cyrilzakka/clinical-trials huggingface dataset:
Effect of a Fibrate and a Statin on Endothelial Dysfunction

The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome.

The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome. The study is a double blind, placebo controlled, crossover study with the order of treatment randomized. Patients will receive each treatment for 8 weeks with a 1 week rest period between treatment periods. Endothelial function will be tested using non-invasive techniques before and after each treatments. A total of 40 subjects with diabetes or the metabolic syndrome will be enrolled at Boston Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 30 years
* Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent) or metabolic syndrome (defined as at least 3 of the following: 1. HDL less than 40 mg/dl for men or less than 50 mg/dl for women; 2. triglycerides greater than 150 mg/dl; 3. waist circumference greater than 40 inches for men and greater than 35 inches for women; 4. fasting glucose greater than 100 mg/dl).
* LDL cholesterol level less than 140 mg/dl
* Able to provide informed consent and complete study procedures

Exclusion Criteria:

* Change in therapy for glucose control or blood pressure less than 1 month before entry
* Hemoglobin A1C greater than 8.0%.
* Renal insufficiency (serum creatinine greater than 1.6 mg/dl in men or 1.5 mg/dl in women.
* Any investigational drug less than 1 month before entry.
* Pregnancy (excluded by urine pregnancy test at study entry with ongoing use of reliable form of birth control) or lactation
* Liver function tests or serum creatinine kinase (CK) greater than 3 times upper limit of normal.
* Clinically evident major illnesses or other problem that would make participation inappropriate
* Clinical history of symptomatic cholelithiasis
* Patients with coronary artery disease, peripheral arterial disease, or cerebral vascular disease will not be enrolled if they are currently taking lipid-lowering therapy
* Patients taking more than 40 mg/day of atorvastatin will be excluded. There is no "ceiling" level for patients taking fibrates.
Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration

This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new device for use in allergen challenge testing.

This will be a multi-center, randomized, cross-over study utilizing the expertise of three Canadian academic centers (University of Saskatchewan, McMaster University, Laval University) that have been performing allergen inhalation challenges and other bronchoprovocation studies for more than forty years.

Each participant will be required to attend the research lab on five occasions (Visits 1-5). At Visit 1, study staff will provide an overview of the study purpose and procedure and answer any questions the participant may have. The individual will then provide consent if they wish to participate (i.e. sign the consent form). Skin prick testing to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test endpoint (STE) and allergen inhalation challenge will then be performed. The participant will be randomized with respect to which nebulizer (Solo® or Wright) will be used first. The choice of nebulizer for the first participant will be via blinded draw. Subsequent nebulizer assignments will alternate. Participants will undergo the STE procedure and methacholine challenge testing (MCT) at visit 2; an allergen challenge will be done the next day at Visit 3 using the same nebulizer as was used for the MCT at Visit 2. Visits 4 and 5 will also be performed on consecutive days and will involve methacholine and allergen challenge testing, respectively, using the nebulizer that was not used at Visits 2 and 3. A minimum of two weeks must separate Visits 3 and 4.

Eligibility Criteria:
Inclusion Criteria:

* baseline FEV1 greater than or equal to 70%
* positive response to inhaled methacholine (i.e. PD20 less than 400mcg)
* evidence of atopy (i.e. positive skin prick test to an allergen that can be used for the inhalation challenge
* absence of respiratory infection for at least 4 weeks
* absence of allergen exposure (or other trigger of upper or lower respiratory symptoms) for at least 4 weeks
* current nonsmoker (ex-smoker allowed; case by case basis; investigator discretion)
* require only infrequent short-acting beta2 agonist (i.e. salbutamol or terbutaline) to treat/control asthma (i.e. no inhaled corticosteroid or combination therapies, no intranasal corticosteroid; anti-histamines etc.)
* general good health with no other medical condition, medication use or lifestyle activities that would influence the outcome of the allergen challenge

Exclusion Criteria:

* pregnant or lactating
Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder

To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design


Eligibility Criteria:
Inclusion Criteria:

* Female and 21 years or older
* Overactive bladder symptoms (subject-reported) for at least 3 months
* Be resident in the United States of America and have access and be able to use a computer with internet access throughout the duration of the study

Exclusion Criteria:

* Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.
* History of cystitis, continence, urogenitalcancer or radiation
* Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.
Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea

Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). It is not well established yet in the literature, which patients with mild to moderate OSA will present a good response to treatment with oral appliances.

