cyrilzakka/clinical-trials huggingface dataset:
Serum Levels of Vitamin D and IL8 in Patients With Periodontitis

We evaluated vitamin D and IL8 levels in the serum of patients with periodontitis as well as the healthy controls to correlate their levels with the degree of periodontitis.

The primary objective of this study is to assess the levels of vitamin D and IL8 in the serum of individuals diagnosed with periodontitis and compare them with those of a healthy control group. The study also aims to establish correlations between these serum levels and the degree of periodontitis severity.

Two groups will be recruited: patients diagnosed with periodontitis and a control group consisting of individuals without periodontal disease.

The participants will be matched for age, gender, and other relevant demographic factors to minimize confounding variables.

Serum samples will be collected from both groups. Periodontitis severity will be determined using established clinical indices, such as probing depth, clinical attachment loss, and bleeding on probing.

Vitamin D levels in the serum will be measured using standardized laboratory techniques.

IL8 levels in the serum will also be quantified using appropriate assays. Statistical analyses will be performed to identify any significant correlations between vitamin D levels, IL8 levels, and the severity of periodontitis.

Subgroup analyses may be conducted to explore potential variations based on demographic factors or other relevant variables.

The study will adhere to ethical guidelines, ensuring participant confidentiality, informed consent, and responsible data handling.

The study anticipates finding associations or correlations between serum levels of vitamin D and IL8 and the severity of periodontitis. This information may contribute to a better understanding of the role of these factors in periodontal health and could have implications for future preventive and therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria:

* presence of at least twenty teeth.
* Periodontitis patients with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2 mm and probing depth (PD)≥4 mm.
* presence of ≥40% sites with bleeding on probing.
* Healthy individuals matched for age and gender, who presented no systemic disease, no drugs were taken, no sites with PD ≥4 mm or CAL ≥4 mm, or radiographic signs of bone loss were enrolled, such as a control group.

Exclusion criteria

* Intake of contraceptives, immunosuppressive, antibiotics or anti-inflammatory drugs throughout the last three months prior to the study.
* Pregnant and lactating females.
* Diabetic patients.
* History of medications that might affect bone and mineral metabolism and/or periodontal health.
* Taking multivitamins and food supplement which contain vitamin D.
* Malabsorption syndrome or patient with chronic diarrhea.
* Treatment with bisphosphonates in the past 12 months or lifetime exposure to bisphosphonates for more than 3 years.
Inspiratory Muscle Training in HFpEF

This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 yrs of age
* Receiving SGLT2 inhibitors and spironolactone (and beta-blocker use for HFpEF patients with hypertension) for \>3 months
* NYHA symptoms I-III
* Body mass index ≤40 kg/m2
* Currently non-smokers with \<20 pack year history
* Able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)

Exclusion Criteria:

* Sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1
* Second or third degree heart block
* Body mass index \>40 kg/m2
* Current smokers and/or smoking history \>20 pack years
* Pregnant women (testing will be done by research team if requested)
* Glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1)
* Individuals who are not able to engage in exercise
* Uremia, history of allergy to iodides
* Peripheral artery disease
* Alanine transaminase and/or aspartate transaminase greater than 2 times the upper limit of normal (via clinical record within the past 6 months)
* Asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea
* Ruptured eardrum or any other condition of the ear
* History of spontaneous pneumothorax or osteoporosis with a history of rib fractures
* History of lidocaine allergy.

For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.
Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)

To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure

The Triage® BNP Test has been cleared by the U.S. Food and Drug Administration as an aid in the diagnosis and assessment of severity of heart failure. In addition to numerous reports describing the diagnostic and prognostic utility of BNP, reports from various pilot studies have described decreases in BNP in association with various heart failure therapies. Other reports have described modest increases in BNP in association with digitalis and beta-receptor antagonism. The observation that the circulating BNP concentration decreases during heart failure therapy, coupled with the ability of BNP to be used as a prognostic tool and assess the severity of heart failure, it is hypothesized that using BNP measurements to guide heart failure therapy could have a significant impact on the care of heart failure patients. This hypothesis is supported by various reports of pilot studies that describe a significant benefit of administering therapy tailored to concentrations of BNP and related peptides. Patients that are discharged after a hospitalization for heart failure will be approached for study enrollment.This is a multi-center, single (patient)-blinded cluster-randomized study. Half of the sites will have BNP measurements available to guide therapy (experimental arm) and the other half of the sites will not have BNP measurements available (control arm). Blood (plasma) will be collected at each visit and appropriate forms completed. Patients will be asked to complete a Minnesota living with heart failure questionnaire and to do a 6-minute walk test. Patients will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

Age 18 or older Patient was hospitalized and treated for heart failure Patient is fully stabilized at discharge Able to give informed consent

Exclusion Criteria:

History of severe pulmonary disease Chronic O2 therapy for COPD Primary pulmonary hypertension History of renal disease requiring dialysis History of severe hepatic disease Patients using LVAD's Stroke, MI, PTCA, CABG or unstable angina within the past 1 month Bi-ventricular pacemaker placement within last 1 month History of severe aortic stenosis History of severe mitral stenosis History of constrictive pericarditis Patient has had a cardiac transplant Status 1 cardiac transplant candidates ICD or DRG assignment of non-Q wave MI within last 1 month Patient has cor pulmonale A re-hospitalization, death or an IV treatment for heart failure before the first post-discharge visit and/or15) Planned chronic IV treatment.
Cortical Activation in Individuals With Finger Amputation During Mirror Versus Imagery Treatment

Goals : ( a) to examine differences in cortical activity during hand movements with a mirror compared to imagery of the same movements, and (b) to examine correlation between cortical activity during imagery or mirror treatment and the pain and performance measures in finger amputees.

