cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerance and Pharmacokinetics Study of Compound Edaravone Injection

Study on the Safety, Tolerance and Pharmacokinetics of Single-dose, Increasing and Loading Dose and Maintenance Dose Sequential Intravenous Infusion of Compound Edaravone Injection in Chinese Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years old (including upper and lower limits);
2. Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);
3. Understand and sign the informed consent voluntarily, and volunteer to participate in this research.

Exclusion Criteria:

1. A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;
2. A comprehensive physical examination, neurological examination, laboratory examination, ECG examination, or cognitive assessment indicates that the subject has an abnormality that the researcher has determined to be clinically significant;
3. Have taken any drug within two weeks before the study administration, and the researcher believes that this situation may affect the evaluation results of this study;
4. There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;
5. Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);
6. A history of alcohol or drug abuse that the investigator believes may affect the evaluation results of this study within one year before the study administration;
7. Cannot quit smoking or drinking during the study period or the carbon monoxide breath test\> 7 ppm during the screening period CO breath test, so if the subject's CO breath is\> 7ppm, but the urine cotinine test is negative, it means that the CO breath test result may be false positive, the subject can be enrolled;
8. As a subject who has participated in any drug clinical trial within 3 months before the first administration of the study;
9. Those who donated blood or blood products ≥400 mL or 2 units within three months of the study;
10. Do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or vigorous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion, etc. during the 24 hours before and during the test;
11. Pregnant or lactating women, or those who tested positive for serum HCG before the test administration, or those who were unable or unwilling to take researcher-approved contraception during the study according to the researcher's instructions;
12. Subjects with poor compliance or unable to comply with the relevant provisions of the research protocol due to personal reasons, the investigator judges that the subjects are not suitable to participate in this clinical study.
Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants

BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The cardiopulmonary functions of these preterm babies may be adversely affected by the patency of ductus arteriosus. Ductal tissues are sensitive to the constricting effect of endothelin-1 and the dilating effect of prostaglandins, inflammatory mediators, and concentration of oxygen.

OBJECTIVE To examine the role of endogenous nitric oxide (NO) and endothelin-1 (ET-1) in the pathogenesis of patent ductus arteriosus of the preterm infants. We hypothesize that the patency of ductus arterious in preterm infants is probably due to inappropriate production of endogenous nitric oxide and the interaction with various inflammatory mediators and prostaglandins, which is different from those of term infants. In addition, the secretion of endothelin is probably decreased. The purpose of this study is to monitor the changes of these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus in preterm infants.

METHODS AND MATERIALS

1. Inclusion criteria:

   1. Preterm infants with gestational age less than 32 weeks or birth weight less than 2000 gm.
   2. Informed consent
2. Numbers of study population:

   With 80-100 evaluable infants (40-50 patients in PDA and non-PDA groups, respectively)
3. Blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is assessed for inflammatory mediator (IL-8, IL-10), nitric oxide metabolites (nitrite and nitrate), endothelin-1, and cGMP
4. Statistical analysis: Student t-test testing the differences of clinical data, Wilcoxon signed rank test for comparing data obtained between the PDA and non-PDA patients, the PDA patients before and after intravenous indomethacin, and those who are responsive or refractory to the therapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of the patency of ductus arteriosus

Exclusion Criteria:

* Congenital anomalies
Lung Recruitment Maneuver As a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients

In this research study we want to learn more about using non-invasive tools as a way to predict whether or not a child under general anesthesia will require and respond to fluid administration.

It is important for an anesthesiologist to know if a child would respond to fluid administration so that they can provide the optimal intervention for low blood pressure and avoid unnecessary treatment.

In this research study we want to learn more about using non-invasive tools as a way to predict whether or not a child under general anesthesia will require and respond to fluid administration.

It is important for an anesthesiologist to know if a child would respond to fluid administration so that they can provide the optimal intervention for low blood pressure and avoid unnecessary treatment.

Eligibility Criteria:
Inclusion Criteria:

* 0 to \< 18 years old
* Undergoing surgery at Boston Children's Hospital under general anesthesia
* mechanically ventilated with an endotracheal tube
* Monitored with an indwelling radial arterial catheter as part of the anesthetic plan for the scheduled surgical procedure

Exclusion Criteria:

* Prematurity
* Low birth weight
* Congenital heart disease
* Left or right ventricular dysfunction
* Cardiac arrhythmia
* Pulmonary hypertension
* Preoperative parenchymal or interstitial lung disease
* Intracranial hypertension
* Poor transthoracic acoustic window
* Obesity
* Allergy to ultrasound transmission gel
* Need for single lung ventilation
* Systemic hypertension on antihypertensive medications
Dose-finding Study of KHK7791 in Hyperphosphatemia Patients

To evaluate the effect and safety of KHK7791 to treat Hyperphosphatemia in ptatients on HD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable chronic renal failure who have undergone hemodialysis three times per week for at least 12 weeks until screening examination.
* Dialysis conditions (dialysate, dialyzer, frequency of dialysis per week, dialysis duration, blood flow rate, and dialysate and substitution fluid flow rates), excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
* Taking phosphate binders three times per day. The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
* Serum phosphorus levels should be in the range of ≥3.5 and ≤6.0 mg/dL at screening examination.
* If on any vitamin D or calcimimetics regimen, then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.

Exclusion Criteria:

* iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
* Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
* History of gastrectomy or enterectomy (excluding endoscopic resection and cecectomy) or having undergone gastrointestinal tract surgery within 3 months before screening examination.
* Having concurrent severe heart disease \[including congestive heart failure, defined as New York Heart Association (NYHA) cardiac functional classification of class III or IV, and cardiovascular disease requiring hospitalization, such as myocardial infarction\] or hepatic impairment (including AST/ALT ≥100 U/L at screening examination, or cirrhosis).
* Developed cerebrovascular disease (such as cerebral infarction and hemorrhage) or cardiovascular disease (such as myocardial infarction and unstable angina) requiring hospitalization within 6 months before screening examination.
* Uncontrollable hypertension or diabetes.
* Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period.
* Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
Evaluating Mobile-based Medication Reconciliation by Patients at Home

Medication reconciliation (MR) is essential to limit drug-related problems that occur during care transitions in and out of care institutions. Pharmacy-led medication reconciliation has been shown to reduce medication discrepancies, preventable harm and hospital readmissions. However, these consultations are time-consuming. The Erasmus Medical Center is currently developing a mobile-based patient portal. After receiving an invitation to perform medication reconciliation in the app, patients can review their medication and allergies at home. Next, pharmacy technicians manually verify all patient-entered data on completeness and quality. The investigators hypothesize that mobile-based medication reconciliation results in increased patient insight. Yet, it is unknown if mobile-based medication reconciliation is feasible, saves time, and is of high quality.

Therefore, the primary study objectives are to assess (1) the feasibility of patients performing medication reconciliation using a mobile-based patient portal, (2) the time investment of pharmacy technicians in mobile-based medication reconciliation (and related costs), in comparison to standard practice, and (3) the quality of patients' pre-verified medication lists. The secondary study objective is to assess patients' and pharmacy technicians' acceptability of performing medication reconciliation using a mobile-based patient portal.

This is a prospective quality evaluation study assessing mobile-based medication reconciliation. All adult patients (18 years or older) who are admitted to (a selection of) clinical ward in Erasmus Medical Center and who are asked to complete medication reconciliation are eligible. In the patient app, patients review ('pre-verify') their medications and allergies, after which pharmacy technicians check and manually approve ('verify') all patient-entered data and determine whether a follow-up interview is needed.

Feasibility is defined as the successful completion rate of digital medication reconciliation, and the need for additional interviews. Time investment by pharmacy technicians (and related costs) are determined by timing the duration of all patient-bound medication reconciliation-related tasks, both in standard care and when using mobile-based reconciliation. The quality of verification is determined by comparing patients' pre-verified medication list to pharmacy technician-verified lists. Acceptability is defined as the perceived usability of medication reconciliation by patients and by pharmacy technicians.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Planned admission to the clinical ward of participating pilot departments in Erasmus MC

Exclusion Criteria:

* No potential subject will be excluded from participation in this study.
Neurogenic Intermittent Claudication Evaluation Study

The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication, relieved by flexion.

The NICE study is a Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius™ PercLID™System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication.

DLSS patients suffering from NIC that would be candidates for surgical treatment without stabilization and/or fusion can be offered participation in the study. After randomization, patients will be treated with either the Aperius™ PercLID™ System or Standalone Decompressive Surgery (SDS). A sample size recalculation reduced the amount of patients to be enrolled from 280 to 128 in both treatment group.

The patient will undergo a study visit at screening / baseline and at 14 days, 6 weeks, 6, 12 and 24 months after surgery. Safety data will be collected during surgery and throughout the 24 months follow up. Procedural details will be collected during surgery and also duration of hospital stay will be collected. At screening / baseline and all follow up visits a physical examination will be performed, the use of pain medication will be documented and the subject will be asked to complete a pain VAS scale (back - leg - buttock / groin pain) and questionnaires (SF36 v2 and Zurich Claudication Questionnaire).

Study subjects are required to undergo X-ray, CT and MRI and fluoroscopy procedures at specified time points during the study.

Eligibility Criteria:
Inclusion Criteria:

* Presence of symptomatic DLSS
* Presence of NIC
* Patient would be candidate for Standalone Decompressive Surgery
* Patient has signed Informed Consent form (ICF)
* Patient is 21 years old or older

Exclusion Criteria:

* Previous lumbar surgery
* Patient is candidate for instrumented Decompressive Surgery
* Patient has back pain without leg pain
* Degenerative Spondylolisthesis greater than grade 1 (Meyerding)
* Symptomatic DLSS at more than 2 levels in the lumbar region
* Spinal stenosis is present at L5-S1 level
Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products

The goal of this study is to modify a smoking prevention program for 5th and 6th grade students to also target vaping e-cigarettes. Aims were to modify the program along with associated materials and to conduct a trial with 5th grade students in the school setting to see how well the updated program worked. Students either participated in the four-week computer based program or continued with their usual tobacco prevention curriculum.

This study showed that students who received the computer program reduced their intentions and willingness to use e-cigarettes or smoke in the future more than did students who used their usual tobacco curriculum.

Given the increase in prevalence of e-cigarette use among youth, investigators modified a smoking prevention program to not only target smoking but also vaping e-cigarettes. Investigators conducted a pragmatic randomized trial with 5th grade students in schools across Arizona and Oregon to evaluate the effectiveness of the updated program in a "real-world" setting. Forty-five schools were randomized to the intervention condition, wherein students used the updated version of Click City®: Tobacco, or the control condition, wherein students were taught their usual tobacco prevention curriculum. Students in the intervention schools decreased their intentions and willingness to use e-cigarettes and cigarettes significantly, as compared to students in control schools. The intervention also significantly changed all etiological mechanisms. The effects on all outcomes of the intervention were similar as a function of state (Arizona vs Oregon), gender, ethnicity (Hispanic vs not Hispanic), and historical timing (prior to school closures in 2020 vs after schools re-opened in 2022). The intervention was also more effective for at-risk students, as defined by student's previous tobacco use, current family use and/or high in sensation seeking. Close to 90% of the students completed the entire program, and most completed it in 3 to 4 weeks, the expected time frame. The effectiveness of the updated Click City®: Tobacco was demonstrated in a "real world" setting and findings suggested that all students can potentially benefit from the program.

Eligibility Criteria:
Inclusion Criteria:

* A 5th grade student in one of the recruited schools
* Student speaks English as a first or second language
* Passive parental consent to participate

Exclusion Criteria:

* Special needs students identified by the classroom teacher as a student who would not understand the questionnaire or the program
* Teacher indicates that they cannot comprehend English.
Stroke Imaging Package Study

Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.

