cyrilzakka/clinical-trials huggingface dataset:
Clinical Comparison of Bulk-fill Restorative and Nano-fill Resin Composite

The aim of this study is to evaluate the clinical performance of a nano-fill and a bulk fill resin composite in class II restorations.

In accordance with a split-mouth design, 50 patients will be received at least one pair of restorations, restored with a nanofill resin composite (Filtek Ultimate \[FU\]) and with a bulk fill resin composite (Tetric EvoCeram Bulk Fill \[TB\]). Each restorative resin will be used with its respective adhesive system according to the manufacturers' instructions. A total of 104 class II restorations will be placed by two operators. The restorations will be blindly evaluated by two examiners at baseline and at 1-, 2-, 3-, 4-, 5-, 6-, 7- and 8- year using modified US Public Health Service Ryge criteria. The comparison of the two restorative materials for each category will be performed with the chi-square test (a=0.05). The baseline scores will be compared with those at the recall visits using the Cochran Q-test.

Eligibility Criteria:
Inclusion Criteria:

* a need for at least two but not more than four posterior tooth-colored restorations
* the presence of teeth to be restored in occlusion
* teeth that were symptomless and vital
* a normal periodontal status
* a good likelihood of recall availability.

Exclusion Criteria:

* partly erupted teeth
* absence of adjacent and antagonist teeth
* poor periodontal status
* adverse medical history
* potential behavioral problems
Chronic Kidney Disease & Therapeutic Exercise

The aim of this study is to evaluate the therapeutic exercise effects in patients with chronic kidney disease. An interventional prospective study is carried out. A sample of 9 patients with chronic kidney disease is recruited. The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic kidney disease

Exclusion Criteria:

* Cognitive impairment and non signed consent inform form.
Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1

This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.

The investigators' recent GWAS discovery of MTNR1B as a novel type 2 diabetes gene has sparked great interest into the role of melatonin in glycemic control, for which the mechanism is largely unknown. This research will determine the effect of melatonin and MTNR1B on glycemic control under highly-controlled, in-laboratory protocols while manipulating circulating melatonin concentrations (both up and down) and assessing glycemic control by frequently-sampled intravenous glucose tolerance tests, as well as in ex vivo human pancreatic islets. This research will provide mechanistic insights into the metabolic effects of melatonin and the MTNR1B risk variant and may help in evidence-based approaches and personalized recommendations to improve glycemic control in night shift workers and late-night eaters.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: 20 and 35 kg/m2
* Age: 21-55 years of age
* Caucasian
* Non-smoking
* With regular sleep-wake cycle
* Passed medical and psychological screening tests

Exclusion Criteria:

* Acute, chronic or debilitating medical conditions
* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Worked night or rotating shift work within past 1 year
* Drug or alcohol dependency
Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to terbinafine or any comparable or similar product.
Scanadu Urine Device Validation Study Protocol

This study will test Scanadu Urine Device for clinical performance and usability.

The objectives of this study are to:

* Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).
* Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
* Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels

Eligibility Criteria:
Inclusion Criteria:

* Female and male
* 18 years old or older
* Pregnant or not pregnant
* Must have experience using an Apple iPhone
* Have no visual impairments
* Able to hold Smart Phone horizontally in raised dominant hand
* Must be able to read and understand English
* Must provide Informed Consent

Exclusion Criteria:

* Has a known history of a visual impairment that may affect reading and navigating the Scanadu Urine app
* Unable to void and collect urine specimen for testing
* Unable to hold phone steady (horizontally) or has history of tremors or conditions such as Parkinson's disease
Hepatitis B Prevalence in the Turkish Population Living in Middle Limburg

This study will assess HBV (HBsAg, anti-HBc and anti-HBs) prevalence in the Turkish population living in Belgium. Additionally, the investigators will determine the risk factors for HBV infection and the uptake of screening, vaccination and antiviral treatment in this hard-to-reach Turkish population.

