychotic, melancholic or bipolar depression (but not uncomplicated major depression)
* Psychotic disorders
* Dementia
* Anorexia or bulimia nervosa
* Alcohol or other substance misuse
* Severe obesity.
A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

In this study 24 adult males and adult females, with overall healthy condition, will consume approximately 30 grams of wild rice every day for 28 days. Cardiovascular risk factors will be assessed at the beginning and at the end of the study.

Cardiovascular disorders (CVD) including hypertension, myocardial infarction and stroke are still among the top causes of mortality and morbidity in both developed and developing countries. Several modifiable and non-modifiable risk factors play a crucial role in pathogenesis of CVD. Among modifiable risk factors, unhealthy diets and sedentary life style have been recognized worldwide. In this regard, many health authorities have developed guidelines to promote consumption of healthy diets and an active life style among the general population and for CVD patients. Furthermore, recent advances in the area of food and nutrition have revealed health promoting properties for some foods beyond their nutritional values. Such foods are generally known as "functional foods." The Department of Food and Human Nutritional Sciences at the University of Manitoba (U of M) is well-recognized for its contribution in this area of research. However, the effects of wild rice have not been tested in clinical trials. Hence, a pilot study is required before performing a large clinical trial to explore the effects of wild rice consumption and its potential mechanisms. This would not only benefit the populations, but also warranty its scope globally. In this study, the investigators will carry out such a study on the cardiovascular benefits of wild rice in 24 women and 24 men (20-40 years old) over a period of 4 weeks. "Test food" including fruit/vegetable salad, energy cookies and casserole will be prepared by Tall Grass Bakery, Winnipeg, Manitoba. These foods will contain approximately 30 grams of wild rice per serving. The participants will be recruited per our standard procedures. After completion of recruitment procedures, including obtaining a fully informed consent form and health information, the participant will be asked to consume one serving of the "test food" every day over 28 days. Vascular measurements, plus urine and blood samples will be collected at day 0 and day 28. Serum lipids, inflammatory markers and fecal bacterial type, and numbers will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Female
* Both genders are healthy
* 20 - 40 years old

Exclusion Criteria:

* Non-pregnant
* Non-lactating
* Non-smokers
* Not obese (Body Mass Index (BMI) \< 30)
* Not currently on any medications for cardiovascular, diabetes, and cancer diseases