cyrilzakka/clinical-trials huggingface dataset:
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).


Eligibility Criteria:
Inclusion Criteria:

* Received two vaccinations during the course of Baxter study 208
* Understand the nature of the study, agree to its provisions and give written informed consent
* For volunteers under 18 years of age - written informed consent of the parents/legal guardian is given

Exclusion Criteria:

* None.

Volunteers assessed for eligibility to receive a third vaccination.

Eligibility to receive third vaccination:

* ELISA value \> 126 VIE U/ml before the first TBE vaccination in Baxter study 208
* Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial)
* Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208
* Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 208
* Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
* Have a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent dose of other alcoholic beverages)
* Have received banked human blood or immunoglobulins within one month of study entry
* Are known to have become infected with HIV (a special HIV test is not required for the purpose of the study) since the last visit of study 208
* Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in study 208
* Have received an investigational new drug within 6 weeks prior to study start
* Have a positive pregnancy test at the first medical examination (for females capable of bearing children)
* Do not agree to employ adequate birth control measures for the duration of the study (for females capable of bearing children)
Hybrid Ceramic on Worn Dentition Patients

Evaluation of hybrid composite-nanoceramic on material characteristic and clinical use over tooth wear patients.

Composite resin is often used to restore patient's dental defficiency, and also the material to cover and protect weak tooth structure. In tooth wear patients, multiple factors attributing to destruct their teeth. The durability and strength of the resotrative material must be reinforced. Nanoceramic infiltrated in composite resin may enhance its mechanical characteristics. Therefore, hybrid composite-nanoceramic material may be effective for tooth wear patients.

Eligibility Criteria:
1. Tooth erosion/attrition/abrasion/abfraction patients
2. Age above 20 years old
3. Return at certain period during the trial
4. Full understanding of written and spoken language
5. Agree with the questionnaire
A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults

This is a first-in-human study in adult healthy participants consisting of two parts. In Part 1, participants will receive one dose of study drug (LEO 153339) or placebo; in Part 2, participants will receive multiple doses of study drug or placebo.

The participants will stay in the clinic for 6 days (Part 1) or for 12 days (Part 2) to have the study doctor assess their safety and to investigate how quickly and to what extent LEO 153339 (and the breakdown product) is absorbed, transported, and eliminated from the body.

The purpose is to assess the safety and tolerability of LEO 153339 when compared to a placebo with no active ingredient.


Eligibility Criteria:
Main Inclusion Criteria:

* Healthy adult males and females.
* Age between 18 and 65 years (both inclusive) at screening.
* A body mass index (BMI) between 18.0 and 32.0 kg/m² (both inclusive).
* In good health at screening and/or check-in (Day -2 and Day -1) as judged by the investigator based on medical history, physical examination, vital signs, 12 lead electrocardiogram (ECG), and clinical laboratory evaluations.

Main Exclusion Criteria:

* Male participants sexually active with a woman of childbearing potential who are not willing to use a barrier method of contraception (e.g. condom) from the time of first dose of investigational medicinal product (IMP) until 3 months after the last dose, in conjunction with this female partner using a highly effective form of contraception. For vasectomised male participants, male participants with a female partner with bilateral tubal occlusion or ligation, and heterosexually abstinent male participants (when this is in line with the preferred and usual life style of the participant and not just being without a current partner), no additional contraception is required.
* Female participants who are pregnant, lactating, or of childbearing potential.
* Any surgical or medical condition or cholecystectomy which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
* Positive polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at Day -2 or Day -1 or within 8 weeks prior to screening or check-in, or contact with COVID-19 positive (or suspected) persons within 14 days prior to first dose.
* Treatment with any prescribed or non-prescribed systemic or topical medication within 7 days prior to the first dose of IMP (excluding paracetamol; including herbal remedies), unless, in the opinion of the investigator and the sponsor, the medication will not interfere with the trial procedures or compromise safety.
* Treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 3 months prior to the first dose of IMP.
* ECG with QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 msec confirmed by repeat measurement at screening.
Diffuse Optical Monitoring with Inhaled Nitric Oxide

This study is a non-randomized, Phase 2 clinical trial designed to measure the cerebral blood flow (CBF) response to inhaled nitric oxide in acute ischemic stroke patients and healthy subjects. The monitoring is a 35 minute session during which cerebral hemodynamics will be monitored with both diffuse correlation spectroscopy (DCS) and transcranial doppler ultrasonography (TCD) while blood pressure, heart rate, cardiac output, respiratory rate, end oxygen saturation, and inhaled nitric oxide (NO)/nitrogen dioxide (NO2) concentration, are continuously monitored.


Eligibility Criteria:
Inclusion Criteria:

Stroke Patients:

1. Age greater than 18
2. Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral artery, on either side of the brain
3. Study can be initiated within 72 hours of stroke symptom onset

3. Ability and willingness to sign informed consent

Healthy subjects:

1. Age greater than 18
2. Ability and willingness to sign informed consent

Exclusion Criteria:

Stroke subjects:

1. History of prior stroke or transient ischemic attack
2. Known cerebrovascular abnormality
3. History of congestive heart failure
4. Presence of pneumonia or active pulmonary infection
5. Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
6. Age less than 18 years
7. Skull defect that would interfere with CBF monitoring
8. Pregnancy
9. Structural brain lesion
10. Prior neurosurgical procedure
11. History of psychiatric disease
12. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study

Healthy subjects:

1. History of any neurological disease
2. History of stroke or transient ischemic attack
3. Known cerebrovascular abnormality
4. History of congestive heart failure
5. History of chronic pulmonary disease such as asthma or chronic obstructive pulmonary disease
6. Presence of pneumonia or active pulmonary infection
7. Current use of any NO donor medication (sodium nitroprusside or nitroglycerin)
8. Age less than 18 years
9. Skull defect that would interfere with CBF monitoring
10. Pregnancy (urine or blood tests will not be performed)
11. Structural brain lesion
12. Prior neurosurgical procedure
13. History of psychiatric disease
14. Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
15. Cognitive impairment
Efficacy and Stability of Dexmedetomidine Sedation Compared to Propofol Sedation in the Drug Induced Sleep Endoscopy

Obstructive Sleep Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Drug Induced Sleep Endoscopy (DISE) is a routinely exam which allows the direct observation of the upper airway during sedative induced sleep. Propofol and Dexmedetomidine are sedatives approved for all diagnostic examinations that required sedation.

Obstructive Sleep Apnea Syndrome affect up 12% in adult population. It is associated with an increase rate of hypertension, metabolic syndrome, depression and adverse cardiovascular events. The evaluation of upper airway obstruction is vital to obtain site-specific treatment. Drug Induced Sleep Endoscopy is a routinely exam which allows the direct observation of the upper airway during sedative induced sleep. Propofol and Dexmedetomidine are sedatives approved for all diagnostic examinations that required sedation.

It's a Randomized Controlled study. 28 participants will be enrolled and randomized in two groups: in the first group the sedation state will be performed with Propofol, while in the second group will be used Dexmedetomidine for allow sedation state. The study will be evaluate the different hemodynamic and respiratory changes during sedation in these two different groups and differences in obstructive endoscopic anatomical patterns. This will be the first study in whic Dexmedetomidine and Propofol will be compared according to European DISE Recommendation published in august 2018 (references)

Eligibility Criteria:
Inclusion Criteria:

* Apnea-Hypopnea Index (AHI) of 15-30.
* Men and women, age 18-65 years, Body Mass Index (BMI) \< 35 Kg/m2,
* Awake oxygen saturation \> 95%
* Able to read and sign the consent form

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease (COPD)
* Liver disease (Child Pugh 1-3)
* History of chronic use of sedatives, narcotics, alcohol or illicit drugs,
* History of 1st and 2nd degree heart block (not paced),
* Left Ventricular Ejection Fraction (LVEF) \< 50%,
* Allergy to propofol or Dexmedetomidine,
* OSHAS (Obstructive sleep apnea/hypopnea syndrome) surgical failure patients
* Pregnant women.
A Decentralized Study on Dietary Influences on Cognitive Functions

The current study aims to investigate the cognitive effects of diet-induced blood glucose fluctuations on cognitive performance in healthy older adults over multiple days, taking advantage of the currently available techniques to continuously measure blood glucose levels and to assess cognitive performance in a real-life setting.

In this fully decentralized study, subjects will undergo two times a three-day measurement period, where their blood glucose will be continuously measured by a minimally invasive sensor and where the cognitive performance is measured at multiple time points throughout a day using a short test battery administered on their mobile phone. In addition to receiving standardized breakfast and lunch meals, the subjects are administered a low-GI(Glycemic Index) or normal-GI(Glycemic Index) snack in the morning and afternoon.

The study has two main scientific objectives. First, the investigators aim to investigate the acute effect of a low versus high-GI snack taken mid-morning or mid-afternoon on cognition, appetite, alertness and mood. To this end the investigators will compare the pre-snack and \~2-hour snack measurements of the two snacks. The investigators hypothesize that the low-GI(Glycemic Index) snack, due to a blunted and sustained PPGR, leads to better cognition, appetite and alertness ratings. Secondly, the investigators aim to explore how daily fluctuations in blood glucose are associated with cognition, mood, appetite and alertness in healthy older adults. To this end the investigators will conduct exploratory correlational analyses between blood glucose parameters, the behavioural outcomes, and subject characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 - 65 years
* Own and use a smartphone that is capable to run the study applications (Android 4.4 or later, OS 12.0 or later)
* Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
* Sufficient vision and hearing to complete study procedures based on medical judgment
* Willing and able to participate and to give written consent to comply with study procedures

Exclusion Criteria:

* Presence or history of a metabolic, neurological, or psychiatric disease
* Use of prescription or OTC medication that may influence gastrointestinal, metabolic or neurological functioning
* Any health, functional or lifestyle factor that in the judgement of the investigator may interfere with the ability to comply with study procedures and/or the generation of valid study data
* Known food allergies
* Use of illicit drugs
* Alcohol intake \>1 units/day • BMI \<18.5 or \>30 kg/m²
* Are a member of the research team or their immediate family members. Immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
Cervical Plexus Block Combined With Translaryngeal Block for Tracheostomy

Current healthcare delivery models emphasize enhanced postoperative recovery (ERAS) with minimal morbidity and shorter hospital stays. Most tracheostomy cases are tumour patients. The more the patients have difficulty in breathing, the more difficult it is to anaesthetize them. Adequate intraoperative anaesthesia and postoperative analgesia with minimal sedation play an essential role in this patient model. In tracheostomy patients, moving away from the general anaesthesia option increases airway safety, and avoiding the local anaesthesia option in the incision area increases patient comfort. The purpose of this study is to assess the safety and efficacy of regional anaesthesia in tracheostomy patients.

after being informed and about the study and potential risks, all patients giving written informed consent will undergo 24 hours screening period to determine the eligilibity for study entry. After a computer-generated randomization list with a 1:1 intergroup ratio, ensuring equal distribution in the two groups, 30 opaque sealed envelopes numbered 1-30 were prepared. The patients were randomly divided into the Group with bilateral CPB with 15 ml 0.5% bupivacaine or the patients with translaryngeal block with 5 ml 2% lidocaine in addition to bilateral CPB.

CPB: cervical plexus block.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 18-65, with American Society of Anesthesiology (ASA) classification I-III and scheduled for elective or emergency tracheostomy.
* A sufficient level of education to understand the study procedures and agree to participate in the study

Exclusion Criteria:

* inability to cooperate
* dementia,
* allergy to local anesthetics and opioids
* regular daily opioid requirements
* abuse of alcohol or medication
* local infection at the site of injection or systemic infection,
* pregnancy.
The Swedish Prison Program is an Intervention Prevention Program Targeting Injecting Drug Users Risk Behaviours and Infectious Diseases

The purpose of the Swedish Prison Program which started back in 1987 and up until 2009 was called "The Social Medicine Remand Prison Project" is to target injecting drug users (IDU) with primary and secondary health interventions with regards to injecting and sexual risk behaviours and infectious diseases such as hepatitis C and B, HIV and sexually transmitted infections (STI).

The overall aim is to assess the effect of different prevention efforts on HIV/HCV risk behaviour and disease outcome among IDUs over time.

