cyrilzakka/clinical-trials huggingface dataset:
Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets

Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.

Eligibility Criteria:
Inclusion Criteria:

* Patients candidates for orthodontic treatment.

Exclusion Criteria:

* Patients with O.D 11 and / or 21 absent.

  * Patients who present dentures of any kind in OD 11 and 21.
  * Patients presenting endodontic OD 11 and 21.
  * Patients presenting data gingivitis day cementing brackets.
Safety and Efficacy of Low-intensity Shockwave Therapy for Peyronie's Disease

Investigation of the effect of Low-intensity extracorporeal shockwave therapy (ESWT) for Peyronie's disease (PD) via a single blind, sham-controlled, randomized clinical trial. Investigators will not be blinded to group assignments, but penile curvature will be assessed from coded patient pictures by a blinded assessor.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old male,
* Untreated Peyronie's disease (excepted oral therapy) (wash out: at least 1 month),
* Single axis penile curvature in erection at 20 - 90 degrees at baseline,
* Dorsal or lateral penile plaque,
* Able and willing to perform ESWT self-treatment under supervision,
* Able to understand and complete patient questionnaires,
* Having sign an informed consent form prior to any study specific procedure,
* Being covered by a national health insurance

Exclusion Criteria:

* Congenital penile deformity,
* Hourglass deformity,
* Circumferential plaque,
* Septal or ventral plaque,
* Plaque that cannot be palpated during clinical examination,
* Previous intralesional injection for Peyronie's Disease,
* Severe erectile dysfunction (EHS \< 3),
* Current penile, malignancy,
* Previous penile surgery except for circumcision or condyloma removal,
* Previous pelvic radiation therapy,
* Anti-coagulant medication, except acetylsalicylic acid up to 100mg daily,
* Previous low-intensity focused shockwave therapy on penis,
* Any other condition that would prevent the patient from completing the study, as judged by the principal investigator,
* Being deprived of liberty or under guardianship.
Single and Multiple Ascending Dose Study of V158866 in Healthy Volunteers

The purpose of this study is to investigate whether V158866 is safe when given to healthy male subjects in single and multiple doses.

A first in human study:

To evaluate the safety and tolerability of single and multiple doses of V158866 in healthy male subjects To assess the pharmacokinetics (PK) of V158866 in healthy male subjects To assess the pharmacodynamics (PD) of V158866 by determining whether V158866 inhibits fatty acid amide hydrolase (FAAH ) in healthy male subjects

Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* be healthy male subjects aged 18 to 45 years inclusive
* Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive
* be able to provide a semen sample
* be willing to use an effective method of contraception (see Section 6.1) for the duration of the study and for 4 months after the last dose of study medication
* be able to comply with the requirements of the entire study
* give written informed consent

Exclusion Criteria:

Subjects must not:

* intend to father a child with their female partner or through sperm donation within 4 months after the last dose of study medication
* have had a vasectomy
* have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
* have multiple drug allergies or be allergic to any of the components of V158866 study medication or its matching placebo (see Section 7)
* have smoked more than 5 cigarettes per day in the 6 calendar months before study drug administration
* consume more than 28 units of alcohol per week, or have a significant history of alcohol abuse
* have a positive test for alcohol or drugs of abuse at screening or admission to any of the dosing sessions
* have donated blood or plasma in excess of 500 mL within 4 months before study drug administration
* have been exposed to any new investigational agent within 3 months before study drug administration
* have clinically relevant abnormal findings on vital signs
* have clinically significant abnormalities on laboratory screening tests
* have clinically relevant abnormal physical findings on examination
* have clinically relevant abnormal findings on 12-lead ECG
* have a mean QTc corrected using Bazett's correction (QTcB) at screening \>430 msec (from 3 supine ECGs, performed at least 5 minutes apart)
* be seropositive for hepatitis B, hepatitis C or HIV viruses at screening
* have any medical or social reasons for not participating in the study raised by their General Practitioner/primary care physician
* have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator
* have had treatment with any prescription medicine within one month or any over-the-counter medicines, except for paracetamol, within one week before study drug administration
Behavioral Treatment of Adolescent Substance Use

This study will continue research designed to improve treatment outcomes for adolescent substance use disorders by integrating neuroscience- and behaviorally-based treatments. In particular, this project will be the first to evaluate whether Working Memory Training can enhance cognitive function and reduce impulsive decision making to improve abstinence outcomes. In addition, an adaptive abstinence-based incentive program will be evaluated as a new method for intervening with those who do not respond to their first-line treatment.