HBV infection is an important public health problem in the Turkish population, i.e. one of the largest migrant populations in Europe. With the introduction of cost-effective antiviral treatments in the past decade, there is a need to identify HBV infected patients who may benefit from treatment. This study will assess the HBV prevalence in the Turkish population living in Belgium. Additionally, the investigators will determine the risk factors of HBV infection and the uptake of screening, vaccination and antiviral treatment in this hard-to-reach Turkish population.

A cross-sectional, epidemiological trial will be conducted in the region Middle Limburg Belgium, where the Turkish adult population (subjects born in Turkey or subjects of which one of the parents is born in Turkey), 18 years of age and older, will be screened for HBsAg, anti-HBs and anti-HBc. Educational meetings concerning viral hepatitis B will be organized and there will be three ways to be screened for HBV: (1) immediately after the educational meetings, (2) at the Outpatient Hepatology Department of Ziekenhuis Oost-Limburg (ZOL) and (3) at home visits. Subsequently, participants will be asked to fill in a questionnaire regarding sociodemographic factors, migration history, risk factors for HBV infection (e.g. sharing toothbrushes, HBV infected family member) and HBV vaccination status. One year after data collection, HBsAg positive patients will be assessed whether they are under follow-up at the general practitioner or hepatologist. The investigators will also gather information regarding the uptake of vaccination in non-immunized subjects.

This study will provide information about the HBV prevalence and distribution of the stages of liver disease in the Turkish population in Belgium. By determining the risk factors for HBV infection, subgroups with an increased prevalence of HBV infection can be identified. This study will also give information on how to organize the healthcare system for screening in hard-to-reach migrant groups and to develop care paths.

Eligibility Criteria:
Inclusion Criteria:

* Turkish origin, defined as one of the parents born in Turkey
* Having a signed informed consent form

Exclusion Criteria:

/
Measurement of the Distances of the Lower Airway in Pediatric Population

Pediatric patients are exposed to increased risk during general anesthesia. A myriad of problems can be encountered in the pediatric population by misplaced endotracheal tubes. Especially, during one-lung ventilation (OLV) a right-sided or left-sided tube is inserted to facilitate the surgery. However, inadvertent tube use, caused by misinterpretation of the distances of the trachea and the main bronchi, may cause unintended hypoxemia, postoperative atelectasis and even mortality.

In this study, investigators will measure the distance between distal margin of right lung upper lobe orifice-carina and carina-lip with the help of fiberoptic bronchoscopy (FOB).

In ASA-PS I-II-III children between 1-18 years of age who are orotracheally intubated for any reason, the fiber optic bronchoscope will be advanced in the tube and first the carina distance and then the carina to right upper bronchus distance will be measured.

Age, weight, height, body mass index (BMI), weight percentile, height percentile, comorbidities, ASA score, tube size, lip margin distance, right upper bronchus to carina distance and right upper lobe to carina distance/ Carina to-lip margin ratio will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing general anesthesia via an endotracheal tube
* ASA I-III

Exclusion Criteria:

* Patients that do not meet age criteria
* Uncontrolled asthma or hyper reactive airway
* hypoxemia, previous thoracic surgery
* ASA \> III
* Unstable hemodynamics
* Patients with tracheal or oral malignancies
* Patients with face trauma
* Informed consent not given
* using a tube with a number too small for the fiberoptic bronchoscope to pass through
Arthroscopy and Manipulation vs a Home Therapy Program in the Treatment of Adhesive Capsulitis

The purpose of this study is to compare two treatments used for treating frozen shoulder which are arthroscopy and forceful stretching of the shoulder and home stretching therapy to see if one relives pain and improves shoulder motion more quickly. The other purpose is to try and understand what causes frozen shoulder. For this purpose, tissue will be taken from the shoulder during surgery and studied for the presence and level of a protein called cytokine (Connective Tissue Growth Factor)

Adhesive capsulitis of the shoulder is a relatively common entity which is poorly understood and produces a significant amount of morbidity in afflicted patients. The natural history of adhesive capsulitis is only just beginning to be understood. It is a self-limiting disease, but may take 18 to 36 months to resolve. During that time, individuals can suffer a significant amount of pain and miss a large amount of work. Many surgeons have treated this process with early manipulation with the outcome never being reported in a prospective manner. Some authors have advocated conservative non-operative treatment, knowing the natural history in most of these shoulders will be near resolution. The primary purpose of this study is to examine in a prospective randomized manner the results of continuous non-operative management versus arthroscopic capsulectomy. This study will determine if operative intervention with an arthroscopic capsulectomy can shorten the natural history of adhesive capsulitis, and give comparable results with non-operative management at final follow-up of 2 years.

A second purpose of the study is to try and identify the mechanism(s) responsible for adhesive capsulitis. Recent research suggests that cytokines and connective tissue growth factor (CTGF) may be involved in the inflammatory and fibrotic processes. The second purpose of this study involves histological and immunohistochemical analysis of capsular and synovial tissue routinely removed during an arthroscopic capsulectomy. Tissue taken from subjects in the surgical treatment group will be compared to tissue from patients undergoing an arthroscopic capsulectomy for reasons other than adhesive capsulitis (control group). Location and concentration of CTGF will be compared between these groups. If levels of CTGF are elevated in the treatment group as hypothesized, development and testing of agents that specifically reduce the action of CTGF may be indicated. A specific agent blocking CTGF has been developed and is nearing clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* frozen shoulder (pain and stiffness) experienced for at least four months and treatment has not helped.

Exclusion Criteria:

* None
Effort-Lung Ultra Sound

The E-LUS study is a prospective, non randomised, monocenter case-control study.

The main objective is to evaluate the association of exercise lung ultrasound data acquired during a stress test on a bicycle ergometer with the diagnosis of heart failure with preserved ejection fraction (HFpEF).

Secondary objectives:

1. To assess the diagnostic performance of exercise lung ultrasound for the diagnosis of HFpEF.
2. To identify the value of the B-lines score on exercise maximizing the sensitivity and specificity for the diagnosis of HFpEF.
3. To evaluate the relationship of the delta of B-lines scores between rest and exercise with the diagnosis of HFpEF.
4. To assess the diagnostic performance of the delta of B-lines between rest and exercise for the diagnosis of HFpEF.
5. To identify the score of the delta of B-lines value between rest and exercise maximizing sensitivity and specificity for the diagnosis of HFpEF.
6. To evaluate the relationship between the resting value of the B-lines scores with the diagnosis of HFpEF.
7. To assess the diagnostic performance of the resting lung ultrasound for the diagnosis of HFpEF.
8. To identify the value of the B-lines score at rest maximizing the sensitivity and specificity for the diagnosis of HFpEF.
9. To evaluate the correlation between the B-line score measured at rest and exercise and the dyspnoea score measured at rest, during exercise, and during the recovery phase.
10. To assess the correlation of the delta of B-lines scores between rest and exercise and the dyspnoea score measured at rest, during exercise and during the recovery phase.

Eligibility Criteria:
Inclusion Criteria (Control group) :

* Patients 65 years of age and older scheduled for a stress test.
* Never diagnosed with either preserved or altered ejection fraction heart failure
* Non-dyspneic (New York Heart Association class I)

Inclusion Criteria (Case group) :

* Patients 65 years of age and older scheduled for a stress test.
* Patients already diagnosed with HFpEF following hospitalization for heart failure (LVEF\>50%)

Exclusion Criteria:

* Patients who are opposed to participate to the research project / the use of their data,
* Pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images (e.g. pulmonary fibrosis, diffuse interstitial lung disease or lung cancer)
* Patients with a history of thoracic surgery
* Patients under legal protection measures (guardianship, curator, judicial safeguard),
* Pregnant women, parturient women or nursing mothers,
* Patients who are unable to express consent,
* Persons deprived of their liberty by a judicial or administrative decision,
* Persons subject to psychiatric care,
* Patients discharged from hospital for a worsening heart failure hospitalization for less than 15 days
Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations

The purpose of the study is to compare the bioavailability of a generic product of amlodipine with that of a reference product when administered to healthy volunteers under fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine obtained from two formulations will be used to access the interchangeability of the products

The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of two to three weeks. During each session, the subjects will be administered a single oral dose of 10mg amlodipine (one BF-Amlodipine Tablet 10mg or one Norvasc Tablet 10mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0 h), and up to 96 h post dose. The plasma concentrations of amlodipine will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Peak plasma concentration (Cmax), Time to maximum concentration (Tmax), Area under the plasma concentration versus time curve (AUC0-last, AUC0-inf) and Elimination half-life (T1/2). Analysis of Variance (ANOVA) will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax, and to assess the bioequivalence of the two products

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 18 to 27
* Accessible vein for blood sampling
* High probability for compliance and completion of the study
* No significant abnormalities in general physical examination
* Electrocardiogram (ECG) recording within normal limits
* Biochemical and haematological parameters within normal limits
* Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until two weeks of last dose administration

Exclusion Criteria:

* History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
* Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry and haematological test
* Tobacco use in any forms
* Regular consumer of alcohol
* Blood donation within 4 weeks prior to the start of the study
* Use of amlodipine within 4 weeks before the study
* Use of antihypertensive medications within 4 weeks before the study
* Volunteer in any other clinical drug study within 2 months prior to this study
* Hypersensitivity to amlodipine or other drugs in its class
* History of drug abuse in any form
* Female subjects who are breastfeeding or pregnant
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)

The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted to Vanderbilt University Medical Center (VUMC) (excluding surgery services)
* on a long acting inhaler or prescribed a long acting inhaler during admission.

Exclusion Criteria:

* Diagnosis of cystic fibrosis
* Diagnosis of graft versus host disease (GVHD)
* no medication insurance
* discharge to any post-acute care facility or inpatient hospice
* death during hospitalization
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits

This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* Voluntarily signed informed consent form
* BMI ≤ 35 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Cardiovascular diseases
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Disturbance of temperature or pain perception
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Malignant tumor
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contageous skin disease
* Elevated body temperature
* Pregnancy
* Breastfeeding
* Injured or otherwise impaired muscles
* Scars, open lesions and wounds at the treatment area
* Basedow's disease
* Previous liposuction in the treatment area in the last six months
* Abdominal wall diastasis
* Unstable weight within the last 6 months
* Previous body contouring treatments in the abdomen area in the last three months
Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol

Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features

At the peak of the COVID-19 (SARS-CoV-2) pandemic in New York City, there was a shortage of hospital resources as well as a fear among many New Yorkers of going to the hospital. Emergency Services dead on arrival calls increased by as much as eight-fold.We created the CROWN Program, a pulmonary physician guided home-care protocol to treat ambulatory COVID-19 (SARS-CoV-2) patients with moderate to high risk features. This is a retrospective review of our CROWN program's patient characteristics, results and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 (SARS-CoV-2) infection Ambulatory

Exclusion Criteria:

* Need for hospital admission
Trans Health: Evaluation of Markers of Cardio-metabolic Health and Well-being in Transgender Youth

This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

This study plans to learn more about puberty blockers and cross (testosterone and estradiol). There is not much known about how these medications affect hormone levels, heart health and overall general health in young transgender individuals.

Eligibility Criteria:
Inclusion Criteria:

* Followed in Endocrinology Clinic or Adolescent Medicine Clinic at Children's Hospital Colorado
* Between age 9 and 21 years (inclusive)
* Identifies as transgender
* Has been on pubertal blockade or cross-sex hormones for at least three months.

Exclusion Criteria:

* Known diabetes
* Presence of significant medical or psychiatric comorbidities
* Using hormones not prescribed by a physician