cyrilzakka/clinical-trials huggingface dataset:
Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS.

A Cross-Sectional Study aims to shed light on potential genetic determinants influencing dental caries susceptibility within this demographic and significantly understanding of genetic factors associated with dental caries, particularly within the context of the Egyptian population, providing valuable insights into the genetic aspects of oral health. The research methodology involved a comprehensive examination of these polymorphic loci ENAM, AMBN, TUFT1 and KLK4 and their prevalence, employing rigorous statistical analyses to establish potential correlations between these genetic variants and susceptibility to dental caries.

The research investigates the distributional discrepancies of specific polymorphic loci ENAM rs3796703, AMBN rs4694075, TUFT1 rs13236243, and KLK4 rs2242670-within the Egyptian population as correlatives and causatives of dental caries susceptibility through the genotyping of enamelin (ENAM rs3796703), ameloblastin (AMBN rs4694075), tuftelin 1 (TUFT1 rs78802584), and kallikrein 4 (KLK4 rs2242670) in 132 adults (males = 74, females = 58) and 72 controls (males = 40, females = 32) referred from various Egyptian hospitals. For each participant, the number of decayed, missing, and filled teeth was charted, and the presence of biofilm/gingivitis/fluorosis was assessed. Bitewing radiographs were taken to detect interproximal caries. In addition, statistical analysis was conducted using Chi-square test, odds ratios, and corresponding P-values.

Eligibility Criteria:
Inclusion Criteria:

* Presence of dental caries or decay in form of discoloration, cavities, or visible enamel softening suggestive of potential caries (Caries-susceptible group)
* Caries-free patients as control group (Caries-resistant group)

Exclusion Criteria:

* The presence of white spots or fluorosis, indicating enamel defects or demineralization, required exclusion from the study.
Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients

Acne rosacea is a chronic acneiform disorder affecting both the skin and the eye. It is a syndrome of undetermined etiology characterized by both vascular and papulopustular components involving the face and occasionally the neck and upper trunk.

This is a pilot phase II study to evaluate the tolerability and safety and to monitor the clinical efficacy of Topical Minocycline Foam FXFM244 in moderate to severe Rosacea patients.

A Pilot, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study. The study will involve three treatment groups. Eligible patients will be randomized to receive either FXFM244 - 1%, FXFM244 - 4% or Placebo, in a blinded fashion. Patients will be treated twice daily for 12 weeks. Following the screening period and baseline visit, study subjects will return at Weeks 3, 6, 9 and 12. A follow up visit will take place at week 16. At each visit, patients will be evaluated via lesion count, global assessment tolerability and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical diagnosis of moderate to severe facial rosacea as determined by:

   * At least 8 but no more than 50 total papules and/or pustules (inflammatory lesions)
   * Presence of moderate to severe erythema
   * Presence of telangiectasia.
   * An Overall Rosacea Severity score ≥2.5
2. Patient is male or female over 18 years of age.
3. No known medical conditions that, in the Investigator's opinion could interfere with study participation
4. Patient is willing and able to comply with all requirement of the protocol
5. Patient is willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

1. Presence of skin diseases at or near the investigational area
2. Immunosuppressed state or other serious systemic disease
3. Signs and/or symptoms of systemic infection
4. Concomitant medication:

   * Use of oral and/or topical antibiotic treatment within 14 days prior to study entry.
   * Use of any topical anti-rosacea agent except antibiotics within 14 days prior to study entry.
   * Use of cyproterone acetate, CPA-containing contraceptives (e.g. Diane) or other corticosteroids (during the last 3 months);
   * Use of retinoids (during the last 4 weeks)
5. Use of artificial sun bath or having a sun holiday during the last 2 weeks
6. Alcohol or drug abuse, according to assessment by the investigator
7. Known or suspected hypersensitivity to Minocycline or any of the excipients in the Study Medication
8. Use of another investigational drug within 30 days prior to entry into this study
9. Pregnant or lactating women.
Study of RAS(ON) Inhibitor Combinations in Patients With Advanced RAS-mutated NSCLC

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with each other.

The first three subprotocols include the following:

Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC

The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on NSCLC.

This is an open-label platform Phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC), and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with KRAS or RAS mutations will be specified in each subprotocol.

Subprotocol A is an open-label, multicenter, Phase 1b/2 study of RMC-6291, with or without RMC-6236, in combination with pembrolizumab, with or without chemotherapy, in patients with KRAS G12C-mutated advanced solid tumors.

Subprotocol B is an open-label, multicenter, Phase1b/2 study of RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with RAS-mutated non-small cell lung cancer (NSCLC)

Subprotocol C is an open-label, multicenter, Phase1b/2 study of RMC-9805 with or without RMC-6236, in combination with other anticancer agents, in patients with RAS G12D-mutated non-small cell lung cancer (NSCLC)

Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.

Eligibility Criteria:
Inclusion criteria:

All Patients (unless otherwise noted):

* ≥ 18 years of age
* ECOG PS is 0 to 1
* Adequate organ function as outlined by the study
* Received prior standard therapy appropriate for tumor type and stage
* Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)
* Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)
* Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C)

Exclusion criteria:

All Patients:

* Primary central nervous system (CNS) tumors
* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
* Major surgery \< 28 days of first dose
* Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids

Other inclusion/exclusion criteria may apply.
Evaluation of PSMA-based PET as an Imaging Biomarker in Prostate Cancer

This research is being done to see if an investigational radioactive imaging agent (radiotracer) called 18F-DCFPyL can help us find prostate cancer at its original site in the prostate gland and in distant sites (bone, lymph nodes) in men diagnosed with prostate cancer before surgery.

The investigators propose to evaluate the feasibility of using a novel small molecule PET radiotracer, DCFPyL to target prostate cancer prostate-specific membrane antigen (PSMA). PSMA is a well studied cell surface marker of prostate cancer with increased expression associated with higher tumor grade and advanced metastatic tumors. More specifically it is associated with a higher Gleason score and there is evidence it can serve as a potential marker for prostate tumor carcinogenesis, progression and as a AR signaling surrogate marker of ADT response. This small molecule PET radiotracer specifically targeting an important prostate specific marker of AR signaling dynamics following ADT, tumor progression and metastatic potential warrants validation as an in-vivo non-invasive imaging biomarker for PSMA expression and prostate cancer detection.

Eligibility Criteria:
Inclusion Criteria:

* Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.
* Key inclusion criteria (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)

  * Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  * Prostate biopsy histology grade ≥ Gleason 8-10
  * Patients considered as candidates for and medically fit to undergo radiation and ADT
  * At least 10 days after most recent prostate biopsy

Exclusion Criteria:

* Prior pelvic external beam radiation therapy or brachytherapy
* Chemotherapy for prostate cancer
* Hormone deprivation therapy
* Investigational therapy for prostate cancer
* Hemorrhagic cystitis or active prostatitis
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk

The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C ≥100 mg/dL
* High cardiovascular risk (diagnosis of HeFH and/or ASCVD)
* Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated statin either alone or in combination with other LMTs

Exclusion Criteria:

* Total fasting triglyceride ≥500 mg/dL
* Renal dysfunction or nephrotic syndrome or history of nephritis
* Body Mass Index (BMI) ≥50kg/m2
* Significant cardiovascular disease or cardiovascular event in the past 3 months
Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately, volitional maneuvers depend of patient effort. The aim of this research is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3 inspiratory pression levels (0, -1 cm H2O and -5 cm H2O).


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and more men or women
* neuromuscular diseases
* Pimax and Snip evaluation Indication

Exclusion Criteria:

* pregnant women
* Usual contre-indications for nuclear magnetic resonance
Comparative Effectiveness of School-based Caries Prevention

Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New York City.

Dental caries is the most prevalent childhood disease in the world and can lead to infection, pain, reduced quality of life, and negative educational outcomes. Multiple prevention agents are available to arrest and prevent dental caries, however little is known of the comparative effectiveness of combined treatments in pragmatic settings. The aim of the presented study is to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries.

This is a longitudinal, pragmatic, cluster randomized, single-blind, non-inferiority trial to be conducted in low-income minority children enrolled in public elementary schools in New York City, New York, United States, from 2018-2023. The primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. Secondary objectives are to assess oral health-related quality of life and educational outcomes. Caries arrest will be evaluated after two years, and caries prevention and secondary outcomes will be assessed at the completion of the study. Data analysis will follow intent to treat, and statistical analyses will be conducted using a two-sided significance level of 0.05.

Notably, the standard of care for dental caries is office-based surgery, which presents multiple barriers to care including cost, fear, and geographic isolation. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the arrest and prevention of dental caries in high-risk children.

Eligibility Criteria:
Inclusion Criteria:

* Any primary school in New York City with a Hispanic/Latino student population greater than 50% and,
* A low-income population (defined as a student receiving free or reduced price lunch) of at least 80%.
* Within participating schools, all children are eligible to participate in the study.

Exclusion Criteria:

* Schools that already have a pre-existing school-based dental health program.
* Within participating schools, exclusion criteria for children include those without informed consent or those with consent but without assent.
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic progenitor cell count. In addition, the yield of stem cell collection between two arms will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* age: above 17 years, below 65 years old
* informed consent
* ECOG 0-1
* autologous stem cell transplant candidate among patients with multiple myeloma

Exclusion Criteria:

* prior history of hematopoetic stem cell transplantation
* history of failure to mobilize hematopoietic stem cells
* history of G-CSF administration within 2 weeks before enrollment to this study
Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis

The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient patients and low gradient patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected severe AS scheduled for evaluation for aortic valve intervention:
* LVEF \> 50 %
* AVA \< 1.0 cm2
* Symptomatic - at least equivalent to NYHA functional class II

Exclusion Criteria:

* Congenital heart disease
* Severe coronary artery disease (main stem, proximal LAD or 3 vessel disease)
* Moderate or severe aortic valve regurgitation
* Moderate or severe mitral valve regurgitation or stenosis
* Moderate or severe pulmonary valve regurgitation or stenosis
* Moderate or severe tricuspid valve regurgitation or stenosis
* Severe pulmonary hypertension (tricuspid valve pressure gradient of 60 mmHg)
* Right ventricular dysfunction (TAPSE \< 17 mm)
* Restrictive cardiomyopathy or cardiac amyloidosis
* Constrictive pericarditis
* Inability to perform supine bicycle exercise
Effect of Fluvastatin on Brown Fat Activity

The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue activity in humans.

Statins, inhibitors of cholesterol biosynthesis, act by inhibiting the enzyme of the mevalonate pathway. Although the clinical benefits of statins are undisputable, they have been shown to increase insulin resistance and incidence of type 2 diabetes mellitus, the mechanism of which is currently not clear.

The main function of brown adipose tissue (BAT) is non-shivering thermogenesis (i.e. heat production through energy dissipation) in brown adipocytes. There has been a growing interest in BAT as a novel therapeutic approach to increase energy expenditure in order to facilitate weight-loss and increase insulin sensitivity.

BAT activity will be assessed using calorimetric test and \[18F\]-Fluorodeoxyglucose (FDG) positron emission tomography (PET).

We speculate that statins inhibit BAT function and that this mechanism may contribute to the above mentioned increase in insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Male volunteers (18-40 y)
* body mass index 19 to 27 kg/m²
* Fluent in German or English

Exclusion Criteria:

* Regular physical exercise of more than \>150 min of exercise per week.
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Clinically indicated intake of the following medications: Corticosteroids, CYP3A4-Inhibitors (Itraconazol, Voriconazol, Fluconazol, Clarithromycin, Erythromycin, Indinavir, Nelfinavir, Ritonavir, Grapefruit juice), Beta-Blocker, Neuroleptics, Tricyclic Antidepressants,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Participation in another study involving ionizing radiation in the same year,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* MRI contraindications: Not MRI-compatible metal in the body, cardiac pacemaker, History of surgery with possible metal clips/parts still in the body, claustrophobia.
* Resting pulse rate \> 70 bpm
* Known arterial hypertension or resting blood pressure \> 130/80 mmHg.
* frequence corrected QT-time (QTc) \>430 ms
* Serum creatinine \> 1.5x upper limit of norm (ULN), i.e.\> 145 µmol/L
* creatine kinase \> 1.5x ULN, i.e. \> 300 U/L
* aspartate transaminase (ASAT) \> 1.5x ULN, i.e. \> 51 U/L
* alanine aminotransferase (ALAT) \> 1.5x ULN, i.e. \> 88 U/L
* Hypothyroidism
* Vitamin D deficiency, Vitamin D3 \< 25 nmol/L
* Intake of anticoagulants or inhibitors of platelet aggregation (e.g. Aspirin, clopidogrel).
* Known tendency to form keloids (hypertrophic scar tissue)
Tight Glycemic Control in Critical Care Patients

The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.

Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.

Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.

Eligibility Criteria:
Inclusion Criteria:

* 15 years of age or older,
* Probability of staying in critical care for more than 48 hours,
* Agreement with the informed consent.

Exclusion Criteria:

* Pregnancy,
* Participating in other trials,
* Diabetic keto-acidosis or diabetic hyperosmolar state,
* Moribund
* Do-not-resuscitate orders,
* Reentry to the critical care unit of the same patient.
A Study in Adult and Pediatric Patients With Cystic Fibrosis

The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis


Eligibility Criteria:
Inclusion Criteria:

* FEV1 40-70% (adults)
* FEV1 \>/=50% (pediatrics)
* oxygen saturation \>90%
* clinically stable
* willing to stay overnight

Exclusion Criteria:

* abnormal renal or liver function
* receiving corticosteroids exceeding 10mg/day or 20 mg every other day
* received intravenous or aerosolized antibiotics 1 week prior to dosing
Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond

The main objective of this project is examining whether there is a relationship between preterm delivery and parental' problematic emotional bond in the early postpartum period.

The secondary outcomes are as follows:

* To evaluate whether there are any differences and similarities between fathers' and mothers' level of parental bonding, stress, anxiety, and depression symptoms in case of premature birth.
* To evaluate whether there is a relationship between preterm delivery and the persistence of maternal' problematic emotional bond three months after childbirth.
* To indicate what kind of predictors might affect the parental' problematic bond in the early postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children born below the 37th week of pregnancy (clinical group) or above the 37th week of pregnancy (control group) hospitalised in a neonatal setting during recruitment period
* Which agreed participating to the study after having complete information about it and sign a consent.

Exclusion Criteria:

* Parents may not participate in the study if one of them suffers from a serious mental illness.
Effects of Intermittent Fasting on Polycystic Ovary Syndrome (PCOS) Compared to Standard Treatment

The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.

After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle.

Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose.

Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction.

After data collection, statistical analyses was done to determine the effect of the different approaches.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20 - 35 years
* Mild to moderate exercise at least 4 times per week
* Body Mass Index (BMI) of 20-24.9
* Diagnosis of PCOS by Rotterdam criteria
* Type of oral contraceptives: combined (estrogens and progestins) in group 1 and 2.
* PCOS Phenotype A, B, C
* nulliparity
* Signed informed consent letter

Exclusion Criteria:

* Menopause or perimenopause
* Night work shifts
* Phenotype D (without hyperandrogenism)
* Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic syndrome, neoplasms, autoimmune diseases.
* Intake of medications on a regular basis, not including oral contraceptives for group 1 and 2.