The study will test two novel strategies to enhance outcomes. Working Memory Training (WMT), an efficacious method for strengthening specific cognitive processes, aims to improve factors (e.g., delay discounting / impulsive decision-making) that have shown a strong relation to substance use and treatment response. Second, more intensive and higher magnitude CM (ICM) will be used to motivate abstinence among teens who are not abstinent by Week 4. The investigators hypothesize that these strategies will improve outcomes by modifying a fundamental cognitive system involved in making choices to engage in risky behavior and by increasing motivation to abstain in early nonresponders. Aim 1 will pilot and refine the new procedures in a community clinic in preparation for the randomized trial. A sequential, multiple assignment randomized trial (SMART) will allow the study to determine the most effective first-line treatment and the most effective adaptive strategy (Aim 2). All teens will begin treatment with CM or CM/WMT. After 4 weeks, responders will continue in their first-line treatments, while nonresponders will be randomized to ICM or to continue with first-line treatment. Aim 3 will conduct mechanistic analyses to assess whether cognitive changes related to WMT engender increased abstinence, and whether specific tailoring variables moderate treatment effects. Aim 4 will gather formative data on implementation factors to inform future large-scale studies and dissemination efforts. Primary hypotheses are: (1) first-line treatment with WMT will improve abstinence outcomes and reduce relapse; (2) strategies with ICM for nonresponders will result in better outcomes than those without; (3) WMT will reduce delay discounting, which will predict outcome. The unique approach holds promise for reducing multiple types of risky behaviors by affecting basic mechanisms that determine impulsive decision-making.

Eligibility Criteria:
Inclusion Criteria:

Participants must be 12 to 26 years of age, must live at home with the parent who will participate, report using marijuana during the previous 30 days or provide a marijuana-positive urine test, meet criteria for cannabis abuse or dependence, and have a parent who can participate.

Exclusion Criteria: DSM criteria for dependence (likely to be adjusted for DSM-5 Use Disorder) on alcohol or other drugs other than marijuana (use of or meeting criteria for abuse of other substances will not be an exclusion criterion), active psychosis, severe medical or psychiatric illness limiting participation, or pregnant or breast-feeding.
Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)

GIOIA represents a multicenter pragmatic prospective cohort study, aimed at evaluating the effects of SGLT2 inhibitors currently marketed (dapagliflozin, canagliflozin, empagliflozin) on markers of vascular, myocardial and renal damage, in patients with type 2 diabetes not well controlled with metformin and/or basal insulin. The changes of the interest outcomes are compared with those obtained with a comparator glucose lowering class (DPP-4inhibitors) over a follow-up of two years.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes for at least 5 years
* new use of an SGLT2-I or DPP4-I as add-on to metformin or insulin according to clinical practice
* HbA1c levels ≥ 7% and ≤ 8.5%
* eGFR ≥ 60 ml/min/1.73 m2

Exclusion Criteria:

* Type 1 diabetes or secondary diabetes resulting from specific causes
* History of neurovascular ulcers
* Previous therapy with SGLT-2i or DPP4-i in the 3 months prior to the study enrollment
* History of cancer within the last 5 years
* Pregnancy or active breast-feeding
* Serum creatinine level ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
* eGFR ≤ 60 ml/min/1.73 m2
Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke

The guideline requires clinical works to screen for primary aldosteronism(PA) in young adults with family history of stroke at early onset. But the prevalence of PA in young adults with stroke onset before 45 years old had never been investigated. The study aimed to discover the prevalence as well as the clinical characteristics between patients with PA and those without PA during stroke attack. In order to fulfill this objective, investigators intended to conduct a cross-sectional study by taking screening and confirmatory tests among young adults who once admitted due to early onset of acute stroke.


