cyrilzakka/clinical-trials huggingface dataset:
Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)

This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered with recommended standard care during the trial.

This is a phase II, multicenter, open-label, randomized, comparator-controlled study to evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly assigned to receive test arm or reference arm in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to comprehend and willingness to sign a written ICF for the study.
2. Male or non-pregnant females, ≥18 years of age at the time of enrolment.
3. Understands and agrees to comply with planned study procedures.
4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen within one week
6. Patients with SpO2 \> 93% and respiratory rate \<30 breaths/min.
7. Illness of any duration, and at least one of the following:

   1. Radiographic infiltrates by imaging (chest x-ray)
   2. Clinical assessment (evidence of rales/crackles or other clinical symptoms on exam).
8. Women of childbearing potential must agree to use at least one primary form of contraception

Exclusion Criteria:

1. ALT/AST \>5 times the upper limit of normal.
2. Patients with respiratory rate \<20 breaths/min and normal SpO2 with confirmed SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).
3. Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19 subjects).
4. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR \<30 mL/min/1.73 m2).
5. Pregnant or breast feeding.
6. Allergy to any study medication or usage of test drug during last 14 days prior to screening
7. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigator's assessment.
8. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.
9. Prolong QT interval (\>450 ms).
End-organ Pathology in Childhood Essential Hypertension

To determine the distribution of left ventricular hypertrophy and retinal vascular abnormalities in children and adolescents with essential hypertension; to evaluate potential risk factors and the time sequence for the development of these end-organ complications in this population.

BACKGROUND:

Elevated blood pressure has been established as an important risk factor for the development of cardiovascular disease morbidity and mortality. The major manifestations of end-organ pathology associated with hypertension include congestive heart failure, ischemic heart disease, stroke, and peripheral artery disease, including renal failure and retinopathy. As blood pressure has been studied in children, it has become evident that adult essential hypertension and its complications may have origins in adolescence and childhood. Clinical observations have shown that some individuals with elevated blood pressure will develop one form of morbidity, while others develop a different form, and still others do not develop any complications. The reasons for this are unknown. Few studies have been done which attempt to delineate risk factors for the development of the different end-organ pathologies in hypertensive individuals. Two end-organ problems are particularly amenable to study in children. Ultrasound examination of the heart allows the non-invasive study of left ventricular hypertrophy which is an important precursor to the development of congestive heart failure. Retinal examination by fundal photograph and fluorescein angiography allows the examination of the effects of elevated blood pressure on the vessels of the eye.

DESIGN NARRATIVE:

The first phase of the study had a cross-sectional design. In this phase, echocardiography was used to measure left ventricular dimensions, mass, volume and function and fundoscopic examination and fluorescein angiography were used to determine retinal vascular abnormalities. Data were collected on the independent variables of age, sex, race, obesity, level and duration of increased blood pressure, ambulatory variability of blood pressure, family history of hypertension, treatment with antihypertensive medication, sodium intake, smoking, alcohol use, fasting blood glucose, hemoglobin, basal plasma renin activity, plasma catecholamines, cardiovascular reactions to mental stress and to exercise. Multiple regression analysis was used to determine which of the independent variables were independently associated with left ventricular mass, creatinine clearance, and retinal vascular abnormality.

The second phase of the study was a longitudinal investigation of the development of left ventricular hypertrophy, changes in left ventricular function and retinal vascular disease, and the temporal relationship of these complications to the risk factors found in the first phase, using a cohort design.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Timing of Re-evaluation After Steps I-II of Periodontal Therapy

Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this randomized clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, probing pocket depth reduction, comprehensive treatment plan, and costs for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Periodontitis stage III-IV
* Full-mouth plaque score (FMPS) \< 25% at the 1-month re-evaluation
* Full-mouth bleeding score (FMBS) \< 25% at the 1-month re-evaluation
* Signed informed consent

Exclusion criteria:

* Age \< 18 yo
* Pregnancy or lactation
* Heavy smokers (\>10 die)
* Conditions or diseases influencing periodontal healing
* Patients that cannot complete the 6 months follow-up
Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can improve the baby's health at birth when compared with delivery at a later point in the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment
* Dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound \<21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization
* No known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician)
* FGR defined as estimated fetal weight (EFW) \< 10th percentile by Hadlock formula with normal umbilical artery Doppler studies and normal amniotic fluid

Exclusion Criteria:

* Known major fetal anomalies
* Multiple gestation or selective reduction of multiple gestation after 14 weeks
* Previous stillbirth at term
* Indications for delivery at \<39 weeks. Common examples include:
* Placenta previa
* Placenta accreta
* Vasa previa
* History of classical cesarean section or myomectomy
* Human immunodeficiency virus (HIV)
* Oligohydramnios (low amniotic fluid, defined as maximum vertical pocket \<2.0cm)
* High-risk pregnancy as determined by the physician. Common examples include:
* Pre-gestational diabetes or gestational diabetes on medication
* Chronic hypertension on medication
* Maternal cardiac disease
* Asthma requiring oral steroids during pregnancy
* Chronic renal disease
* Antiphospholipid syndrome
* Hyperthyroidism
* Prior stillbirth
* Systemic lupus erythematous
* Hemoglobinopathies such as sickle cell disease
Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.

The brain is primarily developed in the third trimester of pregnancy, but continues maturing through the late twenties, especially the prefrontal cortex. Omega-3 long-chain polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell membranes, influence membrane fluidity and signal transduction, and thus learning, cognition and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with limitations in these complex brain functions. Previous studies suggested that such functions could be improved by increasing LCPUFA. The adolescent brain, however, has been largely neglected. This study investigates the effect of one-year daily omega-3 LCPUFA supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents preselected from a population of 700 adolescents with low omega-3 index (\<5%) will receive daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be adjusted individually to reach a target level of 8-11%. The effects on learning (academic achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation, goal-orientation, absenteeism), and in a subsample cognitive processes, in particular perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months. This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a safe intervention, on a large variety of complex brain functions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents aged 14-15 years.
* In lower general secondary education (MAVO/VMBO).

Exclusion Criteria:

* Suffering from hemophilia (blood clotting disorder).
* Allergic to (shell)fish.
Trial Comparing Metabolic Effects of Telmisartan and Amlodipine on Hypertensive Patients With Obesity and Diabetes

Recent studies have shown that obese people are more prone to high blood pressure. With the co-existence of obesity, hypertension and diabetes, patients were more susceptible to hyperlipidemia, coronary and cerebral atherosclerosis and peripheral vascular disease. Abdominal obesity has often accompanied by substantial accumulation of visceral fat, which increased secretion of many inflammatory mediators, cytokines and adipocytokines and played an important role in cardiovascular and metabolic disease. Some reports had shown that angiotensin II receptor blockers (ARB) may improve metabolic profiles in patients with diabetes or metabolic syndrome, in addition to its hypotensive effect. It has been reported that some ARB, such as telmisartan and candesartan, can prevent weight gain and high-fat-induced obesity in experimental animals. However, whether telmisartan intervention on improvement of fat deposition and other related metabolic profiles is better than a CCB drugs (amlodipine) in those obese hypertensive patients with diabetes, was still unknown.


Eligibility Criteria:
Inclusion Criteria:

* Information Consent Signed
* Aged 30\~70 years
* For whom without anti-hypertensive therapy in 2 weeks：140mmHg≤SBP\<180mmHg，或90mmHg≤DBP\<110mmHg. For whom with anti-hypertensive therapies in 2 weeks：SBP\<180mmHg, 且DBP\<110mmHg
* Waist circumference higher than 90cm in men, 80cm in women
* Diagnosed diabetes

Exclusion Criteria:

* Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
* Waist circumference less than 90cm in men, 80cm in women
* Known allergy or hypersensitivity to trial drugs
* NYHA grade Ⅱ\~Ⅳ heart failure, Myocardial infarction or cerebrovascular accident in 1 year preceding the trial
* Acute infections, tumor, severe arrhythmia, mental disease, drug or alcohol abuse
* History of hepatitis or cirrhosis
* History of severe kidney disease
* Pregnant, lactation
* Enrolled in other trials in 3 months
* Any obstacles of follow-up or compliance
Lactoferrin for Prevention of COVID-19 in Health Care Workers

Clinical trial in health care personnel (physicians, nurses or nurse assistants) to determine the effect of orally-administered bovine lactoferrin to prevent SARS-CoV-2 infection. Participants will be randomized to receive daily bovine lactoferrin plus standard measures during 12 weeks or placebo (maltodextrine) for the prevention of SARS-CoV-2. The target enrollment is 336 participants. Each study participant will be monitored twice a week for symptoms of COVID-19 and if symptoms occur, a RT-PCR will be performed. Additionally, we will evaluate asymptomatic infections, by measuring SARS-CoV-2 serology every 4 weeks.

The SARS-CoV-2 infection has affected more than 100 countries around the world being classified as a pandemic by the World Health Organization. Health care providers are at high risk to become infected with the SARS-CoV-2 due to their continuous exposition to infected patients. Multiple strategies are being developed as potential prophylactic regimens, however to date (4th Aug 2020) none has proven to be effective for preventing the SARS-CoV-2 infection. Lactoferrin, an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. It has shown to inhibit the SARS entry to target cells by inhibiting the union of the SARS-CoV-2 spike protein with its receptor (ACE-II receptors), blocking the heparan sulfate proteoglycan receptor and it decreases the viral load of SARS-CoV-2 infecting culture cells in in vitro models. The study hypothesis is that lactoferrin given as a daily oral food supplement to health care workers will decrease the frequency of SARS-CoV-2 infection. The investigators will conduct a randomized double blinded placebo control clinical trial in physicians, nurses and nurse assistants who work in areas of care for patients with COVID-19 (emergency, hospitalization, and Intensive Care Unit) in hospitals in Lima, Peru, to determine the effect of bovine lactoferrin on the prevention of COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 and under 60 years old
* Physicians or nurses or nurse assitant who work in areas of care for patients with COVID-19 (emergency, hospitalization, and Intensive Care Unit) in hospitals in Lima, Peru.
* Healthy participants, without COVID-19 suggestive symptoms
* Participant who wants to participate and signs the informed consent.

Exclusion Criteria:

* Participant who had a previous diagnosis of COVID-19.
* Participant positive in the initial screening for IgM or IgG or a positive RT-PCR for SARS-CoV-2.
* Participant with the following comorbidities: hypertension, coronary heart disease, diabetes mellitus, obesity, chronic lung disease, cancer, kidney failure, or other hematological disease.
* Pregnant woman.
* Participant that are part of another clinical trial or are taking any supplement or preventive treatment for COVID-19.
* Participant with known allergy to cow's milk protein.
Relative Bioavailability Study of SHR3680

This is a single-center, single-dose, randomized, open-label, parallel sstudy to evaluate the relative bioavailability of new and old formulations of SHR3680 tablets in healthy male subjects under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent, and less than 10-year between minimum age and maximum age of the whole subjects;
4. Body weight ≥ 50 kg, and body mass index (BMI) within the range of 19 \~ 26 kg /m2 (including 19 and 26);
5. Agreement to avoid sperm donation for 3 months days after the dose of SHR3680;
6. Glomerular filtration rate (GFR) ≥ 90mL / min / 1.73m2 (see Appendix 1 of the clinical trial protocol for the calculation formula of GFR);

Exclusion Criteria:

1. Any history of epilepsy, including childhood febrile seizures, loss of consciousness, transient ischemic attacks or any conditions that may lead to seizures, such as cerebrovascular disease, brain injury, stroke or brain cancer, etc;
2. Any subject who had any clinically significant acute diseases within one month before screening, including fever or fever as his clinical symptoms, virus, bacteria (including upper respiratory tract infection) or fungi (non-skin) infections;
3. Loss of more than 400 mL blood during the 3 months before the trial (eg, as a blood donor);
4. Allergic constitution;
5. History of drug use, or drug abuse screening positive;
6. Alcoholic or often drinkers;
7. A smoker with 5 cigarettes per day for more than 90 days;
8. Positive serology for hepatitis B surface antigen (HBsAg) and HCV (healthy participants), anti-treponema pallidum virus (TP), or antihuman immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects);
9. Use of any drugs or substances known to be inhibitors or inducers of CYP enzymes within 90 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to SHR3680 administration and during the study.
10. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
11. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
12. From 48 hours before taking the study drug to the end of the study, any subject refused to stop using any drinks containing methylxanthine (such as coffee, tea, cola, chocolate, etc.), alcoholic drinks and any fruit juice; they took drinks or foods containing grapefruit 7 days before the first administration of the study drug;
13. Those who received vaccination within 3 months before screening.
The Influence of Hospital Environment on Eyes Infections in Medical Staff

The investigators want to find out if there is any difference between the microbiotic flora lining the conjunctiva of medical staff that work in the hospital and others who do not work in the hospital.


Eligibility Criteria:
Inclusion Criteria:

* healthy medical workers.

Exclusion Criteria:

* any ocular disease.
* previous ocular surgery.
Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic

Summary:

Background One of the most important roles of psychiatric nurses, who help individuals, families and society in promoting health, preventing diseases and coping with problems, is their educational role. With its educational role, the nurse can help the patient and their family function at the best level in biopsychosocial integrity in preventing and coping with diseases through psychoeducation.

Goals This research was conducted to evaluate the effectiveness of psychoeducational training given to nurses working in a psychiatric clinic.

Design This research is a randomized controlled experimental study. Participants Participants were determined using simple randomization. The sample of the study consisted of 78 nurses (intervention = 39; control = 39) working in a psychiatric clinic in a city hospital in Turkey.

Methods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA).


Eligibility Criteria:
Inclusion Criteria:

* Working in a psychiatric clinic,
* Being a nurse

Exclusion Criteria:

* Not working in a psychiatric clinic
Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis

At present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. It is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for patients with sepsis. Therefore, this study focuses on the efficacy and safety of sodium bicarbonate Ringer's solution compared with normal saline.

Sepsis and septic shock are clinical emergencies requiring immediate treatment and fluid resuscitation. Early effective fluid resuscitation can improve the prognosis of patients. So far, there is no perfect crystalloid solution. Normal saline is the most readily available and economical crystalline fluid for clinical resuscitation. It is isoosmotic and can meet the basic needs of patients in the early rehydration. But it lacks acid-base buffer system and potassium, calcium and magnesium ions, and the level of chloride ions is also significantly higher than that of plasma.

Sodium Bicarbonate Ringer's solution contains physiological levels of Na+(130mmol/L), K+(4mmol/L), Ca2+(1.5mmol/L), Mg2+(1mmol/L), HCO3-(28mmol/L) and Cl-(109mmol/L). It also has citric acid/ sodium citrate buffer system (Citrate3-1.3mmol/L), pH7.3, and osmotic pressure 276mOsm/L. It is the most similar solution to extracellular fluid.

Theoretically，Compared with normal saline, Sodium Bicarbonate Ringer's solution can maintain acid-base balance faster and better when restoring the microcirculation without affecting the level of chloride ion. Therefore we hypothesize that Sodium Bicarbonate Ringer's solution can promote the body to restore to acid-base balance more quickly, and improve organ function more significantly than normal saline.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as sepsis or septic shock according to the definition of Sepsis-3.0 with fluid resuscitation requirement;
* aged between 18 and 80, male or female;
* Signed informed Consent (with delay within 24 hours).

Exclusion Criteria:

* Patients with hypermagnesemia;
* Patients with hypothyroidism;
* Patients predicted to die or discharged within 24 hours after admission;
* Patients with previous history of mental illness, severe hepatic and renal insufficiency, severe cardiac disease, primary severe central nervous system lesions;
* Pregnant or breast-feeding women;
* Patients who have received cardiopulmonary resuscitation；
* Patients who participated in other clinical trials within 30 days;
* Patients have other conditions that are not appropriate for inclusion according to the researcher's judgment.