cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only.

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.

Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.

To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ MMR(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives MMR (0.5ml).

Blood samples will be collected before vaccination and 30 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have participated the clinical trial titled "Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP" (NCT04054882) in 2019, and have finished 3 doses of combined immunization of sIPV and DTaP;
* Subjects aged 18 months old at the date of recruitment;
* With informed consent form (ICF) signed by parent(s) or guardian(s);
* Parent(s) or guardian(s) are able to attend all planned clinical appointments and obey/follow all study instructions;
* Subjects have been vaccinated with a first dose of MMR, but have not been vaccinated with the 2nd dose of MMR and the booster (4th) dose of sIPV and DTaP;
* No less than 14 days since the last dose of vaccination;
* Axillary temperature ≤37.0℃.

Exclusion Criteria:

* With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
* Allergic to any ingredient of vaccine or with allergy history to any vaccine;
* Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
* Administration of immunoglobulins within 30 days prior to this study;
* Acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
* With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection;
* With any serious chronic illness, acute infectious diseases, or respiratory diseases;
* With severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
* With any kind of infectious, purulent, or allergic skin diseases;
* With any other factor that makes the investigator determines the subject is unsuitable for this study.
Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty

This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.

This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty. Patients with STEMI will be randomized into the cocktail group or the control group. Patients in the cocktail group will receive cocktail injection combined with thrombus aspiration. Patients in the control group will receive thrombus aspiration alone. The primary outcome of the cocktail I study is the composite of death, myocardial infarction or class IV heart failure within 1 year. The secondary outcome of the cocktail I study include slow reflow/no reflow during PCI, left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset

Exclusion Criteria:

* Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT
Paracetamol Versus Ibuprofen for PDA Closure

Comparison between the safety and efficacy of oral paracetamol and oral ibuprofen in treatment of Patent Ductus Arteriosus (PDA) in premature infants

A pilot study through which we have studied efficacy and safety of oral paracetamol and oral ibuprofen in treatment of hemodyamically significant pda in preterm neonates. 30 preterm neonates were included in the study 15 per each group. echo was done in the beginning and during treatment with both drugs to follow up the closure of the duct.

Ibuprofen was given as 10 mg/kg/dose in the 1st day followed by 5 mg/kg/dose in the 2nd and 3rd days with follow up echo was done after finishing the course paracetamol was given as 15 mglkg/6 hrs for three days with follow up echo to check the ductal closure.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age ≤ 35 weeks
2. Aged 2-7 days with color Doppler echocardiographic evidence of PDA
3. Urine output more than 1 ml/kg/hr
4. Creatinine concentration level less than 1.8 mg/dl

Exclusion Criteria:

Neonates who have one or more of the following criteria were excluded from the study:

1. Congenital heart diseases of any type including

   * Pulmonary stenosis
   * Anomalus in pulmonary venous drainage
   * Ventricular septal defect
2. Major congenital anomalies as hydrops fetalis
3. Low platelets count (less than 60, 000/mm3)
A Modified Orbital Implantation Technique in Enucleation

To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique in hydroxyapatite orbital implants

To assess the functional and cosmetic outcomes of enucleation with rectus end-to-end suturing surgical technique between 2005 and 2009. All the patients underwent primary enucleation and implantation of non-wrapped HA implants using a technique that involves drawing the ends of the rectus muscles anteriorly and suturing them into a cross-shape in front of the implant. Main outcome measures included occurrence of pain or discharge, soft tissue problems, implant motility, upper lid position, and patients' satisfaction.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

bilateral enucleation severely traumatized orbits, and little or no function of the extraocular muscles adjunctive radiotherapy and/or chemotherapy diabetes vessel inflammation follow-up of less than 6 months
Predictor of Clinical Response to Acthar in Myositis

Comparing the clinical effects of Acthar Gel before and after treatment and compare it to patients with inactive disease.

To compare the clinical impact of Acthar Gel at the cellular and molecular level before and after treatment and compare it to patients with inactive disease. The cohort of active myositis subjects are not actually enrolled in this study, but rather the data for those with active myositis will be obtained from a previously completed trial entitled "Efficacy and safety of Adenocorticotropic Hormone Gel in Refractory dermatomyositis and polymyositis".