1. Patients with acute ischemic stroke within 4.5-72h after onset were prospectively enrolled in our study and underwent standardized clinical and new imaging technique package assessment.
2. New imaging technique package mainly includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI, and ADC), cranial magnetic resonance angiography (MRA), and intracranial vessel wall imaging (High-Resolution Magnetic Resonance Imaging,HRMRI) as well as susceptibility weighted imaging (SWI).
3. The neurofunctional fluctuation during hospitalization as well as 90-day outcomes were carefully assessed. Patients were followed up for 90-days after stroke onset.
4. Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. patients with ischemic stroke and hospitalized during 4.5-72 hours after onset , confirmed by diffusion weighted imaging (DWI).
2. patients with stable vital signs.
3. patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study.

Exclusion Criteria:

1. patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia).
2. patients who is extremely agitated, and cannot comply with MRI exam.
3. patients who declined the consent.
MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement

MASTER study is a 4-year prospective, randomized, open-label, blinded-endpoint study (PROBE) comparing 2 management strategies 1) office BP as a guide to treatment, or 2) 24-hour ABP as a guide to treatment. Study objectives are to investigate whether a management strategy based on out-of-office BP (Ambulatory BP monitoring) versus a management strategy based on office BP measurements is associated with differences in outcome, including cardiovascular and renal intermediate end points at one year; cardiovascular events at 4 years and changes in a number of blood pressure-related variables throughout the study. Patients will be followed-up during the first year focusing on changes in left ventricular mass index (LVMI, co-primary endpoint) and Urinary albumin excretion (UAE, albumin/creatinine ratio, co-primary end-point), and during the whole 48 month period for both changes in LVMI and UAE and events including all-cause mortality, CV morbidity and mortality, cerebral morbidity and mortality.A total of 1240 subjects will be recruited by 30 centers, taking into account a dropout rate of 15% (620 subjects per randomization arm).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects
* Age 35-80 years
* Masked uncontrolled (in treatment) hypertension: office BP \<140/90 mmHg, and one or more of the following situations:

  * Ambulatory daytime BP \>135/85 mmHg
  * Ambulatory night-time ABP \> 120/70 mmHg
  * Ambulatory 24h ABP \>130/80 mmHg
* eGFR ≥45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009)

Exclusion Criteria:

* eGFR \<45 mL/min/1.73 m2 (CKD-EPI creatinine equation 2009), and in particular severe chronic renal failure defined as serum creatinine \> 250 umol/l;
* Patients in unstable clinical conditions;
* Known secondary hypertension;
* Orthostatic hypotension (SBP fall \> 20 mmHg on standing);
* Dementia (clinical diagnosis);
* Hepatic disease as determined by either AST or ALT values \> 2 times the upper limit of normal
* History of gastrointestinal surgery or disorders which could interfere with drug absorption
* Known allergy or contraindications to one of the drugs to be administered in the study
* History of malignancy including leukaemia and lymphoma (but not basal cell skin cancer) within the last 5 years
* History of clinically significant autoimmune disorders such as systemic lupus erythematosus.
* History of drug or alcohol abuse within the last 5 years
* History of non-compliance to medical regimens and/or patients who are considered potentially unreliable
* Inability or unwillingness to give free informed consent
* Pregnancy or planned pregnancy during study period.
Evaluation of a New Blood Pressure Measuring Device.

* A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
* Up to 100 subjects with various levels of blood pressure values will be tested.

The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.

* Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
* Each measurement will be performed simultaneously by two examiners specially trained.
* Informed consent will be obtained from all participants.
* The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or above
* Signed written informed consent

Exclusion Criteria:

* A history of cardiac arrythmia
* Wrist circumference smaller than 13cm or larger than 19.5cm
* Documented peripheral vascular disease
* Damage or injury to the left wrist
* Participation in any other clinical study
* Any acute coronary of cardiovascular illness
Pratical Assessment of DSAEK in the Management of Endothelial Decompensation Following Penetrating Keratoplasty

Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.

A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.

Eligibility Criteria:
Inclusion Criteria:

* with endothelial decompensation after penetrating keratoplasty
* surgery realised by the same surgeon

Exclusion Criteria:

* None