cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.

This study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

This study will enroll approximately 25 pediatric patients to assess the predictive performance of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

All enrolled patients will undergo a series of blood collection procedures during their admission to the pediatric intensive care unit. The levels of inflammatory cytokines, chemokines, and effectors will be assessed and used in multi-biomarker based prognostic and predictive algorithms to determine patients at risk of in-hospital mortality.

Eligibility Criteria:
Key Inclusion Criteria:

1. Age 38 weeks gestation to 21 years of age
2. Admitted to the PICU within the prior 24 hours
3. Indwelling catheters for obtaining blood
4. Meet ≥2 age-adapted SIRS criteria

Key Exclusion Criteria:

1. Anticipated pediatric intensive care unit admission \<24 hours
2. Primary immunodeficiency
3. Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning

This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the brain important for learning and memory will improve verbal learning and memory compared to sham HD-tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 40 years
* Right-handed

Exclusion Criteria:

* concurrent medication likely to affect mental performance
* current history of drug or alcohol abuse or dependence
* any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke.
Impact of the WHO Recommended Vitamin A Supplementation at Immunisation Contacts

High-dose vitamin A to children above 6 months of age reduces all-cause mortality by 23-30%. The WHO recommends vitamin A supplementation (VAS) with the first vaccine after 6 months of age. However, the effect of providing VAS with vaccines has never been investigated. We have hypothesised that the effect of VAS depends on the immune stimulus at the time of supplementation. Hence, the effect might vary depending on which type of vaccine it is given with. In particular, we hypothesised that VAS might be beneficial when given with measles vaccine but not when given with DTP vaccine. Normally the first vaccine after 6 months of age would be a measles vaccine, but many children come late for their DTP vaccinations and receive DTP alone or together with measles vaccine. Hence, it is important to study whether the effect of VAS is the same irrespective of the vaccine(s) administered at the same time.

Guinea-Bissau has not yet implemented the WHO vitamin A policy of providing VAS with vaccines, but plans to do so within the next years. Together with the Ministry of Health in Guinea-Bissau, the Bandim Health Project (BHP) in Guinea-Bissau will investigate the effect on mortality and morbidity of implementing the WHO vitamin A policy in Guinea-Bissau. This will be done in a large randomised trial.

BHP has a demographic surveillance system (DSS) which has followed a population of now more than 150,000 individuals for almost 30 years. Children will be randomised to receive VAS or placebo with their first vaccine after 6 months of age, and will be followed through the DSS to assess mortality and morbidity. Based on previous observations, the effects of VAS might differ according to sex and season. The interaction between VAS, sex, and season will also be studied in the present trial. By identifying situations where VAS may be beneficial, ineffective, or even harmful the study may contribute importantly to optimising the VAS policy for low-income countries.


Eligibility Criteria:
Inclusion Criteria:

* Urban area: 6-17-month-old children, presenting for vaccination at a health centre in the study area.
* Rural area: 6-23-month-old children who are missing one or more routine vaccinations when visited by our mobile team.

Exclusion Criteria:

* Normally applied contraindications for receiving vaccinations, including high fever.
* VAS within last month.
The Effect of Patient's Position After Intra-tympanic Injection

The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). The patients will be asked if they taste the steroids in their throats.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
* Patients who signed an informed consent form

Exclusion Criteria:

* Dysgeusia
* Inner or middle ear malfomation
* Eustachian tube dysfunction
Tissue Microdialysis Monitoring of Liver Grafts

This study will investigate the dynamics of metabolic molecules sampled from human liver grafts during the early postoperative period using tissue microdialysis. The obtained tissue samples will be compared with standard liver function tests and dynamic functional liver assessment tests. The primary objective is to evaluate the clinical feasibility, utility, and non-inferiority of tissue microdialysis in comparison to current standard methods for monitoring liver grafts.


Eligibility Criteria:
Inclusion criteria:

* Adult patients aged between 18 and 65 years.
* Liver transplant candidates on the Slovenian liver transplant waiting list, matched with an available liver graft through the Eurotransplant system, and scheduled for the surgical procedure.
* Signed informed consent to participate in the microdialysis sampling research project, including consent to share the obtained samples with other research studies

Exclusion criteria:

* Patients under 18 or over 65 years of age.
* Refusal to participate in the study.
* Verbal withdrawal of consent at any point during the study, even if informed consent has been previously signed.
* Surgical contraindications preventing the insertion of a microdialysis catheter into the liver graft during the procedure.
* Surgical revision within 48 hours post-transplantation resulting in liver graft loss and removal.
* History of allergic reactions to radiographic contrast media.
* Death during the liver transplant procedure.
Does Microglial Activation Promote Lesion Growth and Progression Among Multiple Sclerosis Patients

The purpose of this study is to assess whether increased microglial activation (measured using TSPO-PET) at lesion rim is associated with more rapid lesion growth during 10 year follow up.

Objective: To evaluate individual MS lesions and their growth during a total of 10 year follow-up after initial positron emission tomography (PET) -imaging with PK11195 or TMSX radioligands.

Background: Focal inflammatory lesions in the white and grey matter of the central nervous system represent the best characterized pathological phenomena of MS disease. Some MS lesions slowly expand over time. Neuropathological studies have detected inflammatory rim formed by activated microglia cells around some MS lesions and it has been suggested that the presence of the inflammatory rim could predict lesion expansion. Our hypothesis is that the lesions with higher TSPO or TMSX radioligand binding at the initial PET scan will expand more during the total of 10-year follow up compared to those lesions with lower radioligand binding. This longitudinal follow-up study will provide a more complete picture of the association of the innate immune cell activation, lesion growth and disease progression.

Study population: The research will recruit approximately 100 MS-patients who have taken part to our previous PET-imaging MS studies in Turku PET centre. The research interventions will consist of magnetic resonance imaging (MRI) scans, blood sampling, clinical neurological evaluation and patient-reported outcome measures (filling forms).

Eligibility Criteria:
Inclusion Criteria:

* Participation to a previous PET imaging study of Airas group
* MS diagnosis

Exclusion Criteria:

* Patients with other neurodegenerative disease than MS
* Contraindication to MR scan investigations
* Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Hereditary Hemorrhagic Telangiectasia (HHT) is a rare (\~ 1/6000) but ubiquitous genetic disease. It is associated with abnormal angiogenesis and autosomal dominant inheritance, leading to telangiectasias and arteriovenous fistulae. More than 95% of patients are concerned by epistaxis (nosebleeds). These events are spontaneous, repeated, irregular, both diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing.

Anti-angiogenic treatments, including bevacizumab, are a new therapeutic option in HHT.

The aim of this study is to evaluate 3 months after the end of the treatment the efficacy on the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab administered as a nasal spray in a repeated manner (3 administrations) in patients with Hereditary Hemorrhagic Telangiectasia complicated by nosebleeds.

This randomized, double-blind, placebo-controlled, seamless phase II/III study is to be carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for second step


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patients who have given their free informed and signed consent.
* Patients affiliated to a social security scheme or similar.
* Patients monitored for clinically confirmed HHT (presence of at least 3 Curaçao criteria) and/or confirmed by molecular biology.
* Patients who have not undergone nasal surgery in the 3 months prior to inclusion.
* Patient with nosebleeds of a monthly duration of more than 20 minutes and justified by follow-up grids completed for at least the 3 months prior to the time of inclusion.

Exclusion Criteria:

* Women who are pregnant or likely to become so in the course of the study.
* Patients not affiliated to a social security scheme.
* Patients who are protected adults under the terms of the law (French Public Health Code).
* Refusal to consent.
* Patients for whom the diagnosis of HHT has not been confirmed clinically and/or by molecular biology.
* Patients with an on-going infectious condition.
* Participation in another clinical trial within the 28 days prior to inclusion.
* Known hypersensitivity to the active ingredient or one of the excipients.
* Known hypersensitivity to products of Chinese hamster ovary cells (CHO) or other human or humanized recombinant antibodies.
* Patients who have incompletely filled in the nosebleed grids in the 3 months preceding the treatment.
* Patients who do not present with nosebleeds with a monthly average duration over the 3 months preceding the treatment of more than 20 minutes ((duration M1 + duration M2 + duration M3) / 3). Remark: only the 3 months strictly preceding the treatment will be taken into account, even if the grids have been completed over a longer period.
* Patients who have received Avastin® intravenously in the 6 months prior to inclusion.
EMG Training for Altering Activation Patterns After Stroke

Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.

Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.

Eligibility Criteria:
Inclusion Criteria:

* Single, unilateral stroke at least 6 months prior to enrollment
* Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale

Exclusion Criteria:

* Visual neglect or deficits (with inability to compensate)
* Upper extremity orthopedic conditions that interfere with movement
* Cerebellar stroke

Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Effect of treatment, safety profile and quality of life scorings.

Eligibility Criteria:
Rectal cancer
Effect of Rocuronium on BIS Values

Aim of this trial is to define if Trend of Four (TOF) values after a bolus of rocuronium is correlated with Bispectral Index BIS values during standard general anaesthesia for breast surgery.

Rocuronium. a curarizing agent, has been shown to decrease Bispectral Index (BIS) in awake volunteers.

However, correlation between Trend of Four (TOF) values after a bolus of rocuronium and BIS values during general anaesthesia for breast surgery has not been defined yet.

Investigators want to analyze this correlation during general anaesthesia conducted using Propofol and remifentanil. All of these drugs will be delivered with Targeted-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil), commonly used to deliver general anaesthesia. At stable anaesthesia maintenance, if requested for surgical (ie more muscle relaxation) or anesthesiological reasons (i.e. avoid air insufflation) a standard Rocuronium bolus (0.6 mg/kg) was given. In these case, with rocuronium bolus justified by clinical reasons, authors will observationally record the BIS values and the TOF values.

Eligibility Criteria:
Inclusion Criteria:

* Undergo General Anaesthesia with Propofol and Remifentanil, and necessity of curarization with Rocuronium for surgical or ventilatory reasons.

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Benzodiazepines praemedication
* Obesity
Turkish Version of the Postoperative QoR-15

Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery after surgery. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into Turkish, and do a full psychometric evaluation of the Turkish version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, orthopedic, gynecological, urologic, eye and ENT surgery, in the University of Health Sciences, Gülhane Education and Rraining Hospital Ankara, Türkiye.


Eligibility Criteria:
Inclusion Criteria:

* aged \> 18 years old
* underwent selective or day surgery with general anesthesia (including all surgical categories except heart and vascular surgery)
* able to complete the QoR-15T in Turkish
* agreed to provide written informed consent to participate

Exclusion Criteria:

* aged \< 18 years old
* patients with a neuropsychiatric disturbance
* not agreed to provide written informed consent to participate
Dietary Salt in Rheumatoid Arthritis

In this study investigators propose to address the following hypotheses: 1) Reduction in dietary sodium will decrease inflammation in patients with rheumatoid arthritis (RA). 2) Reduction in dietary sodium will decrease blood pressure in patients with RA. 3) Reduction in dietary sodium will decrease tissue sodium in patients with RA.

The study is a random-order, 2 period crossover study with washout. Participants will be randomly assigned to be on the high-sodium diet (200mmol/24hours x 8weeks) or low-sodium diet (50mmol/24hours x 8 weeks ) with crossover separated by 4-week washout period. Investigators will allow a 7-day window on the diet (i.e., to facilitate scheduling the diet can be between 7-9 weeks), and investigators will allow a 1-week window for the washout (i.e., washout can be 3-5 weeks).

Investigators will measure changes in inflammation (as measured by DAS28 (using tender and swollen joint count, disease activity and sedimentation rate)), blood pressure measured over a 24 hour period, and tissue sodium (using Magnetic Resonance Imaging (MRI)).

If a relatively simple dietary modification has a clinically important effect on inflammation and blood pressure regulation in vivo in patients with RA, this will have far-reaching implications for the treatment of RA and prevention of Cardiovascular disease in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients older than 18 years who are willing to participate.
2. Satisfy the ACR criteria for the diagnosis of RA.
3. Have stable disease activity as evidenced by no clinically meaningful change in immunomodulating or corticosteroid therapy in the past 1 month.
4. Have moderate disease activity as reflected by a minimum of 3 swollen and tender joints.

Exclusion Criteria:

1. Pregnancy
2. Receiving dialysis
3. Organ or bone marrow transplant
4. Taking diuretics, uncontrolled hypertension (\>160/100 mmHg), or cardiac failure requiring treatment.
5. Severe edema (as judged by the investigator)
6. Diabetes mellitus treated with an insulin pump
7. Major surgery within the previous 3 months
8. Severe co-morbid conditions such as active cancer likely to compromise study participation
9. Unwillingness, or other inability, to cooperate
10. Contraindication to MRI
11. Presence of a condition that could make 24-hour blood pressure monitoring difficult: atrial fibrillation, inability to operate machine, receiving anticoagulants, presence of a condition that in the opinion of the investigator may be exacerbated by blood pressure cuff inflation (e.g., lymphedema).
Optical Properties of Light Cured Luting Agent on Laminate Veneer

The aim of this randomized clinical trial is to evaluate the influence of luting agent, thickness and color of laminate veneers (LVs) and color of dental substrate on the optical properties of LVs.

The following date will be collected (i) the color of dental substrate obtained before and after dental preparation, (ii) the thickness and color of the LVs obtained before of the cementation procedures on white and black value background, (iii) and the final color of the LVs bonded to dental substrates obtained after cementation. For LVs cementation two cements will be used, the light-cured resin cement and the flowable composite, which will be randomly divided into two groups (n=31). The color of LVs will be performed with visual evaluation based on Vita and 3D Master scales and with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on CIEL\*a\* b system. Data collected will be evaluated for translucency parameter (TP) and color variation (ΔE) according to luting agent, thickness and color of the LVs as well as color of dental substrate. Additionally, the color obtained with visual evaluation and with spectrophotometer will be compared to evaluate the level of agreement between the color observed by the operator and the color named by the spectrophotometer.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 18 years of age
* Patients with diastema
* Conoid teeth
* Misaligned anterior teeth
* Discolored teeth and/or teeth with erosion/abrasion
* Posterior occlusal stability
* Individuals who are willing to attend the clinics on predetermined days, to agree to sign the consent form and clarified, after receiving information about the study objectives, risks and benefits associated with the procedures.

Exclusion Criteria:

* Patients with extensive loss of tooth structure
* Subjects suffering from temporomandibular disorders, neurological and oral mucosa diseases
* Inadequate oral hygiene or periodontal problems
* Smokers
Effects of Task-oriented Training on Visual-motor Integration and Upper Limb Function in Children With Down Syndrome

The condition known as Down Syndrome (DS) is caused by trisomy 21, or the presence of an extra copy of chromosome 21. DS is the most common survivable autosomal aneuploidy and one of the genetically complicated problem compatible with post-term human survival. Based on current birth prevalence, the prevalence of DS is around 25%-40%. It is one of the most prevalent disease. Visual-motor integration difficulties are common in children with DS, which affects their capacity to synchronize hand movements with vision. This may have an impact on ADLS like writing, eating, grooming. Both delays in motor skills and visual processing might cause difficulties in this domain.

This study will be a randomized controlled trial conducted in spectrum clinic. This study will be completed in time duration of 10 months after approval of synopsis. Non-probability convenience sampling technique will be used and 28 participants will be recruited in study after randomization. Informed consent will be taken from gradians then, the subjects will be divided into two groups and the Group A (Experimental group) will receive task-oriented training 3 times a week which focus on exercises that improve UL function and visual motor coordination and Group B (Control group) will receive general physiotherapy plan and game-based interventions. Poor visual motor skills are one of the inclusion criteria, but significant intellectual disability, prior involvement in related interventions, and untreated medical or psychological conditions are among the exclusion criteria. The data will be assessed at the baseline and after 8th week of treatment. After data collection data will be analyzed by using SPSS version 23.


Eligibility Criteria:
Inclusion Criteria:

* • Diagnosed down syndrome patient

  * Both male and female
  * Age range 5 to 12
  * Children who has poor VM skills

Exclusion Criteria:

* • Sever intellectual disability

  * Previous participation in similar interventions
  * Uncontrolled medical or psychiatric conditions
  * Low communication skills