cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine

The study aims to answer this question: whether adequate immunity can be achieved in a short time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation schedules? The investigators will test the immunogenicity (the degree of immunity achieved) of each of the immunisation schedules at various times after the injections. If the results of this clinical study are positive, it may then be possible to develop the most successful immunisation schedule so that it can be used routinely. This means that the results of the clinical study have an enormous practical value in preventing TBE in people travelling or moving into areas with a high TBE risk.

The data from at least 99 individuals will be needed if the study is to draw reliable conclusions. One-third of these individuals will receive 3 injections in all: 2 on the first day and the third injection 4 days later (immunisation schedule 1). Another one-third will receive 2 injections in all: one on the first day and one injection 4 days later (immunisation schedule 2). The remaining one-third will also receive 2 injections, both of these on the first day (immunisation schedule 3). Participants will be assigned completely randomly (by chance) to one of these three groups. So each participant stands a 33% chance (a 1:2 chance) of receiving any one particular immunisation schedule. If you agree to take part, the process will be as follows:

Brief Overview of the Course of the Clinical Study:

Vaccination scheme 1

Vaccination scheme 2

Vaccination scheme 3

Vaccinations:

I = Vaccination with FSME-IMMUN 0,5ml

* Scheme 1: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each, 1 vaccination at U2 (day 4), injection into the left upper arm
* Scheme 2: one vaccination at U1 (day 0) and at U2 (day 4), injections into the left upper arm each
* Scheme 3: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* FSME antibody level \< 7IU/ml (ELISA), retrospective
* FSME antibody (IgG) \< 63 VIEU/ml (ELISA), retrospective
* FSME antibody (IgM) negative
* FSME antibody inhibition capacity \<1:10-retrospective
* available for the next 56 days

Exclusion Criteria:

* age not 19 or over 65
* pregnancy
* risk of becoming pregnant
Gastric Procedures for Obesity

This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* morbid obese patients aged from 18-65,
* BMI \> 40 kg/m2 or BMI\> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc.

Exclusion Criteria:

* psychiatric illness,
* substance abuse,
* previous gastrointestinal surgery, and
* any patient who transfers from laparoscopic to convention procedure.
Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia

The purpose of this study is to investigate whether an ultrathin endoscope will improve a patient's tolerance during the procedure. In addition, this study will look at whether local pharyngeal anaesthesia is necessary during ultrathin endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-70

Exclusion Criteria:

* Previous experience of upper endoscopy
* Allergy to local pharyngeal anaesthesia
* Patient requesting sedation during endoscopy
Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm

It has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients have developed complications with lung and kidney function. This study will investigate certain biochemical processes that will potentially reduce these complications. Knowledge gained from this study may also be used to further research in this field through larger studies.


Eligibility Criteria:
Inclusion Criteria:

* Open/Elective EVAR patients

Exclusion Criteria:

* Patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm
Mast Cells and Its Proteases in COPD

Mast cells proteases such as chymase and tryptase will be studied in the tissue of small and large airways in COPD patients


Eligibility Criteria:
Inclusion Criteria:

- COPD patients

Exclusion Criteria:

Other lung diseases, tumors, pregnancy

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Effectiveness of School-Based Weight Management Program in Overweight and Obese Children Between 8-11 Years

Obesity, which is an important public health problem of the last century globally, affects not only adults but also children and young people. Reducing childhood obesity requires effective lifestyle changes and behavioral interventions aimed at healthy nutrition, physical activity and stress management.

to reduce childhood obesity, including school-based multi-component behavioral research in Turkey it has not been demonstrated to parents.

The program, which is planned to be carried out and aims to reduce overweight and obesity in children, is a school-based parenting lifestyle intervention involving multiple behaviors. The program includes family visits, game-based physical activity activities with children, healthy eating recommendations and healthy eating activities with parent participation. The program planned to be implemented was developed to evaluate whether healthy preferences and lifestyle intervention reduce obesity. The aim of this study is to make the positive health behaviors permanent in children, to be a guide for combating childhood obesity and to be useful for future research. to be applied to the research, nutrition consists of 10 sessions, physical activity, including issues such as coping with healthy ways with stress Child Obesity Program (COP), it is thought to overcome this deficiency was needed in Turkey.


Eligibility Criteria:
Inclusion Criteria:

- Overweight or obese children aged 8-11

* Volunteers to participate in the research
* Students who are allowed to participate in the research by their parents

Exclusion Criteria:

* Children with any physical or mental disability and chronic disease (diabetes, metabolic syndrome, heart disease... etc)

  * Children who have normal weight
  * Children who constantly use the drug that can affect weight management (weight gain and loss) The age group included in the study Piaget's development theory coincides with the concrete process period. Concrete
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

The objective of this study is to assess the long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.

This is a single-center, open-label study consisting of 3 phases: Blinded Transition Phase, Open-Label Maintenance Phase, and Taper/Exit Phase. Subjects who have either succesfully completed the CAPSS-271 protocol or who discontinued the CAPSS-271 study due to lack of effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to enroll.

Eligibility Criteria:
Inclusion Criteria:

* Must have either completed the Double-Blind Phase of CAPSS-271 or discontinued the Double-Blind Phase of CAPSS-271 due to lack of efficacy after a minimum of 2 weeks of maintenance treatment.
* Must continue to meet the specific inclusion criteria outlined in CAPSS-271.
* Female subjects must be premenarchal, surgically sterile (hysterectomy, tubal ligation or otherwise incapable of pregnancy); or practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) at study entry and throughout the study; or hormonal contraceptives for at least a 3-month period prior to the start of the study and throughout the study, or be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence. In addition, female subjects of childbearing potential must have a negative urine pregnancy test at Open-Label Visit 1 (Day 1).
* Must be able to read and comprehend written instructions and be willing to complete all headache records and questionnaires as required by the protocol.
* After full explanation of the study, subjects, or their parent/legally authorized representative(s), must demonstrate their willingness to participate by signing an informed consent form. If applicable, pediatric subjects capable of giving assent must sign the assent form.

Exclusion Criteria:

* Subjects who have developed a more painful condition than their headache pain.
* Subjects taking any of the prohibited concomitant medications (See Concomitant Medications section).
* Subjects who are pregnant.
* Subjects with liver function tests ³ 2 times the upper limit of the normal range.
* In the investigator's opinion, subjects with poor compliance during the CAPSS-271 study
Diagnosis of Macrophage Coronary Plaque by Optical Tomographic Imaging

This study evaluated optimal macrophage diagnosis algorithm through comparative analysis between coronary artery, OCT image, and IVUS, and improve a diagnosis rate of vulnerable coronary plaque accompanied with macrophage infiltration.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Patients who are to receive heart transplantation
* Patients or their legal representatives who gave a prior written consent

Exclusion Criteria:

* Impossible to OCT and IVUS analysis due to severe coronary stenosis
The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease

Diabetic kidney disease (DKD) is the leading cause for renal replacement therapy in developed country. DKD is also the primary cause of ESKD among middle-aged and elderly people in China. Renal pathological markers have been proved to have clinical and prognostic value in both non diabetic and diabetic kidney diseases. To discriminate lesions by various degrees of severity, the Working Group of the Renal Pathology Society (RPS) developed a pathologic classification for DKD in 2010. The classification is based on glomerular lesions, with a separate evaluation for interstitial and vascular lesions. In a decade, there were several new characteristics common to DKD, such as the presence of mesangiolysis, glomerular hyalinosis, segmental sclerosis and extracapillary hypercellularity, which have been noted in patients with diabetes and may have prognostic importance. But it is still unclear whether thickening of Bowman's capsule predicts the progression of DKD.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age ≥ 18 years old, male or female 2) Patients diagnosed as diabetes kidney disease by renal biopsy

Exclusion Criteria:

* 1) Patients combined with non diabetes kidney disease; 2) Patients with kidney transplant failure; 3) Patients undergoing zero point puncture for kidney transplantation; 4) less than 5 glomeruli in the renal puncture sample.
Neurofeedback-EEG-VR System for Non-opioid Pain Therapy

This study will assess the feasibility of developing the Neurofeedback-EEG-VR (NEVR) system for non-opioid pain therapy. Subjects suffering from pain will undergo sessions involving VR and Neurofeedback training and their pain will be assessed.

QUASAR and UCSD are conducting a clinical trial on 25 subjects to evaluate the feasibility of a novel Neurofeedback electroencephalography (EEG) Virtual Reality (VR) system aimed at reducing chronic pain. The NEVR device consists of a dry electrode EEG headset combined with a VR Head-Mounted Display (VR-HMD) device and neurofeedback software. This approach relies on retraining the brain's networks to reduce the perception of pain and does not involve pharmaceutical drugs. Patients with chronic lower back pain will be recruited by UCSD at its Altman Clinical \& Translational Research Institute. Patients that meet the recruitment criteria will be asked to conduct 20 1-hour long sessions of EEG-based Neurofeedback in VR over the course of a couple of months. Pain assessment and device usability questionnaires will be conducted prior to and after the first and last sessions, and at intermediate time points. This will be a single arm clinical trial aimed at demonstrating the safety and viability of the NEVR device, with the primary outcome measure being the ability of patients to conduct all 20 sessions safely and comfortably. Secondary outcome measures include assessment of changes in pain perception, and of changes in EEG activity patterns.

Eligibility Criteria:
Inclusion Criteria:

* Chronic back pain that can be of multifactorial etiology inclusive of axial and radicular back pain
* Report a Numerical Rating Scale (NRS, or Visual Analog Score VAS) score of greater than 6/10
* Must be willing to for the duration of the study make no pharmacological adjustments or have additional Interventional therapies, as reported by the patient
* Must have the cognitive capacity to provide consent/assent
* Must be able to sit up in a chair during the recording session
* Must demonstrate understanding of the protocol, its purpose and subject participation
* Must be fluent in English

Exclusion Criteria:

* Measured head size too small or too large for the EEG equipment
* Any significant skull defect
* History of a recent craniotomy (within the last six months)
* Any signs of scalp inflammation, irritation, or abnormal skin conditions
* History of epilepsy or seizures
* Known allergies to any material to be used in this project
* Sight disabilities that make participation impractical
* Hair styles with thick braids or dread locks
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Greece

This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in Greece and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.

