cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Locally Delivered Rosemary Extract Gel in Management of Periodontitis

Rosemary extract is known for its antibacterial, anti-inflammatory and anti-oxidant properties that make it a promising therapeutic aid as a local delivery drug in deep periodontal pockets in adjunct to non-surgical periodontal therapy in management of periodontitis. These properties are due to the high content of phenolic compounds such as carnosic acid, urolic acid, rosmarinic acid or chlorogenic acid. Rosemary extract was previously investigated and proved its effectiveness against periodontopathogens in-vitro. Thus, its selected for this study to be administered in a gel form to assess its efficacy in management of periodontitis.

Sixteen patients with deep periodontal pockets more than 5 mm will be randomly assigned into 2 equal groups. The test group will receive the rosemary extract gel in adjunct to non-surgical periodontal therapy, while the control group will receive placebo gel.

Clinical evaluation of the clinical parameters including probing depth, gingival index, plaque index and clinical attachment level will be recorded.

Microbiological analysis using PCR test will be performed using perio-papers.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders aged between 25-45 years.
2. Healthy adult patients as evidenced by Burket's oral medicine health history questionnaire.
3. Stage III grade B periodontitis with at least two non-adjacent sites in posterior teeth with PD ≥ 6 mm, CAL ≥ 5 mm showing BOP and ≤ 4 teeth lost due to periodontitis.
4. Patients ready to comply with oral hygiene measures.

Exclusion Criteria:

1. Smokers.
2. Pregnant or lactating females.
3. Drug abusers.
4. Patients taking antibiotics or performed any periodontal treatment in the previous 6 months.
5. Patients who have a known allergy or hypersensitivity to rosemary, its constituents, or other members of the Lamiaceae family.
6. Patients with parafunctional habits.
Optimal Administration of Allopurinol in Dialysis Patients

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. Allopurinol is a medication intended to lower uric acid and therefore prevents gout attacks. Its metabolism is mainly renal, and some evidence shows that it is also dialyzable. The hypothesis is that allopurinol would be more efficacious to lower uric acid if it was given after dialysis only. The investigators will then switch administration of allopurinol to bedtime for dialysis patients currently taking that medication.

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. A study has shown an incidence of fifteen percent of gout in the first five years spent in dialysis and it was associated with an increased mortality. Allopurinol is a medication intended to lower uric acid and therefore prevents gout attacks. Its metabolism is mainly renal, and some studies from the early 1960s demonstrated that it is also dialyzable. At the moment, we do not have strong evidence of the optimal dosage of allopurinol with modern techniques of dialysis. The hypothesis is that allopurinol would be more efficacious to lower uric acid if it was given after dialysis only. The investigators will then switch administration of allopurinol to bedtime for dialysis patients currently taking that medication. Dosage of uric acid will be performed to assess the efficacy of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who receive chronic treatments of hemodialysis at Maisonneuve-Rosemont Hospital
* Subjects who take allopurinol for at least a month

Exclusion Criteria:

* Subjects who have had an acute gout attack in the past month
* Subjects with tumor lysis syndrome
* Sujects who have a history of hypersensitivity reaction to allopurinol
* Subjects with hepatic insufficiency
* Women who are pregnant or planning to become pregnant in the next three months
Periodized Aerobic Interval Training in Metabolic Syndrome

Autonomic disfunction present in metabolic syndrome subjects is related by a greater vulnerability of the heart and risk of cardiovascular events. In this context, aerobic interval training has been highlighted by its easy applicability and benefits effects in autonomic modulation in different populations. Therefore the studies that use de aerobic interval training in this different populations didn't realize a periodization of training with preparatory periods with progressive increase of load, specific phases with less duration predominating the intensity and transition periods for recuperation. Additionally, there isn't studies that investigate the effects of aerobic interval training in autonomic modulation of individuals with metabolic syndrome. In this context, periodized aerobic interval training can arise like a new type of treatment that offering security and efficacy in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and anthropometric parameters of individuals with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome according to international diabetes federation (IDF) definition
* Aged between 40 to 60 years

Exclusion Criteria:

* Participants who are currently participating in any regular exercise programs last six months;
* Use of drugs or medication (Except for risk factors of metabolic syndrome control);
* Inflammatory or infectious process;
* Musculotendinous or osteoarticular injuries in the lower limbs and/or spine;
* Chronic pulmonary disease;
* Neurological disorders;
* Cardiovascular disease.
NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification

Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood.

Early start of antimicrobials is the cornerstone of management of critically ill patients. The appropriate time window for this early intervention may vary greatly, but it is considered to be one to 3 hours from hospital admission. However, the choice of the antimicrobials for early intervention relies on empirical selection and may several times be inappropriate due to the emergence of antimicrobial resistance. The only way to overcome this difficulty is guidance through early microbial identification and antibiotic susceptibility testing (AST). However, blood cultures are positive in almost 20% of critically ill patients and AST may delay as much as 72 hours.

This means that another type of approach is warranted which will tackle the major limitation of standard-of-care (SoC) microbiology, namely, the need to incubate whole blood into flasks enriched with growth media which necessitates subculturing once a blood flask turns positive. It is evident that rapid identification of the pathogen followed by AST using whole blood without the need of blood culture can be a major advance in the diagnostic field.

The present study is based on previous analysis of ethylenediaminetetraacetic acid (EDTA) whole blood coming from patients with known bloodstream infection. Next generation sequencing (NGS) of bacterial DNA extracted from whole blood managed to identify the correct pathogen. This study is aiming at the validation of this NGS -based assay in a broader number of patients.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or above 18 years.
* Both genders.
* Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent.
* Patients with high suspicion of infection with at least one sign of the quick SOFA score (i.e. one of mental confusion, more than 22 breaths per minute or systolic blood pressure less than 100mmHg).

Exclusion Criteria:

* Age below 18 years.
* Denial for written informed consent.
* Patients already receiving antibiotics.
* Pregnancy or lactation.
Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.

Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo. Preliminary MBI results indicate a sensitivity of \~88% for the detection of tumors \< 10 mm. The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination.

Hypothesis: MBI has a comparable sensitivity to MRI at a significantly lower cost.

Study Design: A total of 120 patients will be studied. All patients will have been scheduled for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving, or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks of the MRI examination.

Potential Outcomes: This study will provide valuable information on the sensitivity of MBI relative to MRI, and to determine if this new technique can be eventually developed as an alternative to MRI for problem solving.

Eligibility Criteria:
Inclusion Criteria:

* This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.
* Patients must not be lactating or pregnant.
* All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.
* women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).

Exclusion Criteria:

* They are unable to understand and sign the consent form
* They are pregnant or lactating
* They are physically unable to sit upright and still for 40 minutes.
* The breast MRI is for screening purposes or to determine the status of breast augmentation.
* They have undergone breast surgery within the previous year
Clinical Trial in Constitutional Thinness

The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria specific to subjects with constitutional thinness
* Women: BMI less or equal to 17.5
* Men: BMI less or equal to 18.5
* Stable weight for at least 3 months

Inclusion criteria specific to subjects with normal weight

* Men and women: BMI above or equal to 20 but not more than 25
* Stable weight for at least 3 months
* No previous family history of first or second-degree obesity

Inclusion criteria common to both groups

* Age: between 18 and 35 at the inclusion visit
* Normal blood sugar, liver function, lipid and coagulation profiles
* Signed consent form to participate in the study
* Signed consent form for genetic analysis
* Acceptance of a moderate weight gain of 2 kg (less than 10% of body weight)
* Beneficiary or member of a social security system.

Exclusion Criteria:

* Adults with a legal guardian, or subjects unable to act freely due to a decision by a legal or administrative authority,
* Pregnancy in the case of women
* Women without contraception
* Vegetarian subjects or those with lactose intolerance
* Subjects with an eating disorder (DSM IV)
* Significant alcohol consumption equivalent to more than 10 glasses of wine per week
* Severe progressive disorder (diabetes, for example)
* Subjects who undertake intensive physical activity (more than 3 sessions of physical activity per week)
* Significant tobacco consumption equivalent to more than 10 cigarettes per day
* Depression or psychiatric condition (treated with antidepressant or psychotropic medication), depression questionnaire/score
* Medical or surgical history considered by the investigator to be incompatible with this study (stomach or intestinal surgery, for example)
* Subjects receiving treatment that may interfere with the parameters measured: antihypertensives (blockers, centrally acting antihypertensives), anti-hyperlipidemic agents or corticosteroids for more than 8 days
* Inclusion in a different clinical study within the previous 12 weeks.
Remote Exercise Programs and Preventive Training in Asymptomatic Individuals

In recent years, it has been emphasized that preventive approaches are a less costly and more effective way to treat a pathology. Primary preventive approaches should become widespread, especially in problems with changeable risk factors such as spine health. Various preventive approaches and exercise training seem to be an effective way to prevent the development of back and neck pain. Again, in recent years, the pandemic process has increased the interest and need for tele-rehabilitation. As a result, scientific research results on tele-rehabilitation are needed as a necessity to adapt to the Covid-19 epidemic and the globalizing world. The aim of the thesis study planned in this context is to investigate the effectiveness of remote exercise applications on lumbar and cervical region muscle architecture and functionality in asymptomatic individuals.Another aim of this study is to investigate the remote applicability of functional level, quality of life, kinesophobia and cognitive assessment.


Eligibility Criteria:
Inclusion Criteria:

* Have not experienced back and neck pain for at least 3 months,
* Between the ages of 18-55,
* Literate,
* Individuals who are capable of understanding exercises (Montreal Cognitive Assessment Scale (MOCA) (19) total score\> 21) will be included in the study.

Exclusion Criteria:

* Having been diagnosed with cervical or lumbar region pathologies,
* Cervical radiculopathy, thoracic outlet syndrome,
* Malignant condition,
* Have systemic diseases such as neurological, psychological, cardiovascular, rheumatology and loss of function due to these diseases,
* Previous surgery history in the spine and upper extremity, including the cervical and lumbar region,
* Fracture in the spine and upper extremity, including the cervical and lumbar region, with an inflammatory history,
* Acute infection,
* Continuing another rehabilitation program,
* Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients

The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

This is a prospective cohort study to document long-term dental and other oral outcomes in patients who receive external beam and modern radiation therapy (RT) modalities with curative intent, as part of clinical care for a head and neck cancer. Five hundred and seventy-two participants were enrolled in the original study, ORARAD, which included a baseline oral examination prior to the start of radiation therapy and follow-up examinations and data collection at six-month intervals up to 2 years after the start of RT. The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the original ORARAD study
* Willing to participate and comply with all study procedures

Exclusion Criteria:

* Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study (e.g., unable to obtain consent or unable to tolerate an oral examination).
Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.

The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.

Study Phase: Phase II

Primary Objective:

To evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity.

Secondary Objectives:

* the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor.
* safety and toxicity analysis regarding the intraoperative application of the β-probe.
* the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images.
* the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens

Drug Dosage, Formulation, Administration: Intravenous administration of 1.1 MBq/Kg of 68Ga-PSMA-11.

Primary Endpoint: Primary: sensitivity and specificity in a per-region analysis.

Secondary Endpoints:

* comparison of β-probe intra-operatory measurements with ex-vivo ones.
* comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters (SUVmax and PSMA-TV).
* comparison of β-probe measurements and PSMA expression assessed by IHC (PSMA staining).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer
* High-risk prostate cancer (T\>T2c and/or PSA\>20 and/or ISUP\>3)
* Patients suitable for radical prostatectomy + pelvic lymph node dissection
* 68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery
* PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT
* Age \>18 years old
* Willing to sign informed consent

Exclusion Criteria:

* Patient unfit for surgery
* M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation
* Unable to tolerate PET scan
Prospective Comparison of Diagnostic Accuracy Between Contrast-enhanced Harmonic and Conventional EUS-guided Fine-needle Biopsy in Solid Pancreatic Lesions

Endoscopic ultrasonography (EUS)-guided fine-needle aspiration/biopsy (FNA/B) is used to collect biopsy samples from many organs throughout the digestive tract and is useful in diagnosing solid pancreatic lesions (SPLs). The reported diagnostic accuracy of EUS-FNA for SPLs is 85-89.4%, the sensitivity is 82-94.7%, and the specificity is 100%. One randomized controlled trial reported that the fanning technique of FNA was superior to the standard approach because fewer passes were required to establish the diagnosis. However, in many cases, like SPLs with the presence of fibrosis and necrosis background, four or more needle passes are still needed to obtain sufficient biopsy samples. There is a potential risk of tumor seeding associated with multiple needle punctures. Therefore, it is important to minimize the number of needle passes.

Contrast-enhanced harmonic EUS (CEH-EUS) using sonazoid (Daiichi-Sankyo, Tokyo, Japan) is useful to visualize parenchymal perfusion in the pancreas and characterize of SPLs. Because the necrotic or fibrotic area within the SPLs were appeared as non-enhanced area, CEH-EUS could help us to avoid puncture the non-enhancing area hence increased the diagnostic accuracy. Katana et al. reported that conventional EUS-FNA has lower sensitivity (72.9%) for pancreatic adenocarcinoma with non-enhanced areas compared to with enhanced areas (94.3%) on CEH-EUS. Therefore, it would be difficult to obtain sufficient biopsy samples through unenhanced areas of SPLs.

According to the study result by Katana et al., fanning technique in SPLs with avascular areas had a negative impact on diagnostic accuracy of FNA. Because of the retrospective basis of their study, a prospective study is warranted to answer whether CEH-EUS-guided FNA/B is superior to conventional EUS-guided FNA/B with fanning technique in SPLs. The main objective of this randomized trial therefore was to determine whether CEH-EUS-guided sampling to avoid non-enhanced areas within a mass lesion result in more rapid diagnosis requiring fewer FNA/B passes than the conventional EUS-guided FNA/B with fanning needle throughout the mass is targeted.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 20years
* Referred for EUS-guided tissue acquisition for solid pancreatic lesions
* The size of the lesion greater than 1cm in the largest diameter

Exclusion Criteria:

* Patients with coagulopathy or altered anatomy
* Contraindications for conscious sedation
* Pregnancy
* Patients cannot provide informed consent
Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms

The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.


Eligibility Criteria:
* Postmenopausal women, aged 40 to 65 years.
* Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening.
* A history or active presence of clinically relevant important medical disease.
Postoperative Cognitive Function and EEG

In the elderly patients undergoing elective non-cardiac major surgery, the differences of EEG parameters between those with and without postoperative cognitive dysfunction were observed to determine the characteristic changes of EEG parameters related to postoperative cognitive dysfunction


Eligibility Criteria:
Inclusion Criteria:

1. aged 65 and above
2. non-cardiac surgery under general anesthesia;
3. American Society of Anesthesiology(ASA) classification I- II
4. Patients aged 18-40 years old are set as background

Exclusion Criteria:

1. patients with central nervous system diseases and mental diseases
2. preoperative minimal mental status examination(MMSE) score\<24;
3. ASA status III or higher

3) those who have received less than 5 years of education since entering primary school; 4) history of sedatives or antidepressants use; 5) existed or anticipated alcohol or drug abuse(over 40°c and over 100ml per day for the past 3 months); 6) history of surgery within the previous year; 7) those with severe visual or hearing impairment; 8) those participated in other clinical studies within last 3 months;
Machine Learning Predictive Model for Rotator Cuff Repair Failure

There is little overall evidence behind clinical practice guidelines for diagnosis and treatment of rotator cuff repair. The purpose of this study was to compare the performance of different machine learning models that use pre-operative data from an international and multicentric database to predict if a patient that underwent rotator cuff repair could achieve the minimal important change (MIC) for single assessment numeric evaluation (SANE) at one year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Primarily treated for rotator cuff tears by partial or complete surgical repair with a planned arthroscopic procedure
* Reparable tears
* No language barrier hindering questionnaire completion or legal incompetence were not included

Exclusion Criteria:

* missing pre- or post-operative single-assessment numeric evaluation (SANE)