cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effect on Pulpotomy

Pediatric dentistry has always debated the benefits of vital pulp therapy. AIM: The current study was done to differentiate the histo-pathological findings of MTA versus grape seed extract in primary teeth undergoing pulpotomy as pulp dressing substances. Materials and Methods: According to the inclusion criteria, 16 primary teeth were selected in each group. Randomly and equally, the teeth were split into two groups: (MTA group) Group I, and (GSE group) Group II. After nine months, under a light microscope the teeth were evaluated and a clinical follow-up was conducted. Periapical radiographs were also taken at this time.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients with carious primary molars

Exclusion Criteria:

* root resorption
Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension

This study is a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study will be used as secondary use of collected patient information in the database (Japan Medical Data Survey \[JAMDAS\]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosed with essential hypertension (International Classification of Diseases \[ICD\]-10 code: I10) on the index date.
2. Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
3. Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
4. Patients whose BP data can be extracted on the index date.
5. Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
6. Patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date.

Exclusion criteria:

1. Women with a record of pregnancy-related diagnoses, drugs, or medical procedures before or after the index date, or a record of delivery- or abortion-related diagnoses, drugs, or medical procedures after the index date.
2. Prescription of concomitant angiotensin-converting enzyme inhibitor (ACEi); Anatomical Therapeutic Chemical (ATC) code: C09A on, after, or in the 2 days before the index date.
3. Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
4. Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
5. Patients with severe impaired liver functions with Child-Pugh classification C.
Self-management in Patients With Adrenal Insufficiency.

Background: Cortisol deficiency leads to a wide range of clinical consequences. Substitution with glucocorticoids is necessary and demands knowledge and ability to self-management from the patient.

Methods: Longitudinal questionnaire-based observational study including group education.

Research questions: To find out if education in group, enhances patients´ and relatives' knowledge about adequate dose adjustment of cortisone and increases the feeling of safety and QoL in patients with adrenal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

Adrenal insufficiency or relative to a person with adrenal insufficiency

Exclusion Criteria:

-
REal World Data in LYmphoma and Survival in Adults

REALYSA cohort is a population-based epidemiological platform in real-life for lymphomas designed to enrich prognostic data, by integrating together epidemiological, clinical and biological data.

REALYSA is a platform perfectly set up to

* Study prognostic factors using integrated epidemiological and biological data (genetics), to better characterize the determinants of refractoriness and relapse in patients with lymphoma, to follow the growing number of survivors and describe median to long-term sequela, second cancer, quality of life (QoL)...
* Document treatment effectiveness in real life and observance
* Address socio-economical questions


Eligibility Criteria:
Inclusion Criteria:

* Signature of the consent form for participation in the REALYSA cohort
* Aged over 18 at the time of inclusion
* Diagnosed with lymphoma in the last 6 months (180 days)
* Lymphoma subtype belonging to at least one of the 7 histological subtypes: diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, T-cell lymphoma, Hodgkin's lymphoma, Burkitt lymphoma

Exclusion Criteria:

* Anti-lymphoma treatment already received (except pre-phase: typically corticosteroids, vincristine, cyclophosphamide, etoposide, alone or in combination)
* Documented HIV infection
* Any other lymphoma subtype not included in the list in Appendix 1. Of note, are excluded:

  * Chronic lymphocytic leukemia/small lymphocytic lymphoma
  * Hairy cell leukemia and variant
  * Lymphoplasmacytic lymphoma
  * Waldenström macroglobulinemia
  * Primary DLBCL of the central nervous system (CNS)
  * T-cell large granular lymphocytic leukemia
  * Chronic lymphoproliferative disorder of NK cells
  * Mycosis fungoides
  * Sézary syndrome
  * Primary cutaneous T cell lymphomas (mainly diagnosed and treated by dermatologists)
  * Post-transplant lymphoproliferative disorders (PTLD)
The Association Between Arterial Stiffness and Assessment of Hydration State in Peritoneal Dialysis Patients

Dry weight (DW) assessment is essential for the efficient treatment of peritoneal dialysis (PD) patients but so far objective methods for DW assessment have not been established for daily clinical practice. Our aim was to evaluate hydration state in PD patients by using a body composition monitor (BCM) and calf bioimpedance (c-BI) and N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels and to compare both methods with arterial stiffness.

We evaluated 60 patients using a new BCM device that implies a validated body composition model. This method allows correct quantification of extracellular fluid overload or deficiency (normal limits:-1.1 to +1.1L). Patients were assigned to normo and hypervolemic groups according to BCM results. Also, normalized calf resistivity (nRho) was calculated from resistance at 5 Khz using c-BI and the levels of NT-proBNP were measured in all study patients. The analyses of arterial stiffness were performed by using the pulse wave velocity (PWV) technique on the patients. All patients underwent conventional echocardiography and their left ventricular diastolic functions were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Peritoneal dialysis patients
* All participants over 18 years of age

Exclusion Criteria:

* Patients with valvular heart disease
* Patients with coronary artery disease
* Patients with cardiomyopathy
* Patients with ESRD who underwent hemodialysis
OSA Homemonitoring

Up to now, no studies are available where a comparison has been made between the accuracy of, on the one hand, the gold standard PSG and, on the other hand, a home monitoring sleep apnea-diagnostic system, consisting of a pulse oximeter, and accelerometer, a smartphone for snoring analysis, and a mattress for ballistocardiographic (BCG) recordings.

The purpose of this study is twofold. On the one hand, a comparison between the predictive performance of an automated home monitoring system and the gold standard PSG in sleep apnea diagnosis will be performed. The home monitoring system consists of a pulse oximeter, an accelerometer, a smartphone to record ambient sound, and a mattress to record the BCG signal. This system will be provided by KU Leuven and Equilli, two partners that work together with the Sleep Laboratory at UZ Leuven and the group STADIUS of the KU Leuven in the OSA+ project. The system performs automated signal processing and classification in order to determine the presence of sleep apnea events. On the other hand, this study aims to improve the phenotyping of patients suffering from sleep apnea. This task will be first developed using the classical PSG and later an evaluation will be performed on the less obtrusive system.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the sleep lab for a diagnostic polysomnography because of suspicion of sleep apnea will be considered to participate in the trial upon signature of the informed consent.

Exclusion Criteria:

* Patients younger than 18 years
Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition

The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute myeloid leukemia
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF

This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.

The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years; \< 80 years
* Left atrium =\< 6.0 cm
* Documented persistent or longstanding persistent AF
* History of AF =\< 10 years
* Scheduled for a concomitant cardiac procedure

  * Coronary bypass surgery (CABG)
  * Mitral valve repair/replacement
  * Aortic valve replacement
  * ASD repair
  * Tricuspid valve repair/replacement
  * Myxoma
  * Any combination of the above procedures
* Provided written informed consent

Exclusion Criteria:

* Left atrial size \> 6.0 cm (pre-op TTE - parasternal 4 chamber view)
* History of AF \> 10 years
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* History of coagulopathy
* Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA)
* Patients who have active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance
* Patients who are being treated for ventricular arrhythmias
* Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)
* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.
* Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
Evaluating Commercial Anti-Plaque Products and Oral Rinse

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

This clinical research study was to train new examiners for short term plaque clinical methodologies.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers at least 18 years of age.
* Good general health.
* Must sign informed consent form.
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures.
* Moderate or advanced periodontal disease or heavy dental tartar (calculus).
* Two or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that are currently affect salivary function.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Allergy to chlorhexidine.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products.
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for pre-medication for dental treatment or for any other purpose.
* Presence of an orthodontic appliance that interferes with plaque scoring.
* History of allergy to common dentifrice ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)

This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool for the evaluation of both new and existing pharmacological treatments for type 2 diabetes, using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour weighted-mean glucose (WMG) relative to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of \> 7%.
* If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening Visit/Visit 1 Hemoglobin A1C of \>= 6.5% and =\< 7.5%, should then discontinue sulfonylurea usage and undergo washout of sulfonylurea.

Exclusion Criteria:

* History of either stroke, chronic seizures or major neurological disorder within the last 6 months.
* Untreated hypertension with a blood pressure of \> 160/95 mmHg.
* History of neoplastic disease within the past 5 years.
* History of hypersensitivity to vildagliptin or other DPP4 inhibitors.
* Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in another investigational study within 4 weeks prior to screen.
* Used any illicit drug or abusively used alcohol within the past 3 months.
GSK BHR Study (Sont)

The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects with persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosis
* Controller medications or moderate inhaled corticosteroid dose
* Evidence of reversibility

Exclusion Criteria:

* Life-threatening asthma
* Asthma instability
* Concurrent respiratory disease
* Drug allergy
* Respiratory tract infection
* Systemic corticosteroid use
* Immunosuppressive medication use
* Positive pregnancy test
* Tobacco use
* Site affiliation
Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery

Primary objectives of the study are to investigate whether adjuvant treatment in the form of Tranexamic acid (Cyklokapron) and Tocilizumab (RoAcmera) to surgery in patients with chronic subdural hematomaina can:

1. effectively decrease the rate of lesion recurrence requiring re-operation,
2. effectively shorten the time of lesion resolution.

Secondary objectives of the study are:1) assess the postoperative functional outcome and quality of life of participants, 2) assess the postoperative mortality of participants, 3) assess the treatment safety data, 4) assess the cure rate of participants.

Primary endpoints in the study are: 1) determine postoperative recurrence requiring reoperation using clinical examination and CT imaging, 2) determine the time period necessary to complete healing using clinical examination and CT imaging.

Secondary endpoints in the study are: 1) to determine the functional outcome and quality of life of the participants using questionnaires, 2) to determine the mortality of the participants related to chronic subdural hematoma, 3) to determine the treatments complications and adverse events of the participants, 4) to determine the curation using clinical examination and CT imaging.

Eligibility Criteria:
Inclusion Criteria:

* patients with informed consent, without presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.

Exclusion Criteria:

* patients or relatives who refused to consent, presenting of any known contraindication for the use of Tranexamic acid and Tocilizumab.
Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)

The study compares the efficacy of an aggressive versus a moderate initial antihypertensive regimen to reduce blood pressure in patients with Stage 2 hypertension. Additionally, the study examines the effects of blood pressure reduction on the levels of high sensitivity hsCRP. Although the main goal is to determine the overall effect of blood pressure reduction on hsCRP levels, analysis will also evaluate whether an aggressive antihypertensive regimen is more effective than a moderate one in reducing hsCRP levels.


Eligibility Criteria:
Inclusion Criteria:

1. Stage 2 hypertension as defined by the mean of three (3) repeated seated BP measurements of: SBP of 160 to 185 mmHg, inclusive and/or DBP of 100 to 109 mmHg, inclusive.
2. Patients must have documentation of serum creatinine equal or \<2.0 mg/dL, serum potassium equal or \>3.5 and equal or \<5.5 mmol/L, and serum AST or ALT \<2xULN obtained within 3 months prior to Visit 1.
3. Patients must have documentation of HbA1C equal or \<11.0 % obtained within 1 month prior to Visit 1.

Exclusion Criteria:

1. History of secondary hypertension.
2. Pharmacologic antihypertensive therapy with ACE inhibitors, angiotensin receptor blockers, or aldosterone blockers within 3 months prior to Visit 1, or with thiazide diuretics within 1 month prior to Visit 1. The use of other classes of agents which lower BP but are being used for other therapy or for HTN, are allowed as long as these agents are started at least 3 months prior to randomization, are not initiated after enrollment and doses remain unchanged during the study.

Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients

ECMO(Extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure patients. There are two types of ECMO, which is veno-veno (V-V) that can be used in respiratory failure patients and veno-arterial (V-A) that can be used in cardiac failure patients. V-A ECMO can also be used during lung transplantation, substitution of cardiopulmonary bypass, which can show sufficient performance during operation and better postoperative outcome. However, regarding V-A ECMO circulating from femoral vein to femoral artery, there is a pro blem of differential hypoxia which might influence coronary artery and head vessels. In this prospective study, the investigators are planning to put another ECMO catheter into internal jugular vein which takes a role of left to right shunt, to mitigate the hypoxia of coronary artery.


Eligibility Criteria:
Inclusion Criteria:

1. scheduled for double lung transplantation

Exclusion Criteria:

1. patients who have history of coronary artery occlusive disease
2. patients with arrhythmia
DDI Study of Orelabrutinib

This is a phase I, single-center, open-label, fixed-sequence clinical study. The primary objective was to evaluate the effects of multiple administrations of rifampin or itraconazole on the pharmacokinetic characteristics of a single administration of orelabrutinib tablets in healthy Chinese subjects. The secondary objective was to evaluate the safety and tolerability of rifampicin or itraconazole combined with orelabrutinib tablets in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject who can fully understand the objectives, nature, methods and possible adverse reactions of the trial, and volunteers to be the subject, and has signed an informed consent form before the start of any study procedure, and guarantees that any procedure will be participated in by himself/herself;
2. Male or female subjects aged between 18 and 45 years old (inclusive) at the time of screening;
3. Body weight ≥50 kg for male subjects, ≥45 kg for female subjects, and a body mass index (BMI) of 19 to 26.0 kg/m2 (inclusive);
4. Be able to communicate well with investigator, and understand and comply with the requirements of this study.

Exclusion Criteria:

1. Complete physical examination, routine laboratory tests, cardiac color ultrasound and other examinations are abnormal with clinical significance;
2. Hepatitis B surface antigen or E antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or syphilis antibody are positive;
3. C-reactive protein for novel coronavirus screening is abnormal with clinical significance, or the novel coronavirus nucleic acid testing is positive;
4. Have received any drugs and therapy which are in the study protocol within 1 month before screening
5. Have taken prescription drugs, over-the-counter drugs, dietary supplements, or Chinese herbal medicine within 14 days before the first administration of the investigational drug
6. Have any history of clinically serious diseases, or diseases or conditions that the investigator believes may affect the results of the study.
7. Subject who has a childbirth plan during the study period and within 3 months after the end of the study, or the subject and his/her partner do not agree to take strict contraceptive measures during this period;
8. Other subjects judged by the investigator as unsuitable to participate in this study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

This work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.

Sinus surgery is one of the most prevalent surgeries on the ear, nose, and throat (ENT). It is mainly carried out through endoscopy and significantly improves the clinical symptoms of patients with rhinosinusitis. Safe conditions must be maintained for this surgery, and the major problem reported during functional endoscopic sinus surgery (FESS) under general anesthesia (GA) is impaired visibility due to excessive bleeding.

Dexmedetomidine is an α2-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, analgesic-sparing effects and minimal depression of respiratory function. It is potent and highly selective for α2-receptors.

Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life and a favorable safety profile and is,, therefore,, the LA of choice for continuous IV administration.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years old.
* American Society of Anesthesiologists (ASA) physical status I - II.
* Scheduled for elective functional endoscopic sinus surgery.

Exclusion Criteria:

* Diabetes mellitus.
* Coagulation disorders.
* Kidney and liver dysfunction.
* Cerebrovascular disease.
* Cardiovascular problems.
* High blood pressure.
* Asthma.
* Chronic obstructive pulmonary disease (COPD).
* End organ damage.
* Psychosis.
* Taking antipsychotic drugs.
* Allergy to study drugs.
* Substance abuse.
* Taking beta blockers.
* Heart rate of \< 55 beat/minute.