cyrilzakka/clinical-trials huggingface dataset:
Impact of Topical Tranexamic Acid in Breast Reconstruction

Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients.

Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.

PRIMARY OUTCOMES:

I. To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population.

II. To evaluate the impact of TXA on seroma rates compared to control.

SECONDARY OUTCOMES:

I. To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side.

II. To evaluate the impact of TXA on total drain output in the first post operative day.

III. To evaluate the impact of TXA on total drain duration.

OUTLINE:

Participants will only be treated intra-operatively at the time of surgery with topical TXA to one breast pocket. Each participant will serve as own internal control, with one side receiving saline and the other TXA. Participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed breast malignancy OR increased risk for breast cancer
2. Age \>= 18 years
3. Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction
4. Ability to understand a written informed consent document, and the willingness to sign it
5. At least 4 weeks post-completion of chemotherapy or radiation therapy

Exclusion Criteria:

1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
2. Any history of thromboembolic disease
3. Current anticoagulant use
4. Current use of chlorpromazine due to label contraindication
5. Current use of any prothrombotic medical products due to label contraindication
6. Documented or reported allergic reaction to tranexamic acid
7. Male participants
A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Target patients aged 18-75, including those aged 18 and 75
2. Primary IgA nephropathy diagnosed by renal biopsy within 3 months
3. eGFR≥30ml/min/1.73m2
4. 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g
5. Sign informed consent

Exclusion Criteria:

1. Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis
2. Patients who have received kidney transplantation or dialysis
3. Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria\>3.5 g/d, serum albumin\<3.0 g/dl, with or without edema)
4. Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections
5. Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\>8%)
6. Patients with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically significant arrhythmias
7. Patients with poor blood pressure control (systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg)
8. Patients diagnosed with malignant tumors within the past 5 years
9. Patients with known glaucoma, known cataracts, and/or a history of cataract surgery
10. Gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea
11. Patients with severe adverse reactions to steroids in the past, including psychiatric symptoms
12. Patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment
13. Patients who have received any systemic GCS treatment within the past 3 months prior to enrollment
14. Patients taking potent cytochrome P450 3A4 inhibitors (CYP3A4)
15. Current or previous (within the past 2 years) alcoholism or drug abuse;
16. Expected lifespan\<5 years
17. During the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential)
18. Researchers believe that patients who are not suitable for treatment with Nefecon
Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

The purpose of the real-world observational prospective study is to access the renoprotective effects of dulaglutide as well as to explore corresponding mechanisms in patients with Type 2 Diabetic Nephropathy.

Related studies have found that Glucagon-like peptide-1 (GLP-1) receptors are localized on a variety of tissues and cell types in addition to pancreatic β-cells, and GLP-1 and GLP-1 receptor agonists can exert diverse effect on multiple organs and tissues, with pleiotropic potential physiological, pathophysiological as well as pharmacological implications. Multiple clinical trials suggest that GLP-1 receptor agonists can exert renoprotective effects and persuasively inhibit the progression of kidney disease in type 2 diabetic patients. The beneficial effects of GLP-1 receptor agonists on Type 2 Diabetic Nephropathy, independent of their hypoglycemic ability, might are mediated by anti-oxidative stress, anti-inflammatory and natriuresis properties. However, it is not clear whether the above-mentioned properties are involved in the EMT process of renal tubular epithelial cells.

All participants meeting all eligibility criteria received routine medical consultations. During routine medical visits, patients were randomized into two groups (1.07:1) to receive a total duration of 12 months of hypoglycemic therapy - dulaglutide plus other hypoglycemic agents not including GLP-1 receptor agonists (intervention group), and other hypoglycemic agents not including GLP-1 receptor agonists (control group). A random number method was applied for grouping in this study. Dulaglutide and other hypoglycemic agents were administered according to the drug package insert. Of course, the investigators decided on other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk factors based on the latest guidelines throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

* All adults aged 18 and above
* No minors involved in the study
* Diabetic Nephropathy defined as a urinary albumin-to-creatinine ratio ≥30 mg/g at least twice in three measurements within a period of 3-6 months

Exclusion Criteria:

* Patients with other types of kidney disease
* Urinary tract infection
* Type 1 diabetes
Comparison of ECMO Use and Conventional Treatment in Adults With Septic Shock

Although few cases reported successful treatment of septic shock using extracorporeal membrane oxygenation (ECMO) in adults, no studies compared ECMO to conventional treatment (without ECMO) as treatment for adults with septic shock. Since it is difficult to conduct a randomized study to allocate patients in such critical condition, we aimed to conduct a retrospective observational study using propensity score matched analysis to compare the survival of adults with septic shock treated by ECMO or conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* age \>20
* admitted at ICU
* septic shock

Exclusion Criteria:

* nil
Cough Peak Flow for Extubation Prediction

Successful weaning from mechanical ventilation in ICU patients depends on patient ability to breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a dedicated flow-meter that required patient disconnection from the ventilator, limiting the generalizability of this procedure. This study aimed to predict extubation outcome in a consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF measurements were done by freezing ventilator screen and scrolling the cursor to the maximal value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.