Risk behaviour for IDU is sexual risk taking, i.e., sex without a condom, buying or selling sex and injection risk taking, i.e., sharing needle, syringe or paraphernalia.

Eligibility Criteria:
Inclusion Criteria:

* Defined as an injecting drug user, in the prison and probation service and agree to anonymously participate

Exclusion Criteria:

* Being defined as a non-drug user, non-injecting drug user
Endocan in Ventilator-associated Pneumonia

In this study; in patients undergoing mechanical ventilation, making the day series Endocan measurements during the first 5 day to look at whether there is a relationship between the levels of VAP with Endocan. This relationship, if any, aimed to investigate whether correlated with clinical and laboratory findings \[presence of fever, pathological lung X-ray, the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)\] .


Eligibility Criteria:
Inclusion Criteria:

* over 18 age
* Patients whether intubated and connected to a mechanical ventilator

Exclusion Criteria:

* patients intubated due to lung problems such as COPD, asthma, pulmonary embolism , etc.
* Patients with brain tumors
* patients with acute and chronic renal failure
* Patients with hypertension
* Patients with previously diagnosed infection
* Patients with extubated
* patients using antibiotics or corticosteroids before bronchoalveolar lavage fluid samples taken
Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity

This is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* BMI 35-50 kg/m2
* 20-60 y

Exclusion Criteria:

* Severe co-morbidity
* Unmotivated to long term follow up
Active Prevention of MSDs (Musculoskeletal Disorders, Upper and Spine Members) in the Context of Computer Screen Work

Evaluate the benefit of an intervention by a computer program comprising active breaks, in the form of a personalized self-program on functional impairment and / or pain, among employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in connection with the computer work environment.

The benefit of the intervention will be assessed among four groups of subjects: symptomatic and asymptomatic subjects randomized in control or experimental group.

Subjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work. Control group patients had no intervention.

Symptoms of MSD will be assessed via questionnaire before and after intervention, in all groups.

Eligibility Criteria:
Inclusion Criteria:

* - To carry out a professional activity.
* To be involved in a computer work for at least 5 hours a day.
* To be between 18 and 65 years.

Exclusion Criteria:

* - To be in sick leave.
* Rheumatic and neurological diseases which needed treatment.
* Workstations which have been recently changed.
* A behavioral and/or comprehension trouble
Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries

The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.

Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* - 4 to 6 years old patients presented with deep carious lesions in primary molars.
* Apparently healthy children (ASA I, II classification).
* Co-operative children (Rating 3 \& 4 according to Frankle classification)

Exclusion Criteria:

A) Clinical:

* Non restorable primary molars.
* Presence of clinical pathology.
* Presence of mobility or tenderness to percussion.

  * Spontaneous pain.

B) Radiographic:

* Pre-operative radiographs showed external or internal root resorption.
* Presence of furcal radiolucency.
* Presence of periapical radiolucency or widened periodontal ligament space
* More than one-third root resorption detected.
The Effect of Vibration on Pain During Subcutaneous Heparin Injection

Aim: The aim of this research will to examine the effect of the local vibration technique applied to the injection site during subcutaneous low molecular weight heparin (LMWH) injection.

Methods: The patients will randomly assigned to an experimental (vibration) group , a placebo control group, and a nonintervention control group. Participants in the experimental group will give slight vibration to the injection site before the injection will administered; for participants in the placebo group, the device will placed on the injection site but with the vibration button kept switched off, while for the nonintervention control group, routine subcutaneous low molecular weight heparin injection will administered. The level of pain felt by the participants during the administration of the injection will assess with a visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* being over the age of 18
* having a doctor's prescription for subcutaneousheparin 0.6 mL treatment with a ready-to-use syringe and not yet having begun treatment
* having no coagulation disorder
* having no disorder which could affect pain perception,
* having no incision, lipodystrophy or finding of infection at the injection site,
* having no communication problem, and voluntarily agreeing to participate in the research

Exclusion Criteria:

* being under the age of 18
* having diabetes mellitus
* peripheral vascular disease, etc. which could affect the perception of pain
* not being conscious, refusing to participate in the research or opting to leave the study at any point.