Eligibility Criteria:
Inclusion Criteria:

* Healthy Controls:

  * An individual will be eligible to be a control subject if his/her age is 18 years or greater.
* Myositis Remission Control Group

  * Definite or probable PM or DM by Bohan and Peter criteria.
  * PM patients must either possess a myositis-associated autoantibody or undergo adjudication for confirmation of the PM diagnosis by consensus of two experts (Aggarwal or Oddis) to ensure non-PM patients are not enrolled. This step is necessary since there are well known mimics of PM.
  * Age is greater than or equal to 18 years
  * Remission of myositis as defined by a myositis disease global activity score \<1 on the MDAAT and no new immunosuppressive or glucocorticoid therapy or dose change within one year.

Exclusion Criteria:

* Healthy Controls:

  * An existing diagnosis of a CTD
  * A potential immune compromised state, for example, treatment with immunosuppressant or anti-rejection medication or a diagnosis of an immune deficiency disease
* Myositis Remission Control Group:

  * Juvenile DM or PM, myositis in overlap with another connective tissue disease, cancer associated myositis, inclusion body myositis, or any other non immune mediated myopathy.
  * Severe muscle damage defined as a baseline global muscle damage score on the MDI (Myositis Damage Index) of greater than or equal to five centimeters on a ten centimeter VAS.
  * Patients with malignancy within three years of screening (except basal cell cancer or squamous cell cancer of skin.
  * Uncontrolled diabetes, hepatic or renal disease.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East

This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected both retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To identify adherence subject profiling
* To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (that is, above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristic (SmPC)
* Over the age of 2 years
* Under 18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (that is, for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in another interventional clinical study
Neonate Cerebral Activity in Immediate Post Partum

Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. Birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. Ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. Both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks.

In this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. The investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. The investigators will measure interactions by means of correlation analysis between both signals.


Eligibility Criteria:
Inclusion Criteria:

* Full term neonates between 36 and 41 weeks Gestational Age

Exclusion Criteria:

* Premature neonates
* Neonates of twin pregnancy
* Suspicion of congenital malformation seen in antenatal ultrasound
* Any pathology requiring pediatric care from birth
* Newborns whose mothers had a chronic viral infection such as AIDS, hepatitis B or C, or who had a multidrug-resistant bacteria
Effects of Vildagliptine and Glimepiride on Glucose Variability

The purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number of type 2 DM patients. The investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.

We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%).

Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.

Eligibility Criteria:
Inclusion Criteria:

* with type 2 DM
* with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
* who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
* who can be applied with CGMS

Exclusion Criteria:

* who has liver function abnormality or renal function abnormality
* who has any kind of diseases, operations, medical treatments that can affect glucose levels
Hydrus Microstent as a Quality of Life Consideration

The study aims to identify if Hydrus microstent implantation in patients with open angle glaucoma (OAG) at the time of cataract surgery improves quality of life for patients and explore what quality of life factors motivate patients.

Prospective, interventional single arm study of patient-reported outcomes (PRO) via GSS with pre and post ocular surface disease assessment in subjects undergoing bilateral phaco and Hydrus implantation; Study will also explore other QOL factors that may motivate patients to accept Hydrus via Glauc-QOL36 and customized questions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to moderate open angle glaucoma as defined by with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus Microstent
* Current treatment with one or more ocular hypotensive medication
* Corneal thickness between 470 to 610µm
* Potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 LogMAR (20/25) postoperatively

Exclusion Criteria:

* Clinical diagnosis of secondary glaucoma (traumatic, neovascular, mixed-mechanism, uveitic glaucoma)
* corneal opacity or angle abnormalities that make visualizing the angle difficult
* Past ocular surgery
* History of ocular, systemic medications, or systemic diseases/co-morbidities that significantly impact on quality of life or vision (e.g. advanced macular degeneration, autoimmune diseases, mental illness/depression, uncontrolled systemic disease on polypharmacy)
* Severe dry eye requiring secretagogues, serum eyedrops, topical corticosteroids, amniotic membrane grafts
Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam

Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Remimazolam, a recently developed anesthetics, showed faster recovery from anesthesia and stable hemodynamics compared to propofol, the most popular anesthetics. However, few studies have investigated the usefulness of remimazolam for rigid bronchoscopy. Therefore, the investigators compared the usefulness of propofol and remimazolam in total intravenous anesthesia for rigid bronchoscopy.

