cyrilzakka/clinical-trials huggingface dataset:
A Phase I, Autologous ex Vivo Expanded and Activated NK Cell, Magicell-NK, Infusion for Colon Cancer Post Resection Study

This is a Phase I, open-label study to explore the safety profile and to find the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of Magicell-NK in subjects diagnosed with stage I or stage IIa colon cancer post resection from a single site in Taiwan.

During this study, 3 dose levels of Magicell-NK will be tested with a 3+3 design to determine the MTD/MFD: Cohort 1, low dose (2×10\^8 cells), Cohort 2, middle dose (6×10\^8 cells), and Cohort 3, high dose (12\~18 ×10\^8 cells).


Eligibility Criteria:
Inclusion Criteria:

1. A dated and signed informed consent
2. Either gender and aged over 20 years old (inclusive) at date of consent
3. With histologically confirmed stage I or stage IIa colon cancer
4. Received curative colon resection within 4\~8 weeks prior to the screening visit and does not need adjuvant chemotherapy or radiotherapy
5. With no ≥ grade 3 postoperative complications or has been recovered and is suitable for study enrollment according to the investigator's judgment
6. With adequate hematology function:

   * Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
   * Total white blood cell (WBC) ≥ 3,000 cells/μL
   * Platelets ≥ 100,000 counts/μL
   * Hemoglobin ≥ 9 g/dL
7. With adequate hepatic and renal function:

   * Serum creatinine ≤ 1.5 × Upper Limit of Normal (ULN)
   * Total bilirubin (TB) ≤ 1.5 × ULN
   * ALT and AST ≤ 2.5 × ULN
   * Alkaline phosphatase (ALP) ≤ 5X ULN
8. Negative response in HIV and syphilis test
9. Subject with childbearing potential must agree to abstain from intercourse or use highly effective contraceptives from when signing informed consent to the Final/ET Visit.
10. Performance status (ECOG) \< 2
11. Patients agree to be in compliant to clinical protocol planned treatment plan

Exclusion Criteria:

1. Received any other investigational, anti-neoplastic medication (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only), or immune cell therapy within 28 days prior to Day 1.
2. Currently under immunosuppressive or systemic steroid treatment with equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Day 1
3. With known tumor metastasis or coexisting malignant disease
4. With ongoing acute diseases, or within the past 2 years having serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that, judged by the investigator, could interfere with the results of the trial or adversely affect the safety of the subject
5. Known hypersensitivity to aminoglycoside or bacitracin (e.g. Streptomycin, Gentamicin)
6. Known hypersensitivity to any of the components of Magicell-NK, including human serum albumin
7. Female subject who is lactating or has positive urine pregnancy test at screening
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.

General Design

* Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.
* Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.
* Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.

Eligibility Criteria:
Inclusion Criteria

1. Age \>18; Able to give informed consent
2. Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
3. intact PTH (iPTH) \>120 pg/ml at baseline
4. albumin corrected calcium \> 8.5 mg/dL to \< 10.0 mg/dL at baseline
5. Phosphorus \< 4.6 mg/dL at baseline
6. If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

Exclusion Criteria

1. Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
2. Receiving \>50,000 IU per month of ergocalciferol or \> 1000 IU of cholecalciferol per day within the previous 30 days.
3. history of primary HPT
4. On prednisone \> 30 days within the previous 6 months
5. receiving bisphosphonates or calcitonin within the previous 12 months
6. Non-elective hospitalization within the previous 30 days.
7. Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
8. History of renal or other organ transplant
9. History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
10. Receiving cinacalcet within 4 weeks prior to screening.
11. An active drug/alcohol dependence or abuse history
12. History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
13. Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
HRV-B for Symptom Management in Sickle Cell Patients

This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores autonomic balance and reduces pain and other symptoms among patients with sickle cell disease (SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled, pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain, stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether increases in HRV coherence are associated improvements in pain, stress, fatigue, depression, or sleep among study participants.

The purpose of this study is to see if Heart Rate Variability Biofeedback (HRV-B) can reduce chronic pain, stress, depression, anxiety, insomnia, loneliness, helplessness, physical limitations and pain medication dependence. HRV-B is an interactive procedure in which participants relax and breathe regularly while watching a computer screen. The computer screen provides feedback that helps people increase their heart rate variability, which is the difference from beat to beat. HRV-B is a complementary, non-pharmacologic therapy that is now being used to see if it can help sickle cell patients reduce their symptoms of pain, stress, insomnia, fatigue, or depression.

Participants will be randomly assigned to either an Intervention Group or a Comparison Group. Each group will have about 15-20 participants. The Intervention group will receive a baseline assessment including symptom questionnaires, up to six weekly HRV-B training sessions lasting about 45 minutes each, and a follow-up assessment including symptom questionnaires. There are 6-8 total visits for the intervention group and 2 for the control group. The Comparison Group will have a baseline assessment including symptom questionnaires, then six weeks with no training sessions, then a follow up assessment including symptom questionnaires. After the follow up assessment, the Comparison Group members will have the option of receiving the same treatment as the Intervention Group.