Eligibility Criteria:
Inclusion Criteria:

- patients who were once admitted in the First affiliated hospital of Chongqing Medical university(CQMU), with stroke onset less than two weeks

Exclusion Criteria:

death, serious sequela with motor, comprehensive or linguistic dysfunction, patients unwilling to join in, etiology of trauma, infective or tumor disease, patients with impaired cardiac, renal or liver function during admission-
Brain Imaging in the Diabetes Prevention Program Outcomes Study

This is a cross-sectional pilot study of Alzheimer's disease (AD) brain imaging biomarkers in Diabetes Prevention Program (DPP) outcomes study (DPPOS) participants from the New York City sites (Columbia and Einstein), comparing 10 persons originally randomized to metformin and 10 persons randomized to placebo in DPP. All study procedures will be conducted at Columbia University Irving Medical Center. Eligible participants will receive a PET scans and a brain MRI, which may be conducted in one, two, or three separate visits.

Hyperinsulinemia is believed to increase the risk of Alzheimer's dementia through both cerebrovascular and A related mechanisms, and this hypothesis has prompted testing strategies related to hyperinsulinemia and diabetes in the prevention and treatment of Alzheimer's dementia.These strategies usually entail improving insulin sensitivity to lower insulin and glucose levels, such as lifestyle (diet and exercise) and metformin, which were effective strategies for preventing diabetes in the DPPOS. There are conflicting data relating metformin with increased AD risk, and this needs to be clarified in DPPOS. Several laboratory and human studies have suggested that metformin increases the risk of Alzheimer's dementia, but this is countered by other studies indicating that it is beneficial. Preliminary data in humans and animals support the beneficial effects of metformin on Alzheimer's dementia risk.

Eligibility Criteria:
Inclusion Criteria:

* Active participants in the Diabetes Prevention Program Outcomes Study (DPPOS) in New York City originally randomized to metformin or placebo
* 60 years and older

Exclusion Criteria:

* Known dementia
* Contraindications to magnetic resonance imaging (MRI)
* Contraindications to radio-contrast agents.
Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels

The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.

Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance.

The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS.

The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria.
* HOMA values between 2.5 and 3.
* Body mass index of less than 35 kg/m2.
* Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

* Women in treatment with oral antidiabetics.
* Being pregnant or intending to get pregnant.
* Be in fertility treatment.
* To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.
Surfactant Administration by Insure or Thin Catheter

This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.

To compare two approaches for surfactant administration during CPAP in preterm infants, the INSURE and the LISA technique, using premedication intubation protocols, and investigate aspects of safety, stress and pain, timely administration of the drug, response in oxygenation and pulmonary outcome.

Our study asks whether (P) among infants born \<32 weeks' gestation with RDS (I) does surfactant administration with LISA and analgesia premedication (C) versus surfactant administration according to the INSURE protocol (O) improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours of the procedure

Primary outcomes:

1. Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure.
2. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.

Safety outcomes:

1. Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration
2. Number of tries before successful intubation/placement of catheter
3. Positive pressure ventilation during the procedure - yes/no/duration (minutes)
4. Stress and pain (changes in heart rate, blood pressure and BIIP-scale)

Eligibility Criteria:
Inclusion Criteria:

* Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.

Exclusion Criteria:

* Infants requiring surfactant as part of delivery room resuscitation are not eligible.

Infants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.
The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG

Myocardial dysfunction necessitating inotropic support is a typical complication after on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support after coronary-artery-bypass-grafting. With respect to data derived from patients with sepsis shock and results from studies using phosphodiesterase-inhibitors prophylactically, the hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects (hyperlactatemia and hyperglycemia) and renal dysfunction.

Following preoperative written informed consent, patients presenting with a cardiac-index (CI) \< 2.2 l/min/m2 upon ICU-admission - despite adequate mean arterial (titrated with noradrenaline or sodium-nitroprusside) and filling pressures - will be randomized to 14 hour treatment with adrenaline or milrinone to achieve a CI \> 3.0 l/min/m2.

A group of patients not needing inotropes will be used as controls. Hemodynamics, metabolism (plasma lactate, pyruvate, glucose, acid-base status, insulin requirements) and renal function (urinary excretion of alpha-1-microglobulin, creatinine clearance, plasma cystatin-C levels) will be determined during the treatment period and up to 48 hours after surgery (follow up period).

The study is designed as a pilot study including 20 patients per group.

Eligibility Criteria:
Inclusion Criteria:

* cardiac index below 2.2 l/min/m2 upon intensive care unit admission despite optimized filling pressures and normalized mean arterial blood pressure (MAP) after elective coronary artery bypass grafting

Exclusion Criteria:

* intraoperative use of diuretics or hydroxyethylstarch
Cognitive Recovery With Cannabis Abstinence Among High School-Aged Adolescents

This study will use a randomized controlled design to test whether 30 days of cannabis abstinence, compared to 30 days of monitoring, is associated with improvements in cognitive functioning. Non-using controls will also be enrolled to determine the clinical significance of any cognitive improvements with abstinence.

This is a 5-year randomized, longitudinal trial of cannabis abstinence designed to determine (1) if performance improves with abstinence beyond that observed with continued cannabis use, and if so, (2) when during abstinence cognitive improvement occurs, and (3) whether performance in abstinent individuals "returns" to performance levels observed in non-using peers. We hypothesized that abstinent adolescent cannabis users would have more neurocognitive improvement over four weeks compared to non-abstinent cannabis users, and performance would continuously improve throughout four weeks of abstinence. We will recruit 210 adolescents with and without regular cannabis use. Eligible cannabis users will be randomized to either a contingency management intervention which will incentivize 4 weeks of cannabis abstinence (n = 70), or non-contingent monitoring with no abstinence requirement (n = 70). All participants (including non-users; n = 70) will complete cognitive assessments, toxicology testing, self-report questionnaires and semi-structured mood and substance use interviews during the 4-week study as well as one 30-day follow-up visit. Abstinence will be indexed by decreasing levels of cannabis metabolites in urine.

Eligibility Criteria:
General Inclusion Criteria for School-Aged Study Component:

* Male and female adolescents from the Boston area who are between the ages of 10 and 19 (inclusive);
* Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
* Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
* Competent and able to provide written informed consent (if age 18 or older)
* Able to communicate in English language
* Able to commit to 9 study visits in approximately 60 days
* No severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome)
* Able to safely participate in the protocol and appropriate for outpatient level of care

Cannabis-Using Group Inclusion Criteria:

* Use of cannabis at least once per week on most weeks
* Cannabis use reported within 7 days of both baseline visits
* No immediate plan to discontinue cannabis use

Non-Using Group Inclusion Criteria:

* Use of cannabis less than 5 times in lifetime
* No cannabis use in the past year
* No cannabis use before age 16

Exclusion Criteria for School-Aged Study Component

- Passive consent for initial school-wide assessment withdrawn by parent or legal guardian or written parental consent not provided prior to screening
Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients

The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study results will support the regulatory submission in China to make ranibizumab available for clinical use.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Chinese patients 50 years of age or greater.
* Patients with primary or recurrent subfoveal CNV secondary to AMD.
* Patients who have a BCVA score from 73 to 24 characters in the study eye.

Exclusion Criteria:

* Active, or history of, ocular inflammation or infection in the study eye within the last 30 days.
* Uncontrolled glaucoma in the study eye.

Other protocol-defined inclusion/exclusion criteria may apply.