The objective was to assess the performance of CPF to predict early extubation outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Intubation \> 24h
* Eligible for scheduled weaning trial and then scheduled extubation
* Mechanical ventilation from Evita XL ventilator (Dräger, Germany)
* Patient's agreement to participate

Exclusion Criteria:

- Withdrawal decision of life supporting care
Research on the Clinical Effect of Xuefu Zhuyu Decoction in Treating Unstable Angina.

This study evaluates the clinical efficacy of Xuefu Zhuyu Decoction in the treatment of unstable angina pectoris. All of the patients will be divided into 2 arms randomly. One of the arms will be treated by conventional western medicine, the other one will be treated by Xuefu Zhuyu Decoction at the base of conventional western medicine.

Xuefu Zhuyu Decoction has the function of activating qi and promoting blood circulation, which will be used to treat patients with qi stagnation and blood stasis syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with coronary heart disease through coronary angiography or coronary CTA;

Patients have at least one of these symptoms:

1. The stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration;
2. Angina pectoris during rest;
3. The recent occurrence of angina pectoris caused by mild physical activity in the last month.

Exclusion Criteria:

* Patients diagnosed with stable angina; Patients with acute myocardial infarction; Chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; The heart function grade is III or IV; Patients with acute cerebral infarction; Patients complicated with other serious primary diseases; Patients with acute infection in recent 2 weeks; Uncontrolled hypertension (the resting blood pressure \>160/95mmHg within one week); Diabetics emerged with serious diabetic complications; Patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; Pregnant or lactating women.
Low-dose Imaging Technique (LITE)

The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast.

Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18-80
* Women with a suspected or biopsy proven enhancing lesion

Exclusion Criteria:

* Women with a history of adverse reactions to contrast media
* Women with GFR below 30 mL/min/1.73m2
* Women who are pregnant or breastfeeding
Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19

To evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of Peginterferon Lambda-1a, compared with placebo in reducing the duration of viral shedding of SARS-CoV-2 virus in patients with uncomplicated COVID-19 disease.

Patients will attend up to 9 study visits over a period of up to 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years at the time of the assessment
2. Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
3. Diagnosis of COVID-19 disease:

   1. If symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 within 72 hours from swab to the time of commencing informed consent:
   2. If asymptomatic, initial diagnosis of SARS-CoV-2 infection with positive FDA-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent

Exclusion Criteria:

1. Patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent
2. Patients with a known allergy to Peginterferon Lambda-1a or any component thereof
3. Display symptoms of respiratory distress (Respiratory rate \>20, room air oxygen saturation of \<94%.)
4. Participation in a clinical trial with or use of any investigational agent within 30 days before screening
5. Treatment with interferons (IFN) within 12 months before screening
6. Previous use of Peginterferon Lambda-1a
7. History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
8. Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
9. Current or previous history of decompensated liver disease (Child-Pugh Class B or C) or hepatocellular carcinoma
10. Co-infected with human immunodeficiency virus (HIV)
11. Significant abnormal laboratory test results at screening.
12. Other significant medical condition that may require intervention during the study
13. Concurrent use of any of the following medications:

    1. Therapy with an immunomodulatory agent
    2. Current use of heparin or Coumadin
    3. Received blood products within 30 days before study randomization
    4. Use of hematologic growth factors within 30 days before study randomization
    5. Systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization
    6. Any prescription or herbal product that is not approved by the investigator
    7. Long-term treatment (\> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor
    8. Receipt of systemic immunosuppressive therapy within 3 months before screening
To Investigate the Role of Gut Microbiome in ADT Related Metabolic Changes in Prostate Cancer Patients

Prostate cancer is the second most common cancer in male cancer globally and ranked third in Hong Kong. While androgen deprivation therapy (ADT) is the backbone treatment for advanced prostate cancer, it could lead to obesity, metabolic syndrome and increased cardiovascular mortality. Previous studies showed that ADT patients have different gut microbiome compared to non-ADT patients and the gut microbiome might be related to the metabolic changes. However, the underlying mechanism of these metabolic complications is still not fully understood. This study aims to investigate the relationship and related mechanism between the changes in gut microbiomes and ADT-related metabolic change in prostate cancer patients.

It is a prospective longitudinal observational human study. Fifty prostate cancer patients planned for ADT will be recruited. Fecal sample will be collected before initiation of ADT, and then at 3 and 6 months after initiation of ADT. Anthropometric, blood metabolic parameters, serum inflammation markers and panels of microbiome metabolites will be measured at these timepoints. Changes in gut microbiome from baseline to 6 months after initiation of ADT will be assessed. Correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible mechanisms will be explored.

Eligibility Criteria:
Inclusion Criteria:

1. Male subject with age 45 or above
2. Histological diagnosis of prostate cancer (acinar type)
3. Clinically decided for androgen deprivation therapy (ADT) as treatment for prostate cancer

Exclusion Criteria:

1. History of diabetes
2. Patients that have other active treatment for prostate cancer or other cancers (except ADT)
3. Patients received treatment, either surgical or medical, that could lead to decrease in serum testosterone prior to commencement of ADT
4. Patients will be started on other treatments, including chemotherapy, new generation of androgen-receptor targeted agents, radiotherapy etc, within 6 months of the commencement of ADT.
5. Subject with recent antibiotics usage within 3 months.
The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study

An observational, ambispective cohort to learn about the disease progression of axial spondyloarthritis (axSpA) according to the changes from baseline in measures of disease activity, function, and imaging.

This is an observational cohort study of Chinese patients (≥18 years of age) diagnosed with axSpA. Patients are followed at 4-6 month intervals. Data will be collected at baseline and at every follow-up time points. Primary outcomes are the structural damage measured with imaging(Conventional radiography, low-dose CT and MRI) and the disease activity measured with the Ankylosing Spondylitis Disease Activity Scale (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Secondary outcomes are inflammatory markers, Bath ankylosing spondylitis functional index (BASFI) and Bath ankylosing spondylitis metrology index (BASMI).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older and diagnosed with the Assessment of Spondyloarthritis International Society axial spondyloarthritis criteria.

Exclusion Criteria:

* Patients with serious disease in cardiovascular, kidney and blood and endocrine system; history of schizophrenia or epilepsy; pregnant or in lactation period.
Fixed Diet Plan and Calorie Counting Diet in Adolescents

Obesity is a chronic illness and multifactorial etiology, related to genetic factors, environmental and behavioral. Features association with several metabolic abnormalities in childhood, leading to increased risk of cardiovascular disease in adult life. The treatment involves lifestyle change, with balanced diet guidance and encouraging physical activity. The treatment in this age group have brought limited data, in addition to high drop-out rates. A unique type of food guidance is the equivalent calorie count, where calories are converted into points. The objective of this study was to evaluate the variance of Z score of body mass index (ZIMC) of obese adolescents undergoing orientation of two groups of low-calorie diet: traditional and based on the points system, as well as evaluate anthropometric variables, body composition, food intake, metabolic changes and self-monitoring.

METHODS: randomized clinical study with duration of 24 weeks, with 66 adolescents with an average age of 13.7 ± 0.7 years of both genders, with scores of BMI \>= 2 to \<= 4 curve adjusted for gender and age of the World Health Organization. Were verified weight, height, blood pressure and waist circumference, intensity of physical activity and self- monitoring, as well as performed the nutritional guidance to each visit. Laboratory parameters, applying the scale of binge eating, pubertal, stage and body composition were evaluated at the beginning and end of the action. The patients were divided into two groups: one that received guidance of traditional low-calorie diet and meet the food consumption record (RCA), three days (Group A) and another that received low-calorie diet guidance based on the system of points and meet the daily RCA (Group B).


Eligibility Criteria:
Inclusion Criteria:

* Age 12 to 15 years old
* ZBMI ≥+2.0 according to World Health Organization

Exclusion Criteria:

* ZBMI≥+4
* obesity related to genetic syndromes
* End-organ damage
* Taking drugs that promote weight changes
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.


Eligibility Criteria:
Inclusion Criteria:

* Patient was \> 18 years old at time of procedure
* Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™
* Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use
* Patient underwent his/her first follow-up visit within two months post-surgery

Exclusion Criteria:

* No exclusion criteria have been defined for this data collection.