Eligibility Criteria:
Inclusion Criteria:

* SCD patients
* 10 years old
* English literate
* Patient recruited through Greenville Health System
* Any race or ethnicity
* Any sex

Exclusion Criteria:

* Conditions affecting HRV (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina)
* Medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors)
* Pacemaker or defibrillator
* Heart transplant or by-pass surgery within 1 year
* Active seizure disorder or use of antiseizure/anticonvulsant medication specifically for seizures
* Dementia
* Moderate or severe head injury or stroke within 6 months
* Evidence of active substance abuse
* An uncontrolled major psychiatric disorder
* Cognitive disability that precludes participation
* Use of long acting (extended release) opioid medications; however, 'as needed' short acting opioid medication usage is allowable
Urinary Tract Dilations in Prenatal and Postnatal Life

The goals of this study are to use a questionnaire survey to determine the state of awareness of the diagnosis and management of patients with urinary tract dilation across several medical professionals, to predict the severity of the postnatal course and surgical intervention in fetuses with urinary tract dilation detected during pregnancy, and to create a model of prenatal and postnatal care for patients with dilation of the urinary tract for multidisciplinary use.

Currently, in Slovakia, a multidisciplinary standard of health care for patients with dilation of the urinary tract is not present. Prenatal diagnosis of anomalies of the urinary system includes the entire spectrum of anomalies, genetic diseases or anatomical deviations, which have a non-uniform classification and different terminology in a wide range of literature. Therefore, prenatal diagnosis of these anomalies, as well as dilation diseases of the urinary tract, in different centers is different, often subjective and outdated. However, some findings on the urinary tract, even with regard to the sex of the fetus, require great attention, defining the degree of severity and precisely targeted management, the task of which is to prevent serious complications in postnatal life. Dilative diseases of the urinary tract may not be clinically obvious after birth, but in the long term, if they are not detected, serious and irreversible kidney damage may occur. The goals of this study are therefore 1. to confuse the current situation in the multidisciplinary medical sector regarding the issue of dilations of the urinary tract; 2. in the conducted study to identify fetuses with such a degree of dilation of the urinary tract (according to the UTD classification from 2014) that requires stricter management in the prenatal and postnatal period and which are at high risk of surgical intervention postnatally and 3. subsequently create a model of health care for multidisciplinary cooperation for a patient with dilation of the urinary tract.

Eligibility Criteria:
Inclusion criteria:

* Singleton pregnant women whose fetuses were diagnosed with dilation of the urinary tract as an isolated US finding before the 28th week of pregnancy. Fetal patients with subsequent US control in the third trimester after the 28th week of pregnancy.
* Newborns and children with prenatally diagnosed UTD, which, depending on the severity, required a postnatal examination by a pediatric nephrologist within a month after birth and then in his follow-up up to 6 months after birth.

Exclusion criteria:

* Multiple pregnancies
* Urinary tract dilation in fetuses diagnosed in the third trimester
* Associated anomalies in fetuses
* Aneuploidy
* Newborns and children monitored by someone other than a selected pediatric nephrologist Patients who were lost from follow-up
Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) increase cardiovascular risk and endothelial dysfunction. Hydroxychloroquine (HCQ) is expected to improve endothelial dysfunction through some metabolic effects. The investigators intend to find the role of HCQ to improve endothelial dysfunction in RA patients. This study will also evaluate correlation HOMA-IR (homeostasis model assessment-estimated insulin resistance), FFA (free fatty acid) and ox-LDL (oxidized-LDL) level change, with endothelial dysfunction improvement.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid Arthritis patients (2010 ACR/EULAR criteria)
* Being or will be treated with methotrexate (monotherapy)
* Agree to join the study

Exclusion Criteria:

* Autoimmune diseases other than RA
* Acute severe infection, acute coronary syndrome, heart failure, stroke
* Malignancy or chronic inflammatory diseases
* Eye disease involving the retina and visual field defects
* G6PD (glucose 6-phosphate dehydrogenase) deficiency
* History of smoking within last 5 years
* Lipid lowering, insulin resistance lowering, antidiabetic, insulin, ACE(angiotensin converting enzyme)-inhibitor or ARB(angiotensin receptor blocker) drugs
Evaluation of Post-discharge Surveillance Mobile Application for Surgical Site Infection

Objective: evaluate the effectiveness and usability of a mobile application for post-discharge surveillance of surgical site infection as a support system for clinical decision.