Subjects will be enrolled in a multicenter, longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence 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 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 identify adherence subject profiling
* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)
* To assess/describe the impact of the Greek Scientific Service (Patient Support Program)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone (SAIZEN®) via the Easypod™ auto-injector, according to approved Summary of Product Characteristics (SmPC)
* Naïve subjects or already treated with SAIZEN® and Easypod™ for up to 1 year
* Male and female between 2 - 18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's (or subject's if over 18 without fusion of growth plates) written informed consent, given before entering data into the registry, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for its metabolic effects)
* Contra-indications to SAIZEN® as defined in the approved SmPC
* Use of an investigational drug or participation in another interventional clinical study
The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor

Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-segment elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by normal oral P2Y12 receptor antagonists, for example ticagrelor, are delayed in STEMI patients undergoing primary percutaneous coronary intervention (primary PCI), which may be attributed to impaired absorption affecting drug pharmacokinetics (PK) and pharmacodynamics (PD). Another therapeutic goal in the acute treatment of STEMI is reduction of sympathetic stress and catecholamine release, thereby improving the balance between the demand for and supply of oxygen, by analgesia like fentanyl of morphine. To date, there are no studies that have specifically assessed the pharmacodynamics influences of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets. Therefore, In the ON-TIME-3 study, the investigators seek to show the influence of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance.


Eligibility Criteria:
Inclusion Criteria:

i. age ≥18 years

ii. referred by ambulance paramedics to Isala (Zwolle) or Zuyderland Hospital (Heerlen)

iii. diagnosed in the ambulance with STEMI defined as:

1. ongoing chest pain \>30 minutes and \<12 hours duration and
2. ST-segment elevation \>0.1 milliVolt in at least 2 contiguous leads

iv. ongoing chest pain with a pain score (NRS) ≥4

v. the patient has been informed of the nature of the study, agrees to its provisions and has provided verbal informed consent in the pre-hospital phase followed by written informed consent in hospital

Exclusion Criteria:

i. presenting with cardiogenic shock; defined as:

1. systolic blood pressure \<90 mmHg and
2. heart rate \>100/min and
3. peripheral oxygen saturation \<90% (without oxygen administration)

ii. patients with a nasogastric tube in situ or requiring a nasogastric tube

iii. patients who already received fentanyl or paracetamol \<2 hours prior to randomization

iv. patients on current treatment with P2Y12 inhibitors (ticagrelor, clopidogrel or prasugrel)

v. allergy to morphine or paracetamol

vi. patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:

1. hypersensitivity to aspirin or ticagrelor
2. current use of (new) oral anticoagulation
3. history of bleeding diathesis or known coagulopathy
4. active bleeding
5. refusal of blood transfusions
6. history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
7. known severe liver dysfunction

vii. received any organ transplant or is on a waiting list for any organ transplant

viii. patients undergoing dialysis

ix. pregnant or lactating female

x. patients currently participating in another investigational drug or device study
Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)

On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.

Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.

Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes;
* Age between 12 months to 23 months and 29 days;
* Child in good health, with no significant past medical history;
* Have completed blood sampling before vaccination;
* Have not been vaccinated with MMR.
* Agreement by parents/tutors with the child's participation in the study and signing of the Informed Consent Form (ICF);
* Parents/Tutors provide name, address, telephone number and other information for the contact if necessary;
* Parents/Tutors able to understand the risks of the experiment, although minimal;
* Parents/Tutors able to understand and sign the informed consent form.
* Availability of return for collecting post-vaccination samples.

Exclusion criteria:

* Children with a history of measles, rubella and / or mumps.
* Having received MMR vaccine previously, as documented in vaccination card.
* Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.
* Skin lesions at sites of venipuncture.
* Child subject to abnormal bleeding after injections.
* Use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants.
Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method

The purpose of the study is to compare efficacy, complications and safety of the standard method of Combined (superficial and deep) cervical plexus block (SDCPB) with Ultrasound guided Medial Cervical plexus block technique (MCPB).

Hypothesis: Ultrasound assisted MCPB is safer than SDCPB with similar efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Elective Carotid Endarterectomy

Exclusion Criteria:

* Denied consent to block performance, Emergency procedure
Effective Endurance Training in Metabolic Syndrome

To see how fast and how much physical training can reduce risk factors related to metabolic syndrome


Eligibility Criteria:
Inclusion Criteria:

* insulin resistance, impaired glucose tolerance or type 2-diabetes, including two or more of the following factors: Blood pressure ≥ 140/90 mm Hg, Triglycerides Fasting ≥ 1,7 mmol/l, and/or low HDL-cholesterol (≤ 0,9 mmol/l in men, ≤ 1,0 mmol/l in women)
* Obesity, Waist-hip ratio ≥ 0,9 in men, ≥ 0,85 in women or BMI (body mass index) ≥ 30 kg/m2
* Microalbuminuria (albumin secretion ≥ 20 mg/l or 20 - 200 g per minute)

Exclusion Criteria:

-