A cross-sectional study of 20 subjects in a Functional Magnetic Resonance Imaging (fMRI) preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and Jebsen Taylor Hand Function Test will be used.

Goals : ( a) to examine differences in cortical activity during hand movements with a mirror compared to imagery of the same movements, and (b) to examine correlation between cortical activity during imagery or mirror treatment and the pain and performance measures in finger amputees.

A cross-sectional one-meeting study of 20 subjects (finger amputees) in a Functional Magnetic Resonance Imaging (fMRI) preforming mirror therapy hand movement and imagery hand movement. Also, Visual Analogue Scale for pain and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and Jebsen Taylor Hand Function Test will be used.

Eligibility Criteria:
Inclusion Criteria:

* Following unilateral traumatic finger or fingers amputation (1 to 3 fingers)
* Self-reported limited functionality, sensory disorder or pain

Exclusion Criteria:

* Are not comparable with MRI restrictions
* Chronic pain disease
* Psychiatric condition
The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules


Eligibility Criteria:
Inclusion Criteria:

* \[1\]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) \[2\]no suspicious malignant features on ultrasound examination \[3\]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation \[4\]refusal or ineligibility for surgery \[5\]follow-up time ≥6months

Exclusion Criteria:

1. follicular neoplasm or malignancy findings on biopsy
2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
3. patients with cystic nodules
4. patients with contra-lateral vocal cord par- alysis
5. previous radiation to the head and neck
6. ; follow- up time less than 6 months
Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®

The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population.

Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:

* the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value
* the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value
* recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)
* complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.


Eligibility Criteria:
Inclusion Criteria:

Adult population:

* Non opposition to research
* \> 18 years old
* ASA score 1-3
* Undergoing surgery with curarisation through tracheal intubation
* Affiliation to social security

Pediatric population:

* \> 1 year old
* Non opposition to research of child (if able to consent) or representatives with parental authority
* ASA score 1-4
* Undergoing surgery with curarisation
* Affiliation to social security

Exclusion Criteria:

Adult population:

* Allergy to administered drugs
* Known or suspected difficult intubation
* Pregnant women
* BMI \> 40

Pediatric population:

* Allergy to administered drugs
* Known or suspected difficult intubation
Respiratory and Submental Muscles Activity During Inspiration and Expiration in Obstructive Sleep Apnea Syndrome

In this study respiratory and submental muscle activities during during inspiratory and expiratory breathing maneuver at specific workloads will be assessed according to inspiratory and expiratory muscle strength of each obstructive sleep apnea syndrome (OSAS) patient's.

Recurrent upper airway obstruction, apnea-hypopnea events, arousals and asphyxia during sleep increase the respiratory workload in patients with OSAS. This results in chronic overload of the inspiratory muscles -especially the diaphragm- and respiratory muscle fatigue in OSAS. When the literature was checked, there was no study assessing and comparing the activities of M. genioglossus, submental muscles (upper airways dilator muscles) and diaphragm during inspiration and expiration in a workload. Differences in the activity of these muscles according to the type of respiratory maneuver will provide more appropriate respiratory muscle training in patients.

Eligibility Criteria:
Inclusion Criteria:

* Between 35-70 years old
* Diagnosed with mild-moderate OSAS
* Clinically stabile

Exclusion Criteria:

* Anatomical obstructive upper airway
* Occupations that lead to sleep deprivation or alterations in the sleep-wake cycle.
* Comorbidities such as chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases and psychiatric diseases
Insulin Dosing in Diabetic Patients With End Stage Renal Disease (ESRD) or Hemodialysis

The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient men and women 18 years of age and older with a diagnosis of type 2 diabetes mellitus (T2DM) with CrCl ≥60, 16-59 or ≤15 milliliters/minute.

Exclusion Criteria:

* Patients less than 18 years of age, pregnant patients
Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation

Propofol is routinely used for general anesthesia during pediatric heart catheterisation. Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is regarded as an early warning sign of PRIS. In this study the effect of propofol and sevoflurane on serum base excess, pH and lactate are examined during pediatric heart catheterisation.

In this prospective randomised study 40 children are anesthetised for pediatric heart catheterisation with propofol (N = 22) or sevoflurane (N = 18) with ethic committee approval. Base excess, pH and lactate were measured by blood gas analysis at the beginning, during and at the end of the procedure. Changes relative to baseline were analysed by paired t-Test with correction for multiple testing. The study was powered to detect a difference of 1.5 mmol/l for base excess and lactate.