Introduction: Infection of the surgical site (SSI) is one of the main infections related to health care, culminating in financial losses to the health system and high morbidity and mortality, which due to increasingly shorter hospital stays, from 13 to 75% is manifested at home of the patient, requiring health professionals to act more effectively in post-discharge surveillance of this condition. Therefore, considering this problem and the constant evolution of technological resources, with the increase in access and use of smartphones by the population, it is pertinent to develop a mobile application for post-discharge surveillance of surgical site infection. Objective: evaluate the effectiveness and usability of a mobile application for post-discharge surveillance of surgical site infection as a support system for clinical decision. Method: Randomized Clinical Trial to assess effectiveness of a mobile application for post-discharge surveillance of infection of the surgical site. The study will be developed in a large hospital in the city of São Paulo and the study participants will be surgical patients. Expected results: The mobile application for post-discharge surveillance is expected to collaborate in the early detection of potential cases of surgical site infection, to be able to improve post-discharge surveillance strategies, assist in data management, decision making and actions to prevent infection of the surgical site.

Eligibility Criteria:
Inclusion Criteria:

* surgical patients aged 18 to 70 years
* conscious, oriented,
* literate
* have a smartphone compatible with the use of the application
* submitted to traditional anesthetic-surgical procedure
* classified as potentially contaminated
* experience the postoperative period at home

Exclusion Criteria:

* Patients with visual impairment
* physical restriction or communication problems
* undergoing surgery with implants
* videolaparoscopies or robotics sugery
* who already have the diagnosis of SSI at the time of discharge
* have been admitted to the Intensive Care Unit in the postoperative period
Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75\~4.0mm).

Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤80 years, regardless of gender;
2. De novo lesion in a native coronary artery;
3. Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia;
4. Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1;
5. The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting);
6. The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up.

Exclusion Criteria:

1. Reference vessel diameter \<2.75 mm or \>4.0 mm;
2. In stent restenosis;
3. Left main lesion, chronic complete occlusion lesion;
4. Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm;
5. There is a large scale of thrombus in the target vessel, and the thrombus grade \>3 after thrombolysis or aspiration;
6. Severe heart failure (NYHA IV);
7. Severe renal failure (GFR\<30ml/min) or undergoing hemodialysis treatment;
8. Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal);
9. Patients with vein graft restenosis after bypass or severe heart valve disease;
10. Pregnant or breastfeeding female patients;
11. The life expectancy of the patient is less than 12 months;
12. The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications;
13. Anemia (women's hemoglobin \<117g/L, or men's hemoglobin \<134g/L), or thrombocytopenia detected before the intervention within 6 months (\<100×10⁹/L);
14. Planned to perform non-cardiac surgery within 12 months after index procedure;
15. The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint;
16. Heart transplant patients;
17. Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel;
18. The investigator judged that the patient had poor compliance and could not complete the study as required.
Argon Plasma Coagulation and Clip for the Prophylaxis of Post-polypectomy Bleeding After Hot Snare Polypectomy

Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.

This is a multicenter, randomized and controlled study. It aims to discuss the efficacy and safety of argon plasma coagulation（APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）, and analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.

According to the prophylaxis measures, patients enrolled in this study will be randomized into the control group, APC group and Clip group. It will collect participants' data of baseline character, postoperative and follow-up. All statistical analyses will be performed by SPSS 26.0 and Tree Age Pro 2011.

Based on the previous studies, it is presumed that the rate of PPB for the control group, Clip group and APC group is 8%, 2% and 2%. Given two-side testing, an alpha of 0.05 and a power of 90%, allowing for a 5% dropout rate, the smallest sample size is 1287.

Eligibility Criteria:
Inclusion Criteria:

1. age\>18 years
2. the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp）
3. head diameter≥ 10 mm
4. HSP indications were met and no contraindications were found
5. patients (or the legal representative/guardian) with informed consent

Exclusion Criteria:

1. ASA Grade Ⅲ or above, or end-stage disease of major organs (such as malignancy, heart failure, chronic obstructive pulmonary disease, end-stage renal disease and so on)
2. coagulation dysfunction (INR ≥ 1.5, PLT \< 50×10 \^9 / L)
3. use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation
4. there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient
5. incomplete closure of clips (complete closure: spacing between adjacent clips \< 1cm)
6. APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB
7. surgical treatment, vascular intervention, or blood products were used during the operation
8. use other methods to prevent PPB
9. the bleeding site was not confirmed by endoscopy
10. history of intestinal surgery
11. menstruation or pregnancy
12. not following medical advice
13. participated in other clinical trials and signed its informed consent
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese subjects, age at least 20 years at the time of signing informed consent
* Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
* HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
* Body-mass index (BMI) above or equal to 20 kg/m\^2
* Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling

Exclusion Criteria:

* Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
* Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism
* Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal
* Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* Screening calcitonin equal to or above 50 ng/L
* History of pancreatitis (acute or chronic)
* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV