cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

This is a multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of five visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 3\*, Visit 4 and Visit 5\* (\* telephone contact)

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult over aged 50 years
* Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent

Exclusion Criteria:

* Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin
* Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
* Those who have received antiviral agents witin 1 month prior to IP vaccination (topical antiviral agent is allowed)
* Those who have previously received herpes zoster vaccine
* Those who have a history of herpes zoster
* Those with congenital or acquired immunodeficiency
* Those with active untreated tuberculosis
* Those who have received blood products or immunoglobulin within 3 months prior to IP(Investigational Products) vaccination
* Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study
Craniofacial Morphology And Sella Turcica Bridging Associated With Third Molar Agenesis.

The aim of this retrospective study is to analyze the third molar agenesis with respect to sella turcica bridging and other craniofacial patterns in patients asking for orthodontic consultation. The main question\[s\] it aims to answer are:

* is there a relationship between third molar agenesis and sella turchina bridging?
* is there a relationship between third molar agenesis and craniofacial patterns?

Patients referring for orthodontic consultation at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy, will be enrolled for the study according to the inclusion criteria. For each patient, lateral cephalometric radiograph and panoramic radiograph will be performed. For each lateral cephalometric radiograph, a cephalometric tracing will be performed with DeltaDent software (version 2.5.12, Outside Format, Pandino, Italy). Riedel's ANB angle \[Riedel 1952\] has been chosen to determine patients' skeletal class. Steiner's SN\^GoGn angle \[Steiner 1953\] has been chosen to evaluate skeletal divergence. Facial axis (BaNa\^CCGn), Lower Facial Height (LFH) and mandibular plan angle (FH\^GoMe) from Rickett's analysis \[Rickett's 1961\] have been adopted to determine facial growth. According to Jaraback's cephalometric analysis \[Jaraback 1985\], saddle angle, articular angle, upper gonial angle, lower gonial angle will be measured to assess the growth pattern. Linear measurements of sella depth, sella diameter and interclinoid distance \[Silverman 1957; Kisling 1966\] will be calculated. Linear regressions between craniofacial patterns, sella turcica bridging and third molar agenesis will be calculated. A control group with no third molar agenesis will be provided.

Eligibility Criteria:
Inclusion Criteria:

* G stage of Demirjian's classification for third molar maturation or absence of third molar germs
* Patients with one lateral cephalometric digital radiograph executed in Natural Head Position (patients were asked to keep the teeth in contact and the lips relaxed).
* Patients with panoramic radiograph;

Exclusion Criteria:

* Ascertained previous surgical extraction/s of third molar/s
* Orthopedic/orthodontic therapy
* Orthognathic surgery.
Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

Primary Objective:

To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .

Secondary Objectives

* To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
* To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
* To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult aged 18 - 75 years old
2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
3. Planning elective Bunionectomy repair
4. For both males and females: using an acceptable method of birth control
5. If a female: not pregnant or breastfeeding
6. Have a body mass index ≤ 40 kg/m2.
7. Be willing and able to sign the informed consent form (ICF)
8. Be able to complete study procedures and pain scales and to communicate meaningfully in English
9. Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours

Exclusion Criteria:

1. Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
2. Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
3. Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Be on any medication not allowed per the protocol
6. Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
7. Have positive results on the alcohol test (breath or saliva) or urine drug screen
8. Have previously participated in a clinical study with CA-008.
9. Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)
Impact of Lipodystrophy on the Inflammatory State of Non-diabetic Dunnigan Reunion Island Subjects

Few data and small numbers affect the inflammatory profile of Dunnigan patients. The levels of certain pro-inflammatory biomarkers would be found higher in these subjects compared to control individuals. However, in these studies, several confounding factors were not taken into account such as smoking, an underlying chronic inflammatory disease such as diabetes and could limit the interpretation of the results. There is no other observation of the anti-inflammatory status of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult subject (\>18 years old) affected by partial Dunnigan lipodystrophy in the homozygous or heterozygous state (genetic search for the positive mutation carried out before inclusion in the study).
* Person affiliated to or beneficiary of a social security scheme.
* Free, informed and written consent signed by the participant and the investigator.

Exclusion Criteria:

* - Minor
* Persons placed under judicial protection, person participating in another research including a period of exclusion still in progress, severely impaired physical and/or psychological health, which, according to the investigator, may affect the participant's compliance with the study
* Previous known diabetes
* Pregnant woman
* Woman who gave birth less than 6 months ago
* Breastfeeding in progress
* Participation in other research that may have an impact on the evaluation of the main judgment criteria
* Hemoglobin b level \< 7 mg/dl or \< 9-10 mg/dl for patients with cardiovascular or respiratory pathology.
* Proven inflammatory pathologies
* Anti-inflammatory treatment: taking corticosteroids in the last 3 months.
* Active smoking
A Study for Tyrosine Kinase Inhibitors Discontinuation

Treatment of Chronic Myeloid Leukemia (CML) has been revolutionized by the use of tyrosine kinase inhibitors including imatinib mesylate (Gleevec, Novartis Laboratories). Two other inhibitors of the BCR-ABL kinase are currently on the market in France, nilotinib (Tasigna®, Novartis Laboratories) in the first and second-line treatment and dasatinib (SPRYCEL®, Bristol-Myers Squibb Laboratories) in second line. Achieving a complete molecular response (CMR) in patients with Chronic Myeloid Leukemia (CML) treated with tyrosine kinase inhibitors may be currently regarded as the ultimate level of reduction of residual disease. The pilot Stop Imatinib study has opened the way for a french prospective study of stopping imatinib, the STIM study. The results of the STIM study showed that almost 60% of patients exhibited molecular relapse, most frequently within the first 6 months after discontinuation. The parameters that are statistically associated with the loss of complete molecular response are the Sokal score at diagnosis and the total duration of treatment with imatinib. Criteria to define molecular relapse in treatment free remission patients are not well defined and validated. The aim of the study is to validate the loss of major molecular response as a robust criteria for TKI resumption. The patient's population will be CML patients who are offered to discontinue therapy outside the STIM strial.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Chronic Myelogenous leukemia
* mors than 18 years old
* intentionally stop treatment by tyrosine kinase inhibitor

Exclusion Criteria:

* inclusion in a prospective study
* non intentionally stop (adverse event)
* Stop for disease progression
* Death patients
Protocol for the Infusion of Buffy Coat-derived Cryopreserved Platelets in Patients With Severe Thrombocytopenia

The increasing need for blood components and the increasingly careful donor selection procedures, make the availability of blood components very reduced, in particular for platelets that are currently administered preferably "fresh" or cryopreserved, only in emergency conditions.

Exceeding this limit through the spread of use of cryopreserved platelets in the common clinical practice, might help clinicians to avoid wasting valuable products and face periods of particular shortage of donors Some studies already published in the literature over the last decade (1,2) have demonstrated the safety and efficacy of autologous cryopreserved platelets .

The main objective of the proposed study is to evaluate the efficacy and safety of platelets, cryopreserved with DMSO using a a new method, in patients with severe thrombocytopenia.

This is the in vivo phase of a study where availability and efficacy of cryopreserved platelets has been assessed in vitro.

The primary objective of the study is to evaluate the hemostatic efficacy and safety in the recipients of platelets obtained from buffy coat of multiple donors (five), cryopreserved with DMSO using a new patented method, up to 9 months from the collection.

Further goals are the registration of any related- adverse event (idiosyncrasy, allergy, toxicity)

Eligibility Criteria:
Inclusion Criteria:

Cryopreserved buffy coat pooled platelets will be infused, after being thawed, in inpatients at U.O. of Hematology -Policlinic "P. Giaccone"-Palermo, falling into one of the following categories:

* Stable clinical conditions and no complications with platelets ≤ 10,000/microliter;
* With active bleeding and ≤ 20,000 platelets/microliter;
* In the presence of: high blood pressure, high fever, rapid drop in platelets, infection, chemotherapy, coagulation abnormalities with ≤ 20,000 platelets/microliter.

Exclusion Criteria:

Patients

* Suffering from congenital immunodeficiency
* Allogeneic bone marrow transplant candidates
* Bone Marrow Donors for transplantation
* Undergoing bone marrow transplant or
* Suffering from Hodgkin's disease and treated with purine analogues (Fludarabine, cladribine)
Impact of Stent Length and Diameter on Patients Undergoing Primary PCI

The goal of the study is to evaluate the Impact of coronary stent length and/or diameter in patients with ST segment myocardial infarction undergoing primary PCI, on Short term clinical outcomes.

* ST segment elevation myocardial infarction is serious condition to the blood supply to the heart muscle. Rapid reperfusion of the ischemic myocardium using percutaneous coronary intervention (PCI) is the standard treatment for acute myocardial infarction (MI) to rescue the ischemic myocardium and reduce infarction size.
* There are two types of stents:

  1. Drug-eluting stent which achieving local drug delivery to the injured blood vessel at the time of intervention, a drug is released from a polymer coating or loaded directly onto the stent (2). This is the best one.
  2. Bare metal stent is the old one and not effective as DES in reducing vascular restenosis by suppressing smooth muscle cell (SMC) proliferation.
* The management of long coronary lesions by percutaneous coronary intervention (PCI) has become increasingly important because of the rising incidence of long or complex lesions in aging populations (3) Stent length has been considered as an important predictor of adverse events after PCI. The exact impact of lesion length on the short- and long-term clinical outcomes of DES implantations is not clear yet.
* Myocardial necrosis complicates one-third of percutaneous coronary intervention (PCI) and may adversely affect the outcome(4)

Eligibility Criteria:
Inclusion Criteria:

* Patients with ST segment myocardial infarction who are eligible for PCI.
* All categories (all age groups and both sex groups)

Exclusion Criteria:

* Patients with previous PCI.
* Patients of ectatic lesions.
* Patients with with multi vessel disease and suitable for CABG.
* Patients with complex lesions including bifurcational lesions and LM stenting.
Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification

A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy.

Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.


Eligibility Criteria:
Inclusion Criteria:

* LV EF ≤ 35% inspite of optimal drug therapy of heart failure (3 months and longer)
* NYHA II-IV
* favorable prediction of survival for 1 year or more

Exclusion Criteria:

* secondary SCD prevention
* indications for open heart surgery
* hypertrophic cardiomyopathy
* arrhythmogenic right ventricular dysplasia
* genetic channelopathies
Effect of an Educational Intervention on CPR Knowledge and Skills in Schoolchildren

This study aims to evaluate the effectiveness of a CPR intervention for children aged 7 and 8. Given the high prevalence of out-of-hospital cardiac arrests (OHCA) and the proven benefits of early CPR training, the study seeks to determine whether a structured intervention can improve young children's knowledge and skills in basic life support.

What is the effect of a CPR training intervention on the knowledge and skills of 7- and 8-year-old schoolchildren?

Cardiac arrest is a leading cause of mortality worldwide. Research shows that survival rates increase significantly when CPR is performed promptly by a trained bystander. Countries with early CPR training programs in schools, such as Norway and Denmark, report better survival outcomes. However, in Latin America, CPR education in schools is still in its early stages. Evidence suggests that children can effectively learn and retain CPR knowledge, and they can serve as multipliers by passing their knowledge to family and peers.

Study Design:

This is a non-randomized, double-blind controlled trial with four phases:

Intervention Design - Developing an age-appropriate CPR training intervention based on educational and cognitive development theories.

Content Validation - Experts in child education and health professionals will assess the content and delivery methods.

Validation of Assessment Tools - Ensuring reliability in measuring children's CPR knowledge and skills.

Intervention Implementation and Evaluation - The intervention will be conducted in schools, with pre- and post-tests assessing knowledge and skills retention after 3 months.

Expected Outcomes:

Improved knowledge and skill levels in CPR among children who receive the intervention.

Validation of a structured educational approach for teaching CPR to young children.

Contribution to global evidence on CPR education and its potential impact in Bogotá schools.

Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren aged between 7 and 8 years.
* Students enrolled in an educational institution that has authorized their participation in the study.
* Not participating in any other intervention or educational program related to CPR during the study period.

Exclusion Criteria:

* Students whose parents, legal guardians, teachers, or the students themselves report any health condition that prevents them from participating in the study.
* Students who indicate having received prior training in CPR or related skills.
* Students whose parents, legal guardians, or teachers report any cognitive condition that limits their ability to understand and follow the instructions necessary to learn and practice CPR in simulated scenarios.
The Effect of the Movement Imitation Therapy in Preterm (MIT-PB) in Motor Behavior's Quality.

This study aims to assess the effect of a parent-administered intervention program based on MIT-PB in preterm with abnormal general movements during the preterm period. We will describe the short and long-term differences between infants exposed to MIT-PB and infants who follow current standard care.

The quasi-experimental design has been planned to assess the effect of a physiotherapy program carried out in neonatal intensive care and at home during the first months of life. Preterm babies born before 32 weeks gestational age (GA) and/or with less than 1500g showing an abnormal General Movement Assessment (GMA) at 34-36 weeks will be included.

Standardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (PMA), 54 weeks PMA, 6 months, and 12 months.

A qualitative study has been designed to assess the physiotherapy performance and parents' experience.

Three different Hospitals with similar care protocols and sizes will recruit the sample (n=36). The Intervention groups (n=18) will be located at Hospital Josep Trueta of Girona and Hospital Sant Joan de Déu and the control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona).

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born before 32w GA and less than 1500g weight.
* Infants who show Abnormal General Movements (CS-PR pattern) at 34-36w postmenstrual age (PMA).
* Families able to understand/speak Catalan, Spanish or English.
* Families willing to participate who have the informed consent

Exclusion Criteria:

* Infants with congenital abnormalities and/or genetic disorders
* Infants with invasive ventilation or Continuous Positive Airway Pressure (CPAP) at 36 weeks PMA.
* Infants with Normal General Movements at 34-36 w PMA.
* Families not willing to participate.
Virtual Planning of ALT Flap

This study evaluates the advantage of using preoperative virtual planning to design the volume and shape of antero-lateral thigh free flap tissue transfer to reconstruct tongue defects resulted from carcinoma resection and see how this would affect tongue form and speech function.

This is a prospective randomized clinical study consisting of 2 groups A and B each contains 10 patients of total 20 patients. Where group A (control group) where Alt flap harvest for tongue reconstruction after hemi glossectomy is done with the conventional method while group B (study group) the Alt flap design and harvest is virtually planned before the operation.

The main issue regarding tongue reconstruction with ALTF is the matching of the size and shape between the harvested flap and the tongue defect assuming the hypothesis that an adequate flap volume is crucial for maintaining tongue function. Meanwhile, the preoperative planning of soft tissues is relatively difficult due to an undefined standardization and reference points. In this study, investigators will evaluate the use of preoperative virtual planning and 3D reconstructions for the restoration of tongue defects with ALTF. In this study, virtual surgical planning for the resection of the tongue cancer (hemi-glossectomy) will be used and will address flap design, which the investigators will base on anatomical landmarks using the preoperative virtual planning technology. The research team will compare the functional ( speech) and cosmetic outcomes of the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction. The null hypothesis of this study is that there is no significant difference in functional \& cosmetic outcome between the virtually planned ALTF technique with the conventional method for hemi-glossectomy and reconstruction.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary tongue squamous cell carcinoma (SCC) requiring hemi-glossectomy.
2. No alveolar ridge involvement by the tumor process.
3. Planned to undergo tongue reconstruction using ALTF.
4. Patients with a depth of invasion more than 10mm but not crossing midline according to the classification of Ansarin et. al., we perform type IIIA glossectomy.

Exclusion Criteria:

1. Medically unfit patients; those who are not good candidates for long microvascular surgical reconstructive procedures e.g.: advanced Cardiopulmonary diseases.
2. Recurrent tongue carcinoma.
3. Patients with lesions invading the alveolar ridge.
4. Missing or non-compliance for imaging investigations.
5. Patients underwent preoperative adjuvant therapies.
6. No children will be involved in this study.