Objective: To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea.

Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index \< 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration, after two months of treatment with oral appliance). Subjective (sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial characteristic). Good response to treatment with the AIO will be considered as a 50% reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged between 25 and 65 years old
* Epworth sleepiness Scale \> 9
* Apnea-hypopnea index between 5 and 30

Exclusion Criteria:

* Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
* Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
* Loss of posterior dental support to undermine the retention of oral appliance
* Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
* Protrusive displacement lass then five millimeters
* Limited mouth opening
* Alcoholism
* Use of sleep-inducing medications
* Habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle
* Intolerance to CPAP
* Obesity grade II (moderate) or III (severe)
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels

The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.

Eligibility Criteria:
Inclusion Criteria:

* Males and females (age 18-75 years).
* Non-pregnant, non-lactating females
* Women of child bearing potential should use sustained contraceptive preparations or an approved mechanical contraceptive method.
* Eligible and able to participate and have given informed consent
* Must have been following a restrictive diet and does not eat or drink grapefruit
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia
* Available for every clinic visit, which will occur in the morning.

Exclusion Criteria:

* Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia
* Conditions which may cause secondary dyslipidemia.
* Condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
* History of pancreatic injury or pancreatitis, or impaired pancreatic function/injury
* Liver injury
* Impaired renal function
* Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
* Serum creatine kinase (CK) \>5 x upper limit of the reference range (ULRR).
* Uncontrolled hypothyroidism
* Severe acute illness or severe trauma in the last 3 months
* Major surgery, 3 months prior to Visit 1
* Significant cardiovascular disease (CVD) prior to randomization
* Evidence of symptomatic heart failure, gross cardiac enlargement; significant heart block or cardiac arrhythmias. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of \>100 beats per minute at rest.
* Left ventricular (LV) ejection fraction \< 0.25
* History of symptomatic cerebrovascular disease
* Conditions at the discretion of the investigator
* Known HIV infection
* Poorly controlled or uncontrolled hypertension.
* Known muscular or neuromuscular disease of any type
* Neoplastic disease
* Drug abuse or continuous consumption of more than 65 mL pure alcohol per day
* Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system
* Current or recent use of supplements known to alter lipid metabolism
* Hypersensitivity reactions to other HMG-CoA reductase inhibitors
* Concomitant medication not permitted
* Resistant to lipid-lowering medications. Known hypersensitivity or intolerance to any lipid lowering agent
* Excessive obesity
* Regular clinic attendance in the morning impractical
* Signs of mental dysfunction or other factors likely to limit ability to cooperate
Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement

Introduction:

Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites.

Aim:

Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .

Methodology:

Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated at 4 time points

Introduction:

Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites. Various techniques have been suggested to improve properties of conventional GICs such as radiant heat transfer by Light Emitting Diode (LED) or lasers, ultrasonic energy transfer also using of (CaCl2) solution.

Aim:

Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .

Methodology:

Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated immediately after restoration (T0), six months later (T1), and after 12 months (T2) using Federation Dentaire International (FDI) criteria for assessment of dental restorations.

Eligibility Criteria:
Inclusion Criteria:

1. Age group 21 - 45 years.
2. Both males and females will be included.
3. Ability to return for periodic follow-up (good general health).
4. Only co-operative patients.
5. Vital upper or lower carious posterior teeth.

Exclusion Criteria:

1. Teeth with any pathologic pulpal disease.
2. Teeth with previous restorations
3. Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
4. Patients with severe or chronic periodontitis.
5. Patients have allergy to the materials used in this trial. 6- Nonfunctioning teeth with no opposing dentition.
Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY

This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.

This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old and able to provide informed consent
* Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order

Exclusion Criteria:

* Cardiac implantable device (pacemaker or ICD)
* Contact precautions or isolation
* Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)
Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

The main objective of this study was to demonstrate the non-inferiority of intravenous paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30 minutes.