Eligibility Criteria:
Inclusion Criteria:

* Indication for heart catheterization under general anesthesia

Exclusion Criteria:

* Participation in another study
* Preexisting metabolic acidosis
* Contraindication against Propofol
Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351

It is a single center, randomized, open-labeled, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older at time of consent, male or female;
* Normal body temperature;
* Meet either of the following conditions:

  1. Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
  2. Received completed 3 doses of CoronaVac 5-9 months ago;
* Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
* Be able and willing to complete the study during the entire study and follow-up period;
* Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

* Serious chronic diseases or uncontrolled diseases;
* Uncontrolled neurological disorders, epilepsy;
* Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
* Patients with congenital or acquired immunodeficiency;
* History of severe allergy or be allergic to any components of the test vaccines;
* History of hereditary hemorrhagic tendency or coagulation dysfunction;
* Patients with malignant tumors and other patients have a life expectancy less than 1 year;
* Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
* History of previous COVID-19 infection;
* Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
* Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
* Those considered by the investigator as inappropriate to participate in the study.
Manufacture of Clinical T-cell Products for Future Treatment

The aim of this pilot study is to validate the manufacture of T-cell products using GMP-approved reagents for future clinical use. Lymphocytes from whole blood of max 300ml from volunteers or from total 9 volunteer apheresates will be isolated to validate the protocol under Good Manufacturing Practice (GMP).

Viral diseases occur in up to 50% of patients after transplantation. In most cases, there is a reactivation of the virus, which can be found latent or dormant in the body's own cells. The main reason for the occurrence of these diseases is the limited T-cell immunity, which serves to control these viruses in healthy people. To date, there are few effective and, depending on the virus, no established therapies. In addition, the established therapies are often associated with considerable toxicity. An alternative therapy, which has already shown success in the 1990s, is the administration of virus-specific T cells. Adoptive T cell therapies for the major pathogens emerging post-transplant are intended to use. In order to be used as therapy these cells must be manufactured under Good Manufacturing Practice (GMP). Leukapheresis from whole blood of maximum 300ml is used to generate the virus-specific T cells. These cells are examined for purity and specificity and are used for scientific purposes only. The aim of this study is to validate the manufacture of T-cell products using GMP-approved reagents for future clinical use.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* Immunoglobulins (Ig) G available for Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
* Detectable T-cell response for EBV or CMV measured by flow cytometry (\> 0.01%)

Exclusion Criteria:

* Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human T-cell lymphoma virus (HTLV)-I/II
Buprenorphine Detox With Two Types of Treatment. BBD II - 11

The purpose of this study is to compare overall treatment outcome between behavioral versus enhanced behavioral treatment types.


Eligibility Criteria:
Please contact site for information.
ACTION - Anticoagulation Treatment Influence on Post-operative Patients

The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).


Eligibility Criteria:
Inclusion Criteria:

1. Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
2. Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
3. Patient is of legal age in the host country
4. The patient is in sinus rhythm before implantation

Exclusion Criteria:

1. Patient already has a prosthetic valve, other than the valve being replaced at this time.
2. Patient requires double valve implantation
3. Patient requires concomitant CABG
4. Patients requires intra aortic balloon pump at intervention
5. Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis)
6. Patient requires ASA or AVK therapy, i.e. not suitable for randomization
7. Patient is pregnant or nursing.
8. Patient is affected by active endocarditis.
9. Patient is affected by aortic dissection.
10. Patient has history of cerebral ischemia
11. Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk
12. Patient is affected by peripheral vascular disease requiring treatment
13. Patient has previous chronic anticoagulation therapy
14. Patient is allergic to ASA and/or AVK
Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression

The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).

To date, it is unknown which abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD) patients will suffer cardiovascular events or in which patients the AAA or PAD will progress. In the VASCULAID project, the VASCULAID-RETRO study aims to leverage data from existing cohorts and retrospectively collected data to develop artificial intelligence (AI) algorithms able to evaluate the risk of cardiovascular events and extent of disease progression.

In order to build and train the algorithms for the predictions, we plan to retrospectively enroll at least 5000 AAA and 6000 PAD patients AI-tools will be applied to the patient data. Automatic anatomical segmentation on images and image analysis on US, CTA and MRI will be performed. Also, algorithms to predict cardiovascular events and AAA or PAD progression based on multi-source data analysis will be developed.

Patient data from European clinical consortium partners is available. This consortium has access to big cohorts with relevant data for the envisioned study that will be used to enrich the existing registries. These data will be used to refine the algorithms developed for the prediction of cardiovascular events and AAA/PAD progression.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 40-90 years old, with an AAA \>3cm. This includes patients with infrarenal, juxtarenal, suprarenal, iliac (defined as 1.5x its normal diameter) aneurysms, as well as mycotic aneurysms. Patients that have had interventions or ruptures will also be included
* Males and females, 40-90 years old, all PAD patients (Fontaine stages 1,2,3, and 4).

Exclusion Criteria:

* Patients with an ascending, thoracic, thoracoabdominal (type 1-3) aneurysm.