Rigid bronchoscopy usually requires deep general anesthesia, but the duration of the procedure is relatively short. Therefore, anesthesiologists need anesthetics that simultaneously provide hemodynamical stability and faster recovery from anesthesia. Remimazolam showed faster recovery from anesthesia and stable hemodynamic profiles compared to propofol, the most popular anesthetics during general anesthesia. However, few studies have investigated the usefulness of remimazolam during rigid bronchoscopy. In this randomized controlled trial, the investigators want to compare the recovery duration from anesthesia after a rigid bronchoscopy procedure between patients undergoing intravenous anesthesia using remimazolam and propofol.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who undergoing rigid bronchoscopy under general anesthesia in Samsung Medical Center, Seoul, South Korea
* American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

1. patients who are contraindicated in benzodiazepine (e,g., allergy to the drug or have a history of hypersensitivity reactions)
2. drug or alcohol addiction
3. neuromuscular disease or mental illness
4. metabolic disease
5. emergency surgery
6. body mass index \>30 kg/m2 or \<18.5 kg/m2
7. patient's refusal
8. patients in shock or coma
9. Patients contraindicated to remimazolam such as acute narrow-angle glaucoma, sleep apnea, severe or acute respiratory failure, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, severe hypersensitivity to dextran 40.
Hyper-CVAD Treatment in Lymphoblastic Lymphoma

Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment outcome of hyper-CVAD in LBL has reported only in small number of patients from single institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based treatment in LBL.

We will analyze treatment outcome of lymphoblastic lymphoma patients treated with hyper-CVAD regimen from 13 institutions in Korea. In all patients, hyper-CVAD was initial treatment. After achievement of response, patients either underwent hematopoietic stem cell transplantation (HSCT) or consolidation with hyper-CVAD.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 at diagnosis
* Pathologically proven lymphoblastic lymphoma

Exclusion Criteria:

* proven HIV infection
* pretreatment with other regimens
Using Machine Learning to Optimise the Danish Drowning Formula

The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation.

The DDF was published in 2023. It is a text-search algorithm designed to search the unstructured text fields in databases containing electronic medical records to identify all potential water-related incidents. The DDF consists of numerous trigger words related to submersion injury (e.g., "drukn"/ drown, "vand"/water, "hav"/ocean, and "båd"/ boat).

An ongoing study showed impressive performance metrics of the DDF as a drowning identification tool when applied to the Danish PEMR on unrestricted terms. However, the PPV was low for detecting drowning incidents specifically. This study aims to augment the DDF's positive predictive value and reduce the temporal demands associated with manual validation.

Data are extracted from the Danish nationwide Prehospital Electronic Medical Record using the DDF and manually validated before entered into the Danish Prehospital Drowning Data (DPDD).

Data from the DPDD from 2016-2021 will be split into 80% (training data) and 20% (test data) and used to train the machine learning.

Data from the DPDD from 2022-2023 will be used as validation data to calculate the performance metrics for the machine learning.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have been experiencing respiratory impairment from submersion or immersion in liquid (including persistent coughing, respiratory arrest, and unconsciousness).
* The patient must have been in contact with the Danish prehospital Emergency Medical Services.

Exclusion Criteria:

* Duplets
* Invalid civil registration number
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes

The intent of this clinical study is to answer the questions: 1) is the proposed treatment feasible; 2) is treatment effective in improving the disease pathology of patients with diagnosed diabetic erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i
2. Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study
3. Males, age 20-65 years
4. IIEF-5 score is under 16
5. Penile arterial insufficiency or venous leakage (doppler): peak systolic velocity（PSV） \<25 cm/sec, or peak systolic velocity（PSV）\>25 cm/sec, end-diastolic velocity（EDV）\> 5cm/sec, resistance index（RI）\<0.75
6. HbA1c is between 6.5%-10%
7. Physical examination with no abnormalities
8. Willing to consent to participate in the study follow-up
9. Willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters.

Exclusion Criteria:

1. Severe cardiovascular disease (angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy
2. Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) syphilis test
3. Testosterone level is less than 200ng/dL
4. Serum AST/ALT \>3\*upper limit of normal or creatinine \>1.5\*upper limit of normal
5. HbA1c exhibit greater than 10%
6. In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery
7. Patients partner is trying to conceive during the trial period
8. Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study
9. Unwilling and/or not able to give written informed consent