The secondary objectives of this study are:

* To compare the efficacy (non-inferiority) of intravenous paracetamol and ketoprofen at 90 minutes (vns for pain).
* To compare both arms in terms of other administered drugs (for pain).
* To observe and compare side effects between the two arms: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine.
* To determine predictors for the use of intravenous morphine when treating renal colic.
* To compare hospitalization rates between the two groups.
* To compare patient satisfaction concerning care between the two groups (vns for satisfaction)
* To observe and compare changes towards complicated renal colic (obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death)

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for a telephone interview at week 1
* Patient consulting at the Nîmes University Hospital emergency ward with suspicion of renal colic

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contraindication for a treatment used in this study
* The patient has an allergy to ketoprofen or paracetamol, a history of gastric or intestinal ulcers, bleeding disorders, history of asthma triggered by taking ketoprofen or substances with similar activity such as other NSAIDs or aspirin
* The patient has a fever or is hemodynamically unstable, oligoanuria
* The patient presents with an initial verbal numeric pain score of 10/10.
* The patient has a history of aneurysm or aortic dissection, history of renal transplantation, history of renal or hepatic insufficiency
* The patient took paracetamol or ketoprofen 4 hours before emergency treatment.
Seroprevalence of the Anti-SARS-CoV-2 Antibodies (Causing COVID-19) in Kidney Transplant Recipients in Severely Affected Region

Goal of this study is to evaluate the seroprevalence of anti-SARS-CoV-2 antibodies in patients after kidney transplantation who are one of the risk groups for the severe course of the infection and map the progression of the virus throughout this specific part of population, which is also important for possible future epidemics. We will evaluate the seroprevalence of anti-SARS-CoV-2 antibodies according to age and gender. We will compare seroprevalence in all measured antibodies types and we will also assess the development of antibodies level in positive patients.

The Czech Republic (Central Europe region) is one of the most affected countries in the World by COVID 19 pandemic. By 1st of March 2021, the SARS-COV-2 virus infection was proven in the Czech Republic in 1 247 051 thousand people, which is 11.7% of the population (11 627 per 100 000, in the USA 8743/100 000, in the UK 6300/100 000, in the Germany 2879/100 000, France 5379/100 000). The rapidly increasing number of people infected in October 2020 have led to adoption of strict countrywide epidemic measures, which are still largely ongoing. During first 2 months of 2021 was still serious spread of the virus in population with increasing numbers of infected persons.

The SARS-CoV-2 virus can be detected in the body by several ways. The presence of the virus can be directly confirmed by RT-PCR or by determination of viral antigen from a swab from the nasopharynx, throat, direct examination of sputum or aspirate from bronchoscopy, or rectum. Indirect methods of virus detection include the determination of antibodies in the blood. Antibodies can target several structures of the virus: spike protein (S), envelope, membrane or nucleocapsid (NP). The S protein is composed of S1 and S2 subunit. The S1 subunit contains receptor-binding domain (RBD) which is necessary for interaction and entering human cells. In practice, IgG, IgM and IgA antibodies against RBD and NP are usually detected.2,3 With regard of serious development of the COVID 19 epidemic situation in the Czech Republic, we decided to do this prevalence study. Our goal is to evaluate the seroprevalence of anti-SARS-CoV-2 antibodies in patients after kidney transplantation which is also important for possible future epidemics.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Recipient of a transplanted kidney
* Planned visit to the outpatient nephrology clinic of University Hospital Ostrava, Czech Republic, between 1.5. and 30.7.2021 for enrolment
* Planned blood collection and available results of blood tests from planned inspections from 18.1.2021.
* Signed consent to the use of anonymous data for scientific purposes and publications.

Exclusion Criteria:

* disagreement with participation in the study and data analysis
MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).

With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear.

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. Men more than 18 years old with clinical suspicion of prostate cancer;
2. Serum PSA ≤ 20 ng/ml within the previous 3 months;
3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
4. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
5. mpMRI PI-RADS V2.1 score ≥3；
6. Able to provide written informed consent.

Exclusion Criteria:

1. Prior prostate biopsy or prostate surgery;
2. Prior treatment for prostate cancer;
3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
4. Contraindication to prostate biopsy;
5. Men in whom artifact would reduce the quality of the MRI.