cyrilzakka/clinical-trials huggingface dataset:
Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

Observer-blind, randomized, active-controlled prospective intervention study

This trial is randomized, prospective intervention study. A total of 4,050 subjects (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into three study subsets, namely Main Study I, Main Study II, and Exploratory Study: Main Study I for immunogenicity and safety evaluation, Main Study II for safety evaluation, and Exploratory Study for cellular immunity evaluation, with trial design as follow :

* Main Study I, Exploratory Study subset: Observer-blind, randomized, active-controlled prospective intervention study
* Main Study II: Open-label, randomized study to evaluate safety I

Eligibility Criteria:
Inclusion Criteria:

1. Clinically healthy subjects aged 18 years and above.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any COVID-19 vaccine.
3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
4. Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
6. History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
7. History of blood disorders contraindicating intramuscular injection.
8. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.) which according to the investigator might interfere with the assessment of the trial objectives.
9. History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (\> 2 weeks)).
10. History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
12. Subjects plan to move from the study area before the end of study period.
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant

The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function. Patients who will have a left ventricular assist device (LVAD) implanted while they wait for a donated heart will be treated with Anginera. At the time of heart transplant, their diseased heart which is removed will be analyzed by microscopic examination to see what effect Anginera had.

This will be a prospective, multi-center, randomized, open-label, within-patient paired design study. The primary purpose is to analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.

Eligibility Criteria:
Inclusion Criteria:

* Stage D Heart Failure
* Patients having an LVAD implanted as a bridge to transplant.

Exclusion Criteria:

* Biopsy proven acute myocarditis
* Known Giant Cell Myocarditis
* Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction

It is believed that targeted SERCA2a enzyme replacement in HFrEF patients will correct defective intracellular Ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. Additionally, it is hypothesized that correcting SERCA2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.

MUSIC-HFrEF1 is an interventional study of SRD-001, an adeno-associated virus serotype 1 (AAV1) vector expressing the transgene for sarco(endo)plasmic reticulum Ca2+ ATPase 2a isoform (SERCA2a), in anti-AAV1 neutralizing antibody (NAb) negative subjects with ischemic or non-ischemic cardiomyopathy and New York Heart Association (NYHA) class III/IV symptoms of heart failure with reduced ejection fraction (HFrEF).

The Phase 1 trial is an open-label, uncontrolled study investigating two doses of SRD-001 at 3E13 and 4.5E13 viral genomes (vg) in 3-4 participants at each dose level.

The Phase 2 trial is a randomized, double-blind, placebo-controlled trial with prospective assignment to a single dose of either SRD-001 or placebo in a 1:1 ratio and a total sample size of N=50.

Eligibility Criteria:
Main Inclusion Criteria:

* Chronic ischemic or non-ischemic cardiomyopathy
* NYHA class III/IV
* LVEF ≤35%
* Guideline-directed medical therapy for heart failure; ICD

Main Exclusion Criteria:

* Restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (LV) aneurysm
* Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), mechanical circulatory support device (MCSD) or cardiac shunt
* Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LVRS, conventional revascularization procedure or valvular repair in the 6 months following treatment
* Likely need for an immediate heart transplant or MCSD implant due to hemodynamic instability
* Inadequate hepatic and renal function
* Diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative
Effects of Kinesio Tape on Chronic Low Back Pain

This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional disability, and physical activity. The hypothesis is that applying KT to the lumbar spine would improve back-specific body perception, reduce pain and functional disability, and increase physical activity in individuals with CLBP compared to the sham-taping group.

Low back pain (LBP) is prevalent and the leading cause of disability worldwide. In addition, it is often associated with psychological, social, and physical factors that can impact one's ability to function, participate in society, maintain job satisfaction, and socioeconomic status. Therefore, managing it requires a significant amount of healthcare resources. Maladaptive body image and maladaptive beliefs are among the conditions that can be targeted during treatment as they may contribute to the chronicity of LBP.

This clinical trial aims to examine kinesiotape's (KT) short-term effect on individuals with nonspecific chronic LBP (CLBP), including back-specific body perception, pain, functional disability, and physical activity. The hypothesis is that applying KT to the lumbar spine would improve back-specific body perception, reduce pain and functional disability, and increase physical activity in individuals with CLBP compared to the sham-taping group.

Eligibility Criteria:
Inclusion Criteria:

* ability to speak and write Turkish fluently
* have been experiencing low back pain for at least 3 months
* have a pain severity score of ≥4 on the visual analog scale

Exclusion Criteria:

* had significant spinal surgery in the past (fusion or discectomy), spinal surgery within the last six months,
* a diagnosis of a serious spinal condition (such as cancer, inflammatory arthropathy, or vertebral fracture),
* skin allergy to KT or pre-existing skin lesion or infection
* a neurological disease,
* is currently pregnant,
Effects of Cranberry Extractive on the Lipid Profiles in Subjects With Type 2 Diabetes

Cranberry, containing flavonoids, is effective on improvement of lipid profiles in non-diabetic subjects. The Hypothesis of is to assess the effect of cranberry on lipid profiles in type 2 diabetic patients using oral antidiabetic drugs.

Hypercholesterolemia is a notorious risk factor for cardiovascular disease. It had been reported cranberry consumption increased nearly 8% of circulating high-density lipoprotein (HDL) cholesterol levels in non-diabetic subjects. Although characteristics of diabetic dyslipidemia are low HDL and high triglyceride, the benefits of concentrated powder of cranberry juice on lipid profiles were not evident in type 2 diabetic subjects with diet control alone. To the best of our knowledge, the effect of cranberry on lipid profiles in type 2 diabetic subjects using oral anti-diabetic drugs have never been studied, especially total to HDL cholesterol ratio which is important in predicting cardiovascular diseases in Asian and/or diabetic population. Furthermore, cranberry has anti-oxidative effect which is associated with reduction of oxidized low-density lipoprotein (ox-LDL) cholesterol in non-diabetes. Therefore, we conducted a placebo-controlled, double-blind, randomized study to assess the effect of cranberry on lipid profiles in type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic subjects
* age between 50 and 75 years

Exclusion Criteria:

* glycosylated hemoglobin (HbA1c) less than 7% or more than 10%;
* triglyceride more than 4.5 mmol/L;
* current insulin treatment;
* change of the medications for anti-diabetes, hypertension, hyperlipidemia and anti-platelet in recent four weeks;
* abnormal renal function (serum creatinine \> 177 μmol/L;
* abnormal liver function test results (more than two-fold upper limit of normal range);
* severe systemic disease such as immune disorder, cancer, acute or chronic inflammation disease;
* smoking in recent 1 year;
* alcoholism (more than two drinks daily);
* using steroid or drugs with unknown components;
* pregnancy or breast-feeding.
Healthy.io Method Comparison & User Performance Study

The objectives of the Healthy.io Method Comparison and User Performance Study are:

1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer.
2. To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based on a user questionnaire and rating scale.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female, 18-80 years of age
2. Subjects who are healthy or pregnant; or
3. Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite (examples of such diseases include the following):

   * diabetes Type I, Type II, or gestational diabetes (Type III) or,
   * urinary tract infection (UTI)
   * heart disease
   * kidney disease
   * liver disease
   * pregnant women with preeclampsia, gestational diabetes or UTI
   * any pathological findings which might be identified by the urine test (according to the physician discretion)
4. Subject is capable and willing to provide informed consent.
5. Subject has facility with both hands.
6. Subject is capable and willing to adhere to the study procedures
7. Subject is familiar with the use of a smartphone.

Exclusion Criteria:

1. Subject has dementia.
2. Subject has mental disorders.
3. Subject is visually impaired (cannot read the user manual).
4. Subject cannot collect urine in receptacle.
5. Any other reason that might preclude the subject from the study.
Stromal Therapy of Osteodysplasia After Allogeneic Bone Marrow Transplantation

Osteodysplasia or poorly formed bones, "brittle bones" is a genetic disease with no known proven treatments. Some forms of osteodysplasia may cause severe disability and even death.

Eligible patients were limited to those children with Osteodysplasia who had undergone a previous allogeneic bone marrow transplant at St. Jude. The study intervention involved an infusion of a specified number of ex vivo expanded stromal cells obtained from the bone marrow of the same donor from whom they received their primary transplant procedure. These bone marrow stromal cells can become bone-forming cells, called osteoblasts. Participants then received 2 infusions of ex vivo expanded, gene marked cells not less than 6 months after bone marrow transplantation. The second cell infusion occurred between 14 to 21 days after the first infusion in the absence of toxicity. The goal of the study was to evaluate the safety and toxicity of these infusions.

* To determine whether these ex vivo expanded, gene marked marrow stromal cells will engraft in the recipient's bone, bone marrow, and/or skin.
* To begin to investigate whether high proliferative mesenchymal progenitor cells can be expanded ex vivo and retain their progenitor potential in vivo.
* To begin to investigate whether ex vivo expanded bone marrow stromal cells can ameliorate the skeletal dysplasias associated with various genetic disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an appropriate genetic disorder who have had an allogeneic bone marrow transplant and currently maintain complete or mixed hematopoietic chimerism
* Patient must be \< or equal to 18Kg

Exclusion Criteria:

* Presence of infection
* Presence of GVHD (graft versus host disease)or the need for prophylaxis
* Concurrent participation in any investigational study that could potentially confound the interpretation of the safety parameters being investigated in this study.
Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

The aim of this study is to investigate the therapeutic efficacy of intensive insulin in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.

Hypertriglyceridemia-induced acute pancreatitis occurs in about 1-4% of the cases. It is the third leading cause of pancreatitis after biliary and alcoholic etiology. Hypertriglyceridemia can be caused by primary causes, lipid metabolism disorders and secondary causes.

Hyperlipidemic pancreatitis can be provoked when triglyceride levels (TGL) exceed 11.3 mmol/l (1,000 mg/dl). Except for standard symptomatic treatment, plasmapheresis and insulin have been performed to rapidly reduce TGL and chylomicron levels in the blood.The therapeutic efficacy of intensive insulin, standard insulin, and plasmapheresis in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.After acceptance patients will be randomized by random envelope in the 3 groups: Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertriglyceridemia induced acute pancreatitis (AP): Typical pain increase in serum lipase or amylase with serum TG\> 1,000 mg/dL (11.3mmol/L) or serum was milky with serum TG\> 500 mg/dL(5.65 mmol/L)
* Onset of abdominal pain within \<=48h before admission
* moderate severe or severe Acute Pancreatitis according to Atlanta criteria
* except for other AP causes, such as cholelithiasis, alcohol, drugs and so on

Exclusion Criteria:

* other etiologies other than hyperlipidemia leading to AP
* at the same time combined with other etiologies of AP
* appear difficult to reverse respiratory failure, severe systemic circulatory failure, coma and other the endangered symptoms, patients expected to die within 24hours
* disseminated intravascular coagulation, or patients with severe active bleeding
* without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
Intramuscular Peramivir for the Treatment of Uncomplicated Influenza

This is a multinational, randomized, double-blind study comparing the efficacy and safety of two single dose regimens of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female subjects age ≥18 years
* A Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab. A negative initial RAT may be repeated within one hour of obtaining a negative result.
* Presence of fever at time of screening of ≥38.0 ºC (≥100.4 ºF) taken orally, or ≥38.5 ºC (≥101.2 ºF) taken rectally. For subjects with a positive RAT at the time of screening, a subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at time of screening. For subjects with no positive RAT at screening, fever as defined above must be documented at time of screening
* Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
* Presence of at least one constitutional symptom (myalgia \[muscle aches\], headache, feverishness, or fatigue) of any severity (mild, moderate, or severe)
* Onset of symptoms no more than 48 hours before presentation for screening
* Written informed consent

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Presence of clinically significant signs of acute respiratory distress
* History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma
* History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class IV functional status within the past 12 months
* History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance \<50 mL/min)
* Current clinical evidence of active bacterial infection at any body site that requires therapy with oral or systemic antibiotics
* Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy
* Current treatment for active viral hepatitis C
* Presence of known HIV infection with a CD4 count \<350 cell/mm3
* Current therapy with oral warfarin or other systemic anticoagulant
* Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening
* Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days
* History of alcohol abuse or drug addiction within 1 year prior to admission in the study
* Participation in a previous study of peramivir as treatment for acute influenza or previous participation in this study
* Participation in a study of any investigational drug within the last 30 days
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

This is a Phase Ib, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Efmarodocokin Alfa and to make a preliminary assessment of activity of Efmarodocokin Alfa in combination with standard-of-care (SOC) in the prevention of acute graft-versus-host disease (aGVHD) in participants undergoing allogeneic hematopoietic stem cell transplantation (HSCT).


Eligibility Criteria:
Inclusion Criteria:

* Eligible for hematopoietic stem cell transplantation (HSCT)
* Donor meeting human leukocyte antigen (HLA) matching criteria of HLA-matched related or HLA-matched unrelated (HLA-A, HLA-B, HLA-C, and HLA-DRB1, eight out of eight) from either peripheral blood or bone marrow stem cells and meeting donor-eligibility criteria as outlined by the U.S. Food and Drug Administration (FDA) in 21 CFR 1271 (including screening for Zika and SARS-CoV-2 exposure or infection)
* Planned HLA (HLA-A, HLA-B, HLA-C, and HLA-DRB1)-matched (eight out of eight) related or planned HLA-matched (eight out of eight) unrelated HSCT, from either peripheral blood or bone marrow stem cells, for patients with acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) in first complete remission (per institutional criteria) or patients with intermediate or high-risk myelodysplastic syndrome (MDS)
* Planned myeloablative conditioning regimen per institutional guidelines
* Planned aGvHD prophylaxis consisting of tacrolimus and methotrexate; in cases of tacrolimus intolerance, cyclosporine or sirolimus may be used as a substitute

Exclusion Criteria:

* Prior receipt of autologous or allogeneic HSCT
* Diagnosis of myelofibrosis or myelodysplastic/myeloproliferative overlap syndrome
* Treatment with investigational biologic or non-biologic therapy within 5 drug elimination half-lives (or within 90 days or 30 days, respectively, if half-life is unknown) prior to initiation of study drug
* Positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serologies
* History of Grade \>1 cervical intraepithelial neoplasia
* A marked baseline prolongation of QT/QTc interval
* Risk factors for torsades de pointes
* Pregnant or breastfeeding
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Three New Generation Drug Eluting Stent

Aim of this study is to compare at 6 months follow-up, endothelization and malapposition, evaluated by means of optical coherence tomography, in terms of number of struts not endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience.

This is a randomized study aimed at evaluating in 60 patients with either acute coronary syndromes or stable coronary artery disease submitted with PCI and stenting, endothelization and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical coherence tomography in terms of number of struts not re-endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience. Further clinical follow-up will be performed to evaluate MACE at 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter \> 2,5 mm

Exclusion Criteria:

* Known allergy to antithrombotic drugs or to other components of the stent studied Planned surgery 6 months within angioplasty