cyrilzakka/clinical-trials huggingface dataset:
Comparison of Microwave Ablation With Breast Conserving Surgery for Breast Tumor

The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and breast conserving surgery of benign and malignant breast lesion under ultrasound (US) guidance.

A total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent US-guided percutaneous MWA and breast conserving surgery treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. women,
2. with invasive ductal carcinoma of the breast according to core-needle
3. tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 )
4. located at least 10 mm from the skin surface and chest wall.

Exclusion Criteria:

1. men
2. women who were pregnant or breastfeeding
3. radiologic suspicion of multifocality or extensive intraductal carcinoma
4. histologic diagnosis of lobular carcinoma
5. neoadjuvant therapy
6. previous surgery or radiation therapy of the ipsilateral breast.
Trial of Strategies to Communicate Genetic Information to Different Ethnic Subpopulations

The goal of this study is to better understand how clinicians give genetic risk information to patients from multi-ethnic groups and how patients understand this information and remember it and act upon it. In addition investigators want to know how to better communicate with patients about complex health issues across the health literacy divide and communication gap that exists between doctors and their patients.

Any patient referred to the breast cancer and genetic risk counseling clinics in either of the two sites will be eligible to participate as long as they meet the inclusion and exclusion criteria. The research assistant in each site will meet with the patients and explain about the study goals and procedures and ask them to participate in the study. Those interested will be enrolled into the study after obtaining informed consent. For those who refuse to participate, reasons for refusal will be requested and catalogued. All study participants will be followed and the study measures will be tracked at Days 0, 30, 180 and 365. In addition, health care utilization (ER Visits, Hospitalizations, clinic visits, screening tests and procedures) will be tracked both through the electronic medical records and patient interviews (as some patients may seek care in other hospitals for emergencies etc.). Investigators currently do follow-up phone interviews routinely with our patients. Study measures will be administered as described above. For those who drop out from the study, reasons for withdrawal from the study will be explored and catalogued.

Procedures for Treatment Compliance and Treatment Non-completers:

(i) Compliance Procedures: Investigators will monitor degree of compliance with whether study measures were completed on Days 0,7,30 \& 365 intervention. Analyses will be done following the intent-to-treat principle.

(ii) Treatment Non-completers: For those who drop out from the study after Day 0, reasons for withdrawal from the study will be explored and catalogued. They will be asked for feedback about the study intervention and satisfaction with the experience (or the lack thereof).

Procedures for Data Collection: The participants will have the option of submitting the data in person or by phone to the project research associate. The PI will meet with the study personnel at least on a weekly basis to continuously monitor their performance and to ensure adherence to study methodology.

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. Participants should talk with the Protocol Director for any questions. Risks of answering the survey instruments and interview questions are minimal and may occasionally cause distress.

Audio recording of the patient interviews. Investigators will create verbatim transcripts to be analyzed using qualitative methods. Recordings will be stored for a period of 20 years and then erased.

Eligibility Criteria:
Inclusion Criteria:

* Cancer Patients
* Over 18 years of age.

Exclusion Criteria:

* Under 18
* Healthy Volunteers.
Whole Soy and Daidzein on Reduction of Blood Pressure in Postmenopausal Chinese Women

The investigators hypothesize that whole soy or purified daidzein alone could reduce blood pressure and CVD risks in equol-producing menopausal Chinese women.

Hypertension is an important risk factor for cardiovascular diseases. Substantial evidence has also shown that prehypertension \[systolic blood pressure (BP) 120-139 mm Hg or diastolic BP 80-89 mm Hg\] is the strongest predictor of incident hypertension and is associated with elevated risk of cardiovascular diseases. Thus, prehypertension and its progression to hypertension have enormous public health implications. Soybean contains many beneficial components, among which isoflavones have received most research attention. Recently researchers have investigated their influences on vascular functions but only a handful of studies have focused on BP reduction as the primary outcome.The role of whole soy or daidzein on BP is yet unclear.

The investigators hypothesize that whole soy (soy flour) or purified daidzein alone could reduce BP,and decrease CVD risks in menopausal women with prehypertension or initial untreated hypertension. The investigators propose to perform a 24-week double-blind, randomized, placebo-controlled trial in postmenopausal women with prehypertension or stage 1 hypertension. The primary objective is to verify if whole soy (soy flour) or purified daidzein alone has anti-hypertensive effects at a dosage of habitual high soy intake.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal Chinese women with prehypertension or stage 1 hypertension

Exclusion Criteria:

* Medical treatment for blood pressure or lipids reduction hormones replacement therapy in recent 3 months, chronic renal or hepatic diseases
Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients

In neutropenic cancer patients, catheter-related bloodstream infections may cause severe infections and even death. To assess the prophylactic effect of a chlorhexidine coated catheter securement dressing on the incidence of catheter-related bloodstream infections, this open, randomized trial is being carried out. CHG iv Tegaderm securement dressing will be randomized in a 1:1 fashion against Tegaderm Advanced iv securement dressing.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a central venous catheter for chemotherapy of AML or ALL
* Patients receiving a central venous catheter for high-dose chemotherapy with consecutive autologous stem cell transplantation or any other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days
* Age \>= 18 years

Exclusion Criteria:

* Condition with an expected duration of chemotherapy-associated neutropenia of at less than 5 days and an expected duration of central venous catheter use of less than 10 days
* Use of a central venous catheter with antimicrobial coating other than chlorhexidine and/or silver-sulfadiazine
* Limited venous status, impeding acquisition of peripheral blood cultures in case of febrile neutropenia
* Patients previously enrolled in the study
* Tunneled central venous catheters
* Shaldon catheters
* CVC insertion via the V. femoralis
* Fever (T \> 37.8°C) related to a suspected or confirmed bacterial infection at randomization
* Known allergic/hypersensitivity reaction to any compounds of the treatment
* Legal incapacity or limited legal capacity
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat

This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive \[14C\] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg containing approximately 100 μCi of \[14C\] baxdrostat. Subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.


Eligibility Criteria:
Subjects must meet the following inclusion criteria:

* Be males of any race between 18 and 55 years of age
* Have a body mass index between 18.0 and 32.0 kg/m2
* Be in good health, determined by no clinically significant findings from medical history
* Have normal renal function, defined as estimated GFR ≥70 mL/min/1.73 m2
* Agree to use contraception
* Be able to comprehend and willing to sign an ICF and to abide by the study restrictions
* Have a history of a minimum of 1 bowel movement per day
* Agree to refrain from donation of sperm from check-in until 90 days after discharge

Main Exclusion Criteria:

* Significant history or clinical manifestation of any diseases as determined by the investigator
* Prolonged QTcF (\>450 msec)
* Confirmed (eg, 2 consecutive measurements) systolic BP \>140 or \<90 mmHg, diastolic BP \>90 or \<50 mmHg, and pulse rate \>100 or \<45 beats per minute (bpm).
* Postural tachycardia (ie, \>30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic BP of ≥20 mmHg or diastolic BP of ≥10 mmHg upon standing).
* Serum potassium \>upper limit of normal (5.3 mmol/L; ULN) of the reference range and serum sodium \<lower limit of normal (135 mmol/L) of the reference range
* Aspartate aminotransferase, alanine aminotransferase, or total bilirubin values \>1.2 × ULN.
* A known history of porphyria, myopathy, or active liver disease
* Use of any prescription medications
* Corticosteroid use (systemic or extensive topical use) within 3 months prior to dosing
* Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer

Statins are commonly used as cholesterol-lowering medications and have shown effectiveness in the primary and secondary prevention of heart attack and stroke. In addition, several recent studies of human cancer cell lines and animal tumor models indicate that statins may have chemopreventive properties through the arresting of cell-cycle progression. The chemopreventive effect of statins was demonstrated in some kind of human tumors including colorectal cancer. In addition, recent one large epidemiologic study showed that statins decreased risk of gastric cancer. On the other hands, it has been well known that Helicobacter pylori infection induces gastric atrophy and intestinal metaplasia, which are premalignant lesions of gastric cancer. Progression of these premalignant lesions could be limited by H. pylori eradication. In addition, a recent double blind randomization study revealed that simvastatin as adjuvant to standard therapy improves significantly the H. pylori eradication rate. Therefore, investigators conjecture that statins may have an adjuvant role for inhibition of gastric carcinogenesis. investigators aim to evaluate the role of statins in gastric carcinogenesis by observing the changes of gastric inflammation under statins.


Eligibility Criteria:
Inclusion Criteria:

1. Age, between 20 and 70
2. Early gastric cancer or adenoma which is achieved curative resection by endoscopic submucosal dissection
3. ECOG performance status 0 or 1

Exclusion Criteria:

1. Previous subtotal gastrectomy or gastrostomy
2. Repeated endoscopic submucosal dissection
3. Two or more synchronous lesions
4. Presence of gastric or duodenal ulcer except artificial ulcer due to endoscopic submucosal dissection
5. History of drugs which are able to induce gastric ulcer including aspirin, NSAIDs, and steroid (30 days or more, within 1 year at the time of screening
6. Indication of statins, including dyslipidemia, myocardial infarction, and heart failure.
7. Develop of complications caused by endoscopic submucosal dissection, including bleeding, perforation, and pneumonia
8. LDL \< 70 mg/dL
9. Allergy to statins
10. Pregnancy or breast milk feeding
11. Active infection
12. Significant cardiopulmonary disease
13. Active hepatitis or severe hepatic dysfunction
14. Severe renal dysfunction
15. Severe bone marrow dysfunction
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.

Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.

Eligibility Criteria:
Inclusion Criteria:

* Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features
* Current major depressive episode of at least 4 weeks in duration

Exclusion Criteria:

* Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity.
* Unable to comply with study procedures
* Medically inappropriate for study participation in the opinion of the investigator
The Impact of Nurses' Emotional Labor on Job Satisfaction and Burnout

Emotional labor is one of the bases that organizations earn profits. Nursing care needs high emotional labor to offer health care to patients. Among health carers that emphasize a lot on emotional labor, nurses are especially required to include emotional labor as very important parts of their jobs.

This study intends to investigate the association among emotional labor, job satisfaction, and burnout. Furthermore, the moderating effect of job stress , job involvement and emotional intelligence will be studied. The study population includes all nurses (N=18,446) of Taiwan's medical centers. Of which, 20% of randomly selected six medical centers will be delivered a questionnaire in order to further analyze the association of study variables.

The level of emotional labor, burnout, job satisfaction, job stress, job involvement and emotional intelligence of the study samples collected from questionnaires will be analyzed by using descriptive statistics, variance analyses, and SEM techniques in order to understand more the associations among study variables. Results of this study are expected to work as references to improve job satisfaction and decrease the level of burnout of nurses.

Eligibility Criteria:
Inclusion Criteria:

* licensed nurses in the hospitals

Exclusion Criteria:

* part-time nurses
* nurses who work under a year in the hospitals
Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
* Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control throughout the trial including the 5 weeks follow-up period. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
* Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal supplements, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (first dose administration)
* History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
* History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
* Smoking in the last 3 months prior to screening or a positive nicotine test
Efficacy and Safety of RV4104A Ointment in Onychomycosis

The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail)
* Target nail plate showing ≥ 12.5% of clinically infected area
* Patient must have at least 2 mm of the proximal end of the target nail free of infection
* Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)

Exclusion Criteria:

* Patient with more than 2 affected toenails
* Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
* Patient with moccasin-type tinea pedis
* Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit
Combination Effects of High-dose Statin and Trimetazidine on Patients With Aspirin Mono Antiplatelet Therapy 12-months After Coronary Artery Bypass Surgery

Trimetazidine is a metabolic agent without any negative inotropic or vasodilatory properties. In addition, previous reports showed that trimetazidine was effective in reducing intracoronary platelet aggregation and preventing platelet thrombogenesis. Therefore, for the evaluation of these combination effects of statin and trimetazidine on patients with aspirin monotherapy who had previously received CABG and were free of the major adverse cardiac events such as death, MI, TLR, or TVR for 12 months, the investigators hypothesize that atorvastatin 40mg/day would be more effective in the prevention of the further late adverse cardiac and cerebrovascular events than other statin. To test this hypothesis, the investigators will perform a multi-center, randomized, prospective trial aimed at demonstrating the superiority of combination of high dose atorvastatin therapy and trimetazidine to pravastatin in patients with aspirin monotherapy 12 months after CABG surgery in real world practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had previously received CABG 12 months ago
* Patients who were free of death, MI or repeat revascularization within first 12 months after CABG
* Patients with mono antiplatelet therapy with aspirin alone
* Age of 20 years or older
* Patients with signed informed consent

Exclusion Criteria:

* History of DES or BMS implantation within 12 months
* Patients who required the continuing dual antiplatelet therapy or additional other types of antithrombotics or antiplatelets such as cilostazol or ticlopidine, etc besides aspirin after DES implantation
* Patients who could not be prescribed aspirin or statins due to contraindication or severe side effects
* Pregnant women or women with potential childbearing
* Life expectancy ≤ 2 year
Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation

The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months

Exclusion Criteria:

* Insufficient level of motivation
* Another participant in the household
* Patients with current psychotic disorder or major depressive disorder

The investigator will evaluate whether there are other reasons why a patient may not participate.
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single and multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)


Eligibility Criteria:
Inclusion Criteria:

1. Patients (males or females) aged 18 years or older.
2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year
3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
4. Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit.
5. Willingness and ability to comply with clinic visits and study-related procedures.
6. Patients should be able to read, understand, and be willing to sign the ICF

Exclusion Criteria:

1. Presence of any of the following laboratory abnormalities

   * Hemoglobin \< 11 g/dL
   * WBC \< 3.5 × 103/μL
   * Platelet count \< 125 × 103/μL
   * Neutrophils \< 1.75 × 103/μL
   * AST/ALT \> 1.5 × ULN
   * Total bilirubin \> ULN
   * Creatinine \> ULN
   * Creatine phosphokinase \> ULN
2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
3. Active dermatologic conditions that may confound the diagnosis of AD
4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study
6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
7. Known history of human immunodeficiency virus (HIV) infection
8. Pregnant